A Little Below the Belt magazine - Summer 2020

A little below the belt

Making a difference to the lives of people affected by below the belt (bladder, kidney, testicular, penile and prostate) cancers.

AN ANZUP CANCER TRIALS GROUP PUBLICATION

ISSUE 14, DECEMBER 2020

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

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

To find out more or to donate please go to https://www.anzup.org.au/donate/donate.aspx

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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.

ANZUP has members in every state and territory in Australia and New Zealand, with an increasing international membership.

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

Australian Registered Charity: ACN 133 634 956 New Zealand Registered Charity: CC51217

ANZUP aims to improve outcomes for people affected by these cancers. We do this by performing clinical trials to generate new evidence for better treatments, or ways of providing other support.

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

“Every meaningful advance in treatment has been a result of testing a new idea in a clinical trial.”

Professor Ian Davis, ANZUP Chair

ANZUP acknowledges the Traditional Owners of the lands on which our company is located and where we conduct our business.

We pay our respects to ancestors and Elders, past and present. ANZUP is committed to honouring the First Peoples’ unique cultural and spiritual relationships to the land, waters and seas and their rich contribution to society.

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.

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What’s inside 05 Message from the Chair, Professor Ian Davis 07 CEO Update 09 Consumer Advisory Panel (CAP) Update 11 Kev’s Crew 13 Friends of ANZUP 14 Finding a clinical pathway during a pandemic 17 Meet Associate Professor Arun Azad 19 Spotlight on prostate cancer 21 ANZUP’s ENZAMET trial is awarded all three of ACTA’s Trial of the Year Awards 23 Advanced Prostate Cancer Consensus Conference (APCCC): Asia-Pacific (APAC) Satellite Symposium 24 Worldwide prostate cancer trial continues to strongly recruit 25 Where are we in demonstrating economic value in prostate cancer trials...

26 The role of the Prostate Cancer Subcommittee 28 ANZUP trials – prostate 32 Spotlight on bladder and urothelial cancer 34 In the Media...

36 The importance of data to improve patient outcomes with bladder cancer 37 ANZUP trials – bladder

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

@ANZUPtrials / @BelowTheBeltANZ

39 Recruitment nearing completion for world first trial for bladder cancer 40 Spotlight on testicular cancer 42 Testicular Cancer Research Highlights 44 ANZUP trials – testicular 46 Spotlight on kidney cancer 48 Kidney Cancer and Immunotherapy 49 A pilot study for Kidney Cancer 50 ANZUP trials – kidney 52 Spotlight on penile cancer 54 What are the barriers and facilitators to interdisciplinary models of person-centred supportive care in the context of penile cancer?

A mixed methods study...

56 Trials in follow up

ANZUPtrials / BelowTheBeltCancer

ANZUP

@ANZUPtrials

ANZUP Cancer Trials Group

59 2020 Below the Belt Research Fund Recipients 61 How can you get involved?

62 ANZUP registers with workplace-giving platform Good2Give 63 Get inspired and host your own 63 How does your donation make a difference?

64 Below the belt #YourWay

ACN 133 634 956

69 Fundraising heroes

ABN 32 133 634 956

75 Thanks to Corporate Supporters and In-Kind Supporters

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

2020, eh? Isn’t it ironic that last year we had 2020 vision but we never saw it coming? We never considered how our lives would be turned upside down. We never thought we would be blocked from international or interstate or even inter-family travel. We never dreamed of feeling anxiety on seeing an unmasked face coming within a certain distance of us. We never imagined the possibility of breathing air that might kill us or the people we loved. Many of us had never even used Zoom; I read recently that Zoom shares were worth more than the top five international airlines combined. Wouldn’t it be lovely if we knew the future clearly?

Or would it? Leaving aside strategies for winning lotto draws or betting on horse races, would it be helpful to know? Steven Wright is an American comedian known for his deadpan delivery of one-liners and short jokes.

Here’s one: My girlfriend’s so intense... She woke me up the other night and asked, “If you could tell exactly when and how you were going to die, would you want to know?” I said, “Heck no, why?” “Doesn’t matter, just go back to sleep...”

I often tell that to my patients who ask me how long they have to live (although you do have to pick your audience carefully!) It’s a fair question, and one that media and movies have primed everyone to think they must ask, but of course I don’t know the answer, and even if I did, I’m actually not sure that’s the question people are really asking. I think more often people might be trying to say other things, like: “I’m scared.

I don’t know what’s going to happen to me. I don’t know how to navigate the system. You’re talking about frightening things like operations or chemotherapy. I don’t know how to make decisions about this. I’m not even sure what questions I should ask. Of course I’m going to die sometime but I’d like it to be as far away from now as possible. Actually now I’m not even sure

about that – maybe quality of life is more important than how long I’ve got. Surely we can do both. By the way, is there a God, and where can I send complaints?”

The problem is uncertainty. Cancer is what I do, and I’ve been immersed in it for over 30 years, but for this person coming to see me it might be the very first time they’ve even thought about it, let alone had to make decisions about it. Life doesn’t get much more black and white than when you are faced with decisions you don’t know how to make, but that could have profound effects on your life and the lives of those around you. We need people to give advice, and we need confidence that the advice we are getting is sound and reliable.

There’s a thing called “evidence-based medicine.”

Health professionals like to think that wherever possible the care we give is based on evidence showing that it works, and that it is better in some way than the alternatives. Often evidence does exist to guide us, but humans and the diseases that affect them are very complex, and not every situation has been studied and researched carefully. Sometimes we rely on the opinions of experienced people, who know the evidence and can extrapolate from it to give reasonable advice in this situation. That “eminence-based medicine” is not quite as good but sometimes it’s all we have. And right down the list is the information you get from your neighbour down the street whose niece had cancer 20 years ago, or a random page that pops up on Google: some might call that “effluence-based medicine,” and I probably should stop at that point.

The whole field of medicine is improving but it is almost never by big leaps or the “breakthroughs” you hear about in the media all the time. Most of those “breakthroughs” come to nothing, or are about someone killing cancer in a test tube (pretty easy, you could stomp on it) or in a mouse (also pretty easy, and they never ask me about Google). Look for the

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giveaway line: “We are hopeful this might be a treatment for this disease in five years.” That means it hasn’t been tested yet, and the people who have the disease now clearly can’t benefit from it, and the people who might benefit from it if it ever happens probably haven’t even got the disease yet, so who exactly are they trying to pump up? The truth is that a big leap ahead happened perhaps five or six times in the last hundred years: things like the discovery of chemotherapy, or new classes of drugs, or how the immune system can be harnessed to fight cancer. Those big jumps are rare, so when you hear the B word mentioned, beware anything that comes after it…!

The only way we make progress is by careful research. That means learning about what you are dealing with (both the disease, and the person affected by it); understanding what treatment approaches might be available, and what is coming up; testing the new ideas to see if they are safe, and then whether they actually work, and if so how often and at what cost in terms of side effects or other issues, and then finally looking to see how the new approach stacks up to what you have been doing before.

Sometimes the new approach clearly works better, or is easier, or less toxic, or costs less, or has some other advantage. The new approach then becomes the new standard that the next new idea has to beat. Sometimes you test the new idea and find that the older way is actually still the best. In that case: keep doing what you were doing, and back to the drawing board.

We want the best treatments to be available for everyone, and while these cancers are out there affecting people’s lives then we know that there is always room for more improvement.

ANZUP is also dedicated to training the next generation of health professionals and researchers. We do this through our scientific meetings, our Concept Development Workshops, our symposia and preceptorship courses, by providing research grants and fellowships, and by the generous and selfless sharing of knowledge and experience by so many of our members.

We have around 1800 members at the time I am writing this, representing a diverse mix of disciplines and expertise from across Australia, New Zealand, and internationally. And although we are relatively young, having formed only in 2008, ANZUP trials have already had impact on how some of these cancers are managed in Australia and around the world.

We are making progress, but it’s hard, painstaking work, that often takes a long time – literally lifetimes, in many cases. It’s also expensive, and we need to get funding for every trial that we want and need to do. We do that by applying for grants (hard, timeconsuming, low chance of success even for really strong ideas), or by working with industry (they often have their own agendas, or are limited in what they can provide or what we can accept), or through fundraising (and we all experience “donor fatigue” even for the very best of causes).

How can you help? You already have. You’ve read this far, and That’s research. That’s how clinical trials work. That’s why hopefully you will read the rest of this extraordinary it’s so important. Clinical trials are the only reason I publication and become even more aware of who can tell you with any confidence what I think the we are, what we do, why we do it, why these Clinical trials are best approach for you might be. And every diseases need to be talked about, and why the only reason I can time I do, I’m conscious once again of just clinical trials are so important. We hope you how many gaps there are in our knowledge, tell you with any will pass that on to other people so that we and where the evidence does not exist. We confidence what I think can continue to raise awareness. You might need to do better. want to participate in some of our fundraising the best approach for This is where ANZUP comes in. ANZUP is initiatives, and you will find information about you might be. the Australian and New Zealand Urogenital that here too. and Prostate Cancer Trials Group. That’s quite a And if you ever are affected by a mouthful, but what it means is that we are a group of disease like cancer, we hope you might health professionals, researchers, and community representatives, who have come together to try to improve outcomes for people ask your doctor a very simple question: “Is affected by “genitourinary” (“below the belt”) cancers: those there a clinical trial that might be suitable involving the prostate, kidney, penis, bladder, or testicles. You’re for me?” That simple question might open reading this magazine because you’re interested in these cancers, opportunities for you, and will definitely help and perhaps been affected by them either directly or through someone close to you. Either that or you’re really really bored, but others in the future to fight those diseases – we can fix that too.

diseases that none of them ever saw coming.

