A little below the belt consumer magazine - July 2019

A little below the belt Conducting clinical trial research to improve outcomes for bladder, kidney, testicular, penile and prostate cancers

AN ANZUP CANCER TRIALS GROUP PUBLICATION

ISSUE 11, JULY 2019

TESTICULAR • PROSTATE • PENILE • BLADDER • KIDNEY

YOU VS.

CANCER DISCOVER THE LATEST IN CUTTING EDGE CLINICAL TRIALS AND RESEARCH HEAR FROM WORLD-RENOWNED BELOW THE BELT CANCER EXPERTS • Learn from personal experiences about treatment choices and decision making • Listen to valuable advice on the impact of treatments on sexuality and intimacy • Ask a question in the interactive Q&A session with the panel of clinical experts and patients

THE COMMUNITY ENGAGEMENT FORUM SUNDAY 21 JULY 2019 BRISBANE HILTON 1PM – 4PM

TESTICULAR • PROSTATE • PENILE • BLADDER • KIDNEY 2 A LITTLE BELOW THE BELT

BOOK YOUR FREE PLACE anzup@anzup.org.au

www.anzup.org.au

What is ANZUP? The Australian and New Zealand Urogenital and Prostate Cancer Trials Group was formed in 2008, bringing together a world-leading multidisciplinary team of doctors, nurses, other health care professionals, scientists, researchers, and community representatives, all working in areas related to urogenital cancer.

Urogenital cancers are those coming from the testicles, prostate, kidney, penis or bladder.

ANZUP’s work aims to improve the ways a patient with these cancers is treated. Our members and investigators are widely dispersed and busy, working in a range of disciplines. A trial idea only comes to fruition when we are able to provide opportunities for people to meet, work through the science, develop the trial concepts, and write and work through all the other documentation and processes. Then it is necessary to initiate, run, monitor, and report the trial results. All of this relies on the volunteered time of our members, and is separate from the other needs ANZUP has to source the much larger amounts of funding to support the trials themselves.

2019 BELOW THE BELT PEDALTHON, MELBOURNE

We acknowledge the Traditional Owners of country throughout Australia and recognise their continuing connection to land, waters and culture. We pay our respects to their Elders past, present and emerging.

The paper used in this edition is called Maine Recycled Digital – Silk. It is made with fibre derived only from sustainable sources and produced with a low reliance on energy from fossil fuels. The purchase of carbon offsets compensates for emissions produced over an international supply chain, from seedling through to final delivery to the customer.

A LITTLE BELOW THE BELT 3

ANZUP CEO MARGARET MCJANNETT, CANCER TRIALS IRELAND CEO EIBHLIN MULROE, AUSTRALIAN AMBASSADOR TO IRELAND RICHARD ANDREWS, IRISH CANCER SOCIETY CEO AVERIL POWER AND OTHER DIGNITARIES WORKING TOGETHER ON INTERNATIONAL COLLABORATIONS. MORE INFORMATION ON PAGE 8.

The 2019 Below the Belt Pedalthon, Melbourne.

What’s inside

More information on page 46

05 Message from the Chair, Professor Ian Davis 08 CEO Update 11 Consumer Advisory Panel update

ANZUP Cancer Trials Group Limited Registered office Level 6 Lifehouse Building 119-143 Missenden Road Camperdown NSW 2050 T: +61 2 9562 5042 F: +61 2 9562 5008 www.anzup.org.au

@ANZUPtrials / @BTBPedalthon

ANZUPtrials / Below the Belt Pedalthon

ANZUP

@ANZUPtrials

ANZUP Cancer Trials Group

13 Spotlight on prostate cancer 14 Landmark ANZUP clinical trial reports 33% prostate cancer survival benefit from novel hormone therapy 16 ENZA – p 17 Spotlight on Bladder, Urothelial and Penile (BUP) cancer 18 What’s BUP all about?

19 Bladder cancer: a cancer in crisis 22 The challenge of rare cancers: spotlight on penile cancer 23 Spotlight on testicular cancer 24 Finding the funny in cancer 26 Spotlight on kidney cancer 27 Kidney cancer trials 28 UNICAB Trial 29 Top chefs help ANZUP fight ‘below the belt’ cancers 30 The Noel Castan Fellowship 30 International Clinical Trials Day 31 Clinical Trials

ACN 133 634 956

33 Current ANZUP Trials

ABN 32 133 634 956

44 Trials in follow up 46 Melbourne Pedalthon

Published by ANZUP Cancer Trials Group Ltd. Copyright.

Editor Lucy Byers. Contributing editor: Claudia Brooks Graphic design by Designcycle

4 A LITTLE BELOW THE BELT

55 Thanks to Corporate Supporters and In-Kind Supporters

Message from the Chair, Professor Ian Davis Welcome to this latest edition of “A little below the belt.”

How’s your day? Has everything gone to plan? I wonder if anything has annoyed or inconvenienced you today. The emails, the phone calls, the demands on the time, the jobs to be done but you can’t because you’re at work, the person who stole your parking spot, the constant demands in your everyday life. And then on top of that, there always seems to be people who want something more so that they can benefit: your support for their project, your strength to help them move their piano, your money for their needs, and your time for their purposes. Don’t you sometimes get bit tired of it all?

Well, as the old joke goes, “You should have seen the other guy.” There are people whose problems make me look at my own and think perhaps I’m not really that badly off. People who are affected by cancer, either by having it themselves, or having it trying to destroy the lives of the people they love. People who are facing some of life’s most fundamental challenges and stark decisions, often with no good options. These are situations that strike at the heart of who we are and carry the risk that all our future hopes might not come to fruition. I have a little 1-year-old granddaughter, the love of my life (actually one of several life-loves, but that only strengthens the analogy). What if my hopes of seeing her grow up and become the person she should be are all dashed, because I am affected by a cancer or, even more horrible to consider, she is? Right now I’m blessed not to be in that situation, but perhaps you are.

We have to help.

It’s a lot to deal with. And here you are, reading this because for some reason this publication caught your attention.

You might be in a doctor’s office, or you have found this online while searching for information or hope, or someone has given it to you for similar reasons. We are all affected by what cancer does, either directly or indirectly, and sometimes without our even knowing about it.

It’s a horrible unfair terrorist of a disease, and dammit it’s well past time we had some good news.

We have some good news. We are making a difference. Some cancers that previously were essentially untreatable now have multiple options available. We understand better now what people’s needs are in terms of provision of information, or supports, or support for their loved ones and carers.

We have improved systems for collecting information that will give us better handles on why cancers behave how they do and what effects our treatments are having in the real world. We have processes for collecting and studying blood and tissue samples, which are an extraordinary resource donated by our patients that allows us to understand cancers better and to devise new and improved treatments for them. And with all of that, we are finally starting to see progress.

The progress we’re seeing is not what you will read about in a newspaper headline. It’s very rare that a “breakthrough” will occur, where an incurable cancer suddenly becomes curable. Most of the time it’s the small but steady step forwards. That piano is not going to teleport itself to the new spot. If you do a grab and run, you are not going to get far: you’ll hurt yourself and probably damage the piano and innocent bystanders. You are more likely to do the job effectively if you have understood the route, removed the obstacles, gotten yourself into better physical condition, obtained the correct equipment, and done the job in a careful and considered way.

A LITTLE LITTLE BELOW BELOW THE THE BELT 5 A

And it’s a whole lot easier if you have a team of people with their own piano-moving skills and clearly understood parts to play in the job.

Meet ANZUP, the piano-moving team, except that our cancer piano is definitely not one we want to keep. We are here to improve outcomes for people affected by genitourinary cancers: cancers affecting the prostate, kidney, bladder, testicles, and penis. These are awkward, hidden, and sometimes embarrassing parts of the anatomy, but the cancers that affect these areas are ones that have major effects in our community. Some of them only affect men directly, although everybody feels the impact of them. Some of them are uncommon, but they cause a lot of harm or cost the community a great deal of money. Many of them are curable if found early, but when they are advanced they can be incurable and we need to do better in how we look after people affected by them.

So where is that good news? How do we shift this unwanted piano? The only way to improve outcomes is by having better ways to treat the problem, and that can only happen if we have evidence that says this way of doing things is better than that way.

That is what a clinical trial is. A clinical trial allows us to understand how to give a treatment, who might benefit, how much they might benefit, what the unwanted effects might be, and how a new treatment stacks up against existing ones. Everybody who takes part in a clinical trial receives the best possible care, while at the same time generating evidence that might be of benefit to other people affected by that condition in the future. Clinical trials allow us to decide which treatments should be supported by government funding and how best to use limited health care resources. They also sometimes help us know when a treatment should NOT be given: just because something is new and shiny does not mean it is better (you don’t want to replace that unwanted piano with a nice shiny anvil).

“ANZUP” stands for the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. We are an organisation of well over 1500 people involved in the care and research of genitourinary cancers. We are guided by representatives from all the clinical disciplines involved, and with the oversight and an active, engaged, and highly effective Consumer Advisory Panel.

ANZUP has been in existence for only a little over ten years. In that time we have performed clinical trials involving thousands of patients in Australia, New Zealand, and other parts of the world.

We have shown that some apparently good ideas don’t work, so those approaches are not used. We have also shown that some novel approaches do work, not only in terms of improving survival (for example in prostate cancer), but also other outcomes related to the cancer that give benefit to people having that treatment.

6 A LITTLE BELOW THE BELT

ANZUP has a robust pipeline of ideas and new trials that will continue to generate this evidence for our current and future patients. We also have systems that ensure we continue to train and mentor our best and brightest people to be the creative and effective researchers we need in the future, for me and for you and for my granddaughter.

So, thanks for your interest in ANZUP. You will read in this magazine some exciting news about our past, current, and proposed clinical trials. You will hear from people who have participated in these trials and get an understanding of what their experiences have been. You will read about some of our scientific and educational initiatives. And you will also see how some very dedicated people have literally put life and limb on the line to help us with our fundraising. This fundraising helps us perform the clinical trials we need to do, and it also helps us support people to generate new ideas that will eventually become ANZUP trials.

A great example is our Below the Belt Pedalthon, which contributes resources for our Below the Belt Research Fund. But did you know that every dollar raised by the Pedalthons is reinvested back to support research?

We cover the costs of these initiatives by other means, so people who donate can be confident that their donations are directly supporting genitourinary cancer research (while they are also claiming their tax deduction, because we are a registered charity). You can get more information about ANZUP from our web site www.anzup.org.au, where you can also sign up to Friends of ANZUP and be added to our regular mailing list to be kept up to date.

Yes, it’s a lot to deal with. For me, those emails / phone calls / time demands / jobs to be done from the first paragraph above: many of them are about ANZUP work, and it is a joy for me to be part of something that has already made and continues to make big differences for people affected by those cancers. That piano is well on its way to the op shop now. I’m not sure where the parking-spotstealer comes in, but I never said I was great at analogies. I’m pretty sure someone in ANZUP would be able to help me improve on it though, because helping is what they all do best.

Thanks again for your interest in ANZUP. Please help us spread the word of these sometimes-overlooked cancers and of the importance of careful and high quality clinical trials.

IAN DAVIS Chair

FIGHT CANCER BELOW THE BELT Ride or support and help fight prostate, testicular, bladder, penile and kidney cancer

JOIN US AT: SYDNEY MOTORSPORT PARK TUESDAY 10 SEPTEMBER 2019

LIKE CYCLING?

DON’T LIKE CANCER?

The Below the Belt Pedalthon returns for its 6th year, ready for you, your colleagues and networks to take on the ultimate team challenge.

A diagnosis of cancer can turn a life upside down particularly when the best treatment is not known.

The Pedalthon was founded to raise awareness of below the belt cancers and provide ANZUP with the critical funds to improve the lives of more than 27,000 people diagnosed in Australia event year.

Join the fight and ride on Tuesday 10 September 2019 at the iconic Sydney Motorsport Park.

The Sydney Pedalthon is a cycling event for all riders – the keen cyclist, the novice or those looking for a new sporting challenge. Teams of up to six take on the task of riding as many laps as possible within 3 hours and with a sprint challenge for the speed demons in the final hour.

Clinical trials help us move research forward to develop the next step in treatment while giving patients the very best possible care.

Every cent raised by the Pedalthon goes directly towards clinical trial research, which means straight into the hands of experts committed to treating prostate, bladder, kidney, penile and testicular cancer better.

We need your help to find more trials and make a difference.

“Every dollar raised through the Below the Belt Pedalthon for the Below the Belt Research Fund goes back to support research. Do you know of many other charities with 100% investment of fundraising back into their cause?”

ANZUP Chair, Professor Ian Davis

“I can’t wait for the 2019 Below the Belt Pedalthon. Every year the event gets bigger and better and I am looking forward to cheering on everyone as they roll around Eastern Creek raceway raising money for a great cause! I look forward to seeing familiar and also welcoming new faces out there this year!”

Kaarle McCulloch, Pedalthon Ambassador, World Champion Track Cyclist.

For more information go to www.belowthebelt.org.au or email pedalthon@anzup.org.au A LITTLE BELOW THE BELT 7

CEO Update

by Margaret McJannett, ANZUP CEO

As we enter our 11th year, it certainly is an exciting time here at ANZUP. Our membership has grown to over 1,550 members across more than 20 disciplines. We currently have 10 trials recruiting across all the cancers we represent, a number are in follow up and there are some exciting trials in development that we will share with you once recruitment commences later this year.

