Anzup - A little below the belt. Issue 4

A little below the belt Conducting clinical trial research to improve the treatment of bladder, kidney, testicular & prostate cancer

an anzup cancer trials group publication

issue 4, December 2015

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Welcome Welcome to the third issue of the ANZUP Cancer Trials Group consumer magazine A Little Below the Belt. In this issue, exceptional patients share their experience as we explore opportunities available for regional and remote patients to participate in a clinical trial. At the same time we examine some of the unique issues those patients face compared with their city counterparts.

We also meet Dr Craig Underhill, a medical oncologist from AlburyWodonga. Craig is a champion of rural and remote patients, driving their agenda and special needs at a local, state and national level.

We continue to follow the journey taken by our patients and their families as they navigate the health system after a cancer diagnosis.

We also look at a new ANZUP trial that has just received first round funding: The Pain Free TRUS B trial, created by Dr Jeremy Grummet, aims to reduce the pain and anxiety felt by men undergoing a prostate biopsy. Jeremy also outlines his own journey in taking an emerging idea through to a fully developed concept, as well as the challenges he faced when his initial request for funding was declined.

Colin O’Brien is a prostate cancer survivor and a member of the ANZUP Consumer Advisory Panel. He has worked closely with Jeremy in developing the concept from the perspective of the patient. Colin explains how he plays devil’s advocate on the potential trial by putting himself in the patient’s shoes.

Pedalthon riders spotted everywhere!

In July each year, ANZUP hosts an Annual Scientific Conference for its members and members of thePedalthon public. A free was publicanother forum will be Our Below the Belt held on Sunday, 11 July at the Wentworth Sofitel Sydney from 1pmsuccessful andand fundraiser.

4pm.hugely World leading specialistsevent in urogenital prostate cancers will discuss the latest treatments and clinical trials.

All Lion are welcome One friend of ANZUP spotted this Co. to attend, and we encourage you to share this information with your rider in the Sydney CBD long after the ride. family and friends. More information can be found on the ANZUP Wehttp://www.anzup.org.au just loved our jerseys this year. Thanks to website,

ourlook sponsors and Thomson Geer We also forward toGresham introducing you to Anne Wallington.

Anne has been a long-time supporter of ANZUP and runs annually in the Lawyers for helping us achieve our goals.

City2Sea and other community events in memory of ANZUP CAP Chair Belinda Jago’s daughter, Bec.

Testicular cancer is rarely funny. That said, we meet Melbourne actor and comedian Daniel Tobias who has managed to put a comedic spin on something that affects too many young Australian men in their prime. Daniel was diagnosed with testicular cancer just about the time that girls started to take an interest in him. A harrowing regimen of chemo and a subsequent orchiectomy provided the foundation for a hugely successful stage show of which he is both writer and producer. The Orchid and the Crow is an hilarious and poignant musical and theatrical exploration of his journey into and out of testicular cancer. It sounds an unlikely subject, but Daniel’s show is so successful he is about to do a 26-show season at the Edinburgh Fringe Festival.

ANZUP members and supporters work tirelessly to identify new and Watch thebyvideo better treatments for patients affected testicular, prostate, kidney and bladder cancer. However, we know cancer is cruel and, despite our very best efforts, takes those we love. In the past six months, ANZUP has said goodbye to two towers of our Consumer Advisory Panel: Matthew Carr and Ian Roos OAM. We wish to acknowledge their enormous contribution as patient advocates and salute their bravery. Rest in peace with our thanks for your courage and support.

Without the generosity of our patients, their families, friends, and carers, ANZUP would not be able to develop improved treatments.

We need to hear your stories to help others understand the importance of clinical trial research in making real and substantial changes to patient outcomes. Please let us know if you know someone whose story should be told. The contact details for ANZUP are just to the left of this story.

What’s inside 04 ANZUP Chair Ian Davis

What’s inside

06 The ANZUP CAP 08 03 10 04

My Experience on the CAP Welcome Consumer Testing PICF Message from the the Chair

06 The Obituary 12 Journey - Being on an ANZUP clinical trial 07 The Message from the One CAP Stop ChairShop 14 Journey - The 08 Rural health & overview - Dr Craig Underhill 15 The Journey - The doctor’s perspective 09 Brian Cooper ENZARAD trial patient Immunotherapy 10 Steven Trigwell BCG MMC trial patient 16 What is Cancer Immunotherapy 11 From an idea to a trial 18 Journey Research 12 The Daniel Tobias- Clinical - testicular cancerManager’s perspective 15 Telehealth - a revolution in healthcare 20 Journey champions – Testicular Cancer 18 The Fundraising 19 21 20 22 26 25 27 38 28

Searching Sponsors for credible health information Corporate and In-Kind Supporters Current ANZUP trials Treatment for advanced prostate cancer Current ANZUP innovatons Current ANZUP Trials Ask the doctor Below Below the the Belt Belt Pedalthon Pedalthon 2015

ANZUP Cancer Trials Group Level 6, Lifehouse Building 119-143 Missenden Road CAMPERDOWN NSW 2050 Locked Bag 77 CAMPERDOWN NSW 1450

Phone +61 2 9562 5033

Email anzup@anzup.org.au

We thank and acknowledge AstraZeneca

We wish to thank all our contributors to this issue. Their time and for is their support in 2015 in commitment veryinvaluable much appreciated.

theissue dissemination of ANZUP’s We hope ensuring you enjoy this of A Little Below the Belt. Don’t forget to look out for us online, and take “A a moment to readthe through the consumer magazine little below belt”.

Twitter @ANZUPtrials

ANZUP website for all the latest news and trial information.

Published

by ANZUP Cancer Trials Group Ltd. Graphic design: georgiegirldesigns@icloud.com Copyright. Editor Liz Thorp Graphic design by Gen Spilsbury

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ANZUP who are we & what do we do By the Chair of ANZUP, Professor Ian Davis

Welcome to this edition of “A little below the belt,” the magazine produced by ANZUP aimed specifically for the general community!

We are here to improve outcomes for people and their families affected by cancers of the urinary system (prostate, kidney, bladder and testicles). These cancers affect large numbers of people in Australia; not only those who have the cancer but also all of those around them. ANZUP is the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. ANZUP aims to improve outcomes for anyone affected by these cancers. We do so by doing clinical trials so that we can understand these cancers better, work out better ways of treating them and supporting people, and change clinical practice for the better in Australia, New Zealand and around the world.

Our members are people involved in the care of people with these cancers and who do research into them.

We come from a wide range of places, professions and experiences but all with the same goal: we need to make a difference.

The sorts of trials we do are just as varied. When people think of clinical trials, they think of a new drug compared to an old drug. We do those sorts of trials but we also do far more than that. We look at all types of cancer treatment: not just drug treatment, but surgery, radiation treatment, hormone treatment, immune treatments, psychology and supportive care, information needs and others. We try wherever possible to “add value” to these clinical trials by linking in other experts: the lab scientists, the public health experts, the health economists and again many others.

We are not restricted to using a treatment developed by just one company; we are able to work with and between

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a range of organisations including the pharmaceutical or other health care industry partners, other groups like ours elsewhere in Australia and New Zealand or around the world, or with the community or professional organisations.

This puts us in a very unique place.

There are many other organisations working in the area of cancer, and many of them are involved in raising the profile of their cancers of interest or in raising funds for various initiatives. We applaud them and support them whenever we can. ANZUP has a key point of distinction: we are actually doing the clinical trials that answer the key questions. Clinical trials are the way to obtain the information and evidence we need to improve what we do and improve the outcomes for our patients. All types of research are important and need to be supported, but without the clinical trials to tell us whether we are doing any good, then we would just be working blindly.

Clinical trials are hard work and not just for the people who take part in them! They often involve large numbers of people working behind the scenes, to ensure the science is strong, the research is ethical, the research questions are important, the trial is well-designed and can answer those important questions, the people taking part are looked after with the highest quality of care, the information we generate is clear, the results are communicated effectively to all stakeholders (that means you!), and that practice does indeed change and improve. It takes time, lots of it; money, lots of it; and patience, and I think you know where this is

heading. There is no cutting of corners, though: if we tried to do that, then the whole process is compromised and wasted.

It is a great privilege to be part of this and to work with so many people dedicated to the same goal. I am immensely proud of what we all collectively do and humbled at the generosity of everyone who contributes their time, energy and resources.

We are also looking to the future. Every time we do a trial we know that there will always be more questions to be answered, so we need to plan for what the next trials will be even before the first one has finished. ANZUP has robust processes to “scan the horizon” for what will be coming up and to develop new trial concepts to answer those questions. We run Concept Development Workshops to fast-track the development of trial ideas. We have an annual scientific meeting where we share information and expertise in a fantastic atmosphere of collaboration and friendship.

The meeting also includes a community engagement forum that is a great opportunity for the general community to learn more about these cancers, clinical trials and specifically about what we do. We have a Masterclass at this meeting where we run an intensive educational program aimed mainly at trainees, nurses and allied health professionals although we often find many senior people attending as well. This year we ran a very intense “preceptorship” course in prostate cancer again aimed at people early in their careers. We are very conscious that we need to foster and grow the next generation of clinician-researchers because the work will never stop until these diseases are finally eradicated.

ANZUP has great connections with other key groups including other cooperative trials groups, community and advocacy groups and various professional bodies. We have valuable support from Cancer Australia and also in recent years from Cancer Institute NSW. We have links with industry but not in such a way that we lose our autonomy and independence. We also have very strong connections to the broader community and are very conscious that ultimately we must answer to you. Our Consumer Advisory Panel gives us great advice and guidance to help us in all these areas.

I hope you enjoy this newsletter. It is just one of the ways that we promote what it is we do and how we do it. You can also get more information from our website (www.anzup.org.au).

The ANZUP ClinTrials Refer app is generally available for mobile devices and will tell you what trials are running, what they are about and where they are open. We certainly

encourage you to look at all of these things and to consider talking to your treating doctors about whether a clinical trial might be appropriate for you.

Once again this edition of the newsletter is overflowing with interest. You will hear about how the Consumer Advisory Panel works with ANZUP. We have some stories from people who are involved in our trials, and we would love to hear from you as well. The stories continue with contributions from nurses or trial coordinators involved in running the clinical trials. This edition has some information on treating cancers by boosting the immune system including the “Ron Walker” treatment, something of great interest to us and I am sure to many of you. We have information on some great initiatives in bladder and prostate cancer; advice on where to find good health information and how to understand it; details of our trials; and some of the fundraising activities we undertake to try to support our work, including stories from some of the key participants in our Below the Belt Pedalthon held in September. See if you can spot the one most likely to bring home a gold medal from Rio next year!

ANZUP is a not-for-profit charity registered in Australia and New Zealand. We must find the financial resources for every trial we do: we do not have any reliable funding sources to do the actual trials. We have to compete for grant funding or other sources of funding and this is sloooowww and very unreliable, especially when the rate of successful grant funding this year from NHMRC is at its lowest level ever and only likely to get worse. You can help by contributing to our fundraising activities, and there are many ways to do so: not only by donating, but also by participating in our events, raising our profile in the community, showing where we are distinct (we do the trials!), and demanding that more resources be provided to do this important work. You will find information in here about how you can help, or you can visit our website.

You are most likely reading this because these cancers have already touched you or your family in some way, as they do for so many people. You understand how important it is that we do better, and the only way to make a difference is to show the evidence that things can be done better. That is what clinical trials are for. That is why we must keep talking about all this and why the work must go on. That is why we are here.

Thanks for your interest in ANZUP.

Did you know ANZUP is now tweeting to more than 1000 followers?

Our community is sharing trial updates and news across the Twitter network. We are always interested in retweeting your thoughts, stories and insights. At our ASM in July, #ANZUP15 threads made more than 1.2 million impressions in four days. Follow @ANZUPtrials and start communicating with leading professionals today.

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The ANZUP CAP it’s all about you

scientific meeting and attended by some of the world’s leading experts in urogenital and prostate cancer clinical trials. More than 140 members of the public joined us in Sydney this year to hear from leading cancer experts including:

ANZUP Consumer Advisory Panel (CAP) Education Session, 2015 ASM

• Professor Ian Davis, ANZUP Chair and medical oncologist, provided an overview of ANZUP and the importance of clinical trial research;

L-R Belinda Jago (CAP Chair), Leonie Yong, Colin O’Brien, David Swallow, John Stubbs, Max Shub, Peter Stanford, Ray Allen (CAP Deputy Chair), Jason Grey, Joe Esposito, Associate Professor Guy Toner, Les Land, Risto Doneski, Tony Sonneveld, Margaret McJannett (ANZUP CEO)

• Associate Professor Shomik Sengupta, ANZUP Board member and urologist, gave an overview of our current clinical trial research portfolio across the four cancers we focus on;

On behalf of the ANZUP Consumer Advisory Panel (CAP), thank you for your support throughout 2015 through events such as your participation at the Community Engagement Forum, fundraising activities such as the Below the Belt Pedalthon, City2Surf and City2Sea. Thanks also to those who have helped raise ANZUP’s profile in the community through the Twitter handle @ANZUPtrials as well as your other, varied personal networks.

As you will see from Ray Allen’s story on page 8, the CAP’s role is to provide a consumer voice to ANZUP members as they build new trial concepts. Your voice, fostered through the CAP members lived experience of their own “below the belt” cancer journey, ensures that once an ANZUP trial has undergone scientific rigor, it also goes through the “what about me?” question process.

Thanks to grants and the funds raised through the Pedalthon, ANZUP has had the opportunity to bring members together to discuss and explore more concepts this year than in any other. It is a privilege to have been involved both personally and as a CAP member in these exciting new developments.

A highlight of our year was the unprecedented success of the ANZUP ASM Community Engagement Forum.

This free event open to the public, is a feature at the

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• Professor Suzanne Chambers, ANZUP’s Quality of Life and Supportive Care Committee Chair, RN and health psychologist, gave an especially engaging presentation on the impact of life after a cancer diagnosis. She spoke about quality of life issues such as sexual functioning and ways of coping post diagnosis and treatment; • Annabel Childs, a Clinical Trials Nurse Consultant, provided some insight into the role of the clincal trial nurse, how they provide information, support and help the patient and their family navigate through the clinical trial process .

• Denis Cubis, gave a moving and very personal account from a patient perspective. Denis is currently participating in ANZUP’s ENZAMET clinical trial and gave the audience a heartfelt assessment of his life on a trial. His closing statement was: “You have to give yourself every chance, and a clinical trial is the best chance”. Every member of the audience appreciated his approach and honesty.

