ANZUP's 'A little below the belt' consumer magazine

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

AN ANZUP CANCER TRIALS GROUP PUBLICATION

ISSUE 7, JULY 2017

THE GLOVES ARE OFF

YOU VS.

CANCER DISCOVER THE LATEST IN CUTTING EDGE CLINICAL TRIALS LIVE COMMENTARY BY WORLD-RENOWNED UROGENITAL & PROSTATE CANCER EXPERTS

THE COMMUNITY ENGAGEMENT FORUM DIRECT FROM PULLMAN ALBERT PARK MELBOURNE

2 A LITTLE BELOW THE BELT

SUNDAY 16 JULY BOOK YOUR FREE PLACE

A N Z U P. O R G . A U

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 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. To bring a trial to fruition, it is much more productive to get people together to work through the science, develop trial concepts, write the protocol documentation, and other things that need to be done. All of this is separate from the other task of sourcing other resources including funding to support much larger amounts of money to support the trials themselves.

We thank and acknowledge Astellas and AstraZeneca for their invaluable support in ensuring the dissemination of ANZUP’s consumer magazine, ‘A little below the belt’.

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

Join us this September for the Below the Belt Pedalthon and help defeat urogenital cancer!

More information on page 43

What’s inside 03 What is ANZUP? 05 Message from the Chair, Professor Ian Davis 08 Consumer Advisory Panel update 09 Friends of ANZUP 10 CEO update 11

ecret men & women’s business: how difficult is it to S bring this up with your health professional?

14 Spotlight on bladder cancer 15 The Journey – My journey with kidney cancer: Catherine McFarlane 17 Immunotherapy in kidney cancer 18 Spotlight on kidney cancer ANZUP Cancer Trials Group Level 6, Lifehouse Building 119-143 Missenden Road CAMPERDOWN NSW 2050

19 e-TC 2.0: Online intervention helping men get their lives back on track after testicular cancer

Phone 61 2 9562 5042

22 Spotlight on testicular cancer

Email anzup@anzup.org.au

21 Stage I testicular cancer follow-up recommendations – A decision-making aid for patients

27 The ever changing prostate cancer landscape 28 International Clinical Trials Day PCFA online community ClinTrial Refer app 29 Definition: what is a clinical trial?

Twitter @ANZUPtrials

31 How do I find out about clinical trials that may be suitable for me or my family/friends?

33 Current ANZUP Trials

Facebook ANZUP

43 Below the Belt Pedalthon 45 How is ANZUP funded?

Published by ANZUP Cancer Trials Group Ltd. Copyright. Editors Lucy Byers and Steve Gibbons Graphic design by Designcycle 4 A LITTLE BELOW THE BELT

46 What does a donation look like?

47 Corporate Sponsors and In-Kind Supporters

Message from the Chair, Professor Ian Davis

Welcome to this edition of ‘A little below the belt.’ This work of art and science is produced by ANZUP to help us communicate the importance of the “below the belt” cancers, why it is so critical to support clinical trials in this area, and what ANZUP is doing about it. ANZUP is the Australian and New Zealand Urogenital and Prostate Cancer Trials Group and our reason for existence is to improve outcomes for anyone affected by prostate, kidney, bladder or testicular cancers, the “below the belt” cancers of the genitourinary system.

Some of you who are reading this might be return visitors and aware of what it is that we do. We have some great news for you a bit further on, and a whole lot more information elsewhere in this magazine. Thanks for your continued interest in and support of ANZUP. If you are new to us though then you might need a bit of background. ANZUP is a cooperative cancer clinical trials group. That means that we are a group of interested doctors and nurses and a whole lot of other health care professionals, working closely with scientists and members of the community, to do clinical trials to learn more about why some of these cancers cause so much in the way of problems for the people we know and care for. At the time of writing there are 1200 of us working together towards this aim. We want to find better ways of treating them and looking after them. We know that we need to understand more than we do now about how these cancers behave, how best to use the treatments we have, and of course to find out new ways of helping people. It’s not enough just to have an idea or a shiny new drug or piece of equipment;

we have to be able to show that we are improving what we do and that this translates into better outcomes for our patients and their families.

This can only be done through clinical trials. When you hear the word “research” you might think of labs and machines, and “breakthroughs” and news headlines and cured mice and nodding reporters, and head shots of earnest researchers. All these things are true, except maybe the “breakthrough” bit, but more on that later. What we call “basic” research is critically important: the most effective treatments we have were developed because we learned more about the diseases we were trying to treat and the people who are affected by these diseases. You would be forgiven for thinking we are curing cancer every second day if you watch television or read the papers, but sadly this is not the case. Real “breakthroughs,” where the whole field suddenly leaps ahead, are sadly very uncommon: they have only happened four or five times in the whole 20th century. We are talking about things like the discovery of chemotherapy, or new radiotherapy technologies or new treatments deliberately designed to explore the specific weaknesses of cancer cells, or better ways of supporting our patients through the effects of the cancer and its treatment. Did you know that some of those discoveries were made in Australia? Did you also realise that not a single one of them would have made the slightest bit of difference if we had not done the clinical trials that showed their value? It’s great to cure cancer in a mouse (and it’s actually often pretty easy to do it), but humans are not big bald mice and the lessons we learn in the lab have to pass

A LITTLE LITTLE BELOW BELOW THE THE BELT 5 A

some very stringent tests before we are prepared to take them into treatment of humans and eventually into routine practice. Just because it’s new or cool doesn’t mean it’s better.

Most clinical trials are done by pharmaceutical companies and we work very closely with them. I don’t think any of us would begrudge a company becoming wildly successful because they have cured cancer. I would certainly love to be put out of business as a medical oncologist. However, sometimes the important questions to be answered are ones that really cannot be done with the usual pharmaceutical company model. Perhaps it’s an old drug that is off patent and we are looking for novel ways to use it, or combine it with something else. Perhaps the idea involves treatments that come from more than one company. Perhaps it’s not a drug at all but some other intervention aimed at improving cancer outcomes or otherwise helping support our patients. If industry will not do these trials, who will?

Enter the cooperative groups like ANZUP. We talk with our patients and their families, see where the needs are, understand the science, design the questions, do the trials, and generate the evidence that you and we all need to be able to make informed decisions about the best options for you.

We are celebrating more than usual in this magazine because ANZUP has hit some major milestones. We have just completed accrual to a major international trial we have been leading in prostate cancer, the ENZAMET trial. Three years ago we entered our first patient and in March we hit our target of 1100 men around the world who have taken part in the trial. Let’s stop for a moment and celebrate, and be thankful that these men and their families have undertaken this trial, knowing that it might possibly not be of benefit to them directly but will be of incalculable benefit to everyone who follows them.

But this is only the first part of the work. Now we must follow them carefully to see which of the two treatments they could have received on the trial is better. Maybe it’s the new treatment; maybe it’s the old one; maybe they can’t be separated; but whatever we find, it is going to make a difference and will tell us what the next steps need to be.

“We talk with our patients and their families, see where the needs are, understand the science, design the questions, do the trials, and generate the evidence that you and we all need to be able to make informed decisions about the best options for you.”

This is hard work. It is often done outside our employed hours, because all of us are busy (including you). It is time consuming because it has to be done properly: the stakes are too high for us to muck around. It is expensive: the treatment does not just happen and the information does not assemble itself into a nice neat package for us. Sometimes it’s disappointing: we work so hard on something that seems like a good idea only to find that perhaps it wasn’t after all. Although then we realise that this is important to know as well, so that we don’t treat people in ways that are unhelpful or ineffective. And sometimes it is wildly exciting: we discover new information that really makes a difference to people. This makes all the rest of it so emphatically worthwhile.

We are celebrating more than usual in this magazine because ANZUP has hit some major milestones.

6 A LITTLE BELOW THE BELT

We have also ticked over the 100 patient mark on an important trial being run by our surgeons, aimed at improving outcomes for people with a certain type of bladder cancer.

This study will answer an important question but will also have the additional benefit of standardising treatment for this condition across Australia.

We have also confirmed that we now have funding for three new and very interesting trials. Two of them are in kidney cancer, and one trial for the first time is aimed specifically at the less common “non clear cell” type, with both trials involving novel approaches to boost the immune system. Another exciting initiative has come to fruition through links with the Prostate Cancer Foundation of Australia, which has helped ANZUP design a trial that takes a strategy previously used to try to improve scanning methods for prostate cancer, and modify it into an actual treatment that will home in on these cancers to kill them. These are all novel and world-leading trials, demonstrating the quality of the people who are leading them and the value of a group like ANZUP that can bring them to reality. There is a whole lot of other stuff going on through ANZUP as well and you will read about some of this in this publication.

We have to do better. People are still suffering and dying because of these cancers and we cannot allow this to continue. We can only improve outcomes if we can generate evidence that supports better ways of helping and treating people, and then applying that evidence into health care policy and practice. We also need to build an evolving workforce of people who are able to lead and conduct this sort of research and influence treatment patterns

We can only improve outcomes if we can generate evidence that supports better ways of helping and treating people, and then applying that evidence into health care policy and practice. after the information is available. ANZUP puts a lot of effort into supporting the next generation of clinician-researchers so that we can continue and grow our work effectively into the future.

You can help! Just by reading this publication you have indicated your interest. We need public support. We need governments to recognise the importance of this sort of research and to provide the funds we need to do it. We need our patients and their families to be demanding more progress and to be asking their doctors whether clinical trials might be available and appropriate for them. Less than 6 per cent of adult cancer patients in Australia go onto a clinical trial. Think how much faster we could improve what we do if we had more opportunities to do these trials, the resources to do them, and people clamouring for them to be available. You can speak to your local member of parliament and tell them about the great work ANZUP is doing as well as other similar groups working in different areas. They listen to this!