Similarly, ANZUP’s Concept Development Workshops provide an opportunity for early-career researchers to receive mentorship and share fresh concepts for emerging clinical trials. These meetings are a vital element of the work we do at ANZUP, as it is this new wave of researchers who will pave the way for clinical trials research in the future.

ANZUP brings together a leading multi-disciplinary network of oncology, surgical, medical, radiation, nursing, psychology and allied health professionals from within the urogenital cancer field to conduct vital research through clinical trials.

ANZUP is very proud and excited to launch the Noel Castan Fellowship at this years Annual Scientific Meeting in Brisbane.

The Fellowships will help to build ANZUP’s research capacity both now and into the future.

We are fortunate to have a highly active Consumer Advisory Panel (CAP) who provide an invaluable consumer perspective on our clinical trials. We are grateful for the CAP’s contribution and focus on the management of below the belt cancers from a holistic, people-centric perspective.

Fundraising continues to be a vital part of ANZUP’s activities.

In June we celebrated an outstanding achievement here at ANZUP. Our ENZAMET trial (ANZUP 1304) was selected as one of four presentations, out of more than 6,000 submissions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting plenary session. This trial was not only positive and will help inform practice globally it established an extraordinary international collaboration between ANZUP and the international community. We are grateful to the 1,125 patient’s from across 83 cancer centres around the world and our global partners Canadian Cancer Trials Group, Dana Farber Cancer Institute and Cancer Trials Ireland.

You will read more about the ENZAMET Trial on page 14.

Earlier this year I had the wonderful opportunty to visit Cancer Trials Ireland and thanks to the efforts of their CEO Eibhlin Mulroe, I was invited by Richard Andrews, the Australian Ambassador to Ireland, along with Averil Power, (CEO Irish Cancer Society) and other dignitaries to attend a luncheon at the Australian Embassy.

We took the opportunity to enlighten the Ambassador on the successful collaboration we’ve forged with Cancer Trials Ireland and our other international partners as we look to improve treatments and outcomes for our global community!

We are continually seeking opportunities to expand on educational and mentoring opportunities for the next generation of scientists and clinical researchers. This is highlighted by the variety of events ANZUP both hosts and supports each year including ANZUP’s Annual Scientific Meeting, providing a key platform to discuss and present the latest updates in GU cancer treatments, research and supportive care.

8 A LITTLE BELOW THE BELT

This year we will hold our sixth Sydney Below the Belt Pedalthon. The success of this event has provided a platform to raise awareness about below the belt cancers as well as the importance of clinical trials. We have raised $1.5 million since 2014 with 100% of these vital funds supporting our research.

We are extremely grateful to the Pedalthon community; riders, sponsors, donors, supporters and volunteers and hope the sixth year will be as fun – filled and successful as previous Pedalthons.

The Sydney event will be held on Tuesday 10 September at Sydney Motorsport Park. For more information go to www. belowthebelt.org.au In March we held our second Pedalthon event in Melbourne – it was a huge success, building on all the hard work that was put into the inaugural event in 2018. The Pedalthon, held at Sandown Racecourse, was jam-packed full of fun and entertainment with 34 teams and 150 riders participating in the challenge, with over $78,000 raised.

By producing this magazine, ‘A little below the belt’, we aim to provide information on clinical trials and ANZUP to the families and patients of below the belt cancers. In doing so, we hope to keep our ANZUP community in the loop with our regular activities, the latest events and resources. If you are seeking more regular updates from us, we welcome you to join our free initiative, “Friends of ANZUP” to help you stay connected with the work we do. Visit the ANZUP website to sign up: https:// www.anzup.org.au/friendsofanzup.aspx.

Thank you for continuing to support ANZUP.

DO YOU HAVE A STORY YOU COULD SHARE WITH OTHERS? Share your story with us here anzup@anzup.org.au Create awareness and let others know they are not alone

FIGHT CANCER

BELOW THE BELT • TESTICULAR • PROSTATE • BLADDER • KIDNEY • PENILE 14 A LITTLE BELOW THE BELT

A LITTLE BELOW THE BELT 9

FR

EE

to

Jo

in!

Have you or your loved ones been affected by below the belt – prostate, kidney, bladder, penile and testicular – cancers? Do you want to join a community that gives you access to the latest forums, publications, fundraising activities and trials?

Join “Friends of ANZUP” and connect with people whose lives have been impacted by below the belt cancers, and learn from ANZUP clinical experts and researchers.

“Friends of ANZUP” provides: • Information about clinical trials research and how to access them, • Support from people who understand the challenges of living with prostate and urogenital cancers, • The community magazine, ‘A little below the belt’ featuring: o regular updates and stories from health professionals and researchers, o cancer survivors and cancer trial participants points of view, • Invitation to the annual Community Engagement Forum.

Join “Friends of ANZUP” and help us achieve our mission to improve the outcomes and treatment for those living with testicular, penile, prostate, kidney and bladder cancers.

If we can encourage people to ask: “Is there a clinical trial suitable for me?” then we have achieved a major step forward.

To find out more visit: http://www.anzup.org.au/friendsofanzup.aspx or email anzup@anzup.org.au 10 A LITTLE BELOW THE BELT

Consumer Advisory Panel update

By Belinda Jago, CAP Chair

Why we do what we do When you or a family member are diagnosed with a life threatening illness, your life is turned upside down. In most cases, regardless of the success or not of your treatment, life moving forward will be different.

We are a committed group of volunteers whose lives have been directly affected by a cancer diagnosis. For this reason, we have a personal interest in clinical trial research either through the experience or being on a trial ourselves, or having witnessed a family member go through it. As a result, we have a deep understanding of how important clinical trials are in improving patient outcomes.

Many patients and their families experience a few years of The CAP are referred to ANZUP through their treatment regular treatment with a team of clinicians. You learn new team, as they have expressed an interest in wanting to phases and words. You may deal with pain, uncertainty, give back. ANZUP’s members may also think that one of hope, and longer term survivorship issues often related their patients may be suitable. to side effects and grief. You meet people from different ANZUP receives valuable socio economic and cultural infrastructure funding through backgrounds, people who care the federal government via deeply about others, and will Cancer Australia. The primary often chat to other patients while aim of the funding is to support you wait for your appointments. the development of industryYou see less fortunate people independent cancer clinical than yourself and you start to trial protocols. We are also think gosh I’m lucky - which can required to have consumers be strange when you have a “I believe clinical trials can involved in trial process cancer diagnosis! to ensure we consider the When you come to the end of your treatment plan, you find a “new” normal way to live your life.

You take a deep breath and consider what the next step in your life is, which affects both patients and carers. There are no right or wrong answers, only what is best for you and your family.

Some put the experience behind them, some like to support as fundraisers to give back to others who are at the beginning of their cancer diagnosis, and then there are some who really want to go the extra mile and put in a great deal more which can be done through a regular volunteering activity. It is this group of patients/survivors/carers who form the Consumer Advisory Panel (CAP) at ANZUP.

provide important treatment options for patients. Having experienced both kidney and prostate cancer, I was part of the decision making process prior to my surgery.

My role is to promote that concept and raise awareness wherever possible. Since becoming a CAP member I have been able to talk to patients and hopefully help to inform them about the importance of clinical trials while encouraging them to ask their doctor if there is a suitable trial for them”.

Les Land

consumer perspective from concept development to grant applications.

ANZUP leads the way in providing a robust process for the CAP to be able to contribute in a positive way by supporting us with education, training and mentoring. This ensures that we are comfortable and confident to comment from a consumer perspective, on the research ideas.

The CAP is also committed to promoting the benefits of clinical trial research to the wider community in order to help increase participation rates, while working with our clinical members to identify the barriers that can make access to trials difficult.

A LITTLE BELOW THE BELT 11

“I have considerable patient experience and a reasonable level of accumulated knowledge, from a consumer perspective, through my involvement with ANZUP over the past few years.

We have an excellent CAP team and I believe we have achieved an excellent level of acceptance with the clinical membership. ANZUP’s research objective is to work with the CAP to identify the important questions from a consumer perspective which will feed into our horizon scanning”.

“The invitation to become a member of the CAP in 2012 was, and is, an ideal opportunity to provide pragmatic feedback on ANZUP trials as a consumer to improve patient outcomes.

I have a strong interest in improving benchmarking regarding treatment, cancer and outcomes for cancer patients through their journey of the health care system.”

Colin O’Brien

Ray Allen

The CAP’s role is to use our personal cancer experience and the knowledge gained through diagnosis, treatment and follow up for the benefit of current patients and their families.

Over the years we have sadly lost a number of CAP members from cancer. Their message to us is to keep promoting and working hard on new clinical trial ideas.

Whilst we continue to lose patients of below the belt cancers, our work is not done and we will continue to do what we do to help improve outcomes for the future and make a difference.

The ENZAMET trial has reported 33% prostate cancer survival benefit from novel hormone therapy and will help to inform practice. The CAP reviewed the ENZAMET patient information and consent form back in 2014 so it was wonderful to see this translate into a positive trial.

It highlighted the importance of our role from a patient perspective. You can read more about the ENZAMET trial on page 14.

Our thanks also go to the patients and their families who took part the in the ENZAMET trial.

The ENZAMET trial clearly demonstrates I attended ASCO for the why ANZUP does what first time in 2016 and I was it does, and why the delighted to be offered a CAP are involved from second patient advocate a consumer perspective. scholarship through the Clinical trial research is Conquer Cancer Foundation so important, and we this year, allowing me to encourage everyone to ANZUP CHAIR PROFESSOR IAN DAVIS, CEO MARGARET attend this meeting. consider whether there MCJANNETT AND CAP CHAIR BELINDA JAGO may be a clinical trial The ASCO annual suitable for you as part of meeting is the premier scientific program for oncology your treatment plan. On behalf of the CAP, we encourage professionals, patient advocates, industry representatives, you to have a conversation with your specialist and ask, and major media outlets worldwide, with over 40,000 “is there a clinical trial for me?” delegates attending each year. The theme of the meeting this year was ‘Caring for Every Patient, Learning from Every Patient’.

It was truly a memorable experience networking with other patient advocates however this year was extra special as I was able to attend the plenary session as part of a large contingent of ANZUP members and supporters, many who had been involved in the ENZAMET study.

12 AALITTLE LITTLEBELOW BELOWTHE THEBELT BELT

“We encourage you to have a conversation with your specialist and ask, “is there a clinical trial for me?”

Spotlight on prostate cancer

What is prostate cancer?

Prostate cancer symptoms

Prostate cancer develops when abnormal cells in the prostate gland grow more quickly than in a normal prostate, and in an uncontrolled manner. Although not always the case, prostate cancers grow more slowly than other cancer types.

• frequent urination, particularly at night;

Prostate cancer is the most common cancer diagnosed in Australia and the third most common cause of cancer death. One in five men will be diagnosed with prostate cancer by the age of 85. It is more common in older men, with 63 per cent of cases diagnosed in those over 65 years of age.

In 2019, it is estimated 19,508 new cases of prostate cancer will be diagnosed in Australia.

Sometimes there are no symptoms. When symptoms are present, they can include:

• pain on urination; • blood in the urine; • a weak urine stream.

More widespread disease often spreads to the bones and gives pain or unexplained weight loss and fatigue.

Causes of prostate cancer Your risk of prostate cancer can be increased by some of the factors below: • age, increasing greatly if you are aged over 50 years;

The five-year survival rate for men diagnosed with prostate cancer is 95 per cent. Nearly all patients who present with localised disease will live beyond five years.

• family history of prostate, breast or ovarian cancer;

In 2019, it is estimated that there will be 3,306 deaths from prostate cancer in Australia.

• m en of African descent are at higher risk than men of European or Asian descent;

• a diet high in fats and low in fresh fruit and vegetables;

• high testosterone levels.

For prostate cancer clinical trials go to page 42

Information derived from Cancer Australia; https://prostate-cancer.canceraustralia.gov.au/statistics

A LITTLE BELOW THE BELT 13

Landmark ANZUP clinical trial reports 33% prostate cancer survival benefit from novel hormone therapy A landmark Australian led clinical trial has shown that hormone therapy with a drug called enzalutamide can improve the survival of some men with advanced, hormone‐ sensitive prostate cancer.

Findings from the ENZAMET trial, led by the Australian PROFESSOR CHRISTOPHER SWEENEY PRESENTING AT 2019 ASCO ANNUAL MEETING and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The results have shown that men with this type of cancer who receive enzalutamide with standard treatment have a 33% improvement in survival compared to men receiving standard treatment alone.

Five‐year survival from prostate cancer in Australia is high (95%) but this mainly represents men with earlier stages of the disease. ANZUP Chair, Professor Ian Davis, said metastatic prostate cancer was still the second‐ leading cause of cancer death in Australian men after lung cancer.

CO STUDY CHAIRS PROFESSOR CHRISTOPHER SWEENEY AND PROFESSOR IAN DAVIS WITH ANZUP CEO MARGARET MCJANNETT

“On current trends, around 3,500 Australian men will die from prostate cancer this year,” Professor Davis said, “so it is urgent that we research new treatments and ways of using established treatments better.”