• Dr Deme Karikios, a part time medical oncologist and currently undertaking his PhD spoke about the cost of cancer care and cancer drugs is on the rise. Deme examined the “side effects” for patients and doctors as costs increase.

• Dr Haryana Dillon, Deputy Chair of ANZUP’s Quality of Life and Supportive Care Committee and psychologist presented the audience with an excellent guide to sourcing credible health information online. You can read more about this in this edition.

ANZUP volunteers Lesley Tinkler and Jo Stubbs

• Finally Sophie Scott, renowned ABC medical reporter, treated the audience to how journalists filter information about current “breakthroughs” in medical science.

She explained her processes and the checks and balances journalists must put in place to ensure a story does not cause inappropriate hope or heighten anxiety.

We were fortunate to have two of our most recognised and well regarded CAP members Leonie Young and John Stubbs fascinated the closing Q&A session. They did a superb job facilitating what was a most engaging and robust discussion that saw good audience participation and engagement from multiple perspectives.

The Community Engagement Forum for 2016 will be held in Brisbane on Sunday, 10 July. I encourage you to consider joining us – or at least share this invitation with your Queensland friends. To find our more information go to our website www.anzup.org.au.

When my daughter Bec died from kidney cancer in 2012, I was determined not to waste the opportunities that unwanted experience that my family and me experienced.

Each member of the ANZUP CAP brings with them their lived experience – and a dogged determination to help ANZUP achieve its mission to improve the treatment and outcomes for those affected by urogenital and prostate cancer. Each day we commit, each story we tell, every trial we review, we do it for the greater good of cancer patients both here and around the world. I am grateful for the dedication and support of my fellow CAP members and in awe of the ANZUP members who volunteer their time on top of their day jobs to achieve ANZUP’s mission.

We couldn’t do it without you…

For the past four years, two amazing women have volunteered their time and extraordinary administrative skills to help staff at the ANZUP Sydney office and the wider ANZUP membership.

Jo Stubbs and Lesley Tinkler are treasures we wish we could replicate many times over.. Their commitment to ANZUP is exceptional, and their selflessness humbling.

When you receive a printed copy of this magazine, it is because Jo and Lesley have printed, folded and stuffed envelopes for us.

We wish to thank Jo and Lesley for the hours of work, good humour and assistance they have provided to ANZUP over this time. We are truly grateful - and still can’t believe they turn up week after week and never receive a cent!

The one way we can continue to help other patients, carers, family members and friends is to create awareness.

By reading my story, and the stories of everyone in this magazine, you are helping to spread the incredibly important work being done by ANZUP and co-operative trials groups.

I hope you pass this magazine around. I hope you never need to have more than knowledge, but if you do need more you know where to come for the most up to date information on world-class clinical trials research.

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My Experience.

Ray Allen, ANZUP CAP Deputy Chair

ANZUP CAP Deputy Chair, Ray Allen (centre), Dickon Hayne (Chair of Bladder Cancer Subcommittee) and David Pook presenting at the ANZUP ASM, July 2015

INSIDE THE CAP The ANZUP Consumer Advisory Panel (CAP) provides a mechanism for offering advice from a consumer perspective on specific studies, general research directions and priorities.

Its key activities cover the consumer-orientated review of specific clinical trial concepts, including validity of overall trial questions, comments and suggestions regarding the protocol, lay summary, Patient Information and Consent Form (PICF), and other issues as requested.

Members of the CAP may also become involved in other activities such as advising on ways to increase the public profile and awareness of urogenital cancers and the importance of associated clinical trials.

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The CAP reports to the ANZUP Board via the CAP Chair. The CAP Chair is a member of the Scientific Advisor Committee (SAC) by their appointment. CAP members are invited to participate and provide input to the ANZUP SAC subcommittees. The CAP is currently chaired by Belinda Jago, (renal cell trial participant’s parent) and Ray Allen, (prostate cancer survivor), is the deputy chair.

ANZUP’s mission is to conduct clinical trial research to improve the treatment of bladder, kidney, testicular and prostate cancers.

Working with our clincal collegues we are committed to supporting and promoting each person’s right to information concerning trials, and their

right to make a personal, informed choice. As consumer advisers, we are not asked to provide, or expected to have, specific expertise about the scientific or medical merits of a trial.

CAP members are asked to provide the perspective of someone who has been through a similar or related experience. Their role is to advise ANZUP on the issues likely to affect potential participants in a trial.

All ANZUP CAP members undergo appropriate training specific to their role within the panel on how to identify research priorities and better understand and contribute to our clinical trials research.

ANZUP CAP Deputy Chair Ray Allen was asked to provide an overview of his involvement as a CAP member in the Patient Information Consent Form (PICF). Ray details his experience in reviewing PICF’s from a patient’s perspective.

Roles and Responsibilities of the ANZUP CAP The primary focus of the CAP is to provide ANZUP with a consumer perspective on clinical trials issues including:

• The relevance and focus of new trial concepts and protocols under consideration by the SAC and sub-committees;

• Advocating for urogenital cancer clinical trials and the ANZUP research program;

• Ensuring the PICF is easily understood by participants;

• Attending CAP meetings during the year and attending the ANZUP Annual Scientific Meeting (ASM);

• Identifying gaps in research; • Advising on patient recruitment strategies; • Leveraging their networks to promote ANZUP and our trial activities;

• Contributing to the ANZUP ASM and Community Engagement Forum; • Working with ANZUP to improve community understanding.

If you are interested in being involved with the ANZUP CAP, please contact ANZUP Chief Executive Officer, Margaret McJannett: margaret@anzup.org.au

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Consumer testing the PICF The medical and health sectors love their acronyms and abbreviations, and no wonder when you see some of the scientific terms and drug names. Many are longer and harder to pronounce than the names of certain Welsh towns.

My experience reviewing a Patient Information Consent Form

Like a detailed set of plans, specifications and engineering drawings for a bridge or a city building, the working manual for a clinical trial, known as the Protocol, is a complex document, prepared by a multi-disciplinary team of health professionals which sets out every aspect of the conduct of a trial. It will contain detail on the rationale and objectives, participant suitability, precise details of dosage, attendance requirements, risks, and outcomes. The Protocol is written in technical language aimed squarely at the highly skilled clinician who will implement the trial, often in multi-centre locations, and is not generally in a format useful to most trial participants (the patients). For example, I recently reviewed a trial Protocol and counted 45 abbreviations used throughout the document!

As a member of the CAP, I have been personally involved in the review of a broad range of trials across the different disease groups. Beginning with the PICF, I place myself in the position of a potential trial participant and make a note of the questions that arise as I read the document. I will try to look at the PICF both from the perspective of a participant with little or no knowledge and experience of their disease or the trial process, and a participant who might have many years of wearying involvement. I look to see if my questions are adequately answered in the PICF. I check to see if the treatment schedule is correctly calculated and conveyed in the document. I look for wording that may be counter to the participant’s self-esteem; nobody wants to be thought of as a lab-rat.

An integral component of a clinical trial Protocol is the requirement for informed consent. In a nutshell, this is a requirement that the trial participant is given sufficient relevant information about the objectives, methodology, risks and potential outcomes so that they can make an informed decision on whether or not to proceed. The PICF is a form designed to provide comprehensive information to the potential participant and to provide written confirmation that informed consent has been obtained. It must be obtained for every trial participant.

ANZUP’s CAP plays the important role of reviewing the PICF as a trial proposal moves towards implementation.

The CAP review is an integral step in the approval process.

A team of three to four experienced CAP members will be assigned to a typical PICF review. Each will conduct an independent review, with findings and suggestions brought together via teleconference. Members possess a wide range of individual skills and experience. The review team will seek a clear and definitive answer to the question of whether sufficient information is being provided in a clear and understandable form to assist the prospective participant to make a decision about entering the trial - and that the patient understands the risks and potential benefits.

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Where a question is not adequately answered, at least to my satisfaction, I look to the Protocol.

The answers are usually there but, often for good reasons, have not been included in the PICF. I’m not there to review the Protocol. For a start, I’m not qualified to do so. And, more importantly, there are many levels of review within ANZUP that will deal with the concept, aims, and procedures. The fact that the Protocol has got this far means that it has gone through a very robust process of review.

In the end, each member of the aCAP review team needs to be able to say that they understood the information contained within the PICF and would be happy to enter the trial based on that. The review process ends with the review team making a set of recommendations encompassing suggested changes and additions for return to the Protocol author(s). I am happy to say that, in my experience, suggestions emanating from the CAP are seen as a constructive and valuable contribution to the final form of the trial.

The journey Testicular cancer survivor and comedian Daniel Tobias is taking his award winning show The Orchid and The Crow on the road, and you can see him at the Stables Perth Cultural Centre in February. He is hoping to hold a Q&A session about clinical trial research and surviving testicular cancer.

Dan featured in our last edition of “A Little Below the Belt”. Please enjoy this excerpt from Steve Gibbons’ interview with Dan.

The motivation to raise awareness burned brightly in Daniel’s push to bring his own story to the stage 10 years after his treatment and co-incidental with a 10-year check showing he is indeed cancer free.

Meet Daniel Tobias, writer, actor, musician, performer, comic, and the driving force behind The Orchid and The Crow, a personal tale of faith and redemption, life and love, mortality and masculinity, in the face of stage 3 testicular cancer.

Nothing is taboo in what might be viewed as one of the more bizarre comedic subject, and that includes sex. Believe it or not, says Daniel, “girls don’t care that a bloke only has one ball”. Girls cared so little, in fact, that he wrote a song about it.

Dan was a 20-something Melbournian with a love of performance, picking up bits and pieces of work: small parts in soaps such as Neighbours and Blue Heelers, mixed with making music in a couple of bands and taking to the stage in edgier more experiential theatre. He was looking for direction and just didn’t know where to find it.

That is where fate intervened.

Approaching 30, Daniel had been experiencing some nagging stomach pain and went along to a GP to get it checked out. With a forthcoming role in an Adelaide Fringe show, he thought he had better be safe rather than sorry.

The diagnosis was somewhat less than accurate, and with hindsight, tragi-comedic in itself.

“He told me to try some laxatives.”

After several nights of festival accommodation – sleeping in a tent in a caravan park – it became clear Dan’s “gastro-problem” wasn’t going to go away. So it was back to Melbourne and back to the GP who referred him to a specialist.

That was the start of a one-year journey to recovery that effectively both saved and changed his life.

After a battery of tests, there was confirmation of a testicular tumour and surgery to remove it. Then confirmation of secondaries in the abdomen, neck and chest. At just 29, Daniel was a very sick man.

His family, in search of the best care possible, sought out Guy Toner as an expert in testicular cancer. Daniel was transferred to Guy and underwent intensive chemotherapy and subsequently radiotherapy at the Peter MacCallum Cancer Centre.

Associate Professor Guy Toner is the Deputy Chair of ANZUP, Consultant Medical Oncologist at Peter MacCallum and Associate Professor of Medicine at the University of Melbourne.

Read more about Daniel’s story in the July issue of A little below the belt or see his show The Orchid and The Crow (www.orchidandcrow.com).

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The journey

Positive power why one man chose to join an ANZUP trial Imagine how lives might change if you could bottle the power of positive thought and deed as a curative and offer it on the open market.

It is humbling to see how some have the capacity to confront head-on the rough and tumble of life: to face up to a bad hand of cards as another challenge to overcome rather than a harbinger of defeat.

Inevitably, these are also the people with a great love of life - who seize the day and celebrate every grain of good that comes their way.

A prostate cancer diagnosis could have turned Peter’s life upside down. Sure, it has shaken him to the core, but rather than dwell on the negative he is striding out to fight with a determination and athleticism that have been a constant companion for many of his 55 years.

Peak fitness for elite athletes, particularly important as they age, means monitoring of iron and other levels in the blood.

Co-incidental with Peter preparing to get his levels tested he noticed a change in urinary flow.

“I’m always in a hurry. Type A personality. When I tried to force it out quickly, I noticed the flow would go down rather than increase. I put up with this for a while then thought ‘this is all a bit odd’. So I had a blood test which was as much about making sure blood was good for the event as anything else,” he said.

The test came back with a PSA count of 12.

It was a radical change from three years previously when a blood test allied to the 2012 championships revealed a PSA level of zero.

You get the impression that if he had the chance he would take a baseball bat to the disease that has chipped away at his previously extraordinary bill of health.

What Peter now calls, with a measure of understatement, a “surprise result” underlines his first message to men of an age: “I make sure I tell all my friends ‘you’ve got to have a test every year’.”

Fifty-plus, and pre-diagnosis not a single night in a hospital bed, not a filling; nothing other than muscle strains or minor injuries associated with his love of a particular sport.

He said the first step after the PSA result, and before specialist diagnosis, was a course of antibiotics to deal with what might have been a case of prostatitis. The course had no effect.

Peter is a triathlete of renown – a former sprint distance age group triathlon world champion: that’s 750 metre swim, 20 kilometre bike and five kilometre run. He also happens to be a world titled life-saver.

After seeing a specialist, a biopsy returned a Gleason score of 9.

His cancer was discovered in July following a period of training for this year’s world championships in Chicago. Peter was going to compete again for Australia – with his sights firmly set on gold in his age group.

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“In laymen’s terms it means it was reasonably advanced and had spread outside the prostate – I have one on my spine and one on a hip and in a couple of lymph nodes,” Peter said.

Such news would be shattering for some. For Peter, it was almost a call to arms.

“One thing I’m good at is that I’m strong,” he said.

“I’m very much a glass half full bloke so when they told me there was something going on and a Gleason score of 9 there was no breakdown in tears or walk out so I could pull myself together.

“It was well, OK, if that’s the case what are my options? What do I do to move on.

“Four months on I still expect a camera crew to jump out of the bushes as I’m walking … and give me a cheque for a million bucks saying ‘hey, we’ve f…d with your life for the last four or five months but we wanted to see how the average idiot treats bad news, how he handles it, and we’ve been studying your life on Candid Camera – and there’s nothing going on’.”

Peter started hormone therapy after a round of scans before being told about the ENZAMET clinical trial. After learning about the potential benefits of the Phase III trial drug, he was keen to get on board.

In keeping with other applicants, Peter had a 50 per cent chance of being accepted with the other 50 per cent used as a control group. Trial selection is anonymous. “You are a number and it’s a lottery whether you are selected or not,” he said.