ANZUP works towards its goal by doing clinical trials in these cancers to test better ways of helping people. These might be through new drugs or treatments, or better ways of using old approaches, or combining different ways of treating cancer. It might also be about understanding how people deal with their cancer, or what information they need.

Our scientists collect blood or tissue or other samples or data to try to understand better why cancers behave as they do, and why some treatments work and others do not. We want to know what the effects of the cancer or its treatment might be on the quality of someone’s life. We want to know how a new approach might best fit into a health system that has constrained resources.

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Back to Steven Wright, uncertainty, and 2020 as a metaphor for life. No, don’t tell me. If the bus with my name on it is destined to come round the corner next Tuesday, I don’t really want to know today. I do know I want to make every moment until then as good as it can be. And that should be the case for all of us all the time. If I have learned anything from the 2020 experience, it would be this: none of us, especially me, are very good at guessing the future; reality can be far weirder than fiction; living in the moment can be very rewarding; and it’s really valuable when a clear pathway forward becomes evident. And joy can still be found, even without certainty of the future: this time last year I did not know that 12 months later I would be meeting my new grandson for the first time.

Please enjoy this edition of “A little below the belt.”

IAN DAVIS Chair

A message from the CEO, Margaret McJannett

What a year it has been. With all the challenges put before us, our number one priority has remained to conduct high quality clinical trials research to generate evidence and improve treatments and outcomes for patients and their families affected by below the belt (prostate, bladder, kidney, penile and testicular) cancers.

This time last year we were planning and looking forward to another year of hosting our pipeline of innovative concept development workshops and meetings; developing and conducting our clinical trials; and rolling out our key fundraising events, the Below the Belt Pedalthons. We had a plan, AND then came COVID. We had to fine tune our operations in order to maintain productivity, while ensuring the safety and wellbeing of patients, research participants and our health care professionals and staff involved in patient care and research remained paramount.

Despite all this I am delighted to say that all of those activities did happen. Some required a total restructure, many required additional technology and endless Zoom meetings but thanks to the dedication and commitment of our ANZUP members, now 1800, we opened several exciting new trials and all our other existing trials continued despite temporary suspensions.

We are also very excited to announce and celebrate another major success for our ENZAMET trial. The ENZAMET trial has been awarded the Australian Clinical Trials Alliance (ACTA) Trial of the Year Award, the STInG Excellence in Trial Statistics Award and the ACTA Consumer Involvement Awards. A hat trick in clinical trials!!

ACTA is the national peak body supporting and representing networks of clinician researchers conducting investigator-initiated clinical trials within

the Australian healthcare system. The awards are designed to celebrate Australia’s world-leading clinical trials expertise and promote the role, importance and value of clinical trials in Australia.

Being awarded all 3 categories is an incredible achievement but so too are the results of the ENZAMET trial. The results published in the New England Journal of Medicine are already impacting on global practice. This trial demonstrated a 33% improvement in overall survival and a 60% improvement in progression-free survival for men with metastatic hormone sensitive prostate cancer who received enzalutamide.

These awards highlight that clinical trials are the most effective way of determining which treatments, alone or in combination, will provide the greatest survival benefit to the patient with the least adverse outcomes.

We acknowledge and thank the 1125 patients for their participation, the principal investigators, coinvestigators, trials coordinators, nurses and data managers at the 83 cancer centres in Australia, New Zealand, United States, Canada, Ireland and the United Kingdom for their dedication and enthusiasm. We thank Astellas for their financial support and study drug.

Earlier this year we launched our latest theranostic trial ENZA-p. This randomised phase 2 trial aims to compare the effectiveness of enzalutamide in combination with Lutetium-177 PSMA, versus enzalutamide alone, for the treatment of prostate cancer.

Prostate cancer remains the commonest cancer and the second commonest cause of cancer related death in Australian men. Lutetium-177 PSMA (Lu-PSMA for short) is a new treatment in advanced prostate cancer.

Lu-PSMA is a radioactive molecule that attaches to the surface of prostate cancer cells throughout the body.

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The ENZA-p trial aims to determine if adding Lu-PSMA to enzalutamide overcomes resistance to treatment and prolongs treatment responses. This study is being led by Professor Louise Emmett from St Vincent’s Hospital in Sydney. The study has now recruited 12 /160 patients since opening in August. It is also open at 5 out of 13 sites. ANZUP received funding from the Prostate Cancer Research Alliance (PCRA): An Australian Government and Movember Foundation Collaboration, Endocyte (a Novartis company), Roy Morgan Research, GenesisCare and the St Vincent’s Clinic Foundation.

ANZUP hosted the 2nd Advanced Prostate Cancer Consensus Conference (APCCC), Asia-Pacific (APAC) virtual Satellite Symposium in October. This highly successful multidisciplinary meeting (held virtually this year) involved 25 key opinion leaders from 14 countries in the Asia Pacific region. This symposium provided a forum to discuss and debate current questions on the clinical management of men with advanced prostate cancer and help ensure the decisions made are relevant and can be implemented in the Asia Pacific region.

Education and mentoring remain an important focus for ANZUP. Our major annual educational event is the Annual Scientific Meeting (ASM). It was to be held in Adelaide in July 2020 but again, due to COVID-19 restrictions, we sadly had to postpone this meeting.

However, we were excited to introduce a new model for the ASM, in a two-day hybrid format working with local hubs and an interactive virtual meeting platform. This event was held over the last 2 days of November. With over 300 delegates attending the meeting virtually we welcomed a superb international and national faculty allowing us to continue to engage and discuss the challenges we have faced, lessons we have learned and new ways of delivering the best healthcare to people living with below the belt cancers.

ANZUP continues to receive infrastructure funding from the Australian Government through Cancer Australia. This financial and in-kind support is greatly valued, however we still require independent funding to support each and every new clinical trial. It is critical to develop innovative and sustainable funding to allow us to instigate trials and support funding applications and this is why fundraising remains an important part of our activities.

With the cancellation of the Pedalthons due to COVID we were forced to think outside the box! How could we continue to raise awareness and funds during this difficult time, being mindful of the impact of COVID and community restrictions along with budget limitations? The ANZUP Below the Belt #YourWay campaign was launched. This was an exciting new

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challenge encouraging the community to get exercising in September and either run, walk or ride as many km’s as you could. Keeping both your mind and body healthy. We were thrilled with the outcome which was met with amazing enthusiasm, raising ~$170,000 for ANZUP’s Below the Belt Research Fund which will be directed to support our members to develop novel research projects that could possibly lead to future ANZUP trials.

We are very grateful to all those people who donated to, and participated in, the inaugural #YourWay Challenge. We would also like to thank all in-kind supporters and the sponsors who helped make this event possible. We plan to add the Below the Belt #YourWay Challenge as a permanent fixture on the ANZUP calendar!

If you are interested in receiving regular updates from us, we welcome you to join “Friends of ANZUP” to help you stay connected with the work we do.

It’s free and you can join by clicking on the link https://www.anzup.org.au/friendsofanzup.aspx to receive your free copy of this magazine.

I extend my thanks to the hard work and commitment of so many. The level of support we receive from our membership, our “Friends of ANZUP” and from the wider community, organisations large and small, is nothing short of extraordinary.

To the many thousands of patients who participate in ANZUP trials, THANK YOU. Each and every one of you help us to improve treatment and outcomes for patients and their families affected by these below the belt cancers.

On behalf of the ANZUP management team, I wish you and your families a happy, healthy and safe festive season.

Please enjoy this edition of ‘A little below the belt’.

MARGARET MCJANNETT CEO, ANZUP

Consumer Advisory Panel (CAP) update

By Belinda Jago, CAP Chair

As 2020 draws to a close it will certainly be a year that we remember, especially for the Victorian CAP members who were in lock down for many months.

The CAP normally meets face to face but due to COVID-19 we have been using zoom as a meeting platform.

This hasn’t stopped our important contribution to ANZUP’s trials. Including our involvement in the Below the Belt Research Fund application selection process. This has worked really well and zoom has certainly helped in facilitating the discussions especially around the patient / community feedback required as part of the selection criteria.

The CAP did a fantastic job supporting this event by participating, donating, fundraising and promoting.

It provided a great opportunity to focus on something very positive during the pandemic. The event will continue next year in May and I encourage all readers to consider joining the challenge. All funds raised go directly to below the belt cancer research.

I had initially thought about sitting this activity out. It has been a long hard winter in Melbourne. Being home since mid-March, it was a year where there were many special milestones to be celebrated but were all cancelled. Hopefully in 2021 we will start to catch up! We miss our life and although we are way better off than many people we just felt very flat and very unmotivated.

During this challenging year, ANZUP has remained committed to running its TOP ROW L-R; COLIN O’BRIEN, LEONIE YOUNG, JOE ESPOSITO clinical trials and delivering the MIDDLE ROW L-R; MELISSA LE MESURIER, MATT LEONARD, The whole COVID pandemic RAY ALLEN. BOTTOM ROW L-R; LES LAND, BELINDA JAGO, best standard of care for those took us back to when Bec was MICHAEL TWYCROSS impacted by below the belt diagnosed with kidney cancer (bladder, kidney, penile, prostate and testicular) cancers. in 2006 and for the next 5 years we had to learn to deal They have taken a very proactive approach to ensure the with uncertainty, change and no long term planning. health and well-being of the clinical members, staff and You feel you have lost control of your life and now it was especially the community, in particular those patients happening again. participating on our clinical trials.