“The benefits of enzalutamide had already been established for prostate cancers that are no longer responding to hormonal therapy. The actual result in patients starting hormonal therapy noting patients had a 60% improvement in the time it takes to detect the cancer growing again along with a 33% increase chance of survival was far higher than we expected.

Prostate cancer is complex and so are the benefits, side effects and risks of multiple treatments.

14 A LITTLE BELOW THE BELT

THE ENZAMET TEAM AT ASCO

Clinical trials are the most effective way of determining which treatments, alone or in combination, will provide the greatest survival benefit to the patient with the least adverse outcomes.”

Professor Christopher Sweeney, co‐chair with Professor Ian Davis of the ENZAMET trial, said, “This is one of the most significant findings yet in clinical trials for men with metastatic hormone‐sensitive prostate cancer – and a great example of effective international collaboration.”

33%

PATIENTS FROM

1,125 MEN TOOK PART IN THE STUDY

83

AUSTRALIA NEW ZEALAND CANADA USA IRELAND UK

GLOBAL SITES

I’m feeling healthy and strong Owen Reid is 68 and has had prostate cancer for over ten years. After receiving some bad news that his prostate cancer had spread to his lymph nodes, Owen was delivered some hope by his specialist by being prescribed enzalutamide, which works by blocking the effect of testosterone on prostate cancer. Owen has been on the ENZAMET trial for the last three years.

Q: What information did you look for when you were first diagnosed with prostate cancer?

A: I was referred to a prostate cancer specialist (urologist) and I relied on his medical expertise with all the questions I had. I also joined a local support group, where I met other men and heard their stories, what treatments they were on and how they were going.

Q: How did you find out about the ENZAMET trial and what helped you to make the decision to participate?

A: As my PSA (prostate specific antigen) went up, my specialist discussed my case with a multidisciplinary team which included a medical oncologist, radiation oncologist, nuclear medicine specialist and other healthcare professionals. Once they had agreed on the best treatment / trial for me, they went through all the information on ENZAMET and answered all my questions.

I was then referred to Professor Lisa Horvath as my treating specialist on the trial.

OF MEN COULD LIVE A LONGER LIFE

AFTER 3 YEARS

80%

OF MEN WHO RECEIVED ENZALUTAMIDE AND HORMONE TREATMENT WERE ALIVE

72%

OF MEN WHO RECEIVED STANDARD TREATMENT WERE ALIVE

Q: What sort of support and monitoring have you experienced whilst you were on the ENZAMET trial?

A: I was treated at the Chris O’Brien Lifehouse and the medical team and their support was incredible. I can’t fault them at all. It was a great experience. I also have to mention the amazing support of my wife.

Q: What would be your primary message to the community about ANZUP and participating on a clinical trial?

A: First off, always have your checks. If you have a history of cancer, discuss with your GP or if something doesn’t feel right. Make sure you investigate further and if you need to, ensure you have a good specialist who reviews your case and gives you options.

Q: Any further comment you would like to add?

A: I am still going and feeling healthy and strong.

My PSA is now undetectable and I feel 100%.

My prognosis is very good.

‘Fortunately I was put on the trial early enough and I think I am reaping the benefits of that. At this stage I feel like I will live forever’ Owen told Channel Nine News.

Q: What process did you go through when researching information on the ENZAMET trial?

A: Professor Horvath explained all the details about the trial and I felt completely confident with her decision as the healthcare professional.

A LITTLE BELOW THE BELT 15

ENZA – p

by Associate Professor Louise Emmett

Precision medicine is the concept of targeting the right patient for the right treatment at the right time. ENZA-p is a clinical trial that aims to use new theranostic agents to allow more accurate prognostic decision making, and subsequently more effective personalised treatment with less side effects, for men confronting a potentially lethal condition (metastatic castrate resistant prostate cancer). When prostate cancer spreads (becomes metastatic), it often causes health problems and frequently shortens the lifespan of affected men.

A collection of promising new tablet treatments such as the potent hormone blocker enzalutamide/ XtandiÂŽ, prolongs the lives of men with metastatic prostate cancer. However, none of these treatments are curative.

Clinical trials are underway to test a new therapy that treats prostate cancer cells directly with radiotherapy (177Lutetium), which targets a protein on the cancer cell surface (prostate specific membrane antigen or PSMA). Early trials using this new treatment (Lu-PSMA) has shown that it is well tolerated and is effective in treating metastatic prostate cancer. Tests in the laboratory have shown that combining Lu-PSMA with potent hormone blockers, like enzalutamide, may work together to further improve prostate cancer treatment responses. However, many questions remain. We do not yet know which men will benefit from the combination treatment, or at what stage this treatment should be offered to them. This study will hopefully address many of these questions, and in the process improve the standard of personalised medicine for men with metastatic prostate cancer.

16 A LITTLE BELOW THE BELT

The study also aims to answer the questions around whether men should receive these combination targeted treatments earlier, before they have chemotherapy, or to reduce toxicity. To achieve these goals, we plan to use the PSMA imaging and therapy agents in combination with enzalutamide in a randomised clinical trial in men who have not yet had chemotherapy. The study aims to show that treating men with metastatic castrate resistant prostate cancer with rational treatment combinations will improve treatment responses and delay the need for more toxic treatments. The concept of precision medicine can further be understood by understanding ways to best predict which men would benefit from the combined treatment, and how the cancer develops and becomes resistant to these treatments.

We believe that developing complementary non-toxic combinations of drugs that work better together earlier, and then targeting treatments to the men who will best respond, will offer the highest quality of life for the longest possible time.

Spotlight on Bladder, Urothelial and Penile (BUP) cancer What is bladder and urothelial cancer?

Bladder and urothelial cancer is when abnormal cells in the bladder grow and divide in an uncontrolled way.

There are different types of bladder cancer: • u rothelial carcinoma, formally known as transitional cell carcinoma, is the most common form of bladder cancer (80-90%) and starts in the urothelial cells in the bladder wall’s innermost layer • s quamous cell carcinoma begins in the thin, flat cells that line the bladder • a denocarcinoma is a rare form which starts in mucusproducing cells in the bladder.

The stats In 2019, there is estimated to be 3,168 new cases of bladder cancer diagnosed (2,447 males and 721 females).

Bladder cancer is common in people aged over 60 and is significantly more common in men than in women. In 2019, there are estimated to be 1,209 deaths from bladder cancer. The chances of surviving bladder cancer for five years is 54%.

Bladder and urothelial cancer symptoms The most common symptom of bladder cancer is blood in the urine (haematuria), which usually occurs suddenly and is generally not painful.

What is penile cancer?

The penis is part of the male reproductive and urinary systems. Penile cancer is a disease in which malignant (cancer) cells form in the tissues of the penis.

Most penile cancers are squamous cell carcinomas (cancer that begins in flat cells lining the penis).

The stats Penile cancer is rare. Around 103 men are affected by this cancer per year.

Penile cancer symptoms Possible signs of penile cancer include sores, discharge, and bleeding.

These and other symptoms may be caused by penile cancer. Other conditions may cause the same symptoms.

Check with your doctor if you have any of the following problems: • Redness, irritation, or a sore on the penis • A lump on the penis

Causes of penile cancer Infection with human papilloma virus is a risk factor for cancer of the penis. Some other conditions that affect the appearance of the skin of the penis can lead to cancer, so it’s important to see your doctor if you notice white, red or scaly patches.

Other less common symptoms include: • problems emptying the bladder • a burning feeling when passing urine • need to pass urine often • blood in urine • lower abdominal or back pain.

Causes of bladder and urothelial cancer Some factors that can increase your risk of bladder cancer include: • smoking • w orkplace exposure to certain chemicals used in dyeing in the textile, petrochemical and rubber industries • use of the chemotherapy drug cyclophosphamide • family history • chronic inflammation of the bladder.

For BUP cancer clinical trials go to page 34 Information on bladder, urothelial and penile cancer is derived from Cancer Australia https://bladder-cancer.canceraustralia.gov.au/statistics and statistics from Australian Institute of Health and Welfare https://www.aihw.gov.au/getmedia/8c9fcf52-0055-41a0-96d9f81b0feb98cf/aihw-can-123.pdf.aspx?inline=true

A LITTLE BELOW THE BELT 17

What’s BUP all about?

by Professor Dickon Hayne, Bladder, Urothelial and Penile (BUP) Subcommittee Chair

We have a new name for the bladder subcommittee… BUP! – Bladder, Urothelial and Penile Cancer Subcommittee.

Why you ask?

• B ladder cancer describes most of the workload included in the remit of the subcommittee.

• U pper tract transitional cell cancer and bladder transitional cell cancer are both ‘Urothelial cancer’ (diseases of the lining of the urinary tract).

• C oncepts and trials related to upper tract TCC have already been adopted by the bladder cancer sub-committee. Other types of bladder cancer that are not ‘urothelial’ do exist.

• P enile cancer is a rare but significant male cancer not previously specifically recognised by the ANZUP sub-committees and needed a home.

To reflect this we have changed the subcommittee name to the Bladder, Urothelial and Penile Cancer (BUP) subcommittee to recognise the entire range of malignancies dealt with by the group. Whilst there was some debate about the acronym (you can guess what!), ultimately we agreed on BUP.

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Bladder cancer: a cancer in crisis Among Australia’s 15 most common malignancies, bladder cancer remains the only one with survival rates that have deteriorated over the past 30 years. From 2010 to 2014, Western Australian data showed that the 5-year relative survival for bladder cancer had fallen to an alltime low of 53.9%, while the comparative survival for all cancers combined rose to 68.6%. In 2019 it is the 9th most commonly diagnosed malignancy in Australia.

Despite a falling age-standardised incidence of bladder cancer from 17.8 per 100 000 in 1982 to a projected 10.1 per 100 000 in 2019, mortality–incidence ratio has increased from 0.28 to 0.38 over the past two decades.

Unfortunately, many Australian health care practitioners remain unaware of this bladder cancer survival crisis

Table 1. Comparison of Australian bladder cancer incidence and mortality trends since 1982 1982–1988

2015

Overall age-standardised incidence (per 100 000 population)

17.8

10.0

Male age-standardised incidence (per 100 000 population)

30.7

16.7

8.6

4.3

Female age-standardised incidence (per 100 000 population) Mortality: incidence ratio

0.28

0.38

67.2% (1988)

53.9%

Male 5-year survival

–

56.2%

Female 5-year survival

–

46.3%

48.3% (1988)

68.6%

Overall 5-year survival

5-year survival, all cancers combined

Table 1: Data from AIHW Cancer data in Australia report - https:// www.aihw.gov.au/reports/cancer/cancer-data-in-australia/ contents/summary

Why is survival deteriorating?

Our nation’s worsening bladder cancer survival rate is likely multifactorial, and although clinical coding issues may explain a small part of this decline, the probable major contributor is Australia’s ageing population. The percentage of patients diagnosed with bladder cancer aged over 80 years has gradually increased (from 15.7% in 1982 to 36.5% in 2015). In Western Australian data from 2014, bladder cancer was the fifth highest cause of cancer mortality for men aged over 65 years, exceeding that of malignant melanoma. In this older cohort, radical treatment options are reduced, as patients are frequently unsuitable for cystectomy or chemoradiotherapy.

Other disadvantaged groups are rural, Indigenous and female patients, as demonstrated in a South Australian study. Delayed presentation is thought to contribute significantly. The male survival advantage in bladder cancer is a consistent finding internationally and is unusual because females tend to demonstrate a survival advantage for most other malignancies. Reasons for this are poorly understood, but the phenomenon cannot be purely explained by delayed presentation, as the survival matched by stage at presentation is also inferior.

Current referral and treatment pathways for bladder cancer Bladder cancer typically presents with haematuria, or lower urinary tract symptoms such as frequency, urgency or dysuria. Early identification and referral of all patients with visible haematuria is of paramount importance to a timely diagnosis. Bladder tumours are detected with cystoscopy and urinary tract imaging (computed tomography intravenous urogram or ultrasound of urinary tract) and affected patients proceed to rigid cystoscopy with bladder biopsy or transurethral resection of bladder tumour (TURBT). Immediately after TURBT, a single instillation of intravesical chemotherapy is recommended for patients with non-muscle invasive bladder cancer (NMIBC) to reduce the risk of recurrence.

For high grade NMIBC, treatment with adjuvant intravesical immunotherapy (Bacille Calmette Guerin [BCG]) has been the standard of care for the past three

A LITTLE BELOW THE BELT 19

decades. Up-front radical cystectomy can also be offered, but overtreats a large proportion of patients. Neo-adjuvant chemotherapy plus radical cystectomy is the gold standard for curative treatment of muscle invasive bladder cancer (MIBC); however, trimodal treatment with maximal TURBT and chemoradiotherapy is a viable alternative that is perhaps underutilised. Platinum-containing combination chemotherapy is active in patients with metastatic disease.

Immunotherapeutic checkpoint inhibitors appear highly active, with less toxicity, and are currently licenced in the second-line setting.

How can we improve bladder cancer outcomes?