“This was the most high-stressed part of it all for me. Not the Gleason score, not the hospital, not people poking and prodding ‘down there’, but whether I would get on that trial.

Pleasingly I got selected for a drug we know works.”

He was given a choice of four hospitals to undertake the trial.

He chose the nearest to his place of work which says something else about the man: despite having undergone drug treatment and five of the first six rounds of chemotherapy in three week cycles, he hasn’t taken a sick day.

He attributes the fact the chemo isn’t making him feel too unwell to a high level of fitness.

“I’ve pretty much sailed through. All the standard stuff that you read. I have two days, usually on days four and five, where I feel I’ve got a hangover of sorts; like my batteries have been pulled out and everything is a bit more of a grind. Then back to it again.

“Yes, your hair falls out. My finger nails got unbelievably sore.

But really I’m getting through scot-free. Most people at work don’t know and I haven’t missed a day at work.

“I’m touching wood, but I think if you don’t accept it and stay strong, and it hasn’t laid me up, you battle on. That’s the way I’m tackling it, and that’s probably my attitude to life.”

It’s a determination underscored by the fact he is still running, swimming and riding a bike, though there is now a small element of frustration that the effect of the chemo on the oxygen carrying capacity in his blood means (said with a smile in his voice) that he “can’t keep up with little old ladies on dragsters”.

And it’s a strength of purpose reflected in the support of his family who, he said, have been galvanised by his diagnosis.

“My partner and I have only been dating for 18 months.

She has been very supportive and understanding, as has my whole family, my ex and kids.”

Given his experience so far, Peter has a message of encouragement for people debating whether or not to nominate for clinical trial.

“The way I see it, I have to try anything and everything. I was passionate about getting on it. I knew with a Phase III trial that the drug definitely works so, from my point of view, I didn’t have a whole lot to lose.

“It would be different if someone came along and said ‘we’ve got this drug. We don’t know what the side effects are, we don’t know if it’s going to work...’ In this case with ENZA, the people who know more about all this than I do said it would be worth me going on it.

“I would encourage anyone who is dancing round the edges to have a look at something like this.”

Peter accepts he may be on the trial for the long haul and is pragmatic about what the future may hold in terms of his longevity. But for now it’s all about getting on with it.

“I’ve had a dream run. I’ve been a lucky boy to have ticked so many boxes in terms of achievements and things like that – including sailing in the Sydney to Hobart, racing cars, doing triathlons all over the world, still being an active and competing life-saver, just doing a whole lot of stuff that’s been massively rewarding,” he said.

“Most significantly, I have three rippingly active and motivated kids.

“Reality is I accept that I have been dealt this hand so there’s no point in me wasting time and energy on why this thing has got me.

“I’ve just got to make sure life goes on.”

A LITTLE BELOW THE BELT 13

The journey

What is the OSPC The OSPC is designed primarily for men from rural and remote areas of Western Australia who have been identified by a GP as being at risk of having prostate cancer. It was introduced to remove some of the barriers these men face in accessing prostate cancer diagnostics by providing them with a clinic where everything can be accessed in one stop.

Previous research has shown that men with prostate cancer from rural WA have faced longer waiting times for a diagnosis due to multiple visits to urologists. Also, outcomes from prostate cancer in Australia are known to be worse for men living in rural areas.

Any man living in a rural or remote area with either two abnormal PSA (prostate specific antigen) or a suspicious digital rectal examination result, regardless of PSA levels, are eligible to be referred to the OSPC. Who is going to look after you?

The clinical team consists of the urologist who leads the service and the urology nurse who coordinates attendance and arranges the required follow-up. Men have the option of receiving the results of their biopsies from the urology nurse over the phone. If no further specialist input is needed then follow-up could be with their GP. What did the study show?

Data were collected from this clinic on a prospective basis by the urology nurse and outcomes from the first 200 men reported. These 200 referrals were made by 100 different GPs and two other urologists. The range of travel distance was 56 km to 3229km and the average time from referral to biopsy was 33 days.

(By comparison, 20 men who underwent the standard referral pattern showed a median referral biopsy time of 188 days). It is estimated that each participant would have saved an average $1045 on travel cost.

Why the OSPC is a new model for the future of rural health care.

The OSPC is a more streamlined healthcare model than traditional assessment pathways; the patient needs just one meeting with a urologist to arrive at a prostate cancer diagnosis compared with three. The reduced need for travel to and from a metropolitan centre is highly cost-effective and removes a significant barrier faced by men from rural and remote areas in accessing prostate cancer care. This OSPC model frees up outpatient clinic appointments, allowing other patients with potentially serious conditions to be assessed in a more timely manner. Although visiting urology services may also provide many of these advantages, efficiency and reliability is heavily dependent on the regularity of visits and availability of equipment at remote locations.

Our ANZUP members in WA have found that the OSPC is an efficient and effective healthcare model.

It removes many of the barriers (time, distance and cost), and could be applied to other parts of Australia and the world.

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Cancer News The One Stop Shop program A ‘One Stop’ Prostate Clinic (OSPC) for rural and remote men: a report on the first 200 patients Professor Dickon Hayne – Urologist Chair ANZUP’s Bladder Cancer Subcommittee

The One Stop Prostate Clinic opens at Fiona Stanley Hospital The One Stop Prostate Clinic recently opened its doors at Fiona Stanley Hospital. Previously operating from the Fremantle Hospital, the clinic was designed to remove barriers faced by rural men. The FSH head of Urology, and ANZUP Bladder cancer sub-committee Chair, Professor Dickon Hayne said: “The introduction of these sorts of clinics in other countries has been shown to reduce these delays and improve the patient’s prognosis.”

The clinic’s team includes a urologist who leads the service and the urology nurse who coordinates attendance and arranges the required follow-up. Any man living in a rural or remote area with either two abnormal PSA (prostate specific antigen) or a suspicious digital rectal examination result, regardless of PSA levels are eligible to be referred to the OSPC. The clinic offers an effective model for offering better health to men living in rural and remote areas of Western Australia.

The journey

The Doctor’s Perspective Immunotherapy.

The new horizon in cancer treatment

Goldilocks and immunotherapy in GU cancer Associate Professor Andrew Weickhardt – Medical Oncologist Immunotherapy refers to a class of drug and vaccine treatments that harness the body’s own immune system to fight cancer. The use of some new types of immunotherapy drugs is transforming treatment with stunning results in patients with a range of different cancers. In particular, there have been some very promising early results from trials where these drugs were used to treat cancers of the bladder and kidney.

Both bladder and kidney cancer have long been known to respond to immune therapies. It was recognised more than 20 years ago that an injection of a bacterial vaccine (BCG) into the bladder wall would reduce the recurrence of superficial bladder cancer. The vaccine leads to recruitment of immune cells and subsequent death of surrounding cancer cells. Over the same time period, metastatic kidney cancer was commonly treated in some parts of the world with drugs such as interleukin 2 (IL-2) that powerfully stimulated the immune system. While only a small number of patients responded to these drugs, some experienced long lasting cancer control. However, IL-2 therapy was difficult to administer because of the risk of serious side effects due to over activation of the immune system, and could only be used in very selective patient groups. Another drug, Interferon-alfa, had fewer side-effects than IL-2, but seemed much less effective.

The immune system of a cancer patient is theoretically ideal for use in the fight against the disease. Over millions of years, we have evolved a sophisticated immune system to combat viruses, bacteria and other pathogens. Our immune system has an amazing ability to recognise specific proteins that may be attached to invading pathogens and muster a defence using other immune cells. These defence mechanisms include a variety of different cells (described in more detail in the diagram) and antibodies.

In some patients, the immune system may work by itself to eliminate the cancer and rid the body spontaneously of any cancer cells. This rarely occurs, however, because the cancer often evolves mechanisms to hide from the immune system.

The cancer may escape from immune surveillance and begin to grow, possibly by using a protein on the surface of the cancer cell called PD1, to turn off the immune system.

Older drugs such as IL-2 work by activating a particular type of immune cell (CD8+ killer T cells), which can kill cancer cells.

Unfortunately many innocent bystander cells also may fall victim to the T cells, leading to difficult to manage side-effects.

Until recently there was no understanding of how the immune system could be used to treat cancer while avoiding system over-activation and associated nasty side effects. New forms of immunotherapy seem to have hit upon the Goldilocks phenomenon – just the right amount of immune activation to treat the cancer (not too cold!), but not too much to cause excessive side effects (not too hot!) This new type of drug class, called ‘check point inhibitors’ binds to cancer cells that express the PD1 protein. The cancer cells can use this protein on their surface to turn off any nearby T cells and avoid destruction.

By attaching to the PD1 protein, these new drugs expose the cancer to the immune system, which in turn can now destroy the cancer.

Recent trials in both kidney and bladder cancer patients with metastatic disease suggest that this new class of drugs is more effective than standard chemotherapy. Furthermore, most patients tolerate the treatment very well, with only a small proportion suffering from autoimmune side effects compared to earlier drugs such as IL-2. Additionally, about one in five patients seems to attain very long lasting control over their cancer, probably due to the power, memory and specificity of their own immune system.

These are promising early results, but there are plenty of challenges ahead. How long will patients achieve sustained disease control with these well-tolerated drugs? How can we identify which group of patients benefits most? Can these drugs be given with standard chemotherapy and/or radiation to further expand the group of patients that benefits? We need to be mindful that, in the past, it has been difficult to get the ‘porridge just right’: long term control of the cancer using the immune system, free of crippling immune related toxicity.

ANZUP is happy to announce an upcoming trial in 2016 of the combination of pembrolizumab (a PD1 inhibitor) and chemotherapy with radiation for patients with localised bladder cancer. It aims to assess if the combination is safe (not too hot!) and active (not too cold!) increasing the proportion of patients cured. Hopefully the outcomes will be, as Goldilocks would have it, ‘just right’.

A LITTLE BELOW THE BELT 15

Image reproduced with permission from the Cancer Research Institute www.cancerresearch.org

16 A LITTLE BELOW THE BELT

A LITTLE BELOW THE BELT 17

The journey

the Clinical Research Manager’s perspective

Meet the clinical research manager with a difference

Albert takes a lead role as a clinical trials top gun He has a gun in an outstretched but trembling hand as he weighs up whether or not to shoot.

The weapon is pointed squarely at a man slumped in a chair who is clearly at the end of his tether. He shouts at the gunman, goading him to pull the trigger.

A police siren wails and the gunman snatches at his victim’s shirt to reveal a “wire”. He realises he has been further betrayed.

His gun hand steadies as he eyes the victim with a new resolve.

And … “Cut”.

Whether its gangster, submariner, standover man, comedian, or romantic, one thing’s for sure: Albert Goikhman has the ability to talk the stage talk and walk the stage walk - even if the talk has a decidedly Russian-accent. He looks the part with a gun in his hand.

A glance at his show reel will tell you all that. (Just be aware that some of it might be a little confronting – after all, its purpose is to display his wide-ranging acting talent).

Albert is so accomplished that one of the short films in which he starred took two awards at the Cannes Film Festival. “Deeper than Yesterday”, about the emotional breakdown of the crew of a Russian submarine, also won a host of other accolades.

So with a long list of film and theatrical appearances to his credit, as well as projects in the pipeline, it seems obvious that this multi-lingual, Melbourne-based actor, writer and director has plenty to keep him occupied.

Well yes, but with a big twist.

This isn’t his day job.

Far from it.

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The world of stage and film craft is a long, long way from the caring, pioneering and inspiring work that helps save lives through clinical trials.

And for Albert, that’s just the point. Two very different forces capable of delivering a healthy physical and emotional balance.

Albert’s principal inspiration is his job as an oncology nurse, clinical trials co-ordinator and research manager at Peninsula and Southeast Oncology, Frankston, Victoria.

Born in Moscow 45 years ago, he arrived in Australia in 2004 via Israel where original ambition to qualify as an oncology doctor took second place to difficulty in transferring Russian medical training to Israeli requirement.

Subsequently he invested his love of medicine into graduation as an oncology nurse in Tel Aviv with an original focus on paediatrics.

Australia’s gain was Israel’s loss when Albert, his wife and young daughter, decided to shift part way across the world in search of a new life. Within several months, Albert had secured a job, becoming an associate nurse unit manager at Monash Health before moving to the Peninsula and Southeast Oncology Centre (PASO) in 2009.

His unit deals with clinical trials across a wide range of cancers, and right now he is co-ordinating the ANZUP ENZAMET prostate cancer trial. PASO is one of more than 60 centres conducting ENZAMET trials around Australia and worldwide.

Albert is supervising patients from different backgrounds and across a wide age range undergoing treatment to ascertain the efficacy of Enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer.

He is as passionate about the benefits of clinical trials as he is about his overall work in oncology. Ask him if he is encouraged by the results of trials and advances in cancer treatment and you get an idea of what takes precedence in his working life.

“So encouraged is why I will never quit my job,” he said. “Even if in acting I was offered a part in a big film, I would never quit my job because we are so successful, and so close to beating cancer in the future."

“I don’t know how long it will take, but the development of new drugs and treatments is very fast. That’s why I stay in oncology – a new drug comes out nearly every single day along with new approaches to dealing with cancer."

“How fast? A few years ago everyone was giving chemotherapy.

Then came more targeted therapy. Then stem cell therapy, and now we find the body is capable of fighting cancer itself so there is a focus on immunotherapy.”

As part of the process of informed consent, Albert is very conscious of the need to fully brief sometimes very apprehensive patients about a clinical trial. Before the trial begins he takes each patient aside to explain as deeply as possible what he/she can expect. He says he then encourages the patient to go away and think more about the trial, and – if necessary - seek further oncological or GP advice before making a final decision.

“The doctor will explain why we are doing the trial and side effects – things like that. We sit and talk to them about how many times they need to come, how long they need to stay, whether they need to fast, how many scans they need to have, and so on. We try to tell them as much as possible to make them comfortable.

“Yes, there is apprehension but overall most are optimistic.

They come because they want to get better. They want to try new treatment that is an improvement on what is already on the market.”

Albert doesn’t try to sugar-coat the potential for emotional toll, not only on his patients but on the professionals who work with them.

He admits that early in his career, particularly when he was working with children, he found it difficult to deal with the emotional bruises.

“It was really difficult, I will be honest with you. When I started, I was taking everything home.

“But then I took a completely different approach.

I just learned to disconnect myself when at home with my family and try to basically enjoy life as much as possible.