You can also contribute by spreading the word and by demystifying research. Too often people seem to be frightened by the prospect of going onto a clinical trial, thinking that they are being experimented upon and that their treatment might be compromised as a result. Nothing could be further from the truth. The wellbeing of our trial participants is always uppermost in our minds and they will always receive the very best possible treatment. But how can we tell you what that treatment is if we don’t ask the question…?

You might be interested in contributing financially to ANZUP’s work. ANZUP is registered as a charity in every Australian state and territory, and donations are tax deductible. We try wherever possible to direct these donations toward the actual research we are doing, rather than using it to support office costs. As an example, all the funds raised by our annual Below the Belt Pedalthon are directed back to support research that is expected to develop into future ANZUP trials. We know your donations are your hard-earned money and we never take these donations for granted. You can be confident that these funds will be used as you intended.

This magazine contains a wealth of information about ANZUP and its activities. You can find out more from our website. The ANZUP ClinTrials Refer app is freely available for Apple and Android devices, and is a great resource to see what trials are being done, as well as the details of the trials and where they are being conducted. ANZUP holds a Community Engagement Forum every year at its Annual Scientific Meeting and this year it will be held in Melbourne at the Pullman Albert Park on Sunday 16 July 2017.

We hope to see you there to hear more about research and how ANZUP works.

Thanks for your interest in ANZUP. I hope you enjoy this edition of ‘A little below the belt.’

A LITTLE BELOW THE BELT 7

Consumer Advisory Panel update

By Belinda Jago, CAP Chair

The Consumer Advisory Panel (CAP) was established by the ANZUP Board to provide the patient’s perspective across ANZUP’s research activities.

We have a seat on the Scientific Advisory Committee (SAC) where research priorities are set and new concepts are approved. We also participate in regular subcommittee teleconferences for prostate, kidney, testicular and bladder cancers. This is where we hear about various trial ideas being considered and, like our clinical colleagues, provide advice / feedback from a patient’s point of view on how we might feel if the trial was being offered to us. We also provide them with an update on what we have been working on, or are looking for support for through these meetings.

We meet face to face at the Annual Scientific Meeting where we are provided with a comprehensive education program to support the work we do as CAP members.

We also allow time to discuss ideas / projects for the next 12 months.

Another important aspect of our work is to review the Participant Information and Consent Forms (PICF).

These PICFs provide the patient and families/ carers with details about a proposed trial that is being offered to them. These documents tend to be quite lengthy as they need to contain all of the relevant information about the trial, the treatment schedule and

side effects, so we work hard to ensure that that the language used is written in such a way that the patient can make an informed decision as to whether the trial is suitable for them. The CAP has recently reviewed PICFs for some new and important kidney cancer clinical trials that will offer patients some much needed treatment options moving forward.

Members of the CAP are also invited to the Concept Development Workshops. These full day workshops allow clinicians, who have an idea for a new trial, to brainstorm and present potential ideas to a multidisciplinary team of researchers. The CAP once again provides the invaluable insight of a patient’s point of view at this earliest stage of clinical trial development.

So what are the criteria for being a CAP member?

ANZUP CAP members have all been affected by a cancer diagnosis either themselves or through a close family member.It is also helpful if they have been on a clinical trial themselves. However, most importantly, the CAP are committed to promoting clinical trial research so we can achieve our mission to improve the treatment of bladder, kidney, testicular and prostate cancers.

Over the next 12 months the CAP’s focus outside of reviewing trials will be on how we can better engage with the community through new initiatives such as Friends of ANZUP. You can read more about this program at: http://anzup.org.au/friendsofanzup.aspx.

We are committed to growing our community audience and educating patients and their families on how important clinical trial research is, and that there may be a clinical trial that’s right for them.

I would like to close my report with a big thanks to the entire CAP who so freely give their time. We work as a great team and I really appreciate the support and enthusiasm they show when adding the patient voice to ANZUP’s research portfolio.

8 A LITTLE BELOW THE BELT

FR

EE

to

Jo

in!

The “Friends of ANZUP” is a new initiative connecting people whose lives have been impacted by prostate, kidney, bladder or testicular cancers.

Membership aims to provide: • Information about the benefits of clinical trials and how to access them • Support from people who understand the challenges • Information about research conducted by ANZUP • Biannual community magazine, ‘A little below the belt’ featuring regular updates and stories from health professionals, researchers, cancer survivors and cancer trial participants • Invitation to the Community Engagement Forums • Practical resources to help those living with prostate and urogenital cancers • Regular e-news and other resources Join “Friends of ANZUP” and help us achieve our mission to improve the outcomes and treatment for those living with testicular, 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.

There is no membership fee and membership does not need to be renewed annually.

To find out more and join go to: http://anzup.org.au/friendsofanzup.aspx

A LITTLE BELOW THE BELT 9

CEO update By the CEO of ANZUP, Margaret McJannett

ANZUP has had a very busy start to 2017, in what has been a period of significant growth and activity for the organisation.

We have seen an increase in the number and diversity of our clinical trials across all the cancers we represent, the continued building of our national and international collaborations, the expansion of education and mentoring opportunities for the next generation of clinical researchers, while supporting and encouraging our active and engaged membership.

ANZUP now has 1200 members! We are very fortunate to have such a passionate, generous and talented group of individuals working with us across a full range of professional disciplines to make a difference in the lives of people affected

by GU cancers.

In the last year, ANZUP has had seven active clinical trials (and two co-badged studies) running in 136 centres in every state in Australia, New Zealand, as well as with our international collaborators in Ireland, UK, USA, Canada and soon to be in Europe. All up, 2,089 patients have taken part in these trials.

We continue to conduct trials across all urogenital cancers with two renal cell cancer trials now funded and due to commence recruitment in the second half of 2017.

ANZUP continues to work collaboratively with a range of organisations in the genitourinary cancer space to optimise outcomes for patients through clinical research. In March 2016 ANZUP and the Prostate Cancer Foundation of Australia (PCFA) signed a formal agreement to improve access to clinical trials, pledging to work together to raise $1.5 million over three years to fund prostate clinical trials. Thanks to this partnership grant, ANZUP and PCFA are set to launch a landmark prostate cancer trial in the second half of 2017.

Engaging directly with people who have been affected by urogenital cancers is vital to the work we do. We are fortunate at ANZUP to have a very active Consumer Advisory Panel (CAP) who provide a consumer perspective on general research directions and provide input into our clinical trials from conception through to development. The CAP also acts as a link from ANZUP back to the community to promote research and community support.

This year our annual Community Engagement Forum will be held in Melbourne, on 16 July. This event provides the general

10 A LITTLE BELOW THE BELT

public with the opportunity to hear from an experienced team of researchers about the importance of ANZUP and clinical trials in improving treatment and outcomes for people with urogenital cancers. We look forward to another informative and interactive event.

Our major fundraising event, the Below the Belt Pedalthon, continues to grow from strength to strength. In the December edition of this magazine, I reported that we raised an incredible $300,000 from the Pedalthon. Further funds continued to come in and I am thrilled to advise that as a result the Below the Belt Research Fund has more than doubled its funding pool to support important investigator led studies in GU cancers. We look forward to updating you on the successful 2017 projects funded in the next edition.

This publication aims to provide patients and families with information on clinical trials and other activities ANZUP undertakes. Pleasingly, we recently undertook a membership survey and 92% of responders indicated that they see the magazine as a valuable resource for their patients and consumers. We are very grateful to AstraZeneca and Astellas who have provided us with an untied grant so that we can circulate the magazine to more than 400 Cancer Centres across Australia and New Zealand. If you are interested in accessing additional hard copies to have available at your cancer centre or private rooms please don’t hesitate to contact me directly or the ANZUP office (02) 9562 5042.

Our Friends of ANZUP initiative is another great way to stay connected with ANZUP. Free membership includes: • I nformation about the benefits of clinical trials and how to access them; • S upport from people who understand the challenges of prostate, kidney, bladder and testicular cancers; • Information about research conducted by ANZUP; • The biannual ‘A little below the belt’ magazine sent to you; • I nvitations to Community Engagement Forums and practical resources and regular e-news.

To sign up please visit http://anzup.org.au/friendsofanzup.aspx Thank you for supporting ANZUP Cancer Trials Group.

The journey

Secret men & women’s business: how difficult is it to bring this up with your health professional?

By Kath Schubach and Gabriela Den Hollander

GU NURSE PRACTITIONER, KATH SCHUBACH

A diagnosis of cancer and the effects of potential treatment options can impact greatly on the quality of life of patients and their partners. Through improvement in cancer survival rates, people are living longer, often with long-term side effects from their previous treatments.

Sexuality is a fundamental aspect of every individual and patients need access to information on sexuality issues (Stead et al 2003, Fobair et al 2006). Research has demonstrated that patients expect this information will be delivered by their healthcare professional, but clinicians can be reluctant to discuss sexual issues (Hordern & Street 2007).

Kath Schubach is a qualified Nurse Practitioner, with a Masters in Nursing and Post Graduate studies in urology, continence, and oncology nursing.

In 2009, Kath undertook a clinical research fellowship which looked at men with localised prostate cancer, treated with radiotherapy. One of the distressing symptoms for these men was their erectile dysfunction. This symptom is a long-term side effect and usually occurs 18 months after their treatment.

This research identified significant unmet sexual needs among patients attending a specialist cancer centre.

The development and implementation of a Nurse Practitioner (NP)-led sexual health and erectile dysfunction (SHED) clinic was established. The SHED clinic has addressed patients’

BLADDER CANCER SURVIVOR, GABRIELA DEN HOLLANDER

sexual concerns and, in turn, has provided positive outcomes for their wellbeing and quality of life.