A nationwide improvement in bladder cancer mortality requires action at multiple levels. Visible haematuria is the single most predictive symptom of malignancy, with as many as one in five patients referred for specialist assessment being diagnosed with cancer. Improved awareness of the significance of visible haematuria in patients and primary care clinicians promotes early presentation, diagnosis and improved outcomes. All patients with visible haematuria warrant referral to a urologist. When available, referral to a rapid-access haematuria clinic with a streamlined “one-stop” urological assessment, including flexible cystoscopy, is encouraged.

Non-visible haematuria has a much lower association with malignancy, although as many as one in 20 patients are diagnosed with bladder cancer after referral with nonvisible haematuria.

Better treatment of bladder cancer starts with a high quality TURBT, and re-resection if indicated according to the initial pathology. The majority of elective operations are performed in Australia’s private sector, which, for a number of reasons, may restrict access to administration of intravesical therapy, multidisciplinary team management or radical cystectomy in a high volume centre. Centralisation facilitates the integration of enhanced recovery after surgery protocols and is associated with better postoperative mortality outcomes, reduced hospital length of stay, lower re-intervention rates and improved overall survival. Centralisation of cystectomy should be the standard of care. When possible, neo-adjuvant chemotherapy should be offered to patients requiring cystectomy, and has been associated with pathological down staging, improved positive margin rates and improved long term survival data.

Multiple phase 1–3 clinical trials of systemic immunotherapy in metastatic disease have demonstrated promising results relating to survival and disease progression and survival. Agents with proven efficacy include targeted immune checkpoint inhibitors, such as the programmed cell death protein 1 (PD-1) receptor or the programmed cell death ligand 1 (PD-L1). These include pembrolizumab (PD-1), nivolumab (PD-1), durvalumab (PDL1), atezolizumab (PD-L1), and avelumab (PD-L1). As BCG has been an immunotherapeutic mainstay in NMIBC for over three decades, the urological community is excited to see what role these novel immunotherapeutic agents will play in the management of non-metastatic disease including MIBC and high risk NMIBC.

Table 2: How do we improve bladder cancer outcomes?

Prevention

Discourage smoking Avoid exposure to industrial/occupational carcinogens

Early diagnosis

Population awareness for haematuria Clinician education – immediate referral of visible haematuria Rapid referral pathways

NMIBC

Quality TURBT Adjuvant therapy – Adjuvant intravesical therapy – Adjuvant intravesical immunotherapy (BCG) – Systemic immunotherapy (checkpoint inhibitors)

MIBC

Neo-adjuvant chemotherapy Quality cystectomy and enhanced recovery after surgery protocol

Metastatic disease

Systemic chemotherapy Systemic immunotherapy

Better Treatment

Measure outcomes

Stage specific recurrence and survival Quality of life

Clinical research

To address key questions across the entire therapeutic spectrum

20 A LITTLE BELOW THE BELT

The latest in bladder cancer research There are several ground-breaking bladder cancer trials currently underway in Australia, largely under the auspices of the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group. ANZUP is a cancer cooperative clinical trials group that was established in 2008 to improve multidisciplinary collaboration regarding clinical trial research into the management of urological cancers; its bladder cancer subcommittee now has more than 320 members.

High risk NMIBC One such study is the BCG Mitomycin (BCG+MM) trial, a national randomised phase 3 trial of combined BCG plus mitomycin versus BCG alone in the treatment of high risk NMIBC. BCG+MM is now the largest bladder cancer trial undertaken in Australia, with higher accrual to date than many of the previous international studies that determined its conception.

The patient-reported outcomes associated with the diagnosis and treatment of NMIBC are being further investigated in a University of Sydney and ANZUP cobadged, multicentre longitudinal cohort study entitled “Developing a patient-reported symptom index for nonmuscle invasive bladder cancer” (NMIBC-SI - https://www. anzup.org.au/content.aspx?page=nmibc-sievaluation), primarily assessing the patient-reported symptoms and quality of care through their treatment journey.

BCG-refractory NMIBC is challenging to manage, especially in patients unfit for cystectomy. Deviceassisted therapies (thermo-chemotherapy and electromotive drug administration) may have a role, and systemic immunotherapy is being investigated in this space by industry-sponsored trials, such as the phase 2 KEYNOTE-057 (pembrolizumab) and phase 3 KEYNOTE-676 (pembrolizumab plus BCG).

Metastatic bladder cancer There are numerous ongoing national and international industry-sponsored studies investigating the exciting role of immunotherapeutic checkpoint inhibitors as both firstand second-line agents in the metastatic bladder cancer setting. An ANZUP contribution in this space is the now accrued BL12 trial, which randomised 199 patients between nab-paclitaxel and paclitaxel as second-line therapy.

Conclusion Despite these research efforts and the arrival of new immunotherapeutic agents, we are still seeing deteriorating outcomes. In addition to the promotion of rapid access diagnostics and best possible clinical management at each and every stage of the disease, novel approaches are clearly required to reverse these unacceptable trends in this current cancer crisis.

Dr Andrew Moe is a urology registrar at Fiona Stanley Hospital in Perth, and is also affiliated with the University of Western Australia’s School of Medicine and ANZUP. Professor Dickon Hayne leads the urological research team at UWA and chairs the ANZUP Bladder Urothelial and Penile Cancer Sub-committee.

This article was originally published in MJA’s Insight and you can read the original article here: https://insightplus.mja. com.au/2019/20/bladder-cancer-a-cancer-in-crisis/.

PROFESSOR DICKON HAYNE

PCRMIB (Pembrolizumab with Chemoradiotherapy as Treatment for Muscle Invasive Bladder Cancer) is a novel phase 2 trial of bladder-preserving treatment for MIBC. All participants receive curative intent chemo-radiotherapy plus concurrent 3-weekly pembrolizumab.

The NIAGARA trial is an international industry-sponsored phase 3 randomised controlled trial that aims to determine the efficacy and safety of durvalumab in combination with gemcitabine and cisplatin as precystectomy neo-adjuvant therapy.

A LITTLE BELOW THE BELT 21

The challenge of rare cancers: spotlight on penile cancer

By Associate Professor Catherine Paterson, Associate Professor of Nursing, Faculty of Health, University of Canberra.

Globally, penile cancer is an uncommon cancer with a reported incidence of 1 per 100,000 men diagnosed.

Squamous cell carcinoma (SCC) accounts for > 95% of the cases of penile cancer. There is a range of treatments for penile cancer depending on the stage of disease. The primary treatment for penile cancer is surgery, although in the case of precancerous changes or early stage malignancies, minimally invasive treatments such as topical chemotherapy, laser therapy or brachytherapy may be suitable. Surgical treatment involves the removal of the primary tumour with or without performing inguinal (groin) and pelvic lymphadenectomy, depending on clinical indications or the histopathology. Surgery includes the resection of the primary tumour by circumcision, glansectomy (removal of the tissue at the end of the penis) or a partial or total removal of the penis known as a penectomy.

A total penectomy will require a subsequent perineal urethrostomy. This is a surgical procedure that is performed to create a permanent opening at the perineum, which is the skin between the scrotum and the anus, to allow urine to exit the body and not pass along the length of the penis.

The rarity of penile cancer represents a significant challenge to the patient, partner and healthcare professional from initial diagnosis to treatment and into survivorship. All treatments can be disfiguring and can have a profound negative impact on the patient’s sexual function, quality of life, social interactions, self-image and self-esteem. Different modalities of treatment are associated with their own individual challenges for patients, complications, unique psychological burden, and unmet supportive care needs.

I recently led a large international team of researchers and completed a systematic review to evaluate evidence regarding the unmet supportive care needs of men affected by penile cancer and their partners, to create a holistic model of care and inform clinical practice guidelines.

22 A LITTLE BELOW THE BELT

We performed a critical review of journals and resources including CINAHL (The Cumulative Index to Nursing and Allied Health Literature), MEDLINE, PsychINFO, Embase, and the Cochrane Library (CCRT and CDSR) controlled trials databases and clinicaltrials.gov from 1990 to June 2018 according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. Eighteen publications were selected for inclusion in this analysis Across these studies, men reported that the diagnosis and subsequent treatment of penile cancer affected physical, psychological and sexual well-being with each facet impacting and being intertwined with the other at varying degrees. There was varying complexity of unmet needs in men and partners pre-surgery, post-surgery and into survivorship.

In conclusion of this review, moderate evidence exists that men affected by penile cancer experience a range of unmet supportive care needs across the international literature. Further work to evaluate the impact of penile cancer on partners is required.

We reviewed the experience of unmet supportive care needs of men and their partner affected by cancer of the penis. We found good evidence to suggest new models of supportive care and access to specialist nurses are needed.

I am delighted to have been recently nominated as the deputy chair of the ANZUP Quality of Life and Supportive Care subcommittee. Priorities will include addressing important areas of unmet supportive needs to optimise quality of life in uro-oncology patient groups, affected by such rare cancers, which is fundamental to co-designing new innovative models and care pathways.

I very much look forward to supporting the work of ANZUP and to help drive forward research that is clinically meaningful addressing what matters most to people and their families affected by urogenital cancers.

Spotlight on testicular cancer Testicular cancer was once a lethal disease but is now almost always curable, even when it has spread, because of new treatments tested carefully in clinical trials. We still need to do better. This can only happen through understanding the science and by performing clinical trials to see which treatments are the ones most likely to help.

What is testicular cancer?

After skin cancer, testicular cancer is the most commonly diagnosed cancer in men aged 25 – 40.

Each year approximately 850 men are diagnosed with testicular cancer in Australia. This equates to 1% of all cancers in men.

Germ cell tumours are the most common testicular cancers. Under a microscope there are two main types that are quite different when observed – seminoma and non-seminoma cells. Seminoma cells usually occur in men aged 25-45 but can also occur in men over the age of 60.

This form of testicular cancer develops more slowly than non-seminoma cancers. The faster developing, rarer form, of testicular cancer occurs in younger men in their late teens and early 20s.

In 2019, it is estimated that there will be 852 new cases of testicular cancer diagnosed. For Australian men, the risk of being diagnosed with testicular cancer by age 85 is 1 in 218.

The rate of men diagnosed with testicular cancer has grown by more than 50 per cent over the past 30 years, however the reason for this is not known.

The five-year survival rate for men diagnosed with testicular cancer is close to 98 per cent.

In 2019, it is estimated that there will be 23 deaths from testicular cancer.

Testicular cancer symptoms Testicular cancer may cause no symptoms. The most common symptom is a painless swelling or a lump in a testicle.

Less common symptoms include: • feeling of heaviness in the scrotum; • swelling or lump in the testicle; • change in the size or shape of the testicle; • feeling of unevenness; • p ain or ache in the lower abdomen, the testicle or scrotum; • back pain; • e nlargement or tenderness of the breast tissue (due to hormones created by cancer cells).

Causes of testicular cancer An undescended testicle when as an infant or family history, that is, having a father or brother who has had testicular cancer, are a couple of factors that may increase a man’s risk of testicular cancer.

There is no known link between testicular cancer and injury to the testicles, hot baths, wearing tight clothes or sporting strains.

For other testicular cancer clinical trials go to page 37

Information on Testicular Cancer is derived from Cancer Australia https://testicular-cancer.canceraustralia.gov.au/statistics

A LITTLE BELOW THE BELT 23

The journey

Finding the funny in cancer Meet Michael Shafar – a Melbourne based stand-up comedian and writer for Chanel 10’s The Project. He was also diagnosed with testicular cancer in October 2017.

This year Michael launched a new stand up show called 50/50 around Australia which is based on his experience after being diagnosed with cancer. In 50/50 Michael tells of his discovery that he had stage three testicular cancer and his revelatory journey to remission.

At the time of diagnosis, the cancer had spread to his lymph nodes and lungs. His odds of survival were 50/50 - hence the name of the show. Fortunately, after 24 weeks of chemotherapy and numerous rounds of surgery, Michael is on the road to full recovery and has brought his experience to the stage in Perth, Adelaide, Brisbane, Melbourne and Sydney – with sell out shows! Michael also hit the track in March to participate in the Melbourne Pedalthon.

Q: Michael can you tell us a bit about yourself and your cancer diagnosis?

A: I was diagnosed when I was 26, which is a very young age to be confronted with having to consider my own mortality. Being a comedian, finding the comedy and humour in the whole experience was incredibly helpful. It was very empowering being able to find the funny in such a grave situation.

24 A LITTLE BELOW THE BELT

Q: How did you come up with the idea for 50/50?

A: The whole show is based off of my cancer experience from being diagnosed, to undergoing treatment and to finally being in remission. I called the show 50/50 because it’s a reminder of how close I was to not being here, and it reminds me to be grateful that I’m able to perform and do the thing I love.

Q: How did you decide what content to use for your shows?

A: I really wanted the show to be authentic so that it didn’t gloss over the seriousness of the diagnosis and how devastating it was for me, my family and girlfriend.

Having said that, I also really wanted the show to be funny – because that’s what comedy kind of has to be!

There were definitely a few parts of the experience that I didn’t know how to turn into comedy, so they didn’t make it into the show.

The journey Q: What feedback have you received from your shows – making cancer funny?

A: I’ve found that people who have cancer or who have survived cancer really connect with the material.