I spend as much time with my family as possible; whatever I can do with my (two) kids at weekends."

“Working with cancer does make you realise how much you, and your kids, should try to enjoy every moment of life. Take every single moment. Enjoy it.”

In other words, don’t sweat the small stuff.

Such sentiments are even more poignant for Albert.

Six months ago he had his own brush with fate when he was hit with a heart attack. High cholesterol runs in the family.

“I appreciate life even more after that,’’ he said.

Which takes us back to the acting.

“Working with cancer patients, you try to balance your life,” Albert said.

His balance involves regular acting with the Russian Theatre in Melbourne, commercials, and those short and longer-form film and TV roles.

“But it’s always around my working time. I don’t take any time off. I try to organise things around weekends or public holidays, or after work hours. And it works.”

Is there an acting goal?

With a role in Underbelly on his resume, Albert wants to aim higher – for a part in a James Bond movie. With that Russian accent and capacity to unleash an alter-ego, who can deny he is perfect for a follow up to Spectre.

Casting agents – you know where to look.

But don’t expect your new star to give up his day job.

A LITTLE BELOW THE BELT 19

The journey The Doctor’s Perspective - New Trials

98 per cent of men survive testicular cancer – what about the other 2 per cent?

Associate Professor Peter Grimison Chair, Germ Cell sub-committee, ANZUP Medical Oncologist, Chris O`Brien Lifehouse, Sydney Getty Images. Dr Peter Grimison and Simon Clarke

I was recently asked to give an update about testicular cancer to clinicians at an Adolescent and Young Adult Oncology Congress in Sydney. It was exciting to reflect on excellent outcomes. The latest figures from 2011 showed there were 732 cases but only 25 deaths a year in Australia, with 98 per cent of men surviving more than five years.

This means that testicular cancer has the best survival rate of any cancer in men.

After my talk, I reflected on the small number of men with testicular cancer I have had the privilege to care for who didn’t make it – the “two per cent”. It’s always tragic.

Such men are in the prime of their lives (typically aged between 20 and 40), when they are starting careers and relationships, or with a young family. Sometimes treatment fails because men are diagnosed too late, after the cancer has spread extensively throughout the body. More often, however, treatment fails because their cancer is resistant to chemotherapy. ANZUP recognises that one death from testicular cancer is one too many.

ANZUP is working hard to try to ensure that all men with testicular cancer are cured and can live long, productive and healthy lives. One strategy is to improve the ‘first-line’ chemotherapy given when cancer has spread, called ‘BEP’ (Bleomycin Etoposide Cisplatin). ANZUP is leading a trial comparing an ‘accelerated’ form of BEP, given every two weeks, to ‘standard’ BEP given every three. This strategy has worked in other cancers by not giving the cancer time to develop mutant clones with a resistance to chemotherapy.

Our partners across the world clearly think this trial is important, and at their request we are working hard to open the trial in the USA and UK. Another strategy to improve cure rates is to give better ‘salvage’ chemotherapy to those not cured with BEP. Dr Darren Feldman from Memorial Sloan Kettering Cancer Center in New York – one of the most highly regarded centres for treatment of testicular cancer in the world – is leading the ‘TIGER’ trial comparing two types of salvage chemotherapy. One approach is ‘standard’

20 A LITTLE BELOW THE BELT

chemotherapy with TIP, which has fairly similar side effects to BEP. The other approach is ‘high-dose’ chemotherapy with ‘TI-CE’, which requires stem cell transplantation and several weeks in hospital. We don’t yet know if the additional side effects of high-dose chemotherapy improve cure rates. This important trial is already running in the USA and Europe. ANZUP has been very keen to participate in what is arguably the most important current clinical trial in testicular cancer in the world. It gives an opportunity for our patients to be offered the very best treatment, our clinicians to provide the very best treatments available, and for ANZUP to contribute to research that could reduce deaths from testicular cancer in the future.

Our CEO Marg McJannett was given the tough task of funding ANZUP’s participation. Marg approached the Movember charity, which has a focus on men’s health. Movember very generously agreed to fund ANZUP’s participation in the TIGER trial. Our team is working hard to make this happen as soon as possible, and our fabulous CAP is currently reviewing the PICF - a really important information source for patients considering participating in the trial.

Improving cure rates is just one of the areas of research undertaken by the ANZUP Germ Cell sub-committee. We are also working hard to better assist men with early stage testicular cancer by trying to minimise as much as possible the numbers of treatments and tests. And last but certainly not least, we are working hard to do better for the 98 per cent of men who do survive testicular cancer, focusing on their physical and mental health to ensure they have the long, productive and healthy lives they deserve!

I would love to hear more ideas from you on how ANZUP can do research to do better for all men with testicular cancer.

Peter Grimison’s patient Simon Clarke is the Founder of the Below the Belt Pedalthon. When Simon asked Peter how he could help other men like himself, Peter suggested he contact ANZUP. We are so glad he did. Read more about Pedalthon 2015 at the end of the magazine.

Our thanks to our Corporate Supporters 2015 We are very grateful for the infrastructure support we receive from Cancer Australia. However, the funds are not sufficient to support ANZUP’s increasing research activities. In 2012 we established the ANZUP Corporate Supporters’ program and are delighted that this program has continued to grow. Through the program, we have made significant inroads in supporting and facilitating better engagement with our members. We welcome and acknowledge our corporate supporters and partners for 2015.

Our thanks to our in-kind supporters from 2015 We acknowledge and thank the following organisations for their generosity in providing services pro-bono.

A LITTLE BELOW THE BELT 21

Focus on: Treatment options for ad Excluding some forms of skin cancer, prostate cancer is the most common type of cancer diagnosed in men in Australia, with about 20,000 Australian men diagnosed each year. The treatment options for men with advanced prostate cancer have advanced as our understanding of the drivers of prostate cancer has improved.

What are the stages of prostate cancer?

Prostate cancer can be described as either ‘localised’ or ‘advanced’ (metastatic). Localised prostate cancer is when it looks like the cancer is located only within the prostate.

Advanced (or metastatic) prostate cancer is when the cancer has spread to other areas in the body (such as lymph nodes or bone). Sometimes the cancer can spread from the prostate to nearby tissues and organs (such as the bladder or rectum) and this is called ‘locally advanced’ prostate cancer.

How is advanced prostate cancer diagnosed?

Advanced prostate cancer is diagnosed with a bone scan and/or CT scan which looks for cancer spread in the bones, lymph nodes and, much more rarely, the liver or lungs.

Men who are diagnosed with advanced prostate cancer may have had localised prostate cancer in the past, but despite treatment the PSA level rises and advanced cancer develops over time. Other men may be diagnosed with advanced cancer without being aware of having localised prostate cancer and come to the doctor with bone pain or abdominal pain. Sometimes a man may have tests for another reason and prostate cancer is found, even though the man is not feeling unwell.

How is advanced prostate cancer treated?

If the prostate cancer has spread to other parts of the body, the standard treatment is removal of the male hormone, testosterone, because testosterone helps the cancer grow.

This treatment is called androgen deprivation therapy (ADT).

22 A LITTLE BELOW THE BELT

ADT doesn’t cure the cancer but it may help to keep the unwanted effects of the disease ‘in check’ for a period of time. The doctor and patient decide together when ADT SHOULD BE STARTED !$4 HAS SIGNIkCANT SIDE EFFECTS AND THEY can increase over time. Starting ADT earlier rather than later does not seem to increase life expectancy much; the decision is therefore based on balancing the risks of sideeffects against the unwanted effects of the cancer.

What types of ADT are available?

The most common form of ADT used today is a group of medicines called gonadotrophin-releasing hormone (GnRH) blockers. These medicines stop the pituitary gland from making hormones that act on the testes to make testosterone. GnRH blockers are given by injection into muscle or as implants under the skin.

The testes can also be removed by surgery (orchidectomy) to stop the testosterone made by the testes. Orchidectomy was used more often in the past than now.

Sometimes tablets called antiandrogens are added to GnRH blockers or orchidectomy to further block the action of testosterone on prostate cancer cells.

ADT DOESN’T CURE THE CANCER BUT IT MAY HELP TO KEEP THE UNWANTED EFFECTS OF THE DISEASE ‘IN CHECK’

What are the side-effects of ADT? Most men having ADT will have a reduced libido (a lack of interest in sexual activity) and some trouble with getting or keeping erections. /THER COMMON SIDE EFFECTS INCLUDE HOT lUSHES TIREDNESS and sweating, gradual decrease in body hair, thinning of the bones (osteoporosis), reduced muscle strength, and COGNITIVE CHANGES SUCH AS MEMORY PROBLEMS AND DIFkCULTY doing more than one thing at a time. Liver function may be affected if taking tablet forms of ADT and some men gain weight and have some breast development and/or sore nipples.

Weight-bearing exercises such as walking, jogging, climbing stairs or training with weights can help to improve muscle and bone strength for men on ADT.

vanced prostate cancer What is castrate-resistant prostate cancer?

How is the pain from castrateresistant prostate cancer managed?

Most prostate cancers will shrink or stop growing with ADT because it stops testosterone being made in the testes.

However, after some time, which is different for each man, the prostate cancer will start to grow again. The cancer becomes very sensitive to any remaining testosterone made by the adrenal glands and the cancer cells also make small amounts of testosterone. This is called castrate-resistant prostate cancer.

When castrate-resistant prostate cancer spreads to other parts of the body, the following treatments can help with pain and quality of life:

Measurement of PSA levels is used to monitor the response to ADT. For most men an increase in PSA levels means the prostate cancer has progressed.

How is castrate-resistant prostate cancer treated?

r External beam radiotherapy is often given for pain relief to any area of the body where the cancer has spread. r Radio-isotopes (an injectable type of radiotherapy) may be given to destroy cancer cells which have spread to the bone, and to relieve pain. Radium 223 is a modern isotope used overseas; it is being tested in clinical trials in Australia. r Bisphosphonates and other bone-strengthening medicines help to lower bone loss, bone fractures and pain. r Corticosteroids: Prednisolone or similar medicines may be given together with other pain medicines.

Castrate-resistant prostate cancer is treated in different ways and depends on many factors, including: how well the r Weight-bearing exercises can help to improve muscle and bone strength and improve well-being. man is; his other medical problems; if the cancer is causing symptoms such as pain; and where in the body the cancer r Palliative and pastoral care is important when life has spread (only in the lymph nodes or bone, or both, and/ expectancy is limited. A Palliative Care Clinician can help at or liver and lungs). this time.

Your doctor will talk to you about the different treatment r Clinical trials of new treatments are available. To be options. Men usually start with one type of treatment. approved for general use, the new treatment must show Changes to the treatment would be made if the man has a EQUAL OR GREATER BENEkT COMPARED WITH THE CURRENT bad reaction to the treatment, or if despite treatment, the treatment. Participating in a trial can offer new treatments cancer starts to grow again over time. The aim of treatment otherwise not available. However, these treatments may not is to keep a man well, lower symptoms and control the necessarily help your cancer. cancer. However, curing the cancer once it is castrateresistant and/or outside of the prostate gland is usually not possible.

No matter what treatment is chosen at this stage, GnRH blockers are used as well.

Treatment options include: r Antiandrogen tablets: There are different types of antiandrogens in use such as Flutamide and Bicalutamide.

Enzalutamide has recently become available in Australia and it may be offered to some men. It is a very strong antiandrogen that improves survival and quality of life. r Stopping antiandrogen tablets: sometimes, if the PSA level rises, stopping the antiandrogen means the PSA level will go down again. r Chemotherapy: medicines called Docetaxel or Cabazitaxel can improve survival and quality of life. r A medicine called Abiraterone acetate blocks both the adrenal glands and the prostate cancer cells themselves from making testosterone, and improves survival and quality of life.

What new treatments for advanced prostate cancer are on the horizon?

The focus of current research for improving treatments for ADVANCED PROSTATE CANCER IS TO kND OUT WHY TREATMENTS work to control cancer but then stop working (resistance). )F RESEARCHERS CAN kND OUT MORE ABOUT WHY CANCER BECOMES resistant, better treatments will be developed.

2ESEARCH IS ALSO BEING DONE TO kND OUT THE BEST combinations of the new and older treatments to help men at different stages of advanced prostate cancer, and whether some of these newer treatments could be helpful for treatment of localised prostate cancer.

For more information see ‘Prostate problems’ on the Andrology Australia website: www.andrologyaustralia.org/prostate-problems/. If you have any concerns about your prostate health, Andrology Australia recommends that you see your GP. Andrology Australia acknowledges the assistance of Dr Emma Beardsley, MBBS FRACP, Medical Oncologist Frankston Hospital, Monash Cancer Centre & Oncology Clinics Victoria for her assistance in preparation of this article.

Reprinted from The Healthy Male, the newsletter of Andrology Australia, Winter 2015. (https://www.andrologyaustralia.org/prostate-problems/prostate-cancer-treatment/)

A LITTLE BELOW THE BELT 23

Innovation & Education

ClinTrial App In July 2014 ANZUP released its first trial based App. This application was designed for the specialists but will also be a very useful tool for consumers. If you are looking for a trial for your particular cancer you can refer to either the ANZUP website or the new ClinTrial Refer.

The ClinTrial Refer ANZUP app provides a current list of all ANZUP and ANZUP co-badged clinical research trials conducted in cancer centres in Australia and New Zealand.

Designed for oncologists, general practitioners, research unit staff and patients, ClinTrial Refer ANZUP has searchable clinical research trial details, hospital locations and contacts, and inclusion and exclusion criteria.

We hope this will help the community to identify trials that might be suitable.

To download the free app, please visit: • Apple iTunes: https://itunes.apple.com/au/app/clintrial-refer anzup/id894317413?mt=8 • Google Play: https://play.google.com/store/apps/

details?id=com.lps.anzup Or go to the App/Android store and type in ANZUP

Would you like to help us?

Any donation to ANZUP over $2 is fully tax deductible. If you would like to donate to ANZUP, you can donate through our website www.anzup.org.au or by calling ANZUP on +61 2 9562 5033.

100% of every donation made to ANZUP goes towards producing a clinical trial to improve the treatment of bladder, kidney, testicular and prostate cancers.