Gabriela den Hollander is a 68-year-old woman, living in Newcastle NSW, married and a mother to two adult children.

She works part-time as a psychotherapist and is a long-term practitioner of aikido.

A diagnosis of advanced bladder cancer began early in 2014 for Gabriela with occasional pinpricks of bright blood in her clothing, a subsequent GP appointment in May, and referral to a gynaecologist.

Prior to a hysteroscopy in August, a nurse noticed Gabriela’s urine was cloudy and contained blood. Urine testing was undertaken followed by an immediate referral to an urologist and two cystoscopies prior to pre-op chemotherapy during December and January. The cystectomy performed on January 27, 2015 proved successful in removing the cancer and no further therapy was required. Follow up appointments with the oncologist and urologist noted no recurrence of the cancer.

Cancer was a surprise addition to Gabriela’s life. She hadn’t suspected it would be part of her journey. After cancer, and especially the shock of having to face a cystectomy, Gabriela felt mightily relieved that no further treatment was required.

Getting through this had been her primary focus for several months and she is now determined to resume an active life.

A LITTLE BELOW THE BELT 11

The journey

Kath talks with Gabriela about her bladder cancer diagnosis, its impact and lessons learned.

Did your treating team address your sexual health queries/ concerns?

“Throughout this process the treating team did not raise the issue of sexual functioning, except for the urologists saying that my vagina would probably be shorter. Any questions outside their area of expertise went unanswered. Supportive conversations with the practice nurse mostly helped me understand what the treatment entailed, which was a priority for me at that time. Although I searched avidly for more information, Cancer Council booklets advised me to consult my doctor about sexual matters, which I didn’t do.

The Mater Hospital oncology team offered the most information and support, delivered in a thoroughly systematic, compassionate and transparent manner. Their counselling service was of most help in attending to my anxieties about sexual matters, which I raised after treatment had finished. Although I wanted more information sooner, I found it hard to know what to ask and, most importantly, from whom.”

Did you have to bring this up or was it the health professional?

“At each stage of my engagement with the health system, it was usually my husband or I that raised questions about sexual health and functioning.”

Did they refer you to anyone?

“At no stage was I referred to anyone other than to the oncology team counsellor, which was at my request.”

How difficult was it to try and source this information yourself?

“I experienced a fluctuating yet prevailing sense of urgency and anxiety during my cancer treatment. Almost everything was always happening for the first time and I was taking medication to manage my anxiety. As noted above, Cancer Council booklets referred me to my doctor for information.

However, while in treatment I had no medical reason to see my GP, and questions about sexuality usually arose in my mind when there was no one around to answer them. Postoperatively the stoma therapy nurse was of great help in normalising a range of concerns.”

What could have made this process easier for you?

“In retrospect, it would have helped to have been given telephone access to someone who could provide information on sexual health and functioning, including, perhaps, telephone information and a counselling line specifically for cancer patients. This would also benefit people in regional and rural areas. Additionally, specialists could refer patients back to their GP and encourage them to raise matters that specialists cannot address, including gynaecological and sexuality issues. Alternatively, their nurses could be trained in delivering sexual health information. Urologists could also consult with gynaecologists as a matter of course to bring a team approach to the treatment of women with cancer. This would have helped me feel more confident when agreeing to have my ovaries removed instead of wondering what advice a gynaecologist might give, and if there was time to see one before my operation.”

Having gone through your treatment what would you suggest we should offer woman in a similar situation? E.g. diagrams, explanation, tips, etc “At a post-op appointment with the urologist I learned that my vagina had been narrowed by approximately 50 per cent, rather than shortened as previously described. I was particularly shocked because the diagrams provided by two urologists made no mention of this, or of any problems that might arise as a result. Eventually I asked my GP to refer me to a gynaecologist, who assured me that vaginas are very adaptable to such changes. I was then able to consult further and obtain treatment for the prevention of vaginal atrophy, which I’m told is common in older women.”

“Having gone through all of this, and given that female patients may well be a minority group for urologists, I’d like to add the following suggestions: • W omen should be encouraged to ask surgeons for detailed information after their operation, including the likely impact of surgery on sexual functioning. If information is insufficient, let women know to ask for referral to a suitable clinician, such as a gynaecologist or sexual health nurse. Diagrams are helpful when they are accurate, both before and after surgery.

• S upport women to record and give feedback to clinicians about the treatment process, and ask for change.

• O ffer women sexual health counselling as a matter of course.

• P osters, flyers and brochures targeting stoma recipients need to talk about sex.“

12 A LITTLE BELOW THE BELT

Suggested questions to ask your healthcare professional (excerpt from Cancer Council: Sexuality, Intimacy and Cancer. A guide for people with cancer and their partners) • How will this treatment affect me sexually?

• W hat can be done to preserve sexual functioning and pleasure?

Resources to help you with your secret business Cancer Council Sexuality, Intimacy and Cancer. A guide for people with cancer and their partners https://www.cancercouncil.com.au/cancer-information/ after-cancer-treatment/sexuality-intimacy/

• How will this treatment affect my hormones?

ReKindle

• W ill this treatment affect my fertility? What can I do about it?

• Are any changes permanent?

The University of Sydney and the Cancer Council of NSW have identified that many cancer survivors are suffering in silence and need support. They have developed a world-first, personalised online resource called ‘Rekindle’ to improve the sexual wellbeing of all cancer survivors and their partners.

• I f the changes are temporary, how long will I experience them?

Cancer survivors, whether in a relationship or single, and partners, are invited to use this resource.

• W hat treatment options are available to help with sexual issues after cancer?

Rekindle is personally tailored to meet your specific needs. It can be used on any device, including laptops, tablets and smart phones. It is available 24 hours a day, seven days a week.

• W hat changes are likely in the short term and longer term?

• When is it safe to have sex again?

• W hen can I expect to feel like, or enjoy, having sex or being intimate again?

You still can have an active sex life after cancer, so please visit http://rekindleonline.org.au/user

A LITTLE BELOW THE BELT 13

Spotlight on bladder cancer Bladder cancer is said to be the fourth most common cancer in Australian men, and about 3000 Australians are diagnosed with bladder cancer each year.

What is bladder cancer?

Bladder cancer symptoms

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

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

There are different types of bladder cancer: • U rothelial carcinoma, formally known as transitional cell carcinoma, is the most common form (80-90 per cent), 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 2013, 2555 new cases of bladder cancer were diagnosed in Australia. Bladder cancer is common in people aged over 60 and is significantly more common in men than in women.

In 2014, there were 1040 deaths caused by bladder cancer in Australia. The five-year survival rate for Australians with bladder cancer is 53 per cent.

However most people with bladder cancer are cured.

Bladder cancer that has spread to other parts of the body is usually not curable, but there are effective treatments available that can help control it.

Other less common symptoms include: • p roblems emptying the bladder; • a burning feeling when passing urine; • n eed to pass urine often; • b lood in urine; • l ower abdominal or back pain.

Causes of bladder 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; • u se of the chemotherapy drug cyclophosphamide; • diabetes; • f amily history; • c hronic inflammation of the bladder.

For bladder cancer clinical trials see page 34 Footnote: Information on Bladder Cancer is derived from Cancer Council Australia http://www.cancer.org.au/about-cancer/types-of-cancer/bladder-cancer.html

14 A LITTLE BELOW THE BELT

The journey

My journey with kidney cancer

By Catherine McFarlane

Through the course of my work, I come across people every day who have health challenges related to their kidneys. I am an accredited practicing dietitian and PhD scholar who works with patients who have chronic kidney disease.

In July 2016, aged 38, I went from juggling the roles of wife, mother, daughter, sister and dietitian to someone who could add cancer to the list of their daily routine and struggles.

Within weeks of relocating our family of three children and two miniature schnauzers to the Sunshine Coast, a right kidney mass was incidentally detected on a routine ultrasound.

I waited fewer than five days to see a wonderful health professional, urologist Dr Greg Malone. In the short time I waited for advice and a management plan, I grappled with the fear and anxiety of the unknown.

Dr Malone confirmed published statistics that more than 80 per cent of solid kidney masses are malignant tumours. Some of the imaging findings favoured a benign lesion and we were extremely hopeful this was the case. The only way to differentiate between benign and malignant tumours was either by biopsy or surgical resection. I elected to undergo surgical resection.

I cannot describe the fear and anxiety I experienced in the three weeks awaiting surgery. I was terrified.

Overwhelmingly, I feared for my future and that of my husband and children.

Somehow, despite fearing a diagnosis of cancer, fearing the unknown, fearing the surgery itself, and fearing post-operative pain, I made it to the day of surgery.

It went smoothly and I recovered well. Unfortunately, the pathology results confirmed the tumour was a renal cell carcinoma. I am, however, very fortunate it was detected early and was small enough that a partial nephrectomy was undertaken. This provides me with the best chance of maintaining normal renal function while removing the cancer in its entirety. So far so good.

I have had my first round of surveillance scans and my second are looming. I hope the fear in the lead up to

CATHERINE MCFARLANE AND FAMILY

these appointments diminishes with time, as I know there are plenty more ahead.

I had never really considered that I would have any significant health conditions. I have always tried to maintain a reasonable level of health and fitness. I really enjoy running and had completed my second half marathon only three weeks before the tumour was found.

I was certainly not expecting a cancer diagnosis.

I have started running again and have signed up for my third half marathon at the Gold Coast Airport Marathon in July. My main motivation is to raise funds to support ANZUP’s research into kidney cancer. I am very lucky to be surrounded by an incredible group of family and friends who supported me through my surgery. Their support extends to walking and running over the Gold Coast Marathon weekend.

A LITTLE BELOW THE BELT 15

The journey

I was amazed when I read some of the literature surrounding kidney cancer.