I did a show in Melbourne the other week and two older women came up and approached me afterwards to tell me that they were breast cancer survivors, and they hadn’t been able to laugh at the experience until they came along to the show. That really meant a lot to know that, for some people, perhaps the show has helped them to mentally deal with their cancer.

Q: Looking back at the last 12 months, what three things would you tell a person who only just learnt of their cancer diagnosis?

A: It’s difficult to give advice because something that I’ve learned is that everyone’s cancer experience is so unique depending on the type, stage, physical attributes and responsiveness of the patient to treatment.

A few general pieces of advice that I can offer are: 1. Make sure to have a good network of support around you. Don’t be a hero and think you can do it on your own.

2. If you can carry on with the other parts of your life, such as work and family commitments, while going through treatment, that’s fantastic. If you can’t, don’t be hard on yourself.

3. T he whole experience is a marathon and it’s best to look at every stage – whether it’s a round of chemotherapy, radiotherapy, surgery or a recovery period – as just one step in the process. This will mean you don’t get too upset if you get a bad test result, and on the flip side you’ll manage your expectations if you get a good test result.

Q: Plans for future shows?

A: I’ve already started writing my next show for 2020. I’m not sure yet what it will be about, but most likely it will focus on my life post-cancer and the impact it’s had on my perspective.

Find out more about Michael https://www.instagram.com/michael.shafar/ https://www.facebook.com/michaelshafar/ https://twitter.com/michaelshafar https://www.youtube.com/channel/UCt_CF6JYjhUZV_lGb7jCZCg

A LITTLE BELOW THE BELT 25

Spotlight on kidney cancer What is kidney cancer?

Kidney cancer starts in the cells of the kidney. About 90% of kidney cancers are renal cell carcinomas (RCC).

Usually only one kidney is affected but, in rare cases, the cancer may develop in both.

Each year more than 3,000 Australians are diagnosed with kidney cancer. It makes up about 2.5% of all cancers in Australia. Kidney cancer is rare in people under 40 but risk does increase with age. Also, men are almost twice as likely to be diagnosed with kidney cancer as women.

In 2019, there are estimated to be 3,814 new cases of kidney cancer diagnosed (2,539 males and 1,275 females). This is an estimated 2.6% of all new cancer cases diagnosed in 2019.

In 2019, there are estimated to be 1,034 deaths from kidney cancer (682 males, 351 females).

The five-year survival rate for Australians diagnosed with kidney cancer is 77 per cent although most people with kidney cancer localised only to the kidney can be cured.

Kidney cancer symptoms Most people with kidney cancer have no symptoms.

Many are diagnosed with the disease when they see a doctor for a different reason.

Symptoms may include: • blood in the urine (haematuria);

Causes of kidney cancer The causes of kidney cancer are not known, but factors that put some people at higher risk are: • Obesity – Excess body fat may alter certain hormones that can lead to kidney cancer.

• Smoking – Up to one-third of all kidney cancers are thought to be related to smoking. People who smoke have almost twice the risk of developing kidney cancer as non-smokers.

• High blood pressure – Whether it is caused by another medical condition or due to being overweight, high blood pressure increases the risk of kidney cancer.

• Kidney failure – People with end-stage kidney disease have an increased risk of developing kidney cancer.

• Family history – People who have family members with kidney cancer, especially a sibling, are at a greater risk.

• Inherited conditions – About 3–5% of kidney cancers occur in people with particular inherited syndromes, such as von Hippel-Lindau disease, Birt-Hogg-Dubé syndrome, and hereditary papillary RCC. • E xposure to toxic substances at work – After regular exposure to certain chemicals, such as arsenic, cadmium or some metal degreasers, the risk of kidney cancer may be higher.

• p ain or a dull ache in the side or lower back that is not due to an injury; • a lump in the abdomen; • rapid, unexplained weight loss; • constant tiredness; • fever not caused by a cold or flu.

For kidney cancer clinical trials go to page 39

Information on Kidney Cancer is derived from Cancer Australia https://kidney-cancer.canceraustralia.gov.au/statistics

26 A LITTLE BELOW THE BELT

Kidney cancer trials Cancers that start in the kidney are usually a type called renal cell carcinoma. Sometimes they can start in the lining of the tubes that carry urine to the bladder, and those cancers behave more like bladder cancer.

There are various renal cell carcinomas. The most common is called ‘clear cell carcinoma’ because that is what they look like through a microscope. Approximately 85% of renal cell carcinomas are of this type. The remaining 15% is made up of a range of other carcinomas. This is important because treatment aimed at one type of renal cell carcinoma might not work for another type.

Renal cell carcinomas are often found localised in the kidney and usually during tests done for another ailment, like gallstones. Small renal cell cancers can be removed by an operation, but as they get larger the chances of removing all of the cancerous tissues through operation becomes smaller.

Renal cell carcinomas that have spread to other parts of the body are often not curable, but there are now effective treatments to shrink them, or stop them from growing – sometimes for long periods of time. These treatments have been developed based on our understanding of the way these cancers behave. For example, clear cell renal cell carcinomas often rely heavily on blood vessels growing into them. Treatments aimed at stopping that growth can be very effective in this type of cancer. A number of these treatments are now available in Australia and more are being developed.

Other treatments for renal cell carcinoma that has spread include radiation treatment (radiotherapy) and surgery.

Of course, we also try to improve the symptoms and other problems the cancer might cause too, even if those treatments are not aimed directly at the cancer itself.

ANZUP has three renal cell cancer clinical trials open which are as follows:

KEYPAD trial The commonest kind of advanced kidney cancer is called clear cell kidney cancer. Immune therapies have been shown to be effective in about a quarter of patients with advanced clear cell kidney cancer after the standard tablet treatment has failed.

This study will test if a drug (denosumab) usually used to treat osteoporosis (thinning of the bones) or cancer that has spread to the bones, can be added to the immune therapy to increase the ability of the body’s immune system to attack kidney cancer cells. This study is designed to assess the effects and safety of the combination of two drugs; pembrolizumab and denosumab.

All participants on the trial will receive both treatments.

Blood and cancer samples will be collected from each patient to better understand who has benefited and who has been failed by the treatment combination.

UNISoN trial In this clinical trial ANZUP will test whether new immune treatments can help people with rare kidney cancer (‘nonclear cell’ cancer). Non-clear cell represents approximately 25% of people with kidney cancer; and because it is rare there are no treatments currently reimbursed in Australia.

The UNISoN trial will test immune treatments in two different ways; firstly we will find out how well one immune treatment (nivolumab) works alone. If this is unhelpful by itself, then people can continue taking nivolumab but also add in a 2nd immune treatment (ipilimumab). We will discover how many people will benefit from one drug alone, and by doing detailed laboratory testing of people’s cancer samples, hope to also learn who will only benefit from taking both treatments together.

Nivolumab and ipilimumab have been used alone or together in many cancers, so the side-effects are well known and should be manageable. Immune treatments help some people with cancer, especially those with melanoma, common (clear cell) kidney cancer, lung and bladder cancer. Unfortunately they are much less effective in other cancers (like pancreas, prostate and brain cancers). Nivolumab and ipilimumab have not been tested in people with non-clear cell kidney cancers, so ANZUP is delighted to ask this question, and hope to help people with this rare disease.

UNICAB trial This study aims to find how safe, tolerable and effective a new treatment called Cabozantinib is for non-clear cell kidney cancer. All patients will take cabozantinib orally every day, until the medication is no longer effective.

There is no placebo (inactive treatment), which means that everyone who takes part in the trial will receive the active cabozantinib drug.

Cabozantinib is an anti-cancer drug that works by blocking cancer cell growth. Cabozantinib has previously been used in the treatment of many cancers, including clear cell kidney cancer and thyroid cancer. However, it has not been tested in people with non-clear cell kidney cancer.

About 48 participants with non-clear cell kidney cancer are expected to participate in this study, from Australia.

A LITTLE BELOW THE BELT 27

UNICAB trial

By Dr David Pook, UNICAB study chair and ANZUP deputy chair of the renal cell subcommittee

This study aims to find how safe, tolerable and effective a new treatment called cabozantinib is for non-clear cell kidney cancer.

The UNICAB trial was designed to give patients with the non-clear cell variants of kidney cancer another treatment option. These variants make up about 1 in 6 kidney cancers and have not been included in most of the large kidney cancer trials in the past. As a result, none of the newer treatments for kidney cancer are available for this patient group.

The UNICAB trial is for patients with non - clear cell kidney cancer which has progressed on immune therapy or who cannot have immune therapy because of other medical conditions. It was designed so that patients who come off the UNISoN trial can then be enrolled on UNICAB. All patients receive cabozantinib, which is an oral targeted therapy drug which blocks a number of the VEGF (vascular endothelial growth factor) receptors in the same way as other kidney cancer drugs.

As well as this, cabozantinib blocks MET which is known to drive the growth of some non-clear cell kidney cancer variants. The drug is approved already in clear-cell kidney cancer and shown to have manageable side effects. This study is one of the first to look at the effectiveness of cabozantinib in non clear cell kidney cancer and we aim to enrol 48 patients in Australia.

A number of sites are now open across three states with further sites opening over the next three months.

For more information on this trial please go to 41.

NUMBER OF PATIENTS TO BE RECRUITED:

48

IN AUSTRALIA

CURRENTLY OPEN* SA NSW VIC *More sites will open soon.

28 A LITTLE BELOW THE BELT

Cabozantinib is an anti-cancer drug that works by blocking cancer cell growth.

Education and Innovation VOTED BEST SOCIAL MEDIA CAMPAIGN

Top chefs help ANZUP fight ‘below the belt’ cancers

AT THE BJUI JOURNAL SOCIAL MEDIA AWARDS

65

MEDIA OUTLETS COVERED THE CAMPAIGN

In February 2019, ANZUP’s ‘Rude Food’ campaign launched across social media channels Instagram and Facebook.

The ‘Rude Food’ campaign was designed to get the message out about how clinical trial research into ‘below the belt’ cancers is improving health outcomes for patients with prostate, testicular, penile, kidney and bladder cancer.

Over 30 local and international top chefs including Manu Feildel, Ainsley Harriot and Fast Ed got behind the campaign and created ‘Rude Food’ dishes with subtle nods to the anatomy and organs that ANZUP focuses our clinical research on, with a message on why they were involved.

The campaign continued to gain momentum, and in March won the Best Social Media Campaign at the BJUI Journal Social Media Awards held at the 2019 European Association of Urology meeting in Barcelona.

“The ‘Rude Food’ campaign aims to engage men and women in monitoring their health ‘below the belt’ while learning more about the importance of clinical trial research and how they can get involved,” says Margaret McJannett, ANZUP CEO. ‘The campaign objectives were to encourage people to get checked for ‘below the belt’ cancers, generate awareness about the importance of clinical trials in improving treatment and outcomes and to encourage people to ask their doctor ‘Is there is a clinical trial suitable for me?’

“Everyone has been touched by cancer in some way and it can be difficult to know where to start.”

You can see more of the campaign on Instagram https://www.instagram.com/anzuptrials/ and it’s not too late to get involved and to create your cheeky ‘Rude Food’ dish and share it to your social media networks tagging @anzuptrials with the hashtag #rudefood.

The idea behind the campaign was to encourage discussion about these cancers and raise funds for the vital research needed to find preventions and treatments. ANZUP and the chefs encouraged everyone to get involved and create their own ‘Rude Food’ dish and share it with their friends, family & colleagues.

6,446 NEW PROFILE VISITS

16,136

450

FACEBOOK IMPRESSIONS

2,342,721 TOTAL IMPRESSIONS

137,751

FRIENDS OF ANZUP SIGNUPS

VIDEO VIEWS A LITTLE BELOW THE BELT 29

Education and Innovation

International Clinical Trials Day May 20th marks International Clinical Trials Day, an opportunity to celebrate those who strive to find answers to the tough clinical questions. The improvements in health outcomes as a result of clinical trials are momentous, enabling the development of new interventions, helping to raise standards of treatment, and – crucially - benefiting patients by enabling faster access to the latest treatment.

He isolated six pairs of scurvied seamen, administering a different remedy to each.

Lind’s experiment proved his instinct was correct, providing evidence that there was a clear link between the introduction of oranges and lemons into the diet of seamen, and scurvy prevention. Lind’s discovery revolutionised modern medicine and paved the way for clinical trials to come.

Clinical trials hail as far back as the Old Testament.

Daniel’s subscription to a diet of pulses and water had left him fit and healthy, whilst his companions, subsisting on meat and wine (at the recommendation of King Nebuchadnezzar II), fell ill. It was this discovery, the isolation of diet as the cause for poor health, that many deem the first clinical trial.

Today (very much on dry land) clinical trials have evolved into procedures focusing on patient safety and requiring informed consent from all participants. ANZUP’s clinical trials bring together all of the professional disciplines and groups involved in researching and treating below the belt cancers to identify gaps in evidence and areas of clinical need.

Most famously however, was Dr. James Lind’s discovery aboard the HMS Salisbury on this day in 1747, which is widely recognised as the first true clinical trial. Whilst working as a naval surgeon at sea, Dr. James Lind acted on a hunch that the humble citrus fruit could cure scurvy.