DONATE NOW

24 A LITTLE BELOW THE BELT

Current anzup trials If you would like to know more about any of these trials please discuss it with your GP or specialist

Ask questions

Questions you may consider if you participate in a clinical trial If you are thinking about taking part in a clinical trial, here are some important questions to ask: l What is the purpose of the study? l What does the study involve? What kinds of tests and treatments? (Find out what is done and how it is done) l What is likely to happen to me with or without this new research treatment? What could the cancer do and what could this treatment do? l What are my options and what are their advantages and disadvantages? l Are there standard treatments for my case and how does the study compare with them? l How could the study affect my daily life?

l What side effects could I expect from the study?

(There can also be side effects from standard treatments and from the disease itself) l How long will the study last? Will it require an extra time commitment on my part? l Will I have to be hospitalised? If so, how often and for how long? l Will I have any costs? Will any of the treatment be free? l If I am harmed as a result of the research, what treatment would I receive? l What type of long-term follow-up care is part of the study?

A LITTLE BELOW THE BELT 25

About clinical trials

ASK THE DOCTOR –Testicular Cancer Excerpt from: Andrology Australia Fact Sheet: Testicular cancer www.andrologyaustralia.org

How is testicular cancer treated?

The treatment options for testicular cancer depend on the type and stage. An orchidectomy (surgical removal of the affected testis) is the first stage of treatment for all suspected cases of testicular cancer. The removed testis is then sent to a pathology laboratory to confirm the stage and type of cancer. In recent years, surveillance (careful monitoring) has become a more popular option after orchidectomy for localised testicular cancer. This is where the man is checked regularly to assess whether the cancer has moved elsewhere in the body, including the other testis.

Chemotherapy or radiotherapy may be given after surgery to kill off any cancer cells that may have spread to other parts of the body. The level or amount of chemotherapy and radiotherapy will be different for each man and will depend on the stage and type of cancer. The doctor will look at each case individually to assess the chance of the cancer moving from the testis before deciding on the best treatment.

What are the short-term side effects of treatment?

Most side effects of radiotherapy and chemotherapy are short-term and can be minimised with other treatments.

Short-term side effects of testicular cancer treatments

Radiotherapy

Chemotherapy

• Temporary hair loss within the area of treatment that usually grows back once treatment stops

• Temporary hair loss

• Bowel upsets or diarrhoea happen rarely

• Kidney damage • Tinnitus (hearing loss/ringing in the ears) • Neuropathy (nerve damage) with decreased sensation or numbness in hands and feet • Bone marrow suppression leading to a lower white cell count that may cause an increase in infections, and sometimes anaemia (low blood red cell count) • Inflammation of the gums, possibly with mouth ulcers • Inflammation and scarring in the lung after chemotherapy using bleomycin

26 A LITTLE BELOW THE BELT

What follow–up is needed after testicular cancer treatment?

Follow-up and ongoing health checks by qualified health professionals are important after surgery, radiotherapy and chemotherapy, to make sure the cancer has not returned.

Check-ups may include physical examination, blood tests, X-rays and scans, and continue for at least 10 years after treatment. If any new symptoms appear between check-ups, it is important to see a doctor straight away.

Does testicular cancer treatment affect sexual function?

Many men find that testicular cancer and its treatment do not affect their sexual performance in any way. However, the stress and anxiety of cancer can affect sexual function. Concerns about changes in body image may also cause sexual problems and anxiety.

What are testicular implants?

Testicular implants are prostheses or artificial devices made of moulded silicone and filled with a salt solution. Some men choose, for cosmetic or psychological reasons, to have testicular implants during or after cancer treatment to give the scrotum a normal appearance. The implants serve no physiological function and the decision to have one inserted is a very personal choice.

Can testicular cancer cause infertility?

Cancer in a single testis may not affect the chance of having children. After a cancerous testis is removed, in many men the remaining testis continues to make testosterone and sperm.

However, some men who have had testicular cancer may have trouble having children. Men who are diagnosed with testicular cancer are more likely to have lower fertility before any treatment starts. Fertility can be further affected by cancer treatments such as radiotherapy and chemotherapy.

Why is sperm storage important?

All men who are going to have chemotherapy or radiotherapy should speak to their doctor about their fertility before treatment begins. It is highly recommended that men produce semen samples (through masturbation) for sperm storage (also known as sperm banking). Sperm storage should take place before chemotherapy or radiotherapy starts. Semen can be frozen, using special equipment, and stored long-term for future use. If a man wants to father a child at a later stage, the frozen semen is thawed and used in fertility treatments such as IVF (in vitro fertilisation). Modern IVF treatments can be successful with just a few moving sperm.

Expert reviewer Dr Gideon Adam Blecher MBBS (Hons), FRACS (Urol) Western Health, Melbourne Date reviewed: August 2014

Clinical trial phases The National Health and Medical Research Council defines the phases of trials as: Phase IV Phase III

studies are done to study the efficacy of an intervention in large groups of trial participants (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions (or to non-interventional standard care) as well as to monitor adverse effects and to collect information that will allow the intervention to be used safely.

studies are done after an intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use over longer periods of time.

Phase I

clinical trials are done to test a new biomedical intervention for the first time in a small group of people (from 20 up to 80) to evaluate safety (e.g. to determine a safe dosage range and identify side effects).

Phase II

clinical trials are done to study an intervention in a larger group of people ( up to several hundred) to determine efficacy (whether it works as intended) and to further evaluate its safety.

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About clinical trials

ASK THE DOCTOR – Considering a Clinical Trial Questions you might want answered when you consider a clinical trial.

During clinical trials, researchers collect information using proven scientific methods. This means that the results of a study are as trustworthy as possible. However, all clinical trials are different and you should be as well informed about the research as possible before taking part.

When you start a clinical trial, the research team will provide you with a lot of new information on the Patient Information Consent Form (see the Ray Allen article). The research team will talk you through this information which will also be written down for you to take away and digest. The information may include details on treatment or testing procedure, as well as dates and times of any hospital or clinic visits. You will also be provided with contact details for your research team.

You can contact the research team if you have any questions or concerns at any time during the clinical trial.

It is natural that you will have a lot of questions about a clinical trial - and about what it might mean for you. You can discuss your questions with your doctor and the research team.

You may also find some of the answers in the participant information sheet and consent form. These written documents are provided to you at the start of the clinical trial.

When thinking about questions to ask your doctor or the research team, the following tips might be helpful: • Write down your questions in advance to make sure you remember them; • Write down the answers you get, too, so you can go back to them whenever you want to; • Take family, whānau, or a friend along with you for support, and to help ask questions.

Remember, too, you can ask your doctor and the research team questions at any time during the clinical trial. Here are a list of questions you may like to consider: About the clinical trial • What is the aim of the clinical trial and how will it help people?

• Has the treatment been tested before and, if so, what was the result?

• Will the clinical trial use a placebo or a ‘dummy’ treatment?

• Who is funding the trial?

About your involvement in the clinical trial • How might this trial affect my daily life?

• How much of my time will be needed?

• What kinds of tests and procedures are involved?

• Will I have to complete questionnaires or keep a diary?

• Will I need to spend time in hospital?

• Will I need to take time off work or school?

• Where will the trial be conducted?

• Will I have to travel to be involved?

• Will I be able to take my regular medication or treatments while taking part in the trial?

• How long is the trial expected to last?

• How long will I have to be part of it?

• What will happen if I stop the clinical trial, or leave before it ends?

• Who will be in charge of my care?

• Who can I contact for support and information during the clinical trial?

• Will someone be available 24 hours a day?

About the possible risks • What are the risks of taking part in this clinical trial?

• What are the possible side effects of the treatment being tested?

• How do the possible risks, side effects and benefits in the trial compare with my current treatment or care?

• If people receiving one treatment in the trial respond much better than people receiving the other treatment, will all participants be given access to the more effective treatment?

About the costs • Who will pay for the treatment being used in the clinical trial?

• Will I be paid to participate?

• Will my expenses, such as travel, be covered?

• If there are complications arising from the trial, who is responsible for paying for any costs associated with them?

About what happens after the clinical trial • What follow-up care is available after the trial?

• How long will it be before the results are known?

• How do I find out the results?

• Will I have access to the treatment after the trial if I wish to continue with it?

Information provided by Health NZ. Reproduced with permission.

For further information http://clinicaltrials.health.nz/about-trials-in-new-zealand/participants/what-happens-in-a-clinical-trial/

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Where do new trial ideas come from?

Concept Development Workshops

A new initiative for ANZUP in 2014 was the successful introduction of our two Concept Development Workshops (CDW). The second of these took place in Sydney in 2015 as a result of the funds provided by the Below the Belt Pedalthon and the generosity of Mrs Ann Waterford.

CDWs have been used successfully by the ANZ Germ Cell (testicular and ovarian) Trials Group (one of ANZUP’s forerunners) and other cooperative trials groups to initiate and develop trial concepts that subsequently resulted in successful and important clinical trials. ANZUP has wanted to introduce CDWs but lacked the financial resources to do so until this year.

There are three major components to CDWs: 1)

All members were invited to submit a brief concept to be considered for discussion at the CDW. The aim was to encourage members to consider new proposals and submit an idea. This can be helpful for concepts that require broad feedback or further refinement. Younger members (trainees for example) can also find this process rewarding.

2) Presentation of submitted concepts to a multidisciplinary group at the CDW including senior investigators, statisticians, clinical trials centre (CTC) staff and consumers. The resulting discussion is often wide-ranging but aims to define clear “next steps”, which might include forming a working party to create a protocol or re-define the concept with the help of newly identified collaborators.

ANZUP wishes to acknowledge and thank the very generous contribution of Mrs Ann Waterford. Mrs Waterford has made an annual donation to ANZUP in memory of her husband, Dr Waterford.

This donation supported the inaugural bladder cancer CDW as well as bringing ANZUP members to a bladder cancer meeting immediately prior to this year’s ASM in Melbourne. It is only though the generosity of donors such as Mrs Waterford that ANZUP can support our members in coming together to work on concepts and ideas that will see improvement in treatment and outcomes for those affected by bladder and other urogenital cancers.

3) An opportunity for the assembled group to brainstorm – considering gaps in current knowledge and new opportunities for studies.

The CDWs are not intended to replace existing opportunities to submit a concept to any of the sub-committees, or the brain-storming sessions held at ASM. Rather, we hope the CDWs will offer an additional opportunity for concept development, encouraging participation from the breadth of our membership while fostering multi-disciplinary collaboration.

ANZUP plans to hold future CDWs hopefully as an annual event. There are opportunities to expand the workshops by, for example, allowing a full day rather than half day for each type of cancer. Options to improve the workshop format will be based on feedback from the membership after this year’s inaugural events.

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Dr Craig Gedye discusses the recent renal (kidney) Concept Development Workshop

Cancer treatment has improved dramatically in the past two decades; the chance of a cure has risen from around a half to twothirds of all people suffering cancer. This improvement has come mostly from early detection and better treatment during and after surgery. For many patients, however, diagnosis reveals the cancer has already spread, or they are unlucky and the cancer returns despite good treatment. Treating cancer that has spread is a more complex and challenging problem for patients and their doctors.

The improvements seen in recent years for kidney cancer that has spread have come from two new kinds of treatment. For decades, we have had three traditional cancer treatments: knife, fire and poison, otherwise known as surgery, radiation and chemotherapy.

The two entirely new treatments are Keys and Kung-Fu. "Keys" are drugs, usually taken in tablet form; drugs that have been specifically designed to fit "locks" inside cancers. In this analogy, the locks are critical tools that the cancer uses to grow. As only certain keys fit certain locks, only certain drugs help certain cancers. In this case there is a family of drugs that block the blood vessels that grow to support kidney cancer, or that affect the way that kidney cancer cells can use fuel.

"Kung-Fu" is the newest form of cancer treatment: immunotherapy.

Like chemotherapy, immunotherapy is given as an infusion into veins. But the similarity ends there. Where chemotherapy can suppress the immune system, immunotherapy works to unleash it. Where chemotherapy works (or doesn't work) relatively quickly, immunotherapy often takes weeks or months to work. The side effects of immunotherapy can also be very subtle and slow.

Immunotherapy has had the most impact in melanoma, and is only just beginning to be used in kidney cancer.

While these new treatments are helping patients with advanced kidney cancer, many questions remain about how to get the best out of old and new treatments, both in terms of benefit improvement and minimisation of their side effects. There are also many unanswered questions around who benefits from surgery (there may be some patients with small kidney cancers that do not need an operation urgently), and what kind of treatment might help stop kidney cancer recurring after surgery.

30 A LITTLE BELOW THE BELT

ANZUP holds the unique position in Australia and New Zealand of bringing together kidney cancer health care workers to try to find new ways of proving the efficacy of these treatments. The only way to be sure a new treatment is effective, or that there are benefits in a new way of delivering an existing treatment, is by performing a clinical trial. Clinical trials are complex and expensive to run, so team work is essential. Many of the questions most important to patients and doctors may not have been answered during the development of a drug and its being put on the market.

The best forum for discussing these clinical trial ideas are concept development workshops. In a peer support environment, we can discuss, debate and pull apart ideas before developing them further.

There so many factors to consider in the development of a clinical trial that it is only with the beneficial input of all team members (for example surgeons, radiation specialists, medical oncologist, nurses and psychologists), that we can polish and improve a raw idea to the point where it can become a trial for the benefit of patients.

ANZUP holds concept development workshops once or twice annually, and these workshops are vital to the development of trials, and the development of our team members to learn the intricacies of clinical trial development

Current ANZUP trials

Bladder Cancer BCG + MMC

BL12

Trial will assess efficacy of adding MM to BCG

Search for more effective urothelial cancer drugs

Non-muscle invasive bladder cancer is common and causes substantial suffering. Despite best current treatment, it requires removal or irradiation of the bladder within five years in more than 30 per cent of people with high-risk tumours.

Urothelial cancer occurs in specialised cells seen in the urinary system: the kidney, the bladder and associated structures such as the ureters which connect the kidneys to the bladder.

A new treatment called Nab-paclitaxel is being studied for use in urothelial cancer. It will be compared with paclitaxel, which is currently one of the chemotherapy drugs used as standard for this type of cancer.

Recent preliminary studies show promising results from adding MM (mitomycin C), a chemotherapy drug, to current treatment with BCG (bacillus calmette-guerin – a strain of modified bacteria that stimulates an immune response to early cancer cells).

This randomised trial will determine the effects of adding MM on cure rates, survival, side effects and quality of life.

This could potentially provide a simple and cost-effective treatment for patients who suffer from this cancer. Earlier in the year there was a worldwide shortage of the BCG but, fortunately, this has not affected the trial significantly; we are able to continue to get supplies to ensure the trial can continue.