But for those who know me I’m not good at sitting This year has also welcomed positive initiatives. on my hands. I decided I should support the #YourWay Teletrials have been implemented for rural and regional campaign in a more active way and would regret patients, as well as patients who are not comfortable it if I passed up the opportunity. leaving their homes during the pandemic.

So I’m very happy to say we are really glad we joined ANZUP also introduced a new virtual campaign Below the #YourWay challenge. It has really improved our the Belt “#YourWay” developed to raise awareness daily focus in a very positive way as we deal with the and funds for below the belt cancer research. The Melbourne #lockdown blues. #gettingfit #fewblisters annual Pedalthon events were postponed due to AND importantly we are helping to raise much needed COVID-19 restrictions, so the Below the Belt #YourWay funds for clinical trial research.

Challenge took place over the entire month of Tony and I called our team ‘Just the 2 of Us’. Once September and participants could walk, run, cycle or again we thank the many family and friends who swim as many kilometres as they could – keeping both have supported us and ultimately helped clinical trial mind and body healthy. research into these #belowthebeltcancers. This support

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will help improve the lives of families with a loved one like our beautiful Bec. We were delighted to receive news that ANZUP had successfully won three awards from ACTA (Australian Clinical Trials Alliance) Clinical Trials 2020: National Tribute and Award Ceremony including ACTA Trial of the Year. ANZUP’s ENZAMET trial has been recognised as one of the most important clinical research advances for advanced prostate cancer. Not only did ANZUP win ACTA Trial of the Year but also the ACTA STinG Excellence in Trial Statistics Award and the ACTA Consumer Involvement Award.

Blog Post DAY 14 - Tony and I have continued to walk many #YourWay kms in the second week and hope to reach 250kms by the end of Sept - an extra 100kms on what we set out to do.

The CAP were delighted to be involved in the ENZAMET trial and provide a patient perspective.

I would like to acknowledge and congratulate the ANZUP CAP who worked together on the ENZMAMET trial with the trial management committee. In particular, I would like to thank CAP members Ray Allen and Colin O’Brien for adding their own personal experiences with prostate cancer.

More details can be found on page 21.

On behalf of the ANZUP CAP, I wish you a healthy and happy festive season.

May 2021 be bigger and better.

BELINDA JAGO CAP Chair BELINDA & TONY WALKING FOR #YOURWAY

CAP Grant Review Guidelines ANZUP’s mission is to conduct clinical trial research to improve treatment of bladder, kidney, testicular, penile and prostate cancers so we have policies and procedures in place to provide a roadmap for day-to-day operations. These policies and procedures give guidance to decision making, streamline processes and ultimately ensure the safety of the patients involved in our clinical trials.

number of our members, but up until the review of this process, the Consumer Advisory Panel (CAP) had minimal input.

In previous years only two CAP members were appointed to review the applications individually. They would then attend the larger grant review meeting. Feedback from only two of the CAP members did not fully represent the opinions and experience of the entire CAP.

This year we decided to reassess some of our processes and guidelines to ensure they are fit for purpose. It is important our governance processes are based on evidence and feedback so the first step was updating the review process for the Below the Belt Research Fund applications.

The Below the Belt Research Fund was established to support our members in the development of investigator-initiated studies and grants of up to $50,000 are available to successful applications. So it is extremely important all applications are reviewed equally and follow a set procedure.

The decision was then made to review and re-write the CAP Grant Review Guidelines by both the CAP and ANZUP Trials team. The revision meant the entire CAP would now be able to review all the applications together, before two nominated members joined the wider review committee to share the views and feedback of the entire CAP.

The grant review process involves a large 10 A LITTLE BELOW THE BELT

Being able to discuss all grant applications as a complete group made the two nominated members feel much more confident when joining the larger review panel. The revised process meant the CAP review really represented the voice of the community and reflected

what was important while also taking into consideration what ANZUP as an organisation stands for – i.e. to “improve patient outcomes” through following our strategic direction.

Not only was the review process updated but the review ‘score sheet’ was also evaluated and improved. This was necessary to ensure the questions and scoring reflected the knowledge and experience of the CAP and ultimately represents the voice of the patient and public.

This improved process means the CAP can continue to be a mechanism for advice on specific studies, general research directions, and priorities from a consumer perspective.

Clinical trials are an important element of the cancer journey for cancer patients, but there are issues that require clarification for cancer consumers. The CAP will continue to provide a conduit for communication from ANZUP back to the community in order to promote research and engage community support.

We look forward to working with our CAP on the review of future grant applications.

In Memory of Kevin Michael – Kev’s Crew

Kevin Michael was an electrical power auditor, advocate for his workplace health awareness program and a loving husband, father and grandfather. In September this year Kevin passed away peacefully with his family at his side.

Kevin had prostate cancer for over five years, but was always positive and took a proactive approach to the disease. Over the course of Kevin’s treatment, he was put on ANZUP’s ENZAMET trial due to signs of spots in the abdomen and the aggressive nature of the cancer.

After eighteen months on the ENZAMET trial Kevin felt quite good, walking twice a day, playing golf and attending exercise physiology sessions. He also went back to work three days a week and ensured his quality of life was maintained by sharing holidays with his wife, two daughters, son in law and three grandchildren.

The trial gave Kevin more time to enjoy and a better quality of life.

Kevin continued to be proactive in many ways. He enrolled into two other trials for his daughter - the BRCA trial to investigate any links to breast cancer from prostate cancer, and the geriatric trial for over 70 year olds on chemotherapy. This trial included a rehab program to assess his general health, fitness and strength.

He also took part in the Prostmate program (a free program introduced for male employees over 45 years to check their PSA (Prostate Specific Antigen) via blood test on an annual basis). Identifiable irregularities are referred to the individual’s GP. Kevin had the opportunity through his workplace program to talk to other men about his experience with prostate cancer. He was able to encourage men to look after their health and get checked. Through this program more than 140 men have now been tested for prostate cancer. Kevin was firm in saying men should be aware before, during and after any diagnosis.

KEVIN AND MAUREEN MICHAEL AT THE 2018 BELOW THE BELT PEDALTHON, MELBOURNE.

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Through his diagnosis and treatment, Genitourinary nurse practitioner (and his sister in law) Kath Schubach was an incredible support and someone Kevin referred to as his guardian angel.

“I have been nursing for more than 40 years and caring for men with prostate cancer for the last 25 years. I have had the privilege to care for men and their partners through all stages of their cancer journey. I have seen the progress of treatment for prostate cancers evolve with the access to clinical trials and the benefits for men having these treatment options. Kevin was involved in clinical trials and always had a positive outlook towards his illness.

KEV’S CREW AT MELBOURNE PEDALTHON

Kevin was a huge part of my life as I was only 5 years old when he came into our family.

We shared a special bond over the last five years of his illness. When Kevin referred to me as his guardian angel it made me feel proud that I was able to give him some comfort through his cancer journey”.

Kath Schubach In 2018 Kath, with her husband Ross, brother Jim and niece, (Kevin’s daughter) Laura, took to the Sandown Race course to ride as many laps as they could at the Below the Belt Pedalthon in Melbourne. This event raised both funds and awareness for not just prostate cancer research but also other below the belt cancers.

This year due to COVID-19, they took part in the virtual event by walking, running and cycling in the Below the Belt #YourWay Challenge. For both these events they signed up as Kev’s Crew to make a difference, raise awareness and support Kevin.

Who is Kev? ‘Kev is a family member who has had experience with ANZUP being on a clinical trial. Kev had a positive outlook and knows how important clinical trials are for trying to find a cure for prostate cancer. Please help us to raise money for ANZUP Clinical Trials.’

Kath Schubach

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‘For those who don’t know, Kev is my dad and was battling prostate cancer for the past 5 years. He had firsthand experience with ANZUP when he took part in one of their clinical trials.’

Laura Michael

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

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

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

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

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

To find out more visit: http://www.anzup.org.au/friendsofanzup.aspx or email friends@anzup.org.au A LITTLE BELOW THE BELT 13

Finding a clinical pathway in the face of a pandemic

The emergence of COVID-19 has had a large impact on people living with cancer, on healthcare professionals (HCP), and also the delivery of health services. Every day new information is released regarding COVID-19.

This then leads to the rapid development, sharing and implementation of new health regulations. Oncology services have been affected globally, and this has included the speedy transition to telehealth.

Worldwide, various strategies have been implemented to help alleviate and contain the spread of COVID-19.

This has included social distancing and the introduction of quarantining. For those living with below the belt cancers, these measures have sometimes led to distress, increased risk of depression, and social isolation. Consideration is being taken and regularly reviewed for cancer patients but little is known about the experiences among frontline nurses and allied healthcare professionals who care for the patients affected by below the belt cancer. More needs to be discovered about the day-to-day service delivery as well as the nurses and allied healthcare professionals experience addressing the needs of people affected by cancer.

Australia has fortunately experienced lower infection rates in comparison to other countries. Despite this, the impact has been felt across staff and patients in cancer services. As healthcare professionals continue to respond, the opportunity to innovate quickly has been embraced by healthcare leaders.

14 A LITTLE BELOW THE BELT

ANZUP recently held its Annual Scientific Meeting and included a session for nurses and allied healthcare professionals titled, ‘In the Face of a Pandemic, Navigating a Clinical Pathway.’ This session was used to explore the experiences of nurses and allied health professionals caring for people affected by below the belt cancers during the COVID-19 pandemic as well as the impact on people living with cancer and the delivery of healthcare services, particularly the transition to telehealth and teletrials.