We thank all ANZUP members for their dedication to finding answers to clinical questions, and to all the patients who participate in clinical trials. We celebrate them for their commitment to improving health outcomes for themselves and all those affected by testicular, bladder, kidney, penile and prostate cancers.

The Noel Castan Fellowship ANZUP is very proud and excited to launch the Noel Castan Fellowship at the 2019 Annual Scientific Meeting (ASM) in Brisbane. The ASM theme “Making Connections” highlights the need to improve access to high quality information for patients and caregivers, while encouraging links between the various health disciplines, researchers and cross-border collaborations. The aim of the Noel Castan Fellowship is to build ANZUP’s research capacity and increase the translation of information collected from our trials, which will contribute to better understanding of how to optimise patient care.

Applications for fellowships are invited in the fields of: • Bioinformatics or clinical informatics: translation of existing ANZUP trial data; development of new proposals; or • Quality of life: application of current instruments; development/validation of new instruments; translation of data from existing ANZUP trials.

“I am delighted to be able to support ANZUP by establishing the Noel Castan Fellowship in memory of my wonderful husband, who passed away from cancer two decades ago. I understand the value of supporting clinical trials and take this opportunity to congratulate ANZUP on its many successes to date and its collaborative approach”.

Anita Castan

30 A LITTLE BELOW THE BELT

Clinical Trials How do I find out about clinical trials that may be suitable for me, my family or friends?

You can talk to any of the health professionals involved in your care: general practitioners, specialists, nursing or allied health professionals. They should be able to provide general information about clinical trials and may have information on clinical trials that are relevant to you.

Australian Cancer Trials website http://www.australiancancertrials.gov.au/ Hosted by Cancer Australia, the Australian government agency is tasked with providing national leadership in cancer control.

This website provides searchable information on the latest clinical trials in cancer. This website also includes some general information on: • What is a clinical trial?

Support groups or consumer health organisations with an interest in a particular disease or condition may also have information on trials, or be able to link you with other patients who have been involved in trials.



– What are they and why are they important?



– Different types of clinical trials



– Different phases of clinical trials



– What are randomised controlled trials?

Resources

• Treatment choices

ANZUP website



– Safety



– Advantages and risks

http://www.anzup.org.au/content.aspx?page=cancer trials%28patient%29 • A ll ANZUP (and ANZUP co-badged) trials by disease type (bladder, kidney, testicular and prostate).

• E ach trial listed includes a lay summary and information you can print off and take to your doctor/health specialist for referral.

ClinTrial Refer App In July 2014, ANZUP released its first trial based app. Although it was designed for specialists, it is also a very useful tool for consumers. This searchable app allows you to find clinical trials by disease (cancer type), trial site locations and contacts, status (actively recruiting, closed) and inclusion/exclusion criteria.

• Being part of a trial

 – P ractical considerations such as travel (and government travel assistance available for rural/remote patients)  – R esults after the trial finishes – how to access and make sense of them • Q uestion prompt lists – things you may like to ask your cancer specialist about. It is important to understand your disease type, status and treatment options before considering whether to join a clinical trial • A comprehensive glossary, including cancer, medical, drug and treatment terms It is a great place to start if you wish to research the what, why, and how of clinical trials before exploring individual clinical trials.

Other resources/support:

Australian Clinical Trials website

Cancer Australia

https://www.australianclinicaltrials.gov.au/ This site provides a searchable list of trials recorded with the Australian New Zealand Clinical Trials Registry (ANZCTR) and international trials listed on clinicaltrials.gov which have Australian sites. It also allows you to set up an account and subscribe for new clinical trial alerts.

Cancer Australia has a range of resources to support consumers to understand and engage in cancer control, including: • B rochures and information on how to get involved in cancer control as a consumer • V ideos and tools to assist consumers in navigating their treatment options and discussions with clinicians https://canceraustralia.gov.au/about-us/who-we-work/ consumer-engagement For information about cancer support groups in your area, talk to your GP, community nurse or specialist or contact:

Cancer Council 13 11 20 http://www.cancer.org.au/

Prostate Cancer Foundation of Australia 1800 22 00 99 http://www.prostate.org.au/ A LITTLE BELOW THE BELT 31

Make a difference with ANZUP We need your help to improve outcomes for people affected by these below the belt (prostate, testicular, penile, bladder and kidney) cancers and for future generations.

Any donation, large or small, goes straight into the hands of experts to find the answers we need.

To find out more or to donate please go to https://www.anzup.org.au/content.aspx?page=donations

Fundraise for ANZUP

If you are interested in holding an event to support ANZUP or are considering joining an event such as the City 2 Surf, Run Melbourne, Sydney Marathon, Walk to Work Day or any other community event, please contact us at anzup@anzup.org.au or call 02 9562 5042 and we will help you set up the fundraising pages.

100% of every donation made to ANZUP goes towards clinical trial research to improve outcomes for bladder, kidney, testicular, penile and prostate cancers.

ANZUP is a not for profit cancer research charity and is registered on the Australian Charities and Not-for-profits Commission (ACNC) Register and the Charities Services Register in New Zealand. We have obtained Deductible Gift Recipient (DGR) status in all states and territories in Australia and donee status in New Zealand. This means donors can claim income tax deductions for gifts to ANZUP (of $2 or more in Australia and $5 or more in New Zealand) in their income tax returns.

32 A LITTLE BELOW THE BELT

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

Bladder cancer

Testicular cancer

Prostate cancer

ANZUP Trials

ANZUP Trials

ANZUP Trials

l BCG + MM trial

l TIGER

l TheraP

l PCR MIB

l P3 BEP

l Pain Free TRUS B

Co-badged Trial

Co-badged Trial

l NMBIC-SI

l NINJA

Kidney cancer ANZUP Trials

Trials now closed to recruitment

l K EYPAD

l ENZARAD

l UNISoN

l ENZAMET

l UNICAB

l BL12

Co-badged Trial l FASTRACK II

l e-TC 2.0 l proPSMA

A LITTLE BELOW THE BELT 33

Current ANZUP trials

Bladder Cancer BCG + MM Trial

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

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

This randomised trial will determine the effects of adding MMC 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. This trial will recruit 130 patients in stage one and 370 patients in stage two. To date 228 patients are enrolled.

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: https://www.anzup.org. au/content.aspx?page=bladdercancertrialdetails ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).

This ANZUP investigator initiated study is being funded

by Cancer Australia. We acknowledge Omegapharm and Merck Sharp & Dohme for providing study drugs.

34 A LITTLE BELOW THE BELT

Current site locations for the BCG + MM trial: NSW • Concord Repatriation General Hospital • Northern Cancer Institute • Southside Cancer Care Centre • Sydney Adventist Hospital Clinical Trials Unit • The Tweed Hospital • Westmead Hospital VIC • The Alfred Hospital • Austin Hospital • Epworth HealthCare (Richmond) • Footscray Hospital • Frankston Hospital • Royal Melbourne Hospital WA • Fiona Stanley Hospital

Current ANZUP trials

Bladder Cancer PCR MIB Trial

Opened in mid-2016, this trial is aimed at managing bladder cancer that has spread into the wall of the bladder. A combination of chemotherapy and radiotherapy is the current standard treatment. This study aims to assess if it is safe and effective to add an additional new drug called pembrolizumab to the standard therapy of chemotherapy and radiation therapy.

Pembrolizumab is a new treatment that “takes the brakes off” the immune system, allowing it to attack cancers more effectively. Studies of pembrolizumab in widespread bladder cancer have shown benefit, with cancer shrinkage observed in about two thirds of people, and in some cases long periods of disease control. At present, pembrolizumab, is approved for use in Australia for the treatment of advanced melanoma in adults.

It is expected that it will take two years to accrue the required 30 patients. To date, we have six sites active and 17 patients enrolled.

Current site locations for the PCR MIB ANZUP clinical trial: NSW • Chris O’Brien Lifehouse • Liverpool Hospital • Prince of Wales Hospital • Royal North Shore Hospital VIC • Austin Hospital WA • Sir Charles Gairdner Hospital

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: https://www.anzup.org.au/content. aspx?page=bladdercancertrialdetails We thank and acknowledge MSD for their funding and product support.

A LITTLE BELOW THE BELT 35

Current ANZUP trials

Bladder Cancer Co-badged trial NMIBC-SI Evaluation

Non-muscle invasive bladder cancer (NMIBC) makes up approximately 70-80% of all bladder cancer diagnoses.

Treatment is generally intended to reduce the risk of the bladder cancer recurring or progressing to muscle invasive disease. Treatment involves endoscopic resection to the bladder tumours followed by potential intravesical chemotherapy or immunotherapy. Although treatments can significantly reduce the risk of recurrence and progression, there are both benefits and harms that are likely to vary between treatment options. However, little is known about the impact of these treatments on patients’ quality of life.

Current site locations for the NMIBC-SI trial:

This project follows on from Phase I, which involved qualitative research to develop a draft Non-Muscle Invasive Bladder Cancer Symptom Index (NMIBCSI). The aim of the current project is to evaluate the psychometric properties of the NMIBC-SI. This will be conducted across two field tests:

• Monash Medical Centre - Clayton

• F ield Test 1 is a cross-sectional study design asking participants to complete the draft NMIBC-SI questionnaire either on paper or electronically. The purpose of Field Test 1 is to produce a shorter version of the NMIBC-SI by eliminating items with poor psychometric properties.

QLD

• F ield test 2 uses a prospective longitudinal study design to evaluate the clinical validity of the final version of the NMIBC-SI. Participants will be asked to complete the NMIBC-SI along with comparative questionnaires at different time-points during their treatment. The purpose of Field Test 2 is to assess the reliability, validity and responsiveness of the final version of the NMIBC-SI to ensure it is fit for purpose in clinical research.

This study is currently active and recruiting and has enrolled 97 patients. 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: https://www.anzup.org.au/ content.aspx?page=bladdercancertrialdetails ANZUP collaborates with Cancer Australia and Cancer Council NSW. This study is being sponsored by the University of Sydney.

36 A LITTLE BELOW THE BELT

NSW • Concord Hospital • Royal North Shore Hospital • Westmead Hospital • Westmead Specialist Centre VIC • Austin Hospital • Royal Melbourne Hospital WA • Fiona Stanley Hospital

• Mater Hospital Brisbane New Zealand • Cantebury Urology Research Trust • Tauranga Urology Research Ltd USA • Mayo Clinic • University of Minnesota Hospital • University of Kansas

Current ANZUP trials

Testicular Cancer Testicular Cancer/Germ Cell* Tumours TIGER Trial

This randomised phase III trial will study how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumours that have returned after a period of improvement or did not respond to treatment.

Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumour cells.

They either kill the cells by stopping them from dividing or stop them from spreading. Giving chemotherapy before a stem cell transplant halts the growth of cancer cells by stopping them from dividing or by killing them.

Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Current site locations for the TIGER trial: NSW • Chris O’Brien Lifehouse (open) QLD • Princess Alexandra Hospital (open) VIC • Box Hill Hospital (open) • P eter MacCallum Cancer Centre (estimated to open third quarter 2018) INTERNATIONAL • Sites open in the USA, EORTC and UK

It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumours.

Up to 420 patients will be enrolled in Australia, New Zealand and other countries. Currently we have 3 patients enrolled and 4 number of sites open.

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

ANZUP is collaborating with the Alliance for Clinical Trials in Oncology (USA) and EORTC (Europe) and the NHMRC Clinical Trials Centre.

We thank and acknowledge the Movember Foundation for their funding support to conduct the TIGER trial.

For more information, please go to the trials page on the ANZUP website: https://www.anzup.org.au/content. aspx?page=testicularcancertrialdetails

A LITTLE BELOW THE BELT 37

Current ANZUP trials

Testicular Cancer Testicular Cancer/Germ Cell* Tumours PHASE III Accelerated BEP Trial The current standard practice for the treatment of germ cell tumours is the use of the chemotherapy combination called BEP, which consists 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 and better tolerated than a three-weekly schedule. 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 27 sites open in Australia and New Zealand, and 88 patients enrolled. We have also set up the trial in the US, in Ireland with the support of Cancer Trials Ireland and the Medical Research Council, Cambridge University, UK. 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: https://anzup.org.au/ aspx?page=testicularcancertrial details ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).

This ANZUP investigator initiated study is being funded by Cancer Australia. ANZUP has also 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.