Kidney cancer is the 10th most common cancer diagnosis in Australia.

Kidney cancer often has no symptoms in the early stages, with the majority of cancers detected by chance. There is currently no treatment, beyond surgery, to prevent the return of kidney cancer. Treatment options are limited when the cancer has spread to other parts of the body.

I want to raise the profile of kidney cancer in an effort to generate additional funds for research. If you would like to help support this cause, you can donate via the link given below.

I will update you later in the year on the status of our fundraising and whether anyone managed a PB over the weekend!

Finally, I could not tell this story without publicly thanking those who have helped me through the past 10 months or so: Mark, my amazing husband, my best friend.

You have been by my side, kept me calm and provided endless amounts of encouragement.

My children; Xavier, Thomas and Isabelle – you are the light of my life. We love you and are so proud of you.

Our family – Mum and Dad, Duncan and Susan, James and Marie. You have been a constant source of support and you dropped everything to look after us all. We are so lucky to have you.

Our friends – everyone who called, emailed, popped in, cooked food, visited in hospital, visited after hospital and generally looked after us: we are so grateful for your support.

To support Catherine’s kick kidney cancer campaign and funds for ANZUP go to https://gcam2017. everydayhero.com/au/kick-kidney-cancer.

THE MCFARLANE CHILDREN GETTING INVOLVED IN THE KICK KIDNEY CANCER CAMPAIGN

16 A LITTLE BELOW THE BELT

Immunotherapy in kidney cancer Dr David Pook, Medical Oncologist

Using the immune system to treat kidney cancer is not a new concept. Some patients with the disease experience spontaneous regression of their disease, which is thought to be an immune mediated effect, so the disease seems a good candidate for this form of therapy. High dose interleukin-2 has been used since the 1990’s to treat the disease.

The use of immunotherapy to treat solid tumours has taken a huge leap forward recently with the advent of agents which target PD-1 signalling. PD-1 (Programmed Death) is involved in deactivating killer T-cells, which act as the immune system’s “hitmen.”

When a killer T-cell recognises a foreign protein on a cell, it binds to this cell. PD-1 signalling can prevent the killer T-cell from killing this cell. Cancer cells express foreign proteins because of either upregulation or mutation of proteins. If the cancer cells also express PD-1 then this can protect the tumour from an immune attack. Using agents to block this pathway, effectively takes the handbrake off the immune system and can allow it to attack tumours.

This is done by using monoclonal antibodies which bind specifically to either PD-1 (nivolumab and pembrolizumab) or to the PD-1 ligand (atezolizumab and avelumab). The fact that multiple companies are developing similar agents has made drug development very competitive and resulted in multiple trials of these agents in kidney cancer being performed.

Despite these promising results, there is still a large proportion of patients who fail to benefit from these agents. Response rates can be predicted somewhat by examining the amount of PD-1 protein present on tumour samples but current methods are not accurate enough to guide treatment decisions. PD-1 inhibitors are generally well tolerated but removing the handbrake from the immune system can lead to damage to normal organs, most commonly

inflammation of the skin and lungs. Rare immune side effects can be difficult to recognise, and managing patients on these agents is challenging for patients and care providers.

To improve response rates, PD-1 inhibitors have been combined with other agents in ongoing clinical trials.

Nivolumab has been combined with ipilimumab which stimulates helper T-cells by blocking a protein called CTLA-4. This combination has been successfully used in the treatment of metastatic melanoma but has been associated with much greater toxicity than nivolumab alone.

Atezolizumab was separately tested in combination with bevacizumab but this combination did not improve the response rate. Avelumab and pembrolizumab have been combined with the tyrosine kinase inhibitor axitinib and have both shown increased activity compared with single agents. These combinations have entered large trials that are currently running at multiple sites in Australia.

The IDO inhibitor, epacadostat, is an oral inhibitor of the enzyme that coverts the amino acid tryptophan into the immune modulator, kynurenine. This has been combined with pembrolizumab and is showing increased tumour responses in kidney cancer in earlyphase studies, without increasing the toxicity.

Newer immunotherapy agents are also entering clinical trials in combination with nivolumab. BMS-986016 is a LAG-3 inhibitor which has just entered clinical trials in two Australian sites in Sydney and Melbourne, in combination with nivolumab. It is planned that multiple novel immunotherapy agents will be tested at these sites in kidney cancer over the next few years.

A LITTLE BELOW THE BELT 17

Spotlight on kidney cancer Kidney cancer is the 10th most common cancer diagnosis in Australia for both men and women.

What is kidney cancer?

Causes of kidney cancer

Kidney cancer starts in the cells of the kidney. The most common type of kidney cancer is renal cell carcinoma, accounting for about 90 per cent of cases. Usually only one kidney is affected but, in rare cases, the cancer may develop in both.

The causes of kidney cancer are not known, but factors that put some people at higher risk are:

There were 3059 new cases of kidney cancer diagnosed in Australia in 2013. Kidney cancer is more common in men - the risk of being diagnosed by age 85 is 1 in 51 for men compared with 1 in 99 for women.

• a family history of kidney cancer;

In 2014, there were 920 deaths resulting from kidney cancer in Australia. The five-year survival rate for Australians diagnosed with kidney cancer is 75 per cent.

Despite this most localised RCC is cured; metastatic disease is usually not curable but can be treated effectively.

• smoking; • being overweight or obese;

• high blood pressure; • having advanced kidney disease; • b eing male: men are more likely to develop kidney cancer than women; • w orkplace exposure to asbestos or cadmium (construction workers, dock workers, painters and printers); • o veruse of pain relievers containing phenacetin (this chemical is now banned).

Kidney cancer symptoms In its early stages, kidney cancer often does not produce any symptoms.

Symptoms may include: • blood in the urine (haematuria); • p ain or a dull ache in the side or lower back that is not due to an injury;

For kidney cancer clinical trials see page 42

• a lump in the abdomen; • constant tiredness; • rapid, unexplained weight loss; • fever not caused by a cold or flu.

Footnote: Information on Kidney Cancer is derived from Cancer Council Australia https://www.cancercouncil.com.au/kidney-cancer/

18 A LITTLE BELOW THE BELT

e-TC 2.0: Online intervention helping men get their lives back on track after testicular cancer Testicular cancer is the most common form of cancer in young Australian men aged between 18 and 39. Even though more than 95 per cent of men survive testicular cancer, anxiety and depression are almost twice as common in testicular cancer survivors compared with the general population. One in five men feels stressed or down after finishing treatment for this cancer, but few seek help and two thirds of survivors report that the need for help in adjusting after testicular cancer goes unmet. These statistics indicate a new approach to support is required, and that is why a team of cancer survivors, researchers and clinicians developed the e-TC website. The online program provides evidence-based information and psychological strategies for coping with the challenges associated with testicular cancer.

The first online psychological intervention for testicular cancer survivors was developed in 2014/15. The two

groups involved in creating e-TC were: the PsychoOncology Co-operative Research Group (PoCoG) and ANZUP, led by Dr Louise Heiniger.

The initial version of e-TC was rated as highly relevant and useful, but greater tailoring and interactivity were required to make the site more engaging. ANZUP generously provided $50,000 of funding through the Below the Belt Research Fund to enable the site.

An improved version of e-TC (e-TC 2.0) has now been developed by Dr Ben Smith from the Centre for Oncology Education and Research Translation (CONCERT) at the Ingham Institute of Applied Medical Research and a multidisciplinary team consisting of consumers, clinicians and researchers with expertise in testicular cancer, cancer survivorship, and eHealth.

A LITTLE BELOW THE BELT 19

“We saw a high proportion of men interested in e-TC and our pilot study showed some promising results. Thanks to further refinement, we believe e-TC 2.0 will offer a helpful way of supporting testicular survivors that is widely accessible, convenient to access and free from stigma,” said Dr Ben Smith.

5. Relationships and intimacy.

6. Life after testicular cancer.

This revised version will be evaluated by 40 Australian testicular cancer survivors with elevated levels of psychological distress recruited from hospitals and online.

e-TC 2.0 aims to equip testicular cancer survivors with information and strategies to help them deal with common challenges and unmet needs experienced after finishing treatment. This may include dealing with relationship and intimacy issues or concerns about the cancer returning.

Provision of information and support online overcomes barriers, such as stigma, distance and cost, to accessing face-to-face support. As noted by one previous e-TC participant: “It actually provides you a private way of finding information out without actually having to necessarily... disclose everything to somebody and you can get information and know where to go to if you are needing further assistance, which I think is really valuable.” e-TC 2.0 has six modules: 1. T he Foundations Module (Putting together a toolkit to manage stress and worry).

The objective will be to establish the effectiveness of this innovative approach to the delivery of supportive care to testicular cancer survivors who are struggling to adjust and who would otherwise not seek/receive help.

Men who fulfil the study eligibility criteria will be given access to the e-TC 2.0 website and will complete brief questionnaires asking how they are feeling and their satisfaction with the website as they work through it. In addition, participants’ psychological distress, quality of life and supportive care needs will also be assessed prior to accessing the e-TC website, and again after 12 and 24 weeks of access.

Recruitment to the e-TC 2.0 study is now open. If you are interested in being involved or would like to find out more about the study, please visit e-TC.org or contact Principal

2. How you feel after treatment for testicular cancer.

Investigator of the study, Dr Ben Smith by phoning

3. Physical changes and side effects.

02 8738 9244 or emailing ben.smith@unsw.edu.au

4. Masculinity and sexuality.

Website: https://e-tc.org/

20 A LITTLE BELOW THE BELT

Stage I testicular cancer follow-up recommendations – A decision-making aid for patients

The Stage 1 testicular cancer follow-up recommendations are part of a broader set of ANZUP evidence-based recommendations that have been developed by the Germ Cell Subcommittee, and ratified by the Scientific Advisory Committee for use within Australia and New Zealand (see link below).