A lot of productive discussion occurred throughout the meeting and many points were raised in relation to both cancer patients and healthcare staff.

It was reported that many patients benefited from telehealth and not having to travel during the height of the pandemic. Anxiety levels were lessened as well as the financial burden of travel – especially if journeying from a rural or regional location.

Not all patients embraced telehealth – either due to IT limitations in rural areas or lack of experience and confidence using technology. Healthcare staff felt they became IT instructors, coaching their patients through set up and use of their mobile device or computer prior to a consultation.

Communication skills also had to be adjusted during telehealth appointments. Nurses and allied healthcare professionals had to become skilled at interpreting patient responses, body language and reactions during the appointments. They also had to learn to feel comfortable delivering bad news not in a face to face setting. Some patients benefited receiving unexpected results at home. They avoided having to travel after receiving unfavourable news and could process their results in the comfort of their own homes.

Another change in practice during the pandemic was increased involvement of general practitioners (GPs) and nursing services at home. It was noted that GP services are under-utilised and are a vital link, especially in the rural setting. They are a resource that should be included in the clinical treatment pathway moving forward. However, many GPs were also having to convert to telehealth appointments so it will be important, when engaging them in a clinical trial and cancer treatment via telehealth, that it does not become a burden on their time.

Overall, many positives have come from the revised consultation and treatment pathway. Discussion centred around possibly changing patient care permanently and maintaining telehealth and teletrials not just now but when the pandemic is over. Integrated and shared care models with primary care and nurse involvement is a definite benefit not previously

explored. Communication skills may need to become more of a focus for healthcare staff, and the digital literacy of the patient and caregiver will be an ongoing process. But most importantly is consideration of the patient – do they only want telehealth consultations, do they prefer face to face appointments, or is a hybrid of the two the ultimate solution.

“One of the discussion points that has been highlighted is the benefits of telehealth and an integrated approach with primary care and community nursing for the patient�.

Associate Professor Haryana Dhillon Further work and research is being undertaken to try and establish a workable clinical pathway during a pandemic that is beneficial to cancer patients and nurses and allied healthcare professionals. Findings from this research will be presented at relevant scientific meetings and submitted for publication in a peer-reviewed journal.

A LITTLE BELOW THE BELT 15

DO YOU HAVE DO YOU HAVE A STORY A STORY YOU COULD YOU COULD SHARE WITH SHARE WITH OTHERS?

OTHERS?

Share your story with us here anzup@anzup.org.au Share your story with us here anzup@anzup.org.au

Create others know they are Createawareness awareness and and let let others not alone know they are not alone.

FIGHT CANCER

BELOW THE BELT • TESTICULAR • PROSTATE • BLADDER • KIDNEY • PENILE 16 A LITTLE BELOW THE BELT

14 A LITTLE BELOW THE BELT

Meet Associate Professor Arun Azad Chair of ANZUP’s Translational Research Subcommittee

Associate Professor Arun Azad is a medical oncologist and translational researcher with a sub-specialist interest in prostate and urological cancers.

He is Translational Research Subcommittee Chair at ANZUP Cancer Trials Group.

What is Translational Research?

People often ask ‘what is translational research?”

Traditionally, translational research was thought of as bench-to-bedside research, where findings were taken from the laboratory and applied in the clinic. Equally though, translational research can involve bedsideto-bench research, where we take samples from patients and profile them in the laboratory to better understand why patients do or do not benefit from treatment, and why treatment stops working (among many other questions of course).

Translational research applies findings from basic science to enhance human health and well-being.

Translational research takes a scientific enquiry that may be a given problem facing health care practices and then attempts to overcome the problem to help raise aggregate health performance. In a medical research context, it aims to “translate” findings in fundamental research into medical practice and meaningful health outcomes.

Patients who participate in ANZUP trials are asked to consent to the collection of blood and tissue samples to be used to conduct laboratory research for translational research and other studies in Australia and/or overseas.

ANZUP has been extremely successful in a relatively short space of time with leading pivotal studies in urological cancers. The data from these studies has had a major impact on clinical practice, as best evidenced by a study such as ENZAMET which was a key factor in enzalutamide being approved by the Food and Drug Administration (FDA) for metastatic hormone-sensitive prostate cancer. This is a major milestone. At the same, another achievement we should recognise is the integration of translational research sample collection into virtually all ANZUP-sponsored trials, including the ENZAMET study. This provides us with a priceless opportunity to leverage the pivotal clinical trials we are doing, and help deliver better outcomes for those that matter most i.e. patients and their families.

“We (as in all of ANZUP) should feel very proud to be part of such major achievements”.

A/Prof Arun Azad

Translational research implements a “bench-tobedside” approach. It progresses from laboratory experiments through clinical trials to point-of-care patient applications. Harnessing knowledge from basic sciences can lead to production of new drugs, devices, and treatment options for patients. The end point of translational research is the production of a promising new treatment that can be used with practical applications, to then be used clinically or even commercialised.

A LITTLE BELOW THE BELT 17

Our translational research program is most advanced currently for ENZAMET, where Professor Lisa Horvath, Professor James Kench and the National Health and Medical Research Council (NHRMC) Clinical Trials Centre (CTC) are driving the central collection of samples.

ANZUP has a detailed research plan built around analysis of tissue and blood samples, and an outstanding multi-national team of investigators to conduct cutting-edge research. We will adopt a similar approach for the TheraP trial, which has an invaluable collection of serial plasma samples collected.

“As always, we are grateful for the patients and families who enrol on our trials and donate biospecimens that support our translational research.

We could not conduct our activities without these highquality samples. We would also like to acknowledge the participating sites thoroughness in obtaining correlative samples from our ANZUP trials. Bio-specimen collection continues as part of existing trials, including ENZA-p and DASL-HiCaP BCGMM, P3BEP, KEYPAD, UNISoN and PCR-MIB.” A/Prof Arun Azad

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Biospecimen collection for ANZUP’s ENZAMET and ENZARAD trials People who participated in the ENZAMET and ENZARAD trials were asked to consent to the collection of blood and tissue samples for the purpose of laboratory research. This will help us to greater understand why some types of prostate cancer behave differently, why some people respond better than others to treatment, and to help us work out ways to do better in the future.

Over 100,000 samples have been collected around the world through the ENZAMET and ENZARAD trials, and are in the process of being transported to the biobank at Chris O’Brien Lifehouse in Sydney. A comprehensive plan of research for these samples has been developed and will be rolled out soon.

If you would like to support our Translational Research Program please email donate@anzup.org.au.

THE CRYOBANK AT CHRIS O’BRIEN LIFEHOUSE WITH BIOSPECIMENS FROM ANZUP’S ENZAMET & ENZARAD TRIALS. KARENA PRYCE TECHNICAL OFFICER CLINICAL TRIALS AT CHRIS O’BRIEN LIFEHOUSE (LEFT) & DR KATE MAHON - ANZUP MEMBER & DEPUTY DIRECTOR OF MEDICAL ONCOLOGY AT CHRIS O’BRIEN LIFEHOUSE (RIGHT).

Spotlight on prostate cancer The prostate is a walnut-sized gland located between the bladder and the penis. The prostate is only found in men, is just in front of the rectum and forms part of the male reproductive system. The urethra runs through the middle of the prostate, from the bladder to the penis, allowing urine to flow out of the body.

In 2020:

16,700+ estimated new diagnoses in Australia

67%

of cases diagnosed in those over 65 years

3,150+ deaths in Australia each year

What is prostate cancer?

Prostate cancer symptoms

Prostate cancer develops when abnormal cells in the prostate gland grow more quickly and in an uncontrolled manner than in a normal prostate.

Prostate cancer is generally a slow growing disease and a lot of men with low grade prostate cancer live without symptoms, without it spreading and becoming life-threatening for many years. However, high grade disease spreads rapidly and can be harmful.

Appropriate management is very important.

Early prostate cancer usually does not display symptoms. Advanced prostate cancer symptoms can include: • Frequent urination, particularly at night;

Prostate cancer is the second most common cancer diagnosed in Australia and the fourth most common cause of cancer death. One in seven men will be diagnosed with prostate cancer by the age of 85. It is more common in older men, with 67 per cent of cases diagnosed in men over 65 years of age.

• Pain on urination; • Blood in the urine; • A weak urine stream; • Pain in the pelvis or back • Weak legs or feet More widespread disease often spreads to the bones and causes unexplained weight loss, fatigue and pain.

Causes of prostate cancer

In 2020, it is estimated that 16,741 new cases of prostate cancer will be diagnosed in Australia.

Your risk of prostate cancer can be increased by some of the factors below:

The five-year survival rate for men diagnosed with prostate cancer has increased over the years from 60 per cent to 95 per cent. Nearly all patients who present with localised disease will live beyond five years. Thanks to many advances in research and treatment, tremendous progress has been made.

• A ge, increasing greatly if you are aged over 50 years;

In 2020, it is estimated that there will be 3,152 deaths from prostate cancer in Australia.

• F amily history of prostate, breast or ovarian cancer, especially BRCA1 and BRCA2 gene mutations; • A brother or father diagnosed with prostate cancer before the age of 60 years There is also an association with high testosterone levels.

A LITTLE BELOW THE BELT 19

Spotlight on prostate cancer Treatment Options

3. Surgery will become an option if the tumour has not spread outside the prostate. The prostate and some of the surrounding tissue will be removed, including the seminal vesicles. This is called a radical prostatectomy.