Current site locations for the P3BEP ANZUP clinical trial:

• Fiona Stanley Hospital NEW ZEALAND • Auckland Hospital • Christchurch Hospital • Dunedin Hospital • Palmerston North Hospital • Starship Children’s Hospital

NSW

UK

• Calvary Mater Newcastle

• Addenbrooke’s Hospital

• Chris O’Brien Lifehouse

• Royal Preston Hospital

• Concord Repatriation General Hospital

• B eatson West of Scotland Cancer Centre

• Macquarie Cancer Clinical Trials

• Bristol University Hospital

• Nepean Hospital

• Velindre Hospital

• Prince of Wales Hospital

• C ambridge University Hospital Paediatric

• Royal North Shore Hospital • SAN Clinical Trials Unit • The Tweed Hospital • Westmead Hospital

• University Hospital Southhampton • Royal Marsden Hospital • St James Hospital - Leeds

QLD

USA

• Princess Alexandra Hospital

• S aint Mary’s Hospital, West Palm Beach

• Queensland Children’s Hospital • Royal Brisbane & Women’s Hospital SA

• Sinai Hospital of Baltimore • Toledo Children’s Hospital

• Flinders Medical Centre

• W ashington University School of Medicine, St Louis

• Royal Adelaide Hospital

• Dana-Faber Cancer Institute

TAS • Royal Hobart Hospital VIC

• Rady Children’s Hospital • Cincinnati Children’s Hospital • Arkansas Children’s Hospital • Joe DiMaggio Cancer Centre • Nemours Children’s Clinic

• Austin Health

• Augusta University Medical Centre

• Border Medical Oncology

• Vanderbilt University Medical Centre

• Box Hill Hospital • Peter MacCallum Cancer Centre • Sunshine Hospital

38 A LITTLE BELOW THE BELT

WA

Current ANZUP trials

Kidney Cancer KEYPAD

Renal cell carcinoma (RCC) is the 9th most common cancer in Australia and the 10th most common cancer in Western populations. Approximately 75% of kidney cancers are clear-cell renal cell carcinomas (ccRCC). At the moment up to half of patients with clear cell renal carcinoma will die of their cancer.

Immune therapies have been shown to be effective in about a quarter of patients with clear cell renal cell carcinoma after the standard treatment (sunitinib) has failed.

This study will test if a drug frequently used to treat osteoporosis, (thinning of the bones), can team up with immune therapy to improve survival and increase the chance of the cancer shrinking for people with clear cell kidney cancer.

In the trial, people with advanced clear cell kidney cancer will be offered treatment with two antibodies (a type of protein). This trial will investigate if these drugs taken together can increase the ability of the body’s immune system to attack kidney cancer cells.

It is hoped that by combining pembrolizumab with denosumab, (another antibody which is used to help reduce bone loss in osteoporosis and cancer patients), will stimulate the immune system, so that the immune therapy will work better in the tumours.

The study is a collaboration between ANZUP and the NHMRC Clinical Trials Centre. We thanks and acknolwedge Amgen and MSD for providing funding and prodct to support KEYPAD.

Current site locations for the KEYPAD clinical trial: NSW • Calvary Mater Newcastle • Concord Repatriation General Hospital • Northern Cancer Institute • St George Hospital QLD • ICON Cancer Care • Royal Brisbane & Women’s Hospital • Sunshine Coast University Hospital VIC • Box Hill Hospital • Monash Health Clayton • Peter MacCallum Cancer Centre • Ballarat Oncology and Haematology Services SA • Flinders Medical Centre WA • Fiona Stanley Hospital

This study is currently active and recruiting. To date 13 sites have been activated in Australia with further sites to be added and a total of 70 patients to be recruited.

Currently 29 patients have been enrolled.

For more information, please go to the trials page on the ANZUP website: https://www.anzup.org.au/content. aspx?page=kidneycancerfastrackiitrial

A LITTLE BELOW THE BELT 39

Current ANZUP trials

Kidney Cancer UNISoN

In this clinical trial ANZUP will test whether new immune treatments can help people with rare kidney cancer (‘nonclear cell’ cancer). Non-clear cell represents approximately 25% of people with kidney cancer; and because it is rare there are no treatments currently reimbursed in Australia.

The UNISoN trial will test immune treatments in two different ways; firstly the trial will investigate how well one immune treatment (nivolumab) works alone. If this is unhelpful by itself, then people can continue taking nivolumab but also add in a 2nd immune treatment (ipilimumab). The trial will also discover how many people will benefit from one drug alone, and by doing detailed laboratory testing of people’s cancer samples, hope to also learn who will only benefit from taking both treatments together.

Nivolumab and ipilimumab have been used alone or together in many cancers, so the side-effects are well known and should be manageable. Immune treatments help some people with cancer, especially those with melanoma, common (clear cell) kidney cancer, lung and bladder cancer. Unfortunately they are much less effective in other cancers (like pancreas, prostate and brain cancers). Nivolumab and ipilimumab have not been tested in people with non-clear cell kidney cancers, so ANZUP is delighted to ask this question, and hopes to help people with this rare disease.

This study is currently active and recruiting. To date 19 sites have been activated in Australia with further sites to be added. To date, 77 patients are enrolled in Part 1 of the trial with a recruitment aim of 85 participants. Part 2 of this trial has a recruitment aim of 48 participants and currently has 28 patients enrolled.

We thank and acknowledge BMS for providing the study drug and funding to conduct the UNISON trial.

For more information, please go to the trials page on the ANZUP website: https://www.anzup.org.au/content. aspx?page=kidneycancerfastrackiitrial

40 A LITTLE BELOW THE BELT

Current site locations for the UNISoN trial: NSW • Border Medical Oncology • Calvary Mater Newcastle • Campbelltown Hospital • Chris O’Brien Lifehouse • Northern Cancer Institute • Port Macquarie Base Hospital • Prince of Wales Hospital • St George Hospital • St Vincent’s Hospital • Tamworth Hospital • Westmead Hospital VIC • Ballarat Oncology & Haematology Service • Box Hill Hospital • Monash Health – Clayton SA • Adelaide Hospital/ Ashford Cancer Centre Research • Flinders Medical Centre QLD • Royal Brisbane and Women’s Hospital • Sunshine Coast University Hospital WA • Fiona Stanley Hospital

Current ANZUP trials

NEW STUDY

Kidney Cancer UNICAB

This study aims to find how safe, tolerable and effective a new treatment called Cabozantinib is for non-clear cell kidney cancer. All patients will take cabozantinib orally every day, until the medication is no longer effective.

There is no placebo (inactive treatment), which means that everyone who takes part in the trial will receive the active cabozantinib drug.

Current site locations for the UNICAB trial (more sites will open soon):

Cabozantinib is an anti-cancer drug that works by blocking cancer cell growth. Cabozantinib has previously been used in the treatment of many cancers, including clear cell kidney cancer and thyroid cancer. However, it has not been tested in people with non-clear cell kidney cancer.

• Border Medical Oncology

About 48 participants with non-clear cell kidney cancer are expected to participate in this study, from Australia.

VIC • Monash Medical Centre, Clayton NSW

SA • Adelaide Cancer Centre We thank and acknowledge Ipsen for Ipsen for providing the study drug and funding to support the UNICAB trial. For more information, please go to the trials page on the ANZUP website: https://www.anzup.org.au/content. aspx?page=kidneycancerfastrackiitrial

Kidney Cancer Co-badged trial - FASTRACK II Surgery is the standard treatment for primary kidney cancer. However, in some cases, surgery is either not possible or other health problems make surgery high risk. This study involves a relatively new, highly precise multidirectional radiotherapy technique called Stereotactic Ablative Body Radiotherapy (SABR) which will be applied to all participants. The aim of the study is to test the ability of the technique to control cancer within the kidney for those people for whom surgery is not an option, and to examine the side effects of the treatment, including how it may affect your kidney’s function.

This study is currently active and recruiting. To date 8 sites have been activated in Australia and New Zealand. There is a recruitment aim is 70 participants and currently 51 patients are enrolled.

For more information, please go to the trials page on the ANZUP website: https://www.anzup.org.au/content. aspx?page=kidneycancerfastrackiitrial ANZUP collaborates with the Trans-Tasman Radiation Oncology Group (TROG).

Current site locations for the FASTRACK II trial: NSW • Calvary Mater Newcastle • Liverpool Hospital • Royal North Shore Hospital VIC • Peter MacCallum Cancer Centre • The Alfred (William Buckland Radiation Centre) SA • Royal Adelaide Hospital QLD • Princess Alexandra Hospital • Royal Brisbane and Women’s Hospital

A LITTLE BELOW THE BELT 41

Current ANZUP trials

Prostate Cancer TheraP

Lutetium-177 PSMA radionuclide therapy (Lu-PSMA) is a new treatment for advanced prostate cancer. Lu-PSMA is a radioactive molecule that specifically attaches to cells with high amounts of PSMA on the surface of the cells. This allows the radioactivity to be delivered mainly to the prostate cancer cells wherever they have spread, while sparing most normal tissues. Previous small studies of Lu-PSMA showed promising activity in patients with advanced prostate cancer.

This randomised study will compare Lu-PSMA with a type of chemotherapy called cabazitaxel, which is the standard treatment for advanced prostate cancer when other treatments have stopped working. Half the participants will receive Lu-PSMA and half will receive cabazitaxel.

This study will provide further information about the risks and benefits of Lu-PSMA compared with cabazitaxel in men with prostate cancer.

We plan to enrol 200 participants in the study in Australia and currently 176 patients are enrolled. To date, 11 sites have been activated in Australia and New Zealand.

This trial is open and recruiting. If you are interested in participating in the trial, please refer to https://www. anzup.org.au/content.aspx?page=lutetiumprostate cancertrial TheraP is a partnership between ANZUP Cancer Trials Group and the Prostate Cancer Foundation of Australia (PCFA) with support from the Australian Nuclear Science and Technology Organisation (ANSTO), Endocyte, It’s a Bloke Thing, Movember and CAN4CANCER.

42 A LITTLE BELOW THE BELT

Current locations for the TheraP trial: NSW • Liverpool Hospital • Royal North Shore Hospital • St Vincent’s Hospital VIC • The Austin Hospital • Monash Medical Centre – Clayton • Monash Medical Centre – Moorabbin of Monash Health • Peter MacCallum Cancer Centre SA • Royal Adelaide Hospital QLD • Royal Brisbane and Women’s Hospital WA • Fiona Stanley Hospital • Sir Charles Gairdner Hospital

Current ANZUP trials

Prostate Cancer Pain Free TRUS B

A prostate biopsy involves taking small pieces of the prostate through a needle so that it can be looked at through a microscope. A Trans Rectal Ultrasound (TRUS) guided biopsy is the usual method and involves insertion of 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 is a phase 3 double-blind placebo-controlled randomised trial of methoxyflurane with peri prostatic local anaesthesia to reduce the discomfort of trans rectal ultrasound-guided prostate biopsy.

Current locations for the Pain Free TRUS B trial: NSW • Westmead Hospital VIC • The Alfred Hospital • Casey Hospital WA • Fiona Stanley Hospital New Zealand • Canterbury Urology Research Trust • Cardinal Points Research • Tauranga Urology Research

This study will include 420 men. Currently we have 7 active sites across Australia and New Zealand with 386 patients enrolled.

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

This trial is open and recruiting. If you are interested in participating in the trial, please refer to https://anzup. org.au/content.aspx?page=prostatecancertrial details This ANZUP investigator initiated study is being funded

by Cancer Australia. We acknowledge MDI for providing the study drug.

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ANZUP trials in follow up

Trials in follow up

Once a clinical trial is finished, researchers scrutinise all the information collected during the course of the study. Reviewing all the data allows researchers to decide whether the results mean the new intervention should continue to the next phase of clinical trial, or, when applicable, seek approval for broader use by the appropriate authorities. Once a new intervention has been proven to be effective and safe, it may become part of standard treatment for the condition or disease.

Review and analysis of the information can take an extended period of time. So there may be a delay before the results of a clinical trial are known. This is definitely the case with larger trials that can involve thousands of people from many hospitals both in Australia and overseas. In large multi-centre trials the examination of the data and outcomes may take place over several years.

If you have taken part in a trial and specified you wish to know the overall results of the trial, the researchers should make them available to you directly. Usually results of all completed studies will also be made available in papers or reports published in scientific journals.

ANZUP now has five trials in follow-up: • ENZAMET • ENZARAD • BL12 • e-TC • proPSMA

ENZARAD ENZARAD is a randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer.

Enzalutamide is a new hormone treatment taken as tablets. Previous trials have proven that enzalutamide improves survival and quality of life in men with prostate cancer that has stopped responding to standard hormone treatments and chemotherapy. This large, international randomised trial will determine if treatment with enzalutamide can improve survival and quality of life in men starting radiation and hormone therapy for prostate cancer that does not seem to have spread beyond the prostate.

The trial has been led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre.

The trial accrued 802 men from 69 sites across Australia, New Zealand, Canada, the US, Ireland, and the UK. Recruitment closed on 30th June 2018.

ENZAMET ENZAMET is a randomised phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer.

In June 2019 ANZUP reported that the ENZAMET clinical trial showed improved survival at the first interim analysis. Men with metastatic hormone sensitive prostate cancer received enzalutamide or nonsteroidal anti-androgen therapy (NSAA: bicalutamide, nilutamide, or flutamide) in addition to standard of care therapy (androgen deprivation therapy, ADT), with or without docetaxel chemotherapy.

The ENZAMET trial interim analysis showed a 33% improvement in overall survival and a 60% improvement in progression-free survival, for men who received enzalutamide. This translated into 80% chance of survival at 3 years with enzalutamide versus 72% with NSAA. This trial has been led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre.

A total of 1,125 participants from 83 global sites from Australia, New Zealand, Canada, the US, Ireland, and the UK took part in this trial.

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ANZUP trials in follow up

Trials in follow up

BL12

proPSMA

This study was designed to look at whether NabPaclitaxel improves survival and is less toxic, with improved quality of life, compared with Paclitaxel in people with advanced or metastatic urothelial cancer, in the setting where the cancer has grown or come back during or within 12 months of completion of platinum based chemotherapy.