Follow-up will include:

It is recommended that all centres use standardised protocols for follow-up of Stage I testicular cancer which are based on the expected frequency, timing and pattern of disease recurrence; and minimise unnecessary radiation exposure. These recommendations have also been endorsed by the Clinical Oncological Society of Australia, Medical Oncology Group of Australia and Cancer Institute eviQ Cancer Treatments Online.

• P hysical examination: This will include examination of the remaining testicle and the surgical site.

The decision-making aid for testicular cancer patients is designed as a guide to highlight the importance of surveillance and follow-up based on their individual disease circumstances.

Stage I testicular cancer is found in the testicle only and has not spread to any other parts of the body.

When testicular cancer is confined to the testicle, the initial treatment is surgery to remove the testicle containing cancer (orchiectomy). To reduce the risk of the cancer returning, research has shown some patients should receive chemotherapy after surgery (adjuvant chemotherapy) and you can discuss this with your oncologist. After you have received the initial treatment you will need to undergo regular follow-up.

It is very important that you attend all your follow-up appointments as scheduled. Sometimes the cancer may return and the aim of follow-up is to identify and treat this early to ensure the best outcomes. You can discuss with your oncologist the chances of recurrence of the disease given your individual circumstances.

The most common time for the cancer to return is within two years after you have been first diagnosed, although it can happen later. Follow-up occurs for at least 5 years after your diagnosis and is performed by an oncologist. It is more frequent after your initial treatment and then gets less with time. The frequency and duration of follow-up is varied depending on the type of testicular cancer you had (non-seminomatous germ cell tumour or seminoma) and whether you received chemotherapy after surgery.

• C linic appointments: These appointments are to discuss your health and any concerns regarding your body, fertility or mental health after your diagnosis with testicular cancer.

• B lood tests for tumour markers: Blood tests can sometimes identify products produced by testicular cancer and can be used to monitor whether the cancer has returned. Not all testicular cancers produce these markers and so other tests are also needed. The three most important markers are Alpha fetoprotein (AFP), Beta human chorionic gonadotropin (beta-hCG) and Lactate dehydrogenase (LDH).

• C T abdomen and pelvis: A CT abdomen and pelvis is performed to check if the cancer has spread to the lymph nodes of the abdomen or elsewhere.

• C hest x-ray: A chest x-ray is performed to check if the cancer has spread to the lungs. You will only have chest x-rays if the type of testicular cancer was a nonseminomatous germ cell tumour (NSGCT), rather than a seminoma.

• B lood tests for testosterone: The testicles produce testosterone (male sex hormone) and some patients develop low testosterone levels after the testicle has been removed.

As part of the recommendations, ANZUP has developed a separate customisable patient schedule, which your doctor can use to outline the timing of the follow-up required for your type of testicular cancer.

To access the recommendations, go to http:// www.anzup.org.au/docview.aspx?id=493 More general information on testicular cancer can be found at: http://www.cancercouncil.com. au/testicularcancer/

A LITTLE BELOW THE BELT 21

Spotlight on testicular cancer Testicular cancer was 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?

Causes of testicular cancer

Testicular cancer is the second most common cancer in young men (aged 18 to 39).

Some factors that may increase a man’s risk of testicular cancer include:

The most common type is seminoma, which usually occurs in men aged between 25 and 50 years. The other main type is non-seminoma, which is more common in younger men, usually in their 20s.

• undescended testicle (when an infant);

In 2013, 721 new cases of testicular cancer were diagnosed in Australia. 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. It is usually curable even if it has spread widely.

• f amily history (having a father or brother who has had testicular cancer).

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

For testicular cancer clinical trials see page 37

In 2014, there were 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).

Footnote: Information on Testicular Cancer is derived from Cancer Council Australia https://www.cancercouncil.com.au/testicular-cancer/

22 A LITTLE BELOW THE BELT

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 • T E S T I C U L A R • P R O S TAT E • B L A D D E R • K I D N E Y • 14 A LITTLE BELOW THE BELT

A LITTLE BELOW THE BELT 23

The ever changing prostate cancer landscape Dr Ben Tran, Medical Oncologist

During the course of their cancer journey, many patients end up asking me if there are any new treatments on the horizon for prostate cancer. The treatment landscape for prostate cancer is changing so rapidly that invariably the options for patients change significantly over the course of their journey. As a matter of course, I now find it useful to tell my patients a little story about how prostate cancer treatment has evolved over the past decade or so, to help them understand that the landscape is ever-changing.

Up until the mid-2000s, prostate cancer was treated predominantly by urologists and endocrinologists. There were no proven treatment options for patients with castration resistant prostate cancer (CRPC), that is, prostate cancer that was resistant to standard old fashioned hormonal therapy. For many years, the only option was mitoxantrone, a chemotherapy that improved Quality of Life (QoL) but did not improve longevity. For that reason, treatment often focused on manipulating hormonal therapies, changing from one tablet to another.

Everything changed in 2004. Chemotherapy, in particular a drug named docetaxel, (often referred to by its trade name Taxotere), was shown to improve both longevity and QoL. For the first time, medical oncologists were involved in the care of prostate cancer patients, and urologists began to work more closely with medical oncologists. The following years were filled with subtle introductions, such as Zoledronic acid medication which reduced the number of fractures and the pain patients experience from bony secondary deposits. Then in the early 2010s there was a burst of rapid development and new agents.

The first of the new agents was cabazitaxel, (also referred to by its trade name Jevtana), which is another chemotherapy agent that demonstrated improved longevity and QoL in patients who had previously received docetaxel. A number of hormonal agents were then developed. This led to ‘hormone refractory’ prostate cancer being renamed ‘castration resistant’ prostate cancer.

Following on from this, abiraterone acetate (also referred to by its trade name Zytiga) was first proven to improve longevity and QoL in patients who had previously received docetaxel in 2011.

Later, in another study published in 2013, the same benefits were demonstrated in patients who had not yet received chemotherapy.

Enzalutamide (also referred to by its trade name Xtandi) was also shown to improve longevity and QoL in patients who had received docetaxel (study published in 2012) and also in patients who had not (published in 2014). Other new agents that emerged included a radioisotope, radium-223. This was used to treat bony metastases.

Another treatment called denosumab was also found to reduce the number of fractures and pain that patients experience from bony secondary deposits.

24 A LITTLE BELOW THE BELT

The treatment landscape for prostate cancer has never changed so fast.

An example of this is the development around AR-v7. AR-v7 is a change in the androgen receptor protein that leads to rapid tumour growth. In June 2014, preliminary data was presented at ASCO, our annual major international oncology meeting. It was demonstrated that patients who had AR-v7 found in their cancer cells would not benefit from the newer hormonal agents such as enzalutamide or abiraterone acetate. This finding meant there could be options when looking at treatment selection for prostate cancer patients.

Later that year, in November 2014, at another conference, further data was presented that suggested a new drug named galeterone would provide benefit to the same group of patients with AR-v7 in their cancer cells. In a matter of months, we went from discovering a biomarker that identified patients who should not be treated with enzalutamide or abiraterone acetate, to finding a drug that might result in benefit to these patients. Subsequently, a trial was opened to test the benefit of galeterone in patients with AR-v7. But by 2016, we had learnt that AR-v7 was difficult to detect, and was more a marker of poor prognosis rather than predictive of resistance to enzalutamide and abiraterone. Subsequently, the ARMOR3 study was closed early.

There are also recent “good news” changes to the treatment landscape. Results from the CHAARTED study, first presented at ASCO in 2014 were supported by results of the STAMPEDE study presented at ASCO in 2015. These demonstrated that there was significant benefit associated with using docetaxel chemotherapy in the hormone sensitive setting, i.e. when added to Androgen Deprivation Therapy as it is first started. Then now, flash forward only a further two years, and at ASCO 2017, results from the LATTITUDE study and another iteration of the STAMPEDE study have been presented and demonstrate a significant benefit associated with using abiraterone in the hormone sensitive setting. Before long, results from our very own ENZAMET study, testing enzalutamide in this same setting will be presented.

There are other such stories in cancer research. Cancer research is continually evolving and the field of prostate cancer is moving very quickly. As a result, the treatment landscape for patients is also moving rapidly. Patients can be assured plenty is being done to improve outcomes and that the outlook, with so many new therapeutics in development, is greatly improving.

Disclosures: Ben Tran from the Peter MacCallum Cancer Centre has either received research funding, honoraria and/or has an advisory role from Amgen (Denosumab), Astellas (Enzalutamide), Bayer (Radium-223), Janssen (Abiraterone) and Sanofi (Cabazitaxel).

Editor’s note: Due to changes in the treatment landscape, amendments were made between draft and publishing stages.

ENZAMET recruitment target of 1100 patients achieved!

In August 2013, ANZUP’s large, international ENZAMET trial was given the go ahead. The challenge was to recruit more than 1000 eligible patients with advanced prostate cancer.

Previous trials had proven that enzalutamide did improve survival and quality of life in men with prostate cancer who had stopped responding to standard hormone treatments. So the international trial was to determine if treatment with enzalutamide, taken as tablets, could improve survival and quality of life in men starting hormone treatment for newly diagnosed prostate cancer that had spread beyond the prostate.

The ENZAMET trial has gone from strength to strength since the go ahead more than four years ago.

Collaboration has brought together investigators from 83 sites across Australia, New Zealand, Canada, Ireland, the UK and the USA. The trial in Australia has been led

by ANZUP in collaboration with the NHMRC Clinical Trials Centre (CTC) at the University of Sydney.