Men over 40 with a family history of prostate cancer or men over 50 years of age, should talk to their doctor about testing for prostate cancer using the PSA test and DRE as part of their annual health check-up.

4. Radiotherapy can take two forms: a. external beam radiation therapy – where a machine outside the body directs radiation towards the prostate gland b. i nternal radiation therapy (brachytherapy) – where small radioactive ‘seeds’ are placed inside the prostate.

Men should make an individual informed decision about testing based on the latest available evidence on the potential harms and benefits of testing and treatment options for prostate cancer.

Treatment and care of people with cancer is usually provided by a multidisciplinary team, i.e a team of health professionals, both medical and allied health. Your health care team will help decide the most optimal course of treatment and take into consideration:

5. Cryosurgery involves inserting long needles through the perineum into the prostate. Very cold gases are then passed through the needles, which freezes the prostate and destroys cancer cells.

6. Hormone therapy involves reducing the levels of certain hormones in the body, so the cancer can slow its growth or even shrink. Hormone therapy for prostate cancer is also called androgen deprivation therapy (ADT).

7. Chemotherapy can also be used to treat prostate cancer.

8. Immunotherapy for prostate cancer works by helping a patient’s own immune system fight back against cancer cells. It is used to treat advanced cancer or cancer that has spread.

• the stage of the disease • the location of the cancer

Clinical Trials

• the severity of symptoms • your general health and wishes.

Treatment may take various forms and may not be recommended straight away. Options include: 1. Watchful waiting where you might be monitored in case symptoms develop or change.

2. A ctive surveillance when you will likely have regular blood tests to check your PSA level, regular digital rectal examinations, and maybe ultrasounds or biopsies. If the cancer starts to grow or there are signs it is worsening, you might begin treatment.

New drugs and treatment approaches are constantly being developed and researched. New combinations of different strategies and therapies, as well as the development of new drugs, are constantly being trialled and tested to see if they can further improve treatment options and quality of life for men with advanced prostate cancer. Please talk with your doctor to see if there is a clinical trial suitable for you.

You can read more about ANZUP prostate cancer trials on page 28.

References: https://www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/cancer-rankings-data-visualisation https://www.cancer.org.au/about-cancer/types-of-cancer/prostate-cancer/ https://www.prostate.org.au/awareness/for-recently-diagnosed-men-and-their-families/advanced-prostate-cancer/treatment/are-therenew-treatments/

20 A LITTLE BELOW THE BELT

ANZUP’s ENZAMET trial is awarded all three of ACTA’s Trial of the Year Awards

ACTA 2020 Trial of the Year ANZUP was extremely pleased to accept the award of the 2020 ACTA 2020 Trial of the Year for the ENZAMET Trial - Enzalutamide with Standard FirstLine Therapy in Metastatic Prostate Cancer.

This trial is an international, investigator-initiated, open-label, randomised phase 3 trial. It was designed to determine if the addition of enzalutamide to standard androgen deprivation therapy (ADT) improved overall survival (OS) in men with newly diagnosed, hormone-sensitive prostate cancer (mHSPC), compared with an active control arm of ADT plus a first generation non-steroidal antiandrogen (NSAA).

No other approach had demonstrated a survival benefit for mHSPC when ENZAMET was initiated in March 2014, so this represented a major area of unmet clinical need and a critical gap in the evidence.

Enzalutamide is a “next generation” NSAA that blocks androgen receptor signalling more effectively, and improves survival in men with metastatic castrationresistant prostate cancer (mCRPC).

The ENZAMET trial showed a 33% improvement in overall survival and a 60% improvement in progression-free survival, for men who received enzalutamide. This translated into 80% chance of survival at 3 years with enzalutamide versus 72% with NSAA.

The results rapidly changed practice globally. Some clinicians were already using triplet therapy, and stopped doing so. Enzalutamide became a new standard of care. The US FDA approved enzalutamide for this indication on 16 December 2019, less than 10 months after the analysis was triggered. ASCO listed ENZAMET as one of its Clinical Cancer Advances for 2020, in its Annual Report on Progress Against Cancer, published in J Clin Oncol at https://ascopubs.org/ doi/10.1200/JCO.19.03141 on World Cancer Day, February 4, 2020.

“The ENZAMET clinical trial is testimony for a global collaboration to answer an important question that has generated clinically impactful data. We are greatly encouraged by the ability of enzalutamide to increase the longevity of men with mHSPC. The data and the biological samples collected will guide future trials with the goal to make more advances,” said Co-Chairs Prof. Christopher Sweeney and Prof. Ian Davis.

A LITTLE BELOW THE BELT 21

ACTA 2020 STiNG Award for Excellence in Trial Statistics ENZAMET was able to demonstrate that it met each of the statistical planning, execution, and reporting and interpretation criteria specified by the ACTA Excellence in Trial Statistics application and were pleased to accept the 2020 STiNG Award for Excellence in Trial Statistics.

ACTA 2020 Consumer Involvement Award ANZUP was also pleased to accept the ACTA 2020 Consumer Involvement Award as community involvement was key to the success of ENZAMET from the beginning.

ANZUP’s approach to all of its clinical trials is to centre the research question on its value to the community.

Each trial has to address the following questions: What is the clinical need? How can we improve outcomes for those affected by genitourinary cancers? Where are the evidence gaps? What are our patients and their families telling us they require? This consumer-focused approach guides the entire ANZUP strategy.

The ANZUP Consumer Advisory Panel (CAP) plays a vital role in the provision of advice and feedback from a community perspective on ANZUP’s research strategy and priorities, and on community engagement and support. Our CAP provides a mechanism for advice on trial design and conduct, recruitment, and two-way communication strategies to support dissemination of research findings back to the community and to inform ANZUP of the community’s needs.

From the outset the CAP provided invaluable insight and advice on the ENZAMET trial from the patient’s perspective. They made a significant contribution to the patient information and consent form (PICF) through their lived patient experience, highlighting the importance and value of actively engaging consumers.

In recognition of their contribution we now routinely include a statement that PICFs are reviewed by the ANZUP CAP.

22 A LITTLE BELOW THE BELT

The CAP members provided advice around recruitment strategies for ENZAMET, working closely with us in developing our communication strategy to ensure the dissemination of information about the trial, and more recently the results were provided to the broader community in a timely fashion across multiple platforms.

Members of the ANZUP CAP are regarded by the ANZUP membership as indispensable participants at disease subgroup concept development workshops.

Investigators benefit from having consumer input at the earliest stages of trial development which has considerable flow-on benefit through review and implementation phases.

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

ENZAMET Co-Chair Chair, Professor Chris Sweeney

Advanced Prostate Cancer Consensus Conference (APCCC): Asia-Pacific (APAC) Satellite Symposium In advanced prostate cancer, fast and effective drug development has resulted in many treatment options and these all require careful decision-making for each patient.

Clinicians face the progressively challenging task of selecting from multiple potentially effective treatments that are also costly and possibly toxic. Further developments in novel next-generation imaging methods, biomarkers, molecular characterisation, and genetic testing have led to many questions and areas for which there is little evidence to support clinical decision-making.

The Advanced Prostate Cancer Consensus Conference (APCCC) was initiated several years ago and held every second year in Switzerland. This conference provides a forum to discuss and debate current questions on the clinical management of men with advanced prostate cancer, with a special focus on these unclear decisionmaking situations.

Helping ensure the decisions made are relevant and can be implemented in the Asia Pacific region, ANZUP now hosts the Advanced Prostate Cancer Consensus Conference (APCCC), Asia-Pacific (APAC) Satellite Symposium every two years. A group of APAC key opinion leaders in prostate cancer meet to consider the recommendations of the Advanced Prostate Cancer Consensus Conference.

On Monday 26 October 2020 ANZUP hosted the 2nd Advanced Prostate Cancer Consensus Conference (APCCC), Asia-Pacific (APAC) Satellite Symposium virtual meeting. The meeting involved 25 multidisciplinary clinicians from 14 countries: Australia, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Turkey and Vietnam. Participants were selected based on their expertise in the management of advanced prostate cancer in their respective region.

There is great diversity in the Asia-Pacific region from a disease, epidemiological, genetics, social, and healtheconomic perspective. This leads to differences in views of each local key opinion leader who attended the symposium.

The purpose of APAC APCCC 2020 was to: • provide an opportunity for real-world consideration of the consensus recommendations from APCCC 2019 as they apply in the Asia-Pacific region; • c onsider any additional evidence published since APCCC 2019 that may influence consensus recommendations; • p rovide an opportunity to consider the impact of COVID-19 on management of advanced prostate cancer in the Asia-Pacific region.

The meeting focused on five topics discussed at APCCC viewed as most critical for the Asia-Pacific region, as well as an additional discussion about the impact of COVID-19.

Overall the panellist feedback at the APAC APCCC meeting largely aligned with the areas of consensus from APCCC 2019. However, variations in practice were noted and this demonstrated that the reality of practice cannot always conform with best practice recommendations because of resource constraints.

Following this meeting an article will be written summarising the outcomes and will reflect on the relevance for the Asia Pacific region of findings from the 2019 St Gallen Advanced Prostate Consensus Conference.

This article will then be submitted for publication in the BJU International journal – one of the most highly respected medical journals in the world.

ANZUP hopes this symposium continues as an ongoing series of meetings to provide a platform to discuss the real-world application of evidence to the management of patients in the Asia Pacific region. The commitment and interest of panellists demonstrates significant enthusiasm in working together to consider topics important to the region.