It is anticipated that 500 patients will be enrolled in the study in Australia and New Zealand. To date 61 patients have been recruited from 13 sites.

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. aspx?page=trials-bladder ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).

Current site locations for the BCG + Mitomycin trial are: NSW • Concord Repatriation General Hospital • Northern Cancer Institute • Sydney Adventist Hospital • Tweed Hospital • Westmead Hosptial VIC • Austin Health • Box Hill Hospital • Footscray Hospital • Frankston Hospital • Monash Medical Centre • Royal Melbourne Hospital • The Alfred Hospital • Western Hospital WA • Fiona Stanley Hospital

Research is needed to identify more effective treatment after urolithelial cancers become refractory to prior chemotherapy agents. Nab-Paclitaxel is a formulation of the chemotherapy drug paclitaxel which is combined with a human protein albumin.

Potentially, the different formulation creates a less toxic and more effective drug in the treatment of urothelial cancer. Nab paclitaxel is currently approved in Australia for use in metastatic breast, lung and pancreatic cancer.

Neither drug has been approved in Australia for use in urothelial cancer. The aim of the study is to see if nab-paclitaxel can improve outcomes for patients with urothelial cancer that has progressed.

Approximately 100 participants from 27 Australian sites will take part.

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. aspx?page=trials-bladder ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC) and the NCIC (Canada).

Current locations for the BL12 trial are: NSW QLD • Calvary Mater, Newcastle • Townsville Cancer Centre • Concord Cancer Centre • Nambour General Hospital • Prince of Wales Hospital • ICON Cancer Centre • Port Macquarie Base Hospital • Liverpool Hospital • Northern Cancer Institute SA • Ashford Cancer Centre • Flinders Medical Centre

TAS • Royal Hobart Hospital

VIC • Epworth Healthcare (Richmond and Freemasons) • Peninsula Health Frankston Hospital • St Vincent’s Hospital Melbourne • Sunshine Hospital • Eastern Health (Boxhill) • University Hospital Geelong • Border Medical Oncology, Murray Private Hospital Albury Wodonga Health Albury • Ballarat Base Hospital • Peninsula South Eastern Haematology and Oncology Group WA • Fiona Stanley Hospital

A LITTLE BELOW THE BELT 31

Current ANZUP trials

Testicular Cancer/ Germ Cell Tumours P3BEP Phase III Accelerated BEP Trial is seeking new recruits The current standard practice for the treatment of germ cell tumours is the use of the chemotherapy combination called BEP, consisting of three chemotherapy agents Bleomycin, Etoposide and Cisplatin – administered on a three-weekly cycle. BEP is given with a drug called pegylated G-CSF (or pegfilgrastim) that stimulates white blood cell production.

The purpose of this study is to determine whether giving the same dose of BEP on a two-weekly schedule will be more effective than a three-weekly schedule, and will be well tolerated. The two-weekly schedule is called “accelerated BEP” and the three-weekly schedule is called “standard BEP”.

Up to 500 patients will be enrolled in the study in Australia, New Zealand and other countries. Currently we have 29 sites open in Australia and New Zealand recruiting participants at a steady rate. We are also undergoing negotiations to set up the trial in Ireland with the support of the All-Ireland Clinical Research Group (ICORG) and the Medical Research Council, Cambridge University, UK.

Current site locations for the P3BEP ANZUP clinical trial are: ACT: • Canberra Hospital NSW • Border Medical Oncology • Calvary Mater, Newcastle • Chris O’Brien Lifehouse (RPAH) • Concord Repatriation General Hospital • Macquarie Cancer Clinical Trials • Nepean Hospital • Princes of Wales Hospital • Royal North Shore Hospital • Sydney Adventist Hospital • The Tweed Hospital • Westmead Hospital QLD • ICON Cancer Centre ( HOCA Wesley) • Princess Alexandra Hospital • Royal Brisbane & Women’s Hospital

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

SA • Flinders Medical Centre • Royal Adelaide Hospital

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. aspx?page=trials-testicular

TAS • Royal Hobart Hospital

ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).

VIC • Austin Health • Box Hill Hospital • Footscray/Sunshine Hospital • Monash Medical Centre – Moorabin • Peter MacCallum Cancer Centre • Royal Melbourne Hospital WA • Fiona Stanley Hospital (formerly Royal Perth Hospital)

*Germ Cells are the cells in the body that develop into sperm or eggs

NZ • Auckland Hospital • Christchurch Hospital • Dunedin Hospital • Palmerston North Hospital ANZUP has been awarded funding from the Sydney Catalyst Translational Cancer Research Centre for the Phase III Accelerated BEP translational sub-study. This will involve the collection of blood and tissue from participants for future correlative studies.

32 A LITTLE BELOW THE BELT

Current ANZUP trials

Prostate Cancer ENZAMET Trial to examine efficacy of stronger anti-androgen The treatment of metastatic prostate cancer (prostate cancer that has spread beyond the prostate gland to other parts of the body), starts with medications that manipulate the hormone levels in the body. Hormonal manipulation occurs in the form of injections called LHRHA (luteinizing hormone releasing hormone analogues) which are often combined with tablets called anti-androgens. These medications often work very well for prostate cancer, but only for a limited time. Eventually, the metastatic prostate cancer develops resistance to hormonal manipulation (so-called “castrate resistant prostate cancer”) and requires different hormonal therapy, or chemotherapy.

This study is designed to assess a new anti-androgen tablet called Enzalutamide. Enzalutamide is much stronger than older anti-androgens and has been shown, in international trials, to improve outcomes for men with metastatic prostate cancer. These trials have demonstrated that when men develop castrate resistant prostate cancer, Enzalutamide can decrease PSA levels and shrink or stabilise cancer that has spread to other parts of the body such as bones or lymph nodes. Furthermore, quality of life has been improved significantly.

The purpose of the ENZAMET trial is to establish if the use of Enzalutamide earlier in the course of treatment for metastatic prostate cancer may improve life expectancy and quality of life compared with older anti-androgens.

ENZAMET will be an international trial run by ANZUP in multiple centres in Australia, New Zealand, Canada, Ireland and the UK. The aim is to have 1100 participants from these countries. Participants will stay on the study drug until there is evidence of progression and will be followed for a minimum of 3.5 years from entering the trial.

To date, 39 sites have been activated and 164 patients recruited. There are currently 14 sites open in Ireland and the UK led by the collaborative group, Ireland Cooperative Oncology Research Group (ICORG). Fourteen sites have been opened in Canada led by the collaborative group, National Cancer Institute Canada (NCIC). One site is open in the USA at the Dana-Faber Cancer Institute, and negotiations are underway for further sites to be opened in Europe.

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. aspx?page=trials-prostate ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).

Current site locations for the ENZAMET ANZUP Clinical Trial: NSW • Central West Cancer Services • Chris O’Brien Lifehouse • Concord Cancer Centre • Nepean Cancer Care Centre • Northern Cancer Institute • North Coast Cancer Institute, Coffs Harbour • Port Macquarie Base Hospital – NCCI • Prince of Wales Hospital • Riverina Cancer Centre • St George Hospital • St Vincent’s Hospital, Sydney • Sydney Adventist Hospital • Tamworth Hospital • The Tweed Hospital • Wollongong hospital NT • Royal Darwin Hospital QLD • Gold Coast Hospital • Nambour General Hospital • Princess Alexandra Hospital, Brisbane • Royal Brisbane and Women’s Hospital • Townsville Hospital SA • Ashford Cancer Centre • Flinders Medical Centre • Royal Adelaide Hospital TAS • Royal Hobart Hospital VIC • Austin Hospital • Australian Urology Associates • Border Medical Oncology • Box Hill (Eastern Health) • Geelong Hospital • Goulburn Valley Health • Monash Cancer Centre – Moorabbin • Peninsula South Eastern Haematology and Oncology Group (PSEHOG) • Peter MacCallum Cancer Centre- East Melbourne • St Vincent’s Hospital WA • Fiona Stanley Hospital, formerly Royal Perth Hospital • Sir Charles Gardiner Hospital NZ • Auckland City Hospital • Waikato General Hospital

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Current ANZUP trials

Prostate Cancer ENZARAD Trial combines radiotherapy with hormone treatment Prostate cancer is often treated with powerful X-rays (radiotherapy) instead of surgery. The reasons for choosing radiotherapy or surgery are complex, and the focus of a discussion men should have with their treating doctors. We will specifically look at men whose cancers have a higher risk of return after treatment, but which have not yet shown evidence of spread outside the prostate. In this situation we are aiming for a cure, if possible, and the evidence shows this is more likely when radiotherapy is combined with hormone treatment.

This treatment is called Androgen Deprivation Therapy (ADT).

ADT is often in the form of injections called LHRHA (luteinizing hormone releasing hormone analogues) combined with tablets called anti-androgens. Enzalutamide is a new and stronger antiandrogen that has also been shown to work against prostate cancers that are resistant to other anti-androgens.

ENZARAD is a clinical trial for men with this type of prostate cancer where a decision has been made that radiotherapy is the best treatment. This trial is for those who, after discussion with their specialists, were not recommended for radical prostatectomy due to their pathology or core morbidities.

Men who have both testes removed also will not be eligible.

The purpose of the ENZARAD trial is to find out if the addition of Enzalutamide to radiotherapy, plus ADT, will increase survival in those with a prostate cancer apparently confined to the prostate but at high risk of return elsewhere.

It is an international trial run by ANZUP in multiple centres in Australia, New Zealand, Canada, Ireland and the UK. The aim is to have 800 participants from these countries. Participants will stay on the study drug until there is evidence of progression, and will be followed for a minimum of 3.5 years from entering the trial.

Current site locations for the ENZARAD ANZUP Clinical Trial: NSW • Calvary Mater, Newcastle • Campbelltown Hospital • Central West Cancer Services • Chris O’Brien Lifehouse • Gosford Hospital • Liverpool Hospital • Prince of Wales Hospital • Royal North Shore Hospital • Sydney Adventist Hospital • Tamworth Hospital • Westmead Hospital QLD • GCCQ – Tugan and Southport • GCCQ – Wesley and Chermside • Gold Coast Hospital • Mater Adult Hospital • Nambour General Hospital • Princess Alexandra Hospital, Brisbane • Royal Brisbane & Women’s Hospital • Toowoomba Hospital SA • Ashford Care Research • Flinders Medical Centre and Repatriation General Hospital TAS • Royal Hobart Hospital

To date, 34 sites have been activated with another seven Australian and New Zealand sites in the process of being activated with 136 patients recruited. There are currently five sites open in Ireland, led by the collaborative group, Ireland Cooperative Oncology Research Group (ICORG), five open in the USA, and negotiations are underway for further sites in Europe.

VIC • Austin Hospital • Box Hill (Eastern Health) • Epping Radiation Oncology Centre • Epworth Healthcare - Richmond • Frankston Radiation Oncology Centre • Peter MacCallum Cancer Centre (East Melbourne) • Peter MacCallum Cancer Centre (Moorabbin Campus) • Ringwood Radiation Oncology Centre • Western Radiation Oncology Centre, Footscray

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

WA • Fiona Stanley Hospital

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. aspx?page=trials-prostate

NZ • Christchurch Hospital • Auckland City Hospital

ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC) and the Trans-Tasman Radiation Oncology Group (TROG).

34 A LITTLE BELOW THE BELT

Current ANZUP trials

Prostate Cancer RAVES Trial will compare different approaches Radical prostatectomy is the most common curative approach offered to men with newly-diagnosed prostate cancer. Unfortunately, up to half these patients will have factors placing them at high risk of cancer recurring.

Undergoing radiotherapy after an operation is known to improve care rates; what is not known is whether it should be given immediately after the operation or only if PSA rises after surgery indicating active cancer.

Immediate radiotherapy may not benefit all men and can cause serious side effects such as bladder problems and impotence.

International lack of consensus on the optimal timing of radiotherapy has resulted in varied clinical practice.

This Trans-Tasman Radiation Oncology Group (TROG) led Phase III trial, in collaboration with ANZUP and USANZ, will compare the two approaches.

If radiotherapy at recurrence results in equivalent outcomes and improved quality of life, it would become the standard treatment.

A total of 470 men from Australia and New Zealand will participate. There are currently 332 participants registered.

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. aspx?page=trials-prostate

Current site locations for the ENZAMET ANZUP Clinical Trial: NSW • Calvary Mater Newcastle • Campbelltown Hospital • Central West Cancer Centre • Liverpool Hospital • Nepean Hospital • Port Macquarie Base Hospital • Riverina Cancer Care Centre • Royal North Shore Hospital • Royal Prince Alfred Hospital • St George Hospital • St Vincent's Clinic • Sydney Adventist Network: Gosford and Wahroonga • Westmead Hospital QLD • Genesis Cancer Care Queensland • Nambour General Hospital • Princess Alexandra Hospital • Radiation Oncology Mater Centre • Radiation Oncology QLD: Gold Coast • Royal Brisbane & Women's Hospital • Toowoomba Cancer Research Centre • Townsville Hospital VIC • Alfred/William Buckland • Austin Health • Peter MacCallum Cancer Centre - East Melbourne • Peter MacCallum Cancer Centre - Moorabbin WA • Fiona Stanley Hospital • Perth Radiation Oncology • Royal Perth Hospital • Sir Charles Gairdner Hospital NZ • Auckland City Hospital • Auckland Radiation Oncology • Christchurch Hospital • Dunedin Hospital • Palmerston North Hospital • Waikato Hospital • Wellington Hospital

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Current ANZUP trials

Prostate Cancer Pain free TRUS B A phase 3 double-blind placebo-controlled randomised trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasound-guided prostate biopsy (“Pain Free TRUS B”, ANZUP 1501) A prostate biopsy involves taking small pieces of the prostate through a needle so that it can be looked at through a microscope. A TransRectal UltraSound (TRUS) guided biopsy is the usual way of performing a biopsy and involves inserting a thin needle through the wall of the rectum into the prostate using the guidance of an ultrasound probe. An injection of a local anaesthetic (lignocaine) around the prostate is the standard method of reducing the discomfort of a prostate biopsy.

Methoxyflurane (Penthrox®) is a drug given with a simple inhaler and is widely used by First-Aid services to reduce pain. This randomised trial will determine if the discomfort of prostate biopsies can be reduced by giving men inhaled methoxyflurane in addition to their standard injections of local anaesthetic.

This study will include 420 men.

ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHRMC CTC).

36 A LITTLE BELOW THE BELT

We acknowledge MDI for the provision of Penthrox®.

Current locations for the Pain Free TRUS B trial are: WA • Fiona Stanley Hospital

v

THANK YOU

Fundraising Champions

Thank you to every member and supporter of Bec’s Troops.

The Sunday Age City2Sea was held on November 15 in Melbourne. Once again, Belinda Jago and the Bec’s Troops team brought friends and family to the race for a great day of fun and friendship. Together they walked and talked while surpassing their amazing target of $10,000 in donations. We thank them kindly for all their hard work to assist ANZUP’s ongoing research.

A LITTLE BELOW THE BELT 37

2015 Watch the video

38 A LITTLE BELOW THE BELT

Announcing the inaugural Below the Belt Research Fund The 2015 Below the Belt Pedalthon was a huge success. The great effort of all those involved in raising funds allowed ANZUP to launch the Below the Belt Research Fund. The goal of the new fund is to create a pipeline of new ideas to keep trial momentum moving forward. Up to $150,000 will be made available for up to four successful, investigator initiated studies.

A grant panel was appointed by the ANZUP Scientific Advisory Committee to assess the applications and will include consumer representation. Applications will be assessed to consider scientific excellence, significance and/or innovation, feasibility, alignment with goals and objectives of ANZUP and potential to leverage additional funds.

Applications for 2015 were opened in late October and we saw an excellent response with 18 applications submitted by ANZUP members.

Applicants were due to be notified in December with funds potentially made available to projects in January 2016.

Successful Applications Dr Claudia Rutherford and Dr Manish Patel - Development and pre-testing of a patient-reported symptom index for clinical trials of treatments for non-muscle invasive bladder cancer.

Dr Ben Smith - e-TC 2.0: Further development of an online psychological intervention for testicular cancer survivors.

Dr Carmel Pezaro - Defining Primary Resistance to Chemohormonal Treatment with Docetaxel in Men with Metastatic Hormone-Sensitive Prostate Cancer: a preliminary biomarker cohort study.

50 teams registered to ride, including community teams.

$150,000

330 riders took to the track

100 per cent of donations made to riders is committed to the Below the Belt Research Fund A LITTLE BELOW THE BELT 39

With thanks to our sponsors

With thanks to our teams

2.2 visual identity logo

The master logo uses the logo within a Tab device to give it more presence.

1. Preferred logo – Reversed Logo in Tab lock up The Reversed Logo in Tab is the 'go to' logo for all of the Clayton Utz communications. The logo is reversed out of a black Tab. 1.1 Logo in Tab lock up relationship Never change the relationship or the proportions of the Logo in Tab device.

The minimum amount of clearspace around the logo within the Tab should be equal to the size of the 'O' from Clayton Utz. For more information on how the Tab logo lock up works in conjunction with the graphic device see page 11.

1.2. Logo in Tab lock up clear space To allow maximum impact for the Tab lock up when it appears alone, we have determined clear space rules.

"X" equals the height of the Tab. Please ensure that other graphic elements do not fall within this area.

1.3 Logo in Tab lock up minimum size To ensure legible reproduction of our Tab lock up, the minimum width is 20mm. See table showing logo size requirements based on communication format.

2. Master logo Occasionally the logo will be used on its own, the logo should be used in Black or White reversed out of a contrasting background.

2.1 Master logo clearspace Please ensure that appropriate clearspace is used around the logo to allow it to breathe. The clear space is equal to two 'Os' from Clayton Utz.

Formats and Variations 1. Preferred logo – Reversed in a Tab lock up

2. Master logo

1.1 Logo in Tab lock up relationship

2.1 Master logo

2.2 Master logo minimum size The master logo should not be used smaller than 15mm in width.

Notes:

► Do not re-create the logo ► Artwork in Black, Mono, CMYK

► ► ► ►

and RGB can be obtained from production@claytonutz.com or from R:\National\Clients & Markets\ Brand Guidelines\Logos All InDesign templates contain the logo in its correct position The logo can be auto-inserted into Word documents via Insert_ CU logo Only use the logo files provided For examples of how the logo works in practice see Section 5 – Applications Examples and Specifications.

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1.2 Logo in Tab lock up clearspace 2.2 Master logo minimum size 15mm

1.3 Logo in Tab lock up minimum size 20mm

Logo size based on communication format DL

30mm

A6

35mm

A5

40mm

A4

50mm

A3

98mm

Business card

30 mm

Overview of the day Thank you to the record-breaking 50 teams who competed in the 2015 Below the Belt Pedalthon. Thanks also to our wonderful sponsors, Gresham and Thomson Geer Layers.

Thanks also to our very generous supporters who provided products and themselves!

Community Teams • BMX Bandits • The Cousins • Concorders • Cyclepaths • Pedal to the Medal • Has Beans • Has Beans No Longer • Networkers • NSW Pollies – The Hon. Niall Blair MLC and Matt Kean MP • Speed Dealers • The BBQ Chickens • The Tutus • You Pace or Mine?

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Thank you for making the Below the Belt Pedalthon such a huge success Firstly, thank you to Simon Clarke for his vision in creating the Below the Belt Pedalthon and for his commitment to helping ANZUP achieve its mission through this extraordinary charity bike ride.

To every rider who joined us at Eastern Creek with such great esprit de corps and willingness to help the cause, we say THANK YOU! To our wonderful sponsors, Gresham Partners and Thomson Geer Lawyers – thank you for helping us continue this event into its second successful year and for your dedicated participation and support. Thank you also to our wonderful pro-bono supporters, Active Display, AFI Branding, Etixx, Lion Co. and Trek.

Kent Williams and his Entoure team ensured the smooth and safe running of the day.

The competition was intense for some and a whole lot of fun for others, all in support of Simon and his desire to raise awareness about the importance of clinical trial research into testicular, prostate, kidney and bladder cancer. We hope all our riders now have a greater understanding of these cancers and will look out for themselves and their loved ones.

We extend our gratitude to the Hon. Niall Blair, MLC, NSW Minister for Primary Industries, and Minister for Lands and Water, for his terrific effort with the NSW Pollies team.

Minister Blair delivered a personal message to Simon and the Pedalthon team during the awards presentation. He also thanked all the participants on behalf of the Premier.

Thanks also to Mr Matt Kean MP, Member for Hornsby and Parliamentary Secretary for Treasury who also rode a great race!

Professor Ian Davis, Chair of ANZUP, was also an integral part of the day and was overwhelmed by the support and commitment shown by every rider, the sponsors, and the friends of riders.

Read more about Professor Davis’s major announcement.

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Thank you to our wonderful volunteers at registration, set-up, clean-up, jersey swap station, raffle ticket tables and at the award ceremony. These volunteers – friends of ANZUP, Origin Energy and Pfizer Oncology gave up their day to ensure you had a great day. Thank you to each of the volunteers and those who have worked behind the scenes for the past year.

The Subaru NSWIS Men’s road development team and the Subaru NSWIS NKC women’s team joined us once again to help keep pace and help out if you were having a “moment” or technical difficulties. Our NSWIS NKC women’s riders were great company for our riders and their expertise certainly added gravitas to the cycling. Thanks to Brad McGee OAM, Ben Kersten, Brad Macdonald and Kaarle McCulloch for the passion and commitment they gave to Pedalthon.

We have been truly blown away by the success of the day. Thank you again to everyone involved and for joining us in the celebration of awareness. Through your efforts we continue to make a difference and really are humbled by each of your contributions. See you all September 20 next year!

Where does the money go?

On race day, Professor Ian Davis stood in front of the gathered, exhausted cyclists and proudly announced the inaugural Below the Belt Research Fund.

FUNDRAISING HEROES Once again Clayton Utz blew the fundraising off the track.

Congratulations to the ALL GIRLS team - Sonia Goumenis, Emma Covacevich, Linda Evans and Katie Paull - who raised a massive $16,045. There was also an outstanding individual effort by our highest individual fundraiser Martin

Barry from La Trobe Financial who brought in $6584.

Martin rode with the Clatyon Utz Guest’s team. Great work Clayton Utz and thank you for once again being the highest fundraisers. Two years in a row! Will it be a three-peat?

The Clayton Utz All Girls Team: Katie Paull, Emma Covacevich, Sonia Goumenis and Linda Evans. Image: Getty Images

Martin Barry, out in front on the track and on the fundraising board. Image: Getty Images.  A LITTLE BELOW THE BELT 43

CHAMPIONS OF THE TRACK Congratulations to the men at Custom Creative. Winners last year, they backed up in 2015 with a strong return to the Eastern Creek track. They are the 2015 Below the Belt Champions.

2014 and 2015 Champions, Custom Creative: Simon Ball, Dan Bessant, Steve Schenko, Matthew Smithson, Shaun McManus and Brian Appleyard. Image: Getty Images

Top Fundraisers - Individuals

Top Fundraisers - Teams

1. Martin Barry 2. Emma Covacevich 3. Sonia Goumenis 4. Cilla Robinson

1. Clayton Utz “All Girls” 2. Team Gilbert & Tobin 3. Team Clayton Utz Guests

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Announcing the NSWIS NKC Partnership The National Road Series women’s cycling team, Subaru NSWIS NKC, will partner with ANZUP in 2016 in an attempt to improve the profiles of both entities in their respective communities.

Cancer touches all of us and the girls are keen to help by leveraging cycling nationally to promote awareness about clinical trial research.

The Subaru NSWIS NKC team kit will feature the ANZUP logo. Thanks to NSWIS, NSWIS NKC and the girls for their support. We will be watching the team as they compete on the road to Rio 2016 and look forward to seeing them at Eastern Creek straight after the Olympics, on Tuesday 20 September.

Brad Macdonald, Ash Ankudinoff, Mark Simons, Hollee Simons, Andrew Smith, Alicia Macdonald Image: Getty Images

Olympic Watch.

Riders at the Below the Belt Pedalthon may not have been aware that they were cycling with current and future Olympic greats. Ashlee Ankudinoff joined us on race day and is a current Australian team pursuit world champion. Ash is hoping to and is likely to represent Australia at Rio.

making it to Rio. Her team won gold at the meet.

Also riding alongside participants was 20-year-old Alicia Macdonald, the most improved rider in the current Subaru NSWIS NKC women’s 2015 team. Amazingly, she is also a radiography student at Newcastle University.

Ash is also the current NSW road time trial and national omnium champion. She has been a two-time world champion as a junior and once as a senior/elite. Ash’s achievements in cycling are way too many to list here, but she is a hard working dedicated athlete.

Alicia has fought back from adversity since 2010 when she broke her neck and left arm. Despite missing years when she could have further developed her skills, she is now part of the women’s NRS peloton. Alicia loves track endurance racing and holds a number of state track medals in individual pursuit and points racing. She has also been Top 5 in State Criterion and Sydney road titles this season.

Ash is currently focused on track endurance but is also an awesome road athlete and should be able to look at a career on the road after her track career is over.

Ash’s results from the recent UCI Track World Cup held in Cambridge NZ, stand as testament to her commitment to

Alicia hopes to represent NSW at the National track championships in 2016 and continue to improve to Top 10 status in NRS races in the future.

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By Cycling Australia – Gold and Silver for BTB NSWIS riders.

The Australian Track Team claimed a five medal haul of two gold, two silver and one bronze on day two of competition at the New Zealand leg of the UCI Track World Cup Series.

World champions Ashlee Ankudinoff and Amy Cure teamed with Isabella King and Georgia Baker to claim gold in the team pursuit, with dual 2015 world champion Annette Edmondson part of the qualifying line up.

Stephanie Morton claimed two silver medals; first in the team sprint with Kaarle McCulloch and then in the sprint.

Having qualified second fastest, Kaarle McCulloch and Stephanie Morton claimed silver in 33.200secs, just behind the 32.682secs of world champions China. It is the second consecutive silver medal in the event for Morton and Australia after she partnered with Anna Meares in Cali last month.

Cycling Australia. Published online http://www.cycling.org.au/ News/All-News/five-medal-haul-team-pursuit-double-gold-at-attrack-world-cup-in-nz December 3, 2015.

Clayton Utz All Girls team rider and top notch fundraiser Emma Covacevich travelled all the way from Brisbane to race in the 2015 Pedalthon. We caught up with her for a few quick questions about her experience.

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TALES FROM THE TRACK Clatyon Utz Brisbane Partner, Emma Covacevich.

When did you leave Brisbane for Sydney?

I left Brisbane at 7am on Monday 31 August for the Tuesday ride.

I was happy to work from the Clayton Utz Sydney office for the day on Monday and catch up with colleagues and clients.

Where did you stay?

Radisson on O’Connell Street. A couple of other riders who had travelled across from Melbourne were also staying there.

Did you fly straight back after the ride?

That would have been far too exhausting! I stayed in Sydney on Tuesday evening and flew back to Brisbane on Wednesday at 4pm. I also used Wednesday morning as an opportunity to meet with clients.

Was it a smooth trip overall?

Yes, it was surprisingly easy! I had nightmares about how logistically difficult it might be to check my bike in at the airport, but it was quite easy. There were no hiccups to the trip itself.

Did you bring your bike with you?

Yes. I borrowed a bike bag from a friend, checked it in at the airport with no-fuss (flying Virgin), and then caught a station wagon taxi to my hotel in Sydney when I arrived. Ditto on the way home.

Any challenges or funny stories?

The two Clayton Utz teams ordered team jerseys. There were a few mix-ups with sizes and it is fair to say they weren’t made to the right measurements! Mine was a little tighter than I would have liked. The bike ride itself was surprisingly easy – I had done very little training, so expected it to be quite arduous, but the time passed quickly, especially with the support of the NSWIS team to ride along and chat with us. In terms of challenges – upon arriving home on Wednesday night I had a moment of triumphant independence and thought I could carry the bike in the bike box into the house without the assistance of my husband. However my tired body had a different opinion. When I lifted the bike bag out of the car I did hurt my back and ended up having a few days in bed to recover. There is a lesson in that…

Would you do it again?

Absolutely!! What a great event for a great cause. It catered for all levels.

Describe your overall experience of travelling to compete at Pedalthon with your team?

Other than the small matter of my back (which was entirely my own fault!), it was surprisingly easy to get down to Sydney with the bike and out to the track - a great day with great company, for a really great cause. Very fulfilling, not to mention I was quite chuffed that I managed to get through the three hours!