The trial protocol was amended along the way to reflect a change in clinical practice. The trial will now provide data to support the use, or not, of enzalutamide plus ADT, plus docetaxel for some patients. To date, the study has shown there is a pressing clinical need and so recruitment climbed sharply.

The recruitment target of 1100 patients was reached In March 2017. ANZUP would like to thank all who have worked so hard to get ENZAMET to where it is. This is a major milestone and whatever the trial outcome, men with metastatic prostate cancer in the future will benefit from evidence generated during this trial.

The work is by no means over. Completion of recruitment can sometimes mean the trial slips off the radar. The 83 sites involved will continue to treat trial participants according to the protocol, continue to collect high quality and timely data, and ensure this very important work reaches its end point.

Thank you to ANZUP members and patients who have taken part in this very exciting trial.

Watch this space for further updates and outcomes.

A LITTLE BELOW THE BELT 25

Spotlight on prostate cancer

The prostate gland exists in men at the base of the bladder. There is a one in six chance of a man developing prostate cancer, but it can often be cured.

Once prostate cancer spreads is it usually incurable.

Treatment can range from surgery to chemotherapy to “active surveillance”.

Prostate cancer symptoms The symptoms can include: • frequent urination, particularly at night; • pain on urination; • blood in the urine;

What is prostate cancer?

• a weak urinary stream.

Prostate cancer develops when abnormal cells in the prostate gland grow more quickly than in a normal prostate, forming a malignant tumour.

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

Prostate cancer is the third 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.

Causes of prostate cancer

In 2013, 19,233 new cases of prostate cancer were diagnosed in Australia.

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

Prostate cancer that has spread elsewhere in the body is not currently curable, but there are effective therapies available to control it In 2014, there were 3102 deaths caused by prostate cancer, accounting for 13 per cent of all cancer deaths in Australian men.

Some factors that can increase your risk of prostate cancer include: • age, the risk increases after age 50; • f amily history of prostate, breast or ovarian cancer; • a diet high in fats and low in fresh fruit and vegetables; • men of African descent are at higher risk than men of European or Asian descent;

For prostate cancer clinical trials see page 39

Information derived from Cancer Council Australia https://www.cancercouncil.com.au/prostate-cancer/

26 A LITTLE BELOW THE BELT

Mindfulness in advanced prostate cancer

Mindfulness. Being in the moment. Living in the present ... all buzz phrases associated with an ancient Buddhist practice that teaches those who practice to not dwell on the past or worry about the future but just be aware of the here and now.

A recent study by clinicians from Griffith University, the Cancer Council Queensland and ANZUP looked at how mindfulness might help men with advanced prostate cancer.

Mindfulness in this context was called mindfulnessbased cognitive therapy (MBCT) and focused on the relationship between thinking and mood.

Clinical studies show that men diagnosed with advanced prostate cancer, the most commonly diagnosed cancer in men in Australia, develop depression, anxiety and/or post-traumatic stress disorder.

“Intuitively it seems mindfulness might be helpful for men with prostate cancer. However, one aspect of mindfulness, being observant of your experience, did not appear to be helpful.

Until we have more data I would encourage men to explore different types of helping services to find one that matches their personal preferences.”

Professor Suzanne Chambers The study authors suggest that the effectiveness of

The study investigated the effect that mindfulness may have on dealing with these negative emotions. It followed 189 men with advanced prostate cancer, with an average age of about 70, for nine months.

The men were divided into two groups which, in addition to the usual treatment, received either:

mindfulness may be affected by factors including gender, age, education and the type of illness experienced by the patient.

With the evidence building that mindfulness can have real benefits for men with prostate cancer, the challenge now is to encourage men to try it. It may be that an equal

• a self-help booklet or

amount of effort to showing it works, will be needed to

• an eight-week telephone MBCT program.

find the best way to encourage men to give it a go.

A LITTLE BELOW THE BELT 27

Innovation and education

International Clinical Trials Day May 20 was International Clinical Trials Day. Each year we pause to acknowledge the major improvements in health outcomes, courtesy of clinicians dedicated to finding answers to important clinical questions and community members who participate in clinical trials.

In Australia, clinical trials benefit Australian patients because they allow faster access to new treatments. They also bring health professionals together to deliver better care for patients, while scientists, doctors, nurses and specialists also benefit through exposure to the very latest treatment methods.

In particular, the day commemorates when James Lind began his trials into the causes of scurvy.

Lind’s experiments in 1747 were run under very different conditions to today. Serving as a surgeon on the HMS Salisbury, his trial consisted of just 12 men, grouped into pairs and given a variety of dietary supplements from cider to oranges and lemons.

The trial only lasted six days but, within that time, there was a noticeable improvement in the group eating the fruit, thus providing Lind with evidence of the link between citrus fruits and scurvy.

Clinical trials have come a long way since Lind’s discovery!

Thank you ANZUP members and to all patients who participate in clinical trials, in order to improve outcomes for those affected by testicular, bladder, kidney and prostate cancer.

PCFA Online Community The PCFA Online Community is open to everyone who has been impacted by prostate cancer as a place to share their experiences and connect with others.

PCFA ONLINE COMMUNITY – A VALUABLE HUB FOR THOSE AFFECTED BY PROSTATE CANCER

Features of the online community include: • r esearch blog – where members can learn more about the latest prostate cancer research developments and findings; • m oderated forum – where members can chat with people affected by prostate cancer or ask experts questions; • v ideo gallery – The Speaking from Experience series features six men and two partners openly discussing their personal experiences with localised prostate cancer and side effects. Hear how they each faced the different stages in their journey, from diagnosis to treatment, and life after prostate cancer.

It is free and easy to become a member of the PCFA Online Community. Go to http://onlinecommunity.pcfa.org.au/ to join now.

28 A LITTLE BELOW THE BELT

About clinical trials

Definition: what is a clinical trial?

The information below is provided on the National Health and Medical Research Council website www.australianclinicaltrials.gov.au

Clinical trial interventions include but are not restricted to:

Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests are a means to prevent, detect, treat or manage various diseases or medical conditions.

• Cells and other biological products

Some investigations look at how people respond to a new intervention and what side effects might occur. This helps determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available.

• Surgical and other medical treatments and procedures

Clinical trials might also compare existing interventions, test new ways to use or combine existing interventions or observe how people respond to other factors that might affect their health (such as dietary changes).

The World Health Organization (WHO) definition for a clinical trial is:

• Experimental drugs

• Vaccines • Medical devices

• Psychotherapeutic and behavioural therapies • Health service changes • Preventive care strategies • Educational interventions • R esearchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease.

“Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”

A LITTLE BELOW THE BELT 29

About clinical trials

Randomised

Phase III clinical trial

A patient is randomly assigned to receive either the drug being used in the study or a placebo.

Phase III studies are done to study the efficacy of an intervention in large groups of trial participants (from several hundred to several thousand), by comparing the intervention to other standard or experimental interventions (or to non-interventional standard care).

Phase III studies are also used to monitor adverse effects and to collect information that will allow the intervention to be used safely.

Blind The patient doesn’t know what they are receiving. If the study is double-blind the researchers also don’t know which treatment is being given to each patient. The idea behind having a blind study is to prevent bias in the treatment.

Placebo controlled The use of a fake treatment allows researchers to isolate the effect of the drug being used for the trial against the fake treatment. This is known as the placebo effect.

The phases of clinical trials Many clinical trials that develop new interventions are conducted in phases. In the early phases, the new intervention is tested in a small number of participants to assess safety and effectiveness. If the intervention is promising, it may move to later phases of testing where the number of participants is increased to collect more information on effectiveness and possible side effects.

Clinical trials of biomedical interventions typically proceed through four phases.

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

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

30 A LITTLE BELOW THE BELT

Phase IV clinical trial Phase IV studies are done after an intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use over longer periods of time. They may also be used to investigate the potential use of the intervention in a different condition, or in combination with other therapies.

Other clinical trials Researchers may also conduct exploratory studies, sometimes referred to as ‘Phase 0 trials’ or ‘pilot studies’.

These come before Phase I trials and are used to test how the body responds to an experimental drug. In these studies, small doses of the new drug are given once or for a short time to a very limited number of people.

Clinical trials of diagnostic tests are sometimes divided into exploratory phases, challenge phases and advanced phases to see how effective and how accurate the tests are.

What is a trial investigator?

This is the person who will be organising the trial in your hospital.

About clinical trials

How do I find out about clinical trials that may be suitable for me or my family/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.

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.

Resources

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.

Australian Clinical Trials website https://www.australianclinicaltrials.gov.au/

ANZUP website – ‘Trials’ and ‘For Patients and Carers’

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.

http://www.anzup.org.au/content. aspx?page=cancertrials%28patient%29

It also allows you to set up an account and subscribe for new clinical trial alerts.

• 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.

A LITTLE BELOW THE BELT 31

About clinical trials

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.

Other consumer resources/support: Cancer Australia Cancer Australia has a range of resources to support consumers to understand and engage in cancer control, including:

This website also includes some general information on:

• B rochures and information on how to get involved in cancer control as a consumer

• W hat is a clinical trial?

• V ideos and tools to assist consumers in navigating their treatment options and discussions with clinicians

o What are they and why are they important? o Different types of clinical trials o Different phases of clinical trials o What are randomised controlled trials?

• Treatment choices • Being part of a trial o Safety o Advantages and risks o Practical considerations such as travel (and government travel assistance available for rural/ remote patients) o Results 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.