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Worldwide prostate cancer trial continues to strongly recruit In March this year ANZUP was excited to announce the DASL-HiCaP trial was open for recruitment. The ANZUP-led study will be investigating if a new tablet drug, darolutamide, combined with the current standard of care treatments, can improve outcomes for men with high risk prostate cancer that has not spread beyond the prostate area.

Just one month after opening the trial the first patient was recruited. This marked the beginning of the journey to recruit and follow up 1,100 eligible patients over 100 cancer centres across Australia, New Zealand, US, Canada, Europe and Ireland.

Since April 2020 the DASL-HiCaP trial has steadily recruited patients, with 74 patients now enrolled and 22 sites open.

However, two factors may have had some impact on recruitment: 1. S ince the onset of COVID-19 there has been either a reduced diagnoses or delayed diagnosis of prostate cancer as less men are presenting for PSA tests, MRIs and biopsies. This is definitely more common in Victoria than other states.

2. S ome hospital sites who are taking part in the study have delayed opening but this has been due to individual circumstances.

As COVID-19 cases and restrictions are now reducing, the recruitment barriers should resolve and even more prostate cancer patients join this promising trial.

Prostate cancer remains the most common cancer diagnosed in Australian men with an estimated 16,741 cases in 2020 and an estimated 3,152 deaths from prostate cancer. The outcomes of the trial will be measured in terms of whether the addition of darolutamide decreases the risk of spread of prostate cancer to other parts of the body as well as improving quality of life and potentially decrease the risk of prostate cancer death.

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Men with high risk prostate cancer should always consider their options carefully. They should seek advice regarding the pros and cons of surgery, radiation treatment and hormonal treatment. As part of that they could consider DASL-HiCaP if their doctor considers them suitable.

In the coming months we are looking to reach more study milestones with the trial set to open in Canada, and in Ireland, the UK and US in early 2021.

Our thanks to study chairs Professor Chris Sweeney and Dr Tamim Niazi for leading this important trial.

“It has been great to see this important trial for men with high-risk localised prostate cancer able to be activated and start recruiting during this COVID-19 period.

Congratulations to everyone involved and we look forward to opening the trial internationally later this year.�

Professor Lisa Horvath, Professor Scott Williams & Professor Shomik Sengupta DASL-HiCaP ANZ Leads

Where are we in demonstrating economic value in prostate cancer trials: An update on the ICECaP Project by Associate Professor Richard De Abreu Lourenço, Research Fellow with CHERE and the Project Manager for the Cancer Research Economics Support Team (CREST).

Previously, we reported on research being undertaken at the Centre for Health Economics Research and Evaluation (CHERE) in collaboration with ANZUP to address one of the central questions of the Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP) project; can intermediate outcome measures be used to assess value for treatments in prostate cancer?

quality of life, whether they represent value for money and how much evidence we have about the way they work. The findings from that research are currently being finalised and will be an important input into understanding the potential trade-offs that we as a society might consider when deciding between making a treatment available on the basis of intermediate outcomes.

This research is focusing on how we can use intermediate measures of outcomes, like five-year metastasis free survival, to demonstrate to governments that new treatments represent value for money – that they are cost-effective.

In all, the research that Rafael is undertaking acknowledges that often, rather than waiting for long-term evidence of survival or quality of life, governments and their advisory bodies make decisions about value for money on the basis of intermediate measures. One of the key considerations for these decision-making bodies is how much confidence they can have that those intermediate measures reflect what can be expected in terms of longer-term outcomes (e.g. survival). The work is well on the way to being able to demonstrate the accuracy of the links between intermediate and long-term outcomes, giving governments and decision makers greater confidence in their use for making decisions about which medicines to fund. This is critical as we see new medicines emerging, often on the basis of early trial evidence, with a desire to have those made available through our publicly funded health care system. Ultimately, providing decision makers with greater confidence that we can use that early trial evidence to make important funding decisions has the potential to make new treatments available sooner.

What has happened since our last update on this project? Perhaps the most significant update is that Rafael de Feria Cardet joined the PhD program at CHERE UTS where he is working on RAFAEL the ICECaP project. Rafael has a degree in DE FERLA pharmacy, industry experience working in how medicines are regulated and public sector experience in applying health economics to medicine funding. He started his career as a health economist at the Health Technology Assessment department in the Ministry of Health, Chile.

Since joining CHERE at the beginning of 2019 he has made important inroads into the ICECaP health economics project. With input from local clinical, industry and patient advisors he has looked into how the relationships between intermediate outcomes-like metastases free survival – and overall survival can be used to develop economic analyses that can be used by governments when making decisions about drug funding. That analysis is currently in the testing phase and the next few months will see it tested and honed further to address whether decision makers can have confidence in the use of those intermediate data to inform funding decisions.

This work is supported by untied funding received from Astellas Pharma Singapore Pty Ltd and Janssen Global, and is coordinated by the ANZUP Cancer Trials Group.

He has also led important research to understand how we, as members of society – and therefore as taxpayers – would advise governments thinking about funding medicines for prostate cancer. This considered how individuals value differences in how those medicines might affect disease, RICHARD DE ABREU LOURENÇO PRESENTS HIS CONCEPT

A LITTLE BELOW THE BELT 25

The role of the Prostate Cancer Subcommittee Professor Lisa Horvath is the chair of the ANZUP Prostate Cancer subcommittee and Professor Jarad Martin is the deputy chair. They lead the subcommittee and provide oversight of trials within the Prostate Cancer trials portfolio, as well as development of new trial concepts. The Prostate Cancer Subcommittee is made up of over 500 members of different disciplines from around Australia and New Zealand.

Meet the Professors!

Professor Lisa Horvath Professor Lisa Horvath is the Director, Department of Medical Oncology, and inaugural Director of Research at the Chris O’Brien Lifehouse. She is also the Professor of Medical Oncology (Genitourinary cancer) at the University of Sydney and Head of Advanced Prostate Cancer Research at the Garvan Institute for Medical Research.

She has an active clinical practice and is involved with a large number of clinical trials in prostate and colorectal cancers in addition to phase I trial work.

Having completed medical school at the University of Sydney and trained in medical oncology at Royal Prince Alfred Hospital, she subsequently worked at the Garvan Institute completing her PhD in translational research in 2004. She has authored over 100 original research papers published in peerreviewed journals in the last 20 years across the fields of cancer biology, biomarkers and clinical trials.

Prof Horvath has been involved in numerous ANZUP clinical trials over the last 10 years as well as an author on the ENZAMET study. She is a board director for ANZUP, and a member of the ANZUP Scientific Advisory Committee.

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Professor Jarad Martin Professor Jarad Martin is a Radiation Oncologist and departmental Director of Research working at the Calvary Mater Newcastle.

He completed his fellowship in 2005 and undertook a genitourinary oncology clinical research fellowship at the Princess Margaret Hospital in Toronto, winning the academic excellence in research award from that institution. His primary clinical and research interests are in urologic and gastrointestinal cancers, including the application of stereotactic radiotherapy for genitourinary tumours. In 2006 he accepted a position in Regional Queensland in Toowoomba and established the Toowoomba Cancer Research Centre (TCRC).

Prof Martin assumed the Australasian Primary Investigator role for the successful PROFIT clinical trial randomising men with prostate cancer to receive either a standard 8 week course or an experimental 4 weeks’ regimen of radiotherapy. He relocated to Newcastle in 2012 and continued to develop a number of senior roles in national bodies. He was the Clinical Liaison for Trans-Tasman Radiation Oncology Group (TROG) from 2012-2015 and was the chair of the Faculty of Radiation Oncology Research Committee from 2011-2015. He has been on the executive committee of the Faculty of Radiation Oncology Genitourinary Group (FROGG) as well as the Scientific Advisory Committee of ANZUP. Prof Martin has several currently accruing multicentre prospective clinical trials, over 70 peer reviewed publications, and has also recently completed a PhD.

Q&A with Professor Lisa Horvath A: Can you tell us why you are involved in the Prostate Cancer Subcommittee?

Lisa Horvath (LH): I became involved as I wanted to contribute to prostate cancer clinical trials, and ANZUP as the peak body was the obvious vehicle to do this.

I have worked in Prostate Cancer for 20 years and always enjoyed research and clinical trials.

Why is the subcommittee important to ANZUP and its trials portfolio?

LH: With all of ANZUP’s subcommittees, we need to concentrate on the tumour type. We need to work on new ideas, and bring new ideas to the table, new drugs, improved lifestyle and quality of life for our patients. More research into biomarkers and different therapeutic approaches to improve people’s longevity and improving their quality of life.

What are the roles and responsibilities of the subcommittee?

LH: The subcommittee provide input into new protocols. The subcommittee is also there to provide enthusiasm, interest and discussion, sparking ideas for new trials. This is a forum to bring different disciplines together, to discuss ideas and see if they are going to work. These subcommittees have input with a multidisciplinary approach.

The role of the ANZUP subcommittees The Scientific Advisory Committee (SAC) consists of a core group of members representing the major disciplines relevant to ANZUP, nominated and appointed upon the recommendation of those groups. In addition, chairs of the SAC subcommittees are members of the SAC by virtue of their appointment as Chair. The SAC meets by teleconference quarterly with one annual face-to-face meeting during the Annual Scientific Meeting.

The SAC is advised by disease specific subcommittees (Prostate, Renal, Germ Cell and Bladder/Urothelial/Penile) and non-disease-specific subcommittees (Quality of Life & Supportive Care and Translational Research). The disease specific subcommittees are responsible for oversight of trials within their portfolios, as well as development of new trial concepts. These subcommittees meet by teleconference quarterly and intend to meet face-to-face at least once per year.