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TALES FROM THE TRACK Pfizer rider Naushad Mistry

What if you hadn’t been on a bike since you were a child and then decided to ride a couple of hundred kilometres?

What if that caused you to reflect on the fact that your grandparents were Olympic cyclists?

Pfizer Pedal Pushers Mark II (L-R) Steve Nielsen, Cameron Dodds, Naushad Mistry, John Paul Pullicino, Greg Dunn, Linda Corrigan. Image: Getty Images

This is the story of Naushad Mistry, Brand Manager for Pfizer Oncology and Below the Belt Pedalthon participant. Naushad’s grandfather and grandmother were both champion cyclists in India which, for his grandmother, was extremely unusual for a woman in the 1930s. In 1938, Naushad’s grandfather defeated two cyclists from Great Britain who stopped off in Bombay while on their return to the UK by ship after the Empire Games in Sydney. One of the British riders was a bronze medallist at the Sydney games and the Berlin Olympics in 1936. These efforts led to Naushad’s grandfather being sponsored to the World Road Racing Championships in Valkenburg in the Netherlands later that year. World War II subsequently erupted putting world sporting events on hold. At age 36, Naushad’s grandfather represented India in the 1948 Olympic Games in London in the road race. He also competed in the Warsaw-Berlin-Prague “Peace Race” in 1954.

Naushad’s mother and uncle were both national cycling champions in India. However, when his mother migrated to Australia in 1967 and asked for an Australian equivalent of the UCI racing licence at the velodrome in Melbourne, the official refused her! She asked: “Is it because I am Indian?” The official replied: “No, it’s because you’re a woman!” How things have changed.

Despite coming from a cycling family, Naushad preferred playing AFL, cricket and athletics and hadn’t ridden an adult bike until two years ago when he bought bikes for his young family to enjoy the outdoors together. Suffering from a chronic knee problem since a debilitating Aussie Rules incident more than 20 years ago, Naushad had been unable to engage in cardio exercise … until now! Discovering the joys and benefits of riding a bike which actually strengthened his weakened right knee and leg, Naushad signed up for the Pedalthon, putting in an amazing effort on the track.

Training for and riding in the Pedalthon forced Naushad to engage in physical activity the like of which he hadn’t done for 20-something years. With a personal goal of riding 40 km, he was thrilled with the 63 km he achieved during the challenge.

Encouraged to increase his activity levels by his exciting experience with Pedalthon, Naushad is now looking to buy a new road bike for himself and is already gathering his Pfizer Pedal Pushers Mark II team for the 2016 event.

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Left photo - Naushad’s grandfather Malcolm in India in the 1930s. Top Right photo - Naushad’s grandmother, third from left, riding in Bombay, India, 1940s. Bottom Right photo - Naushad’s grandfather, Malcolm, (centre) with Mills (left) and Braddick (right) in Bombay after the Empire Games in Sydney in 1938.

On behalf of Pfizer Oncology and our Pfizer Pedal Pushers Mark II team, I would like to thank you for putting on such an awesome event. Whilst you cannot predict the weather, the day could not have been more appropriate for riding. The venue was amazing and the support was fantastic. My gears stopped working two hours into the race and your bike mechanic had me back on my bike within five mins. The food and drink at the end was greatly appreciated and getting a medal was the icing on the cake!

We all loved participating and we look forward to doing it again next year and exceeding what we achieved in terms of funds raised and distance ridden.

Naushad Mistry

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TALES FROM THE TRACK Deloitte Brisbane (soon to be Sydney) Partner, Ian Blatchford It’s about 400 kilometres by road from Sydney to Port Macquarie, Brisbane to Coffs Harbour or Melbourne to Mt Gambier; say around five hours in a car.

Now imagine doing the equivalent of one of those trips week in, week out.

On a bike It takes a certain dedication – some might say obsession – to hit the road on two wheels day after day after day, not only to stay fit but, for some, race ready.

It’s all about racking up the kilometres.

Around 4.30am, well before many of us wake up, never mind think about work, you will find Ian Blatchford out of the comfort of home and pedalling his way towards that 400 kilometres a week.

And that’s before he starts his day job.

Within a few hours he will have swapped the Lycra for a suit and tie as a key executive with Deloitte, based in Brisbane.

Ian, 42, helps major corporate clients get through huge transformation programs, with a particular focus on risk and risk management.

He managed to complete his 30, 3.9 kilometre laps in three hours, five minutes and 57 seconds, putting him in ninth place overall – second among the accounting category.

But then he is well used to road racing – and more.

Born in South Africa, he has ridden bikes around the world as his love of two wheels accompanied a burgeoning career in places as diverse as the Middle East, United States and United Kingdom.

He became so good at riding that he raced for Great Britain in the 2002 World Championship Iron Man event in Hawaii.

“I have been riding bikes since I was 11 years old in South Africa.

The thing that really inspired my love of the sport was watching Stephen Roche win the 1987 Tour de France. That was amazing.”

That was the year Roche became one of only two riders to win the Triple Crown of cycling: the Tour, the Giro d’Italia and road racing World Championship. You can see grainy video of the finish of the key leg that helped him take the Tour on You Tube, complete with commentary from a very excited Phil Liggett.

“I have raced bikes on the road and in triathlons. I have raced all over Australia – elite level racing. I travel a fair bit.”

That means taking the bike on a plane – Ian now has the put-it-inthe-hold bike box challenge down to around five minutes.

So how did such an accomplished racing cyclist, who races as part of the Cobra9 team, become interested in taking part in this year’s Pedalthon?

Now, as a participant in the Below the Belt Pedalthon, he is helping projects deliver life-altering results of a very different kind.

In part because Ian handles the client relationships between Deloitte and Origin which, in turn, has a corporate connection with the family of Pedalthon founder Simon Clarke. Wheels within wheels, so to speak.

This year, Ian was part of a five-person Deloitte team that joined 50 other teams for the hugely popular September Pedalthon around the Eastern Creek raceway.

So it became a perfect opportunity to both spread the health message, help raise funds for ANZUP and mix with clients at the same time,

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ANZUP Pedalthon “As a participant in the inaugural 2014 Pedalthon it was with equal measures of excitement and trepidation that I agreed to ride in the 2015 event; memories of numb bum all too fresh in my mind! As a keen commuter cyclist and a regular participant in organised cycling events I have an average level of fitness, however, the thought of four hours on a bike is still pretty overwhelming. But that is one of the best things about the Pedalthon, the spectrum of abilities is enormous and the only mandatory criteria are enthusiasm and a willingness to get in there and do your best, knowing that every little bit of fundraising makes a difference.

“Deloitte is really big into health and wellbeing,” he said.

“We all recognise that there is a good cause behind it. The cycling community is heavily involved in charitable events – Tour de Cure, for example - and this was another chance to contribute to a good cause.

“I thoroughly enjoy the sport and had the chance to mix with clients, too. It was a great opportunity to bond with colleagues as well.

It was ideal. Three hours riding around Eastern Creek. It was a good day – and we raised about $2500.”

And then there was a genuine, personal appreciation of the issue of Below the Belt cancers. The association between cycling and testicular cancer is openly discussed and has been the focus of numerous studies.

The positive atmosphere on the day of the ride was contagious: after locating the rest of my team, checking in, getting our bikes safety tested and taking full advantage of the generous amenities in our team shed we were ready to race. The range of bikes and gear was amazing; everything from basket bikes through to high-end racing bikes and as we headed off for our first slow lap of the Eastern Valley Raceway I experienced what it’s like to be part of a peloton.

After the first ‘slow’ lap we were off, the hours flew by, and the laps rolled in. The upbeat atmosphere and camaraderie among the cyclists were evident from the outset with people talking and chatting for the whole four hours. With the active support crew offering constant motivation, it was easy to keep going despite the achy legs and inevitable bum numbness.

When the flag for the final lap was waved, it was no small relief to coast into my shed for a long cool drink and a well-deserved (in my opinion!) buffet lunch.

After upping my laps on the 2014 ride, I was proud to have been a participant and am definitely keen to repeat my effort in 2016!”

Bonnie Laxton-Blinkhorn

“I had my own scare some years ago,” Ian said. “It is really sobering when you find something and have to go for tests.

It really makes you think.”

Ian received the all clear, but his own experience did help bring a certain focus to the cause race-day.

More than 330 riders registered for this year’s event, a 34 per cent increase on numbers for the inaugural event in 2014.

Pedalthon is proving so successful in raising much needed funding that it has triggered the launch of the Below the Belt Research Fund, a brand new ANZUP initiative to support clinical trials.

The announcement of the fund at this year’s event by ANZUP chair Ian Davis sparked 18 highly qualified applications for the three grants on offer totalling $150,000.

So now planning is underway for the third Pedalthon, and Ian Blatchford is determined to be back. “We will continue to support them, and even hopefully increase that support next year,” he said "At least the travel will be a little easier – that Deloitte career is about to take him, his wife and two young children to Sydney. Along with all the cycling gear, of course."

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Professor Ian Davis with Below the Belt Pedalthon Ambassador and Patrons Kaarle McCulloch, Ben Kersten and Brad McGee OAM. Image: Getty Images

Pedalthon Ambassador - Kaarle McCulloch Passion and courage are Kaarle’s rolled gold It is a remarkable comeback, though stellar sprint cyclist and Below-the-Belt Pedalthon ambassador Kaarle McCulloch never really went away.

Given what she now knows about the extent of her injury, she can reflect on how her performance might have improved had she been pain free.

Despite years battling a persistent injury she still managed to rack up three world championships, Olympic bronze, Commonwealth Gold and a host of national titles.

“I had torn some cartilage in my thoracic back which created a rotation. Because we were training so hard every single day, I started doing things like sitting crooked on my seat to make up for that rotation and that made my knee sore,” Kaarle said.

Then in October this year, fewer than 12 months after returning to the top of racing following a long period off the bike and rehab, she picked up three gold at the Oceania championships in New Zealand.

Combined with a team sprint silver in the world cup round in New Zealand this month, it’s a huge step in the right direction for her battle to make the Australian team for the 2016 Olympics in Rio. Not bad for someone who, in early 2014, questioned whether she would be fit enough to go on – mentally as well as physically.

Suffice to say, Kaarle knows all about triumph in adversity and the need to maintain passion and drive to overcome the demons of doubt that can dog even the most determined person.

Kaarle had spent five years riding through constant pain in her knee. In many ways, she had learned to live with it.

It was only during a period of intensive treatment shortly before the Olympic Games in 2012 that medical experts found the problem was actually in her back, not her leg.

Despite the pain, she put in a typically world-class ride at the Games with fellow sprint champion Anna Meares to take bronze.

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“So for the five years I had that injury a lot of the treatment was purely on the knee when the knee was really just a warning sign, saying ‘hang on, there is something wrong here you need to fix up’.

“Post-London, when I came back to training and realised the pain wasn’t going away I decided I needed to do something – get a fresh set of eyes on it.

“By January 2014 I had just about had enough. I wasn’t riding very well. I couldn’t see any improvement from my training and knew the injury was one of the biggest factors limiting my improvement.”

The back problem was finally isolated through further investigation at the NSW Institute of Sport. Kaarle was ordered to take two months off. The sobering message: go back to basics – but no guarantee of freedom from pain.

So she was off the bike for the first time in nearly 10 years.

After investing so much of her life in the sport it was understandable she started to question the future.

It was the thought of missing out on Rio in 2016 that spurred her on.

“I think the realisation that the Olympics might not be a possibility was pretty harsh. I thought to myself that if I was going to do another Olympic cycle I would have to do it injury free, otherwise I just wouldn’t be able to do it.”

“Every step I have made since then has been positive. A really positive thing.”

The first objective was freedom from pain followed by assessment of whether it would be remotely feasible to return strongly enough to make the Olympic team.

The news to date is good.

As we now know, that was no pipe-dream.

She has been based at the NSW Institute of Sport since moving back to Sydney in 2013 after five years in the high-performance unit in Adelaide. While the institute provides all the athletic support she needs, living in Sydney also means access each weekend to the family farm near Campbelltown. She is also squeezing in study for a Bachelor of Education in Human Movement with Charles Sturt University.

Right now there is no “significant other”.

“I have been pain free for over a year now, and it’s been amazing,” she said.

Apart from getting back to the top of the cycling tree with her results this year, Kaarle sees her recent world cup team selection as a big boost to her Rio chances. Three cyclists: Kaarle, Anna Meares and Stephanie Morton are vying for the two Olympic spots.

“My motto at the moment is to give the selectors every reason to select me. That’s what I’m feeling. I have an incredible team behind me and we are pushing as hard as we can to give everything we’ve got.”

Kaarle’s track record is all the more amazing when she admits she once thought cycling was a “really stupid sport”.

Athletics had been her love with a list of accolades as a junior.

Then, at 17, she started struggling with motivation and the thought she might not be good enough to realise her dream of competing for Australia.

“I had absolutely no desire for the bike,” she said. I thought riding around on a bike on a velodrome was absolutely ridiculous. It was my step-father (Ken Bates) who more or less forced me one day to go and try.

“It was literally a life-changing moment. I got on the track at Hurstville Oval one Monday afternoon in January 2005 and fell in love with it within just a couple of laps. That night I didn’t want to tell Kenny I actually liked it, but within two weeks I had aspirations

of making the Olympics.”

“I would like a partner in my life one day, but right now I’m just way too busy for that. I realised the other day when my housemates went out to dinner and I was already in my pyjamas thinking about training the next day.”

So it’s a tribute to Kaarle’s sense of selflessness that she didn’t hesitate when approached by ANZUP’s Liz Thorp so see if she would be a Pedalthon ambassador.

She was front and centre in Martin Place in June, outfitted in Lycra, bike by her side, for the official launch of this year’s event. And she was at Eastern Creek in September helping guide riders around the course and offering tips and other encouragement.

“It’s a fantastic charity event and I really loved the idea of it.

The circuit, and people who don’t necessarily ride turning up and, essentially, having a go.

“And then there is making money for such a good cause.

I certainly appreciate the efforts that ANZUP are going to and the way they are going about this event. I was also drawn by the fact ANZUP has some big goals for Pedalthon – to make it even bigger and better for people engaging with the event to make more money for research.”

Clearly, Kaarle is passionate about her cycling. We are grateful it’s a passion she is so willing to share.

Thank you to everyone involved in the Below the Belt Pedalthon. We hope you will all be back on Tuesday, September 20 2016.

Registrations open March 2016.

www.belowthebelt.org.au

#BTBPEDAL16

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