Prostate cancer is the most commonly diagnosed cancer in Australian men. If detected early, when disease has not spread, there is a high chance of cure.

Relapse, however, is not uncommon despite careful selection of patients prior to surgery or radiotherapy.

This, in part, reflects a failure to detect disease spread at baseline due to limited accuracy of current scanning techniques. More accurate scanning may improve outcomes by redirecting patients with disease spread from futile local treatments to more appropriate management.

Urothelial transitional cell cancer (uTCC) is a type of cancer that typically starts in the cells that line the inside of the urinary system. People with “advanced or metastatic urothelial cancer� have cancer which has spread beyond the region of the urinary system, typically to lymph nodes, the wall of abdomen or pelvis, bones or other organs. Chemotherapy is commonly used in this situation. Chemotherapy drugs of a type called taxanes have commonly been used as a second line treatment. This family of chemotherapy drugs include Nab-Paclitaxel and Paclitaxel.

Recruitment to this study ceased on the 7th April 2017 and sites are being closed out. As part of this process, sites are required to submit documents and begin the process of archiving all trial records for 15 years from the end of the trial. And once it becomes available the final trial publication will be submitted to the Human Research Ethics Committee.

e-TC 2.0 A team of cancer survivors, researchers and clinicians developed the e-TC website, which provides evidence-based information and psychological strategies for coping with the challenges associated with testicular cancer.

This study aims to evaluate the use and satisfaction with the e-TC website in men who have finished treatment for testicular cancer and are feeling stressed, down or worried about their cancer coming back. Men were recruited through clinicians at participating centres and online via search engine and social media advertising.

The study has now closed to recruitment with 40 participants having taken part.

This clinical trial will investigate a new type of scan which provides whole body images of prostate cancer spread. Early experience suggests that this new technology, called PSMA PET/CT (prostate specific membrane antigen positron emission tomography/ computed tomography), is superior to current scanning techniques. PSMA PET/CT has capacity for wide availability at relatively low cost. Performing a single better test rather than several less accurate scans will also be cheaper, improve patient experience and expose patients to lower amounts of radiation.

This is a randomised study at multiple centres around Australia comparing PSMA-PET/CT to conventional imaging. If the initial work-up does not demonstrate tumour spread, patients will cross-over to the other imaging arm. We hope to prove that PSMA-PET/ CT has superior diagnostic performance, should be used as a first-line test for staging prior to surgery or radiotherapy and will result in significant changes to patient management. Results of this trial will be used to support funding of this new technology in Australia and internationally.

The trial has now closed to recruitment and enrolled 300 participants in Australia.

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Melbourne Pedalthon The second Melbourne Pedalthon was held on Sunday 17 March with 34 teams participating, who raised more than $78,000 for ANZUP’s Below the Belt Research Fund!

Melbourne certainly turned on the great weather, with sunny and warm conditions all day, which kept the riders smiling and pedalling, showing their dedication to the cause – to fight cancer below the belt.

Thank you to every rider and volunteer who joined us out at Sandown Racecourse. Our thanks also go to the Melbourne Racing Club Foundation for their generous support of the venue, Sandown and to our sponsors including Platinum Sponsor, Bristol-Myers Squibb, Silver Sponsor Ipsen and Drinks Station Sponsor BOQ Specialist.

The family challenge was a huge hit again – with over 18 adults and kids participating, including our youngest riders ever – 2 and a half year old Henry and his cousins 4 year old Milly and Harry.

A special thanks to Associate Professor Andrew Weickhardt and Professor Shomik Sengupta who shared with the audience how the Below the Belt Research Fund supported their studies, and the importance of the funds raised at events such as the Pedalthon. Thanks also to Associate Professor Jeremy Shapiro and Dr David Pook who have been huge supporters of bringing the Pedalthon to Melbourne.

We are delighted to announce that we will be holding the 2020 Melbourne Pedalthon on Sunday 15 March at Sandown Racecourse. Thanks go to our venue partner Melbourne Racing Club Foundation for their ongoing support and commitment to ANZUP and the Pedalthon.

Further details will be available via www.belowthebelt.org.au with registrations opening later this year.

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Melbourne Pedalthon

ASSOCIATE PROFESSOR JEREMY SHAPIRO AND DR DAVID POOK

Who was there?

3 Balds and Braun

Ipsen Isotopes

AXA XL

LOEG - league of extraordinary gentlemen

Back Before Ten Thirty Becs Troops Becs Troops 2 Bladder pros BMS (A) - Team BMS B - Team BMS C(RO) - Team BMS D(REAM) - Team Cabrini Team Cam McLaren Daniel Podbury Eastern Cycling Cartledge’s Cavaliers

Matthew Robertson Moore for Ben and Louise 1 Moore for Ben and Louise 2 Moore for Ben and Louise 3 Moore for Ben and Louise 4 Perpetual Peddlers Sengupta Family Team Cowan Shafar VICUNI ITS The Bags The Kabuki - Men Tour de Cure

Eastern Cycling Club

Williams Family

Edwina Gallagher

Zippy Zeps

Far Kew Cycling Club Far Kew Cycling Club 2 Glynn Matthews Ipsen Impalas Ipsen Incredibles Ipsen Interlopers

“The Pedalthon was set up several years ago by Simon Clarke who was affected by genitourinary cancers and wanted to find some way of giving back to the profession.

Since then we’ve generated $1.5m of research funds and every dollar of that fundraising has been ploughed back in to support further research.

It’s a great day, a day of enjoyment and fun and a fair bit of healthy competition as well.”

Professor Ian Davis, ANZUP Chair

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Melbourne Pedalthon

2019 Below the Belt Pedalthon Melbourne MONEY RAISED:

$78,000+

34 TEAMS

150

2,934 LAPS RIDDEN

RIDERS

9,095 “There’s a lot of people here connected to the cause, there’s a lot of people here that know somebody who’s going through it now or sadly somebody that they’ve lost.”

Kent Williams, Race Director

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KMS CYCLED

100%

OF MONEY RAISED IS COMMITTED TO THE BELOW THE BELT RESEARCH FUND

Melbourne Pedalthon

Congratulations to Shomik Sengupta, our 2019 Melbourne Pedalthon fundraising champion who has raised an incredible $3,741!

Fundraising heroes Top fundraisers

THANK YOU TO EVERY RIDER FOR YOUR FUNDRAISING EFFORTS.

Individuals

Teams

• Shomik Sengupta • Leo Lipp • Peter Mackie

• Becs Troops • The Kabuki – Men • Sengupta Family

Congratulations to the highest fundraising team Becs Troops who raised $5,273 – well done to Tom, Mikaela, Liss and Penny.

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Melbourne Pedalthon

Champions of the track

Congratulations to the 2019 Below the Belt Champions (Open Race), Back Before Ten Thirty who completed 148 laps in 3 hours.

Congratulations to the other winners of the day • Best Dressed Garage: Becs Troops • Fastest Lap – Male: Glen Newman • Fastest Lap – Female: Sue Phillips • Most Number of Laps (Open Race / Individual): Matthew Robertson • Most Number of Laps (Age Group / Individual / Female):

• Most Number of Laps (Family / Individual): Aneer Sengupta • Sprint Challenge (Fastest 2 Laps / Individual): Glen Newman • Youngest Riders: Harry Lyons, Milly Lyons, Henry Pannifex • Highest Fundraiser (Team): Becs Troops

- Under 30: Katie Cookson

• Highest Fundraiser (Individual): Shomik Sengupta

- 30 - 40:

Natasha Ward

- 40 - 50:

Larnie Morrison

• Most Number of Laps (Family / Team): Williams Family

- 50 - 60:

Sue Phillips

- Over 60: Jan Pannifex • Most Number of Laps (Age Group / Individual / Male): - Under 30: James Chapple - 30 - 40:

Matthew Robertson

- 40 - 50:

Glen Newman

- 50 - 60:

Jo Spano

- Over 60: Doron Gradstein

The 2019 Below the Belt Champions (Family Challenge) are the Williams Family.

Congratulations to Scott, Kirsty, Amelia and Eloise!

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• Most Number of Laps (Open Race / Team): Back Before Ten Thirty

Melbourne Pedalthon

Platinum Sponsor “Our crew of 16 BMS-Australia cyclists geared up for ANZUP’s Below the Belt Pedalthon in March to help defeat testicular, prostate, bladder and kidney cancers. We entered 4 teams into the ride which raises crucial awareness and funds to support research that will improve outcomes for Australians affected by these ‘below the belt’ cancers. As a company we are proud to sponsor this worthwhile cause and we got involved early by hosting a fundraising blend and spin in the office a few days before the race. Thanks for having us ANZUP, looking forward to Below the Belt Pedalthon – Melbourne 2020.”

Marc Mikhail, Head of Medical Advocacy and Strategy

Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. We are focused on helping patients in disease areas including oncology, cardiovascular, immunoscience and fibrosis. Each day, our employees work together for patients – it drives everything we do.

Not only did 16 members of the BMS team ride at the Below the Belt Pedalthon, they also held their own internal ‘Blend and Spin’ fundraiser.

At the company’s Melbourne – based headquarters the team made delicious banana smoothies by riding bikes. The team raised $638 in 38 minutes. The office fundraiser made pharma news via pharmadispatch.

Venue Partner The second Melbourne Pedalthon was made possible by the generous support of venue partner, the Melbourne Racing Club (MRC) Foundation, with providing ANZUP with Sandown Racecourse.

The MRC Foundation is the philanthropic arm of the Melbourne Racing Club, and provides a centralised, coordinated approach to their charitable giving and community support. The Foundation assists a diverse range of groups and organisations, particularly those within the areas of our three racecourses, Pegasus Leisure Group venues across Victoria and participants in the racing industry.

The MRC Foundation hopes to engage the wider Victorian community via generating charitable funds and other in kind support in order to enrich the life’s of people in need.

We are delighted to partner with the MRC Foundation for the 2020 Melbourne Pedalthon on Sunday 15 March at Sandown Racecourse.

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Melbourne Pedalthon

Silver Sponsor “With a passion for improving the lives of patients, Ipsen partnered with ANZUP’s Pedalthon to raise funds for urogenital cancers. This is our second year of involvement and ANZUP must be acknowledged for the way it organises the Pedalthon. The ride accommodates a diverse range of rider abilities, from the competitor to the commuter and everyone in between. This allows more people to participate and with this in mind Ipsen entered four teams this year – Ipsen Impalas, Ipsen Isotopes, Ipsen Interlopers and Ipsen Incredibles – made up of Ipsen employees, family and friends. We are proud to say together we raised over $5000 going toward ANZUP clinical trials to improve the lives of Australian patients. We look forward to riding again in 2020.”

Ipsen held their own internal fundraiser at their head office, ‘a smoothie bike race’ making fruity smoothies while fundraising for the Pedalthon. Even though Ipsen had 4 teams competing at the event, the other staff wanted to get involved, and even made branded cookies.

Mark Taylor, Oncology Business Manager, Ipsen

Drinks Station Sponsor

Our thanks to BOQ Specialist for their support as this year’s drinks station sponsor. We welcomed Jesse and Zain who gave the riders water bottles, hats, stress balls and plenty of other goodies, including a business card draw.

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Melbourne Pedalthon

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Melbourne Pedalthon

‘Becs Troops want to make a difference to help future patients and their families in loving memory of Bec who died from kidney cancer at 19 years of age in 2011. We love the clinical trial research work conducted by ANZUP Cancer Trials Group Ltd and we want to support them by raising money as part of our participation in Below the Belt Pedalthon Melbourne.’ Becs Troops

‘I am very involved with ANZUP, and will be riding in the 2019 Melbourne Below-the-Belt Pedalthon to raise funds for them. Every cent raised in this event goes to supporting research - in the last 2 years alone, ANZUP has provided 15 grants from the Below the Belt Research funds. These research projects will help improve outcomes for patients suffering from genitourinary cancer.’ Professor Shomik Sengupta

A special shout out to one of our Pedalthon ambassadors and supporters Jonny Harrison who came 3rd in the Jetblack 24 hour mountain bike event last weekend. Jonny was looking the part in his branded ANZUP and Below the Belt Pedalthon cycling kit and riding as ‘Below the Belt Racing’.

Congrats Jonny, you are an inspiration!

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Dr David Pook, ANZUP Member riding in his Pedalthon cycling gear during ASCO in Chicago.

Thanks to Corporate Supporters and In-Kind Supporters Corporate Supporters

In-Kind Supporters

We are very fortunate to have our corporate supporters and partners who enable ANZUP to better support our members and, ultimately, patients and their families. Our 2019 corporate supporters include:

We acknowledge and thank the following organisations for the generosity they have shown by providing their pro bono services.

Our 2019 in – kind supporters include:

Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Ipsen, Janssen and Pfizer Oncology

Active Display Group, AFI Branding and The Saturday Paper.

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Ride or support and help fight prostate, testicular, penile, bladder and kidney cancer.

Sydney Pedalthon Tuesday 10 September 2019 Sydney Motorsport Park, Eastern Creek, NSW

Melbourne Pedalthon Sunday 15 March 2020 Sandown, Springvale, VIC

For more information go to www.belowthebelt.org.au