32 A LITTLE BELOW THE BELT

https://canceraustralia.gov.au/about-us/who-wework/consumer-engagement For information about cancer support groups in your area, talk to your GP, community nurse or specialist or contact:

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

Prostate Cancer Foundation of Australia http://www.prostate.org.au/ 1800 22 00 99

Kidney Health Australia http://kidney.org.au/ 1800 454 363

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

Bladder cancer

Prostate cancer

ANZUP Trials

ANZUP Trials

l BCG + MM Trial

l ENZARAD

l PCR MIB

l Pain Free TRUS B

Co-badged Trial

Kidney cancer

l NMIBC-S1

Co-badged Trial

Testicular cancer

l FASTRACK II

ANZUP Trial

Trials now closed to recruitment

l P3 BEP

Co-badged Trial l e-TC 2.0

l ENZAMET l BL12

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 mitomycin, 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 mitomycin 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. It is anticipated that 500 patients will be enrolled in the study in Australia and New Zealand. To date 116 patients have been recruited from 12 sites.

Current site locations for the BCG + MM trial: NSW • Concord Repatriation General Hospital • Northern Cancer Institute • Sydney Adventist Hospital Clinical Trials Unit • The Tweed Hospital • Westmead Hospital VIC • Austin Hospital • Epworth Healthcare (Richmond) • Footscray Hospital • Frankston Hospital • Royal Melbourne Hospital • The Alfred 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: http://anzup.org.au/ content.aspx?page=trials-bladder ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).

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

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. The current standard treatment is a combination of chemotherapy and radiotherapy. 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.

Current site locations for the PCR MIB ANZUP clinical trial:

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.

VIC

NSW • Prince of Wales Hospital • Chris O’Brien Lifehouse

• Austin Hospital • Peter MacCallum Cancer Centre WA • Sir Charles Gairdner Hospital

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

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

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

ClinTrial Refer app ANZUP released its first trial based app in July 2014. This application was designed for the specialists but will also be a very useful tool for patients and their carers.

If you are looking for a trial for your particular cancer you can refer to either the ANZUP website or the new ClinTrial Refer ANZUP app.

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

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

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

To download the free app, please visit: • Apple iTunes: https:// itunes.apple. com/au/ app/clintrial-refer-anzup/ id894317413?mt=8 • Google Play: https:// play.google.com/ store/apps/details?id=com.lps.anzup • Or go to the App/Android store and type in ANZUP A LITTLE BELOW THE BELT 35

Current ANZUP trials

Bladder Cancer Co-badged trial NMIBC-S1 Non-muscle invasive bladder cancer (NMIBC) makes up approximately 70-80 per cent of all bladder cancer diagnoses. Treatment is generally intended to reduce the risk of the 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 patient quality of life.

This study is currently active and recruiting. To date 35 patients have been recruited to the study from 8 sites.

Please speak with your doctor if this is of interest to you or someone you know. For more information, please go to the trials page on the ANZUP website: http://anzup. org.au/content.aspx?page=trials-bladder

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

NSW

ANZUP collaborates with Cancer Australia and Cancer Council NSW. This study is being sponsored by the University of Sydney.

Current site locations for the NMIBC-SI trial:

• Royal North Shore Hospital • Westmead Hospital • Westmead Specialist Centre VIC

• 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.

• 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 that it is fit for purpose in clinical research.

36 A LITTLE BELOW THE BELT

• Austin Hospital • Monash Medical Centre - Clayton • Royal Melbourne Hospital WA • Fiona Stanley Hospital QLD • Mater Hospital Brisbane

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 than a three-weekly schedule, and will be well tolerated. The two-weekly schedule is called “accelerated BEP” and the three-weekly schedule is called “standard BEP”.

Up to 500 patients will be enrolled in the study in Australia, New Zealand and other countries. Currently we have 28 sites open in Australia and New Zealand, and 38 patients enrolled. We are also undergoing negotiations to set up the trial in Ireland with the support of Cancer Trials Ireland and the Medical Research Council, Cambridge University, UK.

• Macquarie Cancer Clinical Trials • Nepean Hospital • Prince of Wales Hospital • Royal North Shore Hospital • SAN Clinical Trials Unit • The Tweed Hospital • Westmead Hospital QLD • Princess Alexandra Hospital • Royal Brisbane & Women’s Hospital SA • Flinders Medical Centre • Royal Adelaide Hospital TAS • Royal Hobart 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: http://anzup.org.au/content. aspx?page=testicularcancertrialdetails 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.

Current site locations for the P3BEP ANZUP clinical trial: ACT • Canberra Hospital NSW • Border Medical Oncology • Calvary Mater Newcastle • Chris O’Brien Lifehouse

VIC • Austin Health • Box Hill Hospital • Monash Medical Centre - Moorrabin • Peter MacCallum Cancer Centre • Sunshine Hospital WA • Fiona Stanley Hospital New Zealand • Auckland Hospital • Christchurch Hospital • Dunedin Hospital • Palmerston North Hospital ANZUP has been awarded funding from the Sydney Catalyst Translational Cancer Research Centre for the Phase III Accelerated BEP translational sub-study. This will involve the collection of blood and tissue.

• Concord Repatriation General Hospital

A LITTLE BELOW THE BELT 37

Current ANZUP trials

Testicular Cancer Co-badged trial e-TC 2.0

About one in five men feel stressed or down after finishing treatment for testicular cancer, but few seek help for this. That’s why 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 of, and satisfaction with, the e-TC website by men who have finished treatment for testicular cancer and who are feeling stressed, down or worried about their cancer recurring. Men will be recruited through clinicians at participating centres and online, via search engine and social media advertising.

Current site locations for the e-TC 2.0 trial: NSW • Chris O’Brien Lifehouse • Concord Repatriation General Hospital • Northern Cancer Institute • Royal North Shore Hospital VIC • Monash Cancer Centre • Peter MacCallum Cancer Centre

Men who fulfil the study eligibility criteria will be given access to the e-TC website and, as they work through it, will complete brief questionnaires asking how they are feeling and their satisfaction with the site. In addition, participants’ psychological distress, quality of life and supportive care needs will be assessed prior to accessing the e-TC website and again after 12 and 24 weeks of access.

This study is currently active and recruiting. For more information, please go to the trials page on the ANZUP website: http://anzup.org.au/content. aspx?page=trials-testicular If you are interested in being involved or would like to find out more about the study, please visit: e-TC.org

Read about e-TC on page 19

38 A LITTLE BELOW THE BELT

Current ANZUP trials

Prostate Cancer ENZARAD – more patients required

Prostate cancer is often treated with powerful X-rays (radiotherapy) instead of surgery. The reasons for choosing radiotherapy or surgery are complex, and are the focus of a discussion that men should have with their treating doctors. We will specifically look at men whose cancers have higher risk of returning after treatment but have not yet shown any evidence of spread outside the prostate. In this situation we are aiming for a cure, if possible, and the evidence shows that this is more likely when radiotherapy is combined with hormone treatment. This treatment is called Androgen Deprivation Therapy (ADT). ADT is often in the form of injections called LHRHA (luteinizing hormone releasing hormone analogues) and combined with tablets called anti-androgens. Enzalutamide is a new and stronger anti-androgen that has also been shown to work against prostate cancers that are resistant to other anti-androgens.

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

ENZARAD is a clinical trial for men with this type of prostate cancer where a decision has been made that radiotherapy is the best treatment. This trial is for those who, after discussion with their specialists, were not recommended for radical prostatectomy due to their pathology or core morbidities. Men who have both testes removed also will not be eligible. The purpose of the ENZARAD trial is to find out if the addition of enzalutamide to radiotherapy, plus ADT, will increase survival in men with a prostate cancer apparently confined to the prostate but at high risk of return elsewhere.

• Calvary Mater Newcastle

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

To date, 56 sites have been activated in Australia, New Zealand, Ireland, UK and US with 518 patients recruited. There are currently six sites open in Ireland, eight in the UK, led by the collaborative group, Cancer Trials Ireland and two sites are open in the USA.

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

These ANZUP investigator initiated studies are being financially supported by Astellas, who are also providing enzalutamide.

Current site locations for the ENARAD ANZUP TROG Clinical Trial: NSW

• Campbelltown Hospital • Central West Cancer Services • Chris O’Brien Lifehouse • Genesis Cancer Care Newcastle • Gosford Hospital • Liverpool hospital • Prince of Wales Hospital • Royal North Shore Hospital • Sydney Adventist Hospital • Tamworth Hospital • Westmead Hospital QLD • Genesis Cancer Care QLD – Tugun and Southport • Genesis Cancer Care QLD – Wesley and Chermside • Nambour General hospital • Oncology Research Australia, Toowoomba Hospital • Princess Alexandra Hospital Brisbane • Radiation Oncology /Centre – Gold Coast

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

• Radiation Oncology Services – Mater Adult Hospital • Royal Brisbane & Women’s hospital • Townsville Hospital

A LITTLE BELOW THE BELT 39

Current ANZUP trials

SA

Ireland

• Ashford Care Research (Adelaide Radiotherapy Centre)

• Beacon Private Hospital Dublin

• Flinders Medical Centre and RGH

• Cork University Hospital

TAS • Royal Hobart Hospital VIC • Austin Hospital

• Galway University Hospital • Mater Misericordiae University Hospital • Mater Private Hospital • St. Luke’s Hospital USA

• Box Hill (Eastern Health)

• Beth Israel Deaconess Medical Center (BIDMC)

• Epping Radiation Oncology Centre

• Dana Farber Cancer Institute

• Epworth Healthcare - Richmond • Frankston Radiation Oncology Centre

UK

• Peter MacCallum Cancer Centre (East Melbourne)

• Addenbrookes Hospital

• Peter MacCallum Cancer Centre (Moorabbin Campus)

• Charing Cross Hospital

• Ringwood Radiation Oncology Centre

• Guys and St Thomas Hospital

• Sunshine Hospital

• Kent & Canterbury Hospital

• Western Radiation Oncology Centre Footscray

• Nottingham City Hospital - City Campus

WA • Fiona Stanley Hospital New Zealand • Auckland Hospital • Christchurch Hospital

40 A LITTLE BELOW THE BELT

• Royal Marsden Hospital • Royal United Hospital Bath • University Hospital Southampton • Velindre Cancer Centre • Western General Hospital

Current ANZUP trials

Prostate Cancer Pain Free TRUS B

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 (“Pain Free TRUS B”, ANZUP 1501).