The non-disease-specific subcommittees are involved as required in trial development and management in order to ensure maximum value is added to every trial. These subcommittees meet by teleconference as required and intend to meet face to-face at least once per year.

If someone is thinking of joining the committee what would you say to them / what do they need to know?

LH: Please join us. The subcommittee is inclusive to all healthcare professionals working in the prostate cancer space.

Over the next 12 months, what do you hope to achieve leading the Prostate Cancer Subcommittee?

LH: Enhance the multidisciplinary approach to prostate cancer clinical trials, including getting more surgeons, nurses and allied health involved in clinical trials.

I would really like to see nursing / allied health led studies. Encourage nurses and allied health to put forward concepts to be considered at the concept development workshops. Look at different techniques, supportive care and quality of life. How we get the best nursing care to our patients.

Anything else you would like to add?

LH: Onwards and upwards. Roll on 2021, may the world be a calmer and happier place.

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ANZUP trials - prostate

ANZUP are currently running a number of prostate cancer trials.

For more details information about these trials, go to the ANZUP prostate cancer trials web page: https://anzup.org.au/content.aspx?page=trials-prostate

ENZA-p Status: Open and recruiting Location: Australia wide Planned sites: 13 Patients recruited: 13 • Patients required: 160

Enzalutamide is a potent hormone therapy that prevents testosterone from reaching prostate cancer cells, thereby stopping cancer growth. It is already widely used in men with prostate cancer that has stopped responding to standard hormone treatments (castration-resistant prostate cancer). However, most cancers become resistant to enzalutamide over time, with almost 1 in 4 being resistant from the start of treatment.

The ENZA-p clinical trial aims to compare the effectiveness of enzalutamide in combination with LuPSMA, versus enzalutamide alone for the treatment of prostate cancer. This is a randomised study, so half the men in this trial will be randomly allocated to receive Lu-PSMA and enzalutamide, and the other half will be randomly allocated to receive enzalutamide alone.

We plan to enrol 160 participants across Australia.

Many prostate cancers, in particular those that have spread or become resistant to hormonal therapies, have a substance on their cell surface called prostate specific membrane antigen (PSMA). Lutetium-177 PSMA (LuPSMA for short) is a new treatment in advanced prostate cancer. Lu-PSMA is a radioactive molecule that attaches to the surface of prostate cancer cells throughout the body. This drug is given as an injection through the vein and allows targeted radiation to be delivered directly to prostate cancer cells.

https://anzup.org.au/content.aspx?page= prostatecancertrialdetails

Smaller pre-clinical studies have demonstrated synergistic effects by combining Lu-PSMA with enzalutamide. It is possible that Lu-PSMA can prevent early resistance to enzalutamide, extending the time that men benefit from treatment.

28 A LITTLE BELOW THE BELT

Current locations for the ENZA-p trial: NSW • St Vincent’s Hospital VIC • Austin Health • Peter MacCallum Cancer Centre QLD • Royal Brisbane SA • Royal Adelaide Hospital

ENZA-p is funded through the Prostate Cancer Research Alliance (PCRA) – a program jointly funded by the Australian Government and the Movember Foundation (Movember).

ANZUP trials - prostate

DASL-HiCaP Status: Open and recruiting Location: Australia & Internationally Activated sites: 22 Patients recruited: 89 • Patients required: 1100

The purpose of this study is to see if a new tablet drug, darolutamide, combined with the current best treatments, can improve outcomes for men with high risk prostate cancer that has not spread beyond the prostate area.

Previous studies have shown promising results for darolutamide preventing disease progression and improving survival for men with advanced prostate cancer.

This is a randomised controlled trial, which means that, in addition to best standard treatments, half the participants on the study will receive darolutamide, and the other half will receive placebo.

DASL-HiCaP is being led internationally by ANZUP with another exciting opportunity to collaborate with our partners at the NHMRC Clinical Trials Centre, the Canadian Cancer Trials Group, Cancer Trials Ireland (Ireland and UK), and the Memorial Sloan Kettering Cancer Center and Prostate Cancer Clinical Trials Consortium in the US. The University of Sydney is the Sponsor and and the NHMRC Clinical Trials Centre is the global coordinating centre.

We plan to enrol 1,100 men from Australia, New Zealand, Canada, US, Ireland, and the UK. For more information please refer to https://www.anzup. org.au/content.aspx?page=trials-prostate.

Current locations for the DASL-HiCAP trial: AUSTRALIA NSW • Border Medical Oncology • Calvary Mater Newcastle • Campbelltown Hospital • Chris O’Brien Lifehouse • GenesisCare Newcastle • Gosford Hospital • Liverpool Hospital • Prince of Wales Hospital • St George Hospital • St Vincent’s Hospital VIC • Peter MacCallum Cancer Centre • Peter MacCallum Cancer Centre (Bendigo Campus) • Peter MacCallum Cancer Centre (Moorabbin Campus) QLD • Icon Cancer Centre-Gold Coast University Hospital • Princess Alexandra Hospital • Radiation Oncology Princess Alexandra Hospital Raymond Terrace • Royal Brisbane and Women’s Hospital • Townsville Hospital SA • Ashford Cancer Centre Research WA • Fiona Stanley Hospital TAS • Royal Hobart Hospital NEW ZEALAND • Auckland City Hospital

A LITTLE BELOW THE BELT 29

Co-badged trials - prostate

#UpFrontPSMA Status: Open & recruiting Location: Australia wide Activated sites: 5 Patients recruited: 13 • Patients required: 140

Most prostate cancer cells have a molecule on their surface called prostate cancer specific membrane antigen (PSMA). PSMA can be targeted with Lutetium-177 PSMA (Lu-PSMA), a radioactive drug that kills prostate cancer cells anywhere in the body. This investigational drug is not approved for use in Australia by the Federal Government’s Therapeutic Goods Administration (TGA). It is a new form of treatment that is effective in some patients with metastatic prostate cancer. It is a radioactive substance that, after injection into a vein, attaches to prostate specific membrane antigen (PSMA). The treatment enables delivery of highly targeted radiation to cancer cells. The emitted radiation only travels about 1mm, which means it mainly causes the death of cancer cells, while avoiding healthy cells, and seems to be well tolerated with few side effects. This is called radionuclide therapy or theranostic therapy. The purpose of this randomised controlled clinical trial is to compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own. Previous clinical trials have shown promising activity of Lu-PSMA in treatment of patients with metastatic prostate cancer.

Docetaxel is a chemotherapy drug that is approved by the TGA to treat prostate cancer and has been used for many years in the treatment of metastatic prostate cancer.

Since Lu-PSMA radiotherapy and docetaxel chemotherapy are both effective in treating metastatic prostate cancer, it is possible that using Lu-PSMA in addition to standard docetaxel chemotherapy at the beginning of the treatment course may improve patient outcomes when compared to treatment with docetaxel alone.

30 A LITTLE BELOW THE BELT

A recent phase 2 clinical trial, showed the effectiveness of Lu-PSMA when used as a last treatment option and helped control disease progression.This study brings the use of Lu-PSMA forward as a first option to patients, with the hope of disease eradication and potential cure.

The trial is open and recruiting.

For more information please refer to https://anzup.org. au/content.aspx?page=prostatecancertrialdetails Current locations for the #UpfrontPSMA trial: NSW • St Vincent’s Hospital Sydney QLD • Royal Brisbane and Women’s Hospital VIC • Peter MacCallum Cancer Centre • Austin Hospital

#UpFrontPSMA is funded through the Prostate Cancer Research Alliance (PCRA) – a program jointly funded by the Australian Government and the Movember Foundation (Movember).

Co-badged trials - prostate

NINJA Status: Open & recruiting Location: NSW and VIC Activated sites: 12 Patients recruited: 81 • Patients required: 474

The NINJA clinical trial aims to compare two emerging schedules of radiotherapy in the treatment of intermediate or high risk prostate cancer. Participants will be randomly assigned to one of two radiotherapy schedules as part of this study. In schedule 1 (called Stereotactic Body Radiotherapy) participants will receive 5 radiotherapy treatments over 2 weeks, and in schedule 2, (called Virtual High Dose Rate Boost), participants will receive Stereotactic Body Radiotherapy delivered in 2 treatments over 1 week followed by 12 treatments of conventional external beam radiotherapy over 2 and a half weeks. It is hoped this research will potentially improve the accuracy and quality of radiotherapy treatment in prostate cancer.

This study will include 474 men. Currently we have active sites across Australia and New Zealand with 81 patients enrolled.

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.

Current locations for the NINJA trial: NSW • Calvary Mater Newcastle • Campbelltown Hospital • GenesisCare Hurtsville • GenesisCare Newcastle • Liverpool Hospitals • Illawarra Cancer Centre • St George Hospital • Westmead Hospital VIC • Peter MacCallum Cancer Centre (Parkville) • Peter MacCallum (Moorabbin) QLD • Princess Alexandra Hospital • Princess Alexandra (ROPART)

This study is being led by the TransTasman Radiation Oncology Group and co-badged with ANZUP. The study is being funded by Cancer Australia, and we acknowledge MDI for providing the study drug.

A LITTLE BELOW THE BELT 31

Spotlight on bladder and urothelial cancer What is bladder cancer?

The bladder is an organ in your pelvis that is part of the urinary system. It works with the kidneys to eliminate the body of waste products from the blood.