Current locations for the Pain Free TRUS B trial: NSW • Australian Clinical Trials • Concord Repatriation General Hospital

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.

• Westmead Hospital VIC • The Alfred • Casey Hospital WA • Fiona Stanley Hospital

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.

New Zealand • Canterbury Urology Research Trust

This study will include 420 men. Currently we have active sites across Australia and New Zealand with 88 patients participating.

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 http://anzup. org. au/content.aspx?page=trials-prostate This ANZUP investigator initiated study is being funded

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

A LITTLE BELOW THE BELT 41

Current ANZUP trials

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 6 sites have been activated in Australia and New Zealand, with 11 patients recruited.

For more information, please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. aspx?page=clinicalkidneycancertrials This study is led by Trans-Tasman Radiation Oncology Group (TROG) in collaboration with ANZUP.

42 A LITTLE BELOW THE BELT

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

‘Keep riding, spread the message and thank you for being part of the Pedalthon’ – Simon Clarke, Pedalthon Founder.

Register your team now Tuesday 19 September 2017 Let’s keep riding to help defeat urogenital cancers The race to beat testicular, kidney, bladder and prostate cancer is on. We invite you to join the fight and ride with us on Tuesday, September 19, at Sydney Motorsport Park, Eastern Creek.

Since 2014, the Pedalthon has welcomed more than 900 riders who have completed more than 13,000 laps and raised over $840,000 for the Below the Belt Research Fund.

The Pedalthon was founded to promote awareness of these common cancers and, in doing so, provide ANZUP with the critical funds to help improve the lives of so many.

The event also aims to change how we view, act, respond and treat testicular, prostate, kidney and bladder cancers.

We can defeat these below the belt cancers – but only with your support!

Now in its fourth year, we aspire to hit the $1 million fund-raising mark.

#BTBPedal17

Whether you are an avid cyclist, new to the sport, or just looking for a challenge, the Below the Belt Pedalthon, riding for four hours to defeat four cancers, is the race for you.

As the name suggests, teams of up to six are challenged to ride as many laps as possible within four hours.

Book your team now for the ultimate team challenge, or support by donating towards this important fund.

To find our more visit www.belowthebelt.org.au

2016 Below the Belt Research Fund successful applicants and their concepts The 2016 Below the Belt Pedalthon was a huge success with brilliant team spirit creating such positive energy. The event more than succeeded in raising funds and awareness of below the belt cancers as well as the importance of clinical trials and the role they play in fighting cancer.

Pedalthon founder Simon Clarke said: “I can say from my experience so far, the biggest impact often comes from the smallest act.” Thanks to many more generous small acts from riders, donors and sponsors, over $300,000 was raised, a remarkable achievement.

To add to the mix, and thanks to an astonishing fundraising effort, an additional $144,000 was raised by an incredibly generous patient. The Below the Belt Research Fund now has more than $445,000 in funding available.

This year 12 high quality applications were submitted by potential investigators with a wide variety of disciplines, interests and expertise.

The submissions are currently being reviewed by a panel of experts.

In line with ANZUP’s Strategic Plan and the support of the Below the Belt Pedalthon, we established the Below the Belt Research Fund to support our members in the development of investigator initiated-studies. Grants of up to $50,000 are on offer to successful applicants.

The successful applicants will be presented their grants at the ANZUP Annual Scientific Meeting (ASM) in Melbourne July 18, 2017.

You can read more about the successful projects in the next edition of “A little below the belt” or on our website www.anzup.org.au

A LITTLE BELOW THE BELT 43

Below the Belt Pedalthon Melbourne Sunday 18 March 2018 Following on from the success of the Sydney Below the Belt Pedalthon, ANZUP is thrilled to launch the Below the Belt Pedalthon in Melbourne.

With the generous support of the Melbourne Racing Club Foundation, the inaugural ride will be held at Sandown Racecourse on Sunday 18 March 2018.

SAVE THE DATE AND JOIN US!

“We are delighted to be supporting ANZUP in launching the inaugural Below the Belt Pedalthon in Melbourne with the use of Sandown as the venue for the event.

The MRC Foundation has been established to enable the Melbourne Racing Club to centralise its charitable and community support, focussing on: • C haritable Support – leveraging the Club’s assets to partner with charities and non for profit organisations; • S ocial Impact – developing partnerships with charitable and community organisations to address broad societal issues that exist in our industries; and • L ocal Community – provide support to local organisations surrounding our 3 racecourses (Caulfield, Mornington and Ladbrokes Park) and our 13 Pegasus Leisure Group venues.

We look forward to seeing the Victorian community at the event on Sunday 18 March 2018” THE MRC FOUNDATION

“We are delighted to be launching the Below the Belt Pedalthon in Melbourne, which will provide ANZUP a platform to engage with the Victorian community, whilst raising awareness of urogenital cancers. The event will promote important health messages, educate the public on clinical trials and attract a new fundraising stream to support ANZUP’s research activities.

As members of ANZUP, we are excited to be involved in the inaugural event, and using the Pedalthon, as a mechanism to communicate ANZUP’s mission, to improve treatments and outcomes for those living with testicular, prostate, bladder and kidney cancers.

See you at Sandown 18 March 2018!”

MEDICAL ONCOLOGISTS A/PROF JEREMY SHAPIRO AND DR DAVID POOK

The ride is open to all with challenges for riders of different levels and ages.

More information coming soon. To register your interest or for sponsorship opportunities email: pedalthon@anzup.org.au

Riding to defeat testicular, prostate, bladder and kidney cancer in Melbourne!

44 A LITTLE BELOW THE BELT

How is ANZUP funded?

ANZUP’s infrastructure and operational budget is supported by funding through Cancer Australia, a Federal Government agency.

ANZUP is not allowed to use any of the Cancer Australia money to conduct a clinical trial. Each time an ANZUP member develops an idea, we need to go out and find the funding to do that study.

This might happen through a grant, it might be through fundraising and donations, or it might be through support from a company or individual, but we have to gather the resources to do those clinical trials for each and every project.

We are very conscious that there are many other groups raising funds for cancer organisations such as the Cancer Council, Movember and the Prostate Cancer Foundation of Australia, for example. These are all wonderful organisations, doing fantastic work, and in some areas we overlap.

Why fundraising makes a difference As a group, we must raise funds to conduct every study.

Typically, it takes between two and three years from the initial idea for ANZUP to know whether it will receive funding. This is before any trial can take place. The trial itself is then added to those years. That’s a long time between coming up with a potentially life-changing solution and implementing it as a new practice.

If ANZUP raised enough money to be self-funding, we could begin a trial within a much shorter time frame.

This means we could have the evidence and change outcomes for our patients in a lot less time than it currently takes.

‘If ANZUP raised enough money to be self-funding, we could begin a trial within a much shorter time frame. This means we could have the evidence and change outcomes for our patients in a lot less time than it currently takes.’

A LITTLE BELOW THE BELT 45

What does a donation look like?

We are so grateful to those who have already put their hands up for ANZUP. We would also like to thank the many people who have made personal donations directly to ANZUP. Your contributions are making a difference.

One hundred per cent of a donation goes directly towards clinical trials research for us to achieve our mission: to improve treatment for those affected by testicular, kidney, bladder and prostate cancers.

$50k - $250k

$10k - $500k

$1m - $5m

Be kind in-kind

Kick off a pilot study

Give a grant or fund a scholarship

Support a clinical trial

Why in-kind makes a difference?

Invest in a pilot study to test the feasibility of promising drug therapies, surgical methods, post-operative care and palliative care options.

Inspire our culture of research by providing a grant or scholarship to clinicians involved in the care of patients with urogenital and prostate cancer.

Invest in a clinical trial to test the effectiveness, side effects and best dose of potential treatments for urogenital cancers.

Investment and support can come in all shapes and sizes.

In-kind donations include providing the budget for a specific staff member, meeting room use, auctionable goods for fundraising, advertising support and creative support, and can help us deliver more interesting and educational information.

How you can help Any donation to ANZUP over $2 is fully tax deductible.

If you would like to donate to ANZUP, you can donate through our website www.anzup.org.au or by calling ANZUP on +61 2 9562 5042. https://www.anzup.org.au/donate/donateStep1Details.aspx

If you are interested in holding an event to support ANZUP or are considering joining an event such as the City 2 Surf, City 2 Sea, Sydney Marathon, Walk to Work Day or any other community event, please let us know and we will help you find the fundraising pages.

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

46 A LITTLE BELOW THE BELT

CORPORATE 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 2017 corporate supporters include: Astellas, Bayer, Bristol-Myers Squibb, Ipsen, Janssen, MSD, Novartis, and Tolmar Australia.

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

Active Display Group, Bloke and The Saturday Paper.

A LITTLE BELOW THE BELT 47

Below the Belt Pedalthon Riding for 4 hours to defeat 4 cancers Testicular, prostate, kidney & bladder cancers JOIN US AT SYDNEY MOTOR SPORTS PARK TUESDAY 19 SEPTEMBER 2017

Pedalthon’s vision is to make a difference by raising awareness of these highly

#BTBPedal17

prevalent but “less glamorous” below the belt cancers and, to provide ANZUP Cancer Trials Group with critical funds to improve the lives of so many.

For more details or to register a team visit www.belowthebelt.org.au Australian & New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group 48 A LITTLE BELOW THE BELT