The bladder has muscular walls that stretch to store urine until it is ready to empty. Urine is liquid waste made by the two kidneys and then carried to the bladder through two tubes called ureters. When you urinate, the muscles in the bladder contract, and urine is forced out of the bladder through a tube called the urethra. Your bladder can hold about 500ml of urine, but you usually feel the need to urinate when it’s holding around 300ml. And just like the urethra, ureters, prostate and renal pelvis, the bladder is lined by a layer of tissue called the urothelium.

Bladder cancer develops when abnormal cells in the lining of the bladder grow and divide in an uncontrolled manner. Cancer that begins in the urothelium of the bladder is much more common than cancer that begins in the urothelium of the urethra, ureters, prostate, or renal pelvis.

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

If you develop bladder cancer in the lining of the bladder it is called superficial bladder cancer. But if the cancer cells spread to the muscle wall of the bladder, or even further to other organs or lymph nodes, it is called invasive bladder cancer.

32 A LITTLE BELOW THE BELT

Bladder cancer remains the only cancer with survival rates that have deteriorated over the past 30 years.

Bladder cancer was the 11th most commonly diagnosed cancer in Australia in 2020. In 2020, it is estimated 3098 cases of bladder cancer will be diagnosed in Australia (2389 males and 710 females).

This is equivalent to an estimated incidence rate of 9.6 cases per 100,000 persons. In addition, it is estimated there will be 1016 deaths in Australia from bladder cancer but from 2012 – 2016 on average, 54.3% of people diagnosed with bladder cancer survived 5 years after diagnosis.*

Bladder cancer is common in people aged over 60 and is significantly more common in men than in women.

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

Other less common symptoms include: • Problems emptying the bladder; • A burning sensation when passing urine; • Pain when urinating; • Need to pass urine often; • Back pain or lower abdominal pain.

Causes of bladder and urothelial cancer Some factors that can increase your risk of bladder and urothelial cancer include: • smoking; • older age; • family history; • diabetes treatment using the drug pioglitazone; • w orkplace exposure to certain chemicals used in dyeing in the textile, rubber and petrochemical industries; • use of the chemotherapy drug cyclophosphamide; • c hronic urinary tract infections.

Common treatment approaches Many times, the best option might include more than one of type of treatment. Surgery, alone or with other treatments, is used to treat most bladder cancers. Early-stage bladder cancers can often be removed. But a major concern in people with earlystage bladder cancer is that new cancers often form in other parts of the bladder over time. Taking out the entire bladder (called radical cystectomy) is one way to avoid this, but it causes major side effects. If

the entire bladder is not removed, other treatments may be used to try to reduce the risk of new cancers.

Whether or not other treatments are given, close follow-up is needed to watch for signs of new cancers in the bladder.

Depending on the stage of the cancer and other factors, treatment options can include: Bladder cancer surgery - type of surgery done depends on the stage of the cancer.

Intravesical therapy - the doctor puts a liquid drug right into your bladder rather than giving it by mouth or injecting it into your blood.

Chemotherapy - it can be given in 2 different ways, either straight into the bladder or given in pill form or injected into a vein or muscle. The drugs then go into the bloodstream and travel throughout the body.

Radiation therapy - uses high-energy radiation to kill cancer cells.

Immunotherapy - is the use of medicines to help a persons own immune system recognise and destroy cancer cells.

Targeted therapy - as researchers have learned more about the changes inside cells that cause cancer, they have developed newer drugs that target some of these changes. These targeted drugs work differently from other types of treatment, such as chemotherapy, and they may work in some cases when other treatments don’t.

Clinical trials - several ground-breaking bladder cancer trials using some of the therapies listed above, are currently underway in Australia. You can read more about ANZUP’s bladder cancer trials on pg 38.

Among Australia’s 15 most common cancers, bladder cancer remains the only one with survival rates that have worsened over the past 30 years. This can mainly be attributed to Australia’s ageing population as the percentage of patients diagnosed with bladder cancer over the age of 80 years has gradually increased.

However, if there was not a delay presenting to the doctor, then early identification and referral can lead to timely diagnosis. In addition, the hope is that novel approaches are identified through clinical trials that will help reverse the trend of deteriorating survival rates in bladder cancer.

* https://www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/summary

A LITTLE BELOW THE BELT 33

In the media:

Fiona Stanley Hospital urological surgeon puts songwriting talent to the test for Below The Belt campaign Credit: Adam Poulson | Melville Gazette | August 31, 2020 A urological surgeon at Fiona Stanley Hospital has put his musical skills to use promoting a fundraising campaign for “below the belt” cancer research.

Professor Dickon Hayne has a list of titles as long as his arm, though “musician” is not one he wears comfortably.

Yet Prof. Hayne, who is heavily involved with the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group, has had a lifelong love of music.

So when COVID-19 lockdowns were enforced, he busied himself writing songs with daughters Natasha and Zoe, who are keen vocalists.

One of those compositions, dubbed Your Way, has since been adopted as the theme song for ANZUP’s seventh annual Below The Belt fundraiser.

“ANZUP is a charity that supports conducting really high quality trials to try and push the boundaries in cancer care,” Prof. Hayne explained.

With COVID-19 making such an event impossible, this year’s fundraiser was extended for the entire month of September, with participants encouraged to walk, run, cycle or swim as many kilometres as possible.

Prof. Hayne said money raised would go towards research and clinical trials to improve the lives of people with prostate, testicular, bladder, kidney and penile cancers.

“The idea of calling them ‘below the belt’ cancers is trying to draw attention to the fact that people are more embarrassed to talk about bladder cancer or prostate cancer, for example, and it’s really important that people do present to their doctors when they have symptoms, because it can make a big difference,” he said.

“A classic one is blood in the urine for bladder cancer.

It’s so important if people see blood in their pee, even once, that they go and see their doctor.”

Visit https://www.belowthebelt.org.au/event/ yourway2020/donate to donate.

“It’s the organisation that’s actually getting urogenital cancer research done in Australia, so I’m absolutely a signed-up supporter.

“I just asked them, ‘Do you want to use this song for something’, and the title gave them the idea for the campaign.”

Below The Belt campaigns usually involve mass pedalthons in NSW and Victoria, which since 2014 have raised about $1.75 million.

MUSICIAN AND PROFESSOR OF UROLOGY, DICKON HAYNE. CREDIT: ADAM POULSEN/MELVILLE GAZETTE

Article source and copyright attributed here: https://www.perthnow.com.au/community-news/melville-gazette/fiona-stanley-hospital-urological-surgeon-puts-songwriting-chops-to-the-test-forbelow-the-belt-campaign-c-1261902?utm_campaign=share-icons&utm_source=clipboard&utm_medium=clipboard&tid=1607630300742

34 A LITTLE BELOW THE BELT

23 Sep 2020 Author: Jade Jurewi cz Article type: Publica tion Page: 61 West Australian, Th e Readership: 472000 AVE: $11562.12 Circulation: 149168

In the media:

Below the belt study vital This copy is licens ed by Copyright Ag ency for the purpo ses of a Press Clipp licensed: www.righ ing Service. Any reu tsportal.com.au se of

this article must be

Credit: Jade Jurewicz | The West Australian | September 23, 2020 page 1 of 1

THE FIONA STANLEY HOSPITAL TEAM HOSTING A COMMUNITY DAY TO RAISE AWARENESS FOR ANZUP DURING THE #YOURWAY CHALLENGE.

A LITTLE BELOW THE BELT 35

The importance of data to improve patient outcomes with bladder cancer

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

It can take different forms. It is the fourth most common cancer in Australian men with the most common symptom of bladder cancer being blood in the urine, which can occur suddenly and is generally not painful.

In 2020 an estimated 3098 people in Australia will be diagnosed with bladder cancer.

Radical cystectomy (bladder removal) surgery for bladder cancer is associated with significant risk of morbidity and mortality to patients. Currently there is a lack of good quality research carried out specifically in patients who underwent radical cystectomy to identify treatments or interventions that actually improve patient outcome.

The ACCEPT study is a secure online collaborative multicentre cystectomy database which acts as a portal for data collection. The data obtained will allow healthcare professionals to analyse the type of interventions currently used by participating urologists and the associated outcome and complications. Subsequently, this information will be used to formulate intervention and control arms for a future randomised controlled trial.

The study is led by ANZUP member Professor Dickon Hayne based at Fiona Stanley Hospital in Perth, Western Australia. To date there are 78 patients participating in the study with six other member sites and their patients in Queensland, Victoria and NSW preparing to join the study over the coming months. This is the first study of its type for bladder cancer.

36 A LITTLE BELOW THE BELT

At ANZUP’s recent Annual Scientific Meeting, Prof Hayne presented an update on the progression of the ACCEPT study: • F irst reported data from the database is being analysed; • T he range of data includes large contemporary and unselected Australian cases; • R esults compare favourably to national and international literature particularly in relation to major complications and mortality; • S upports evidence based principles of high volume surgeons and centres and adoption of best practice to improve cystectomy outcomes; • Widespread participation is encouraged to help improve patient outcomes across Australia, New Zealand and globally.

“We are delighted to have data from the ACCEPT database to analyse. Working into the future we hope to galvanise additional multicentres to make this project a truly effective tool for cancer.”

Professor Dickon Hayne.

The ACCEPT study has been funded by ANZUP’s Below the Belt Research Fund and more recently support has been received from the McCusker Foundation. ANZUP is extremely grateful to the McCusker Foundation for their support.

ANZUP trials - bladder

ANZUP are currently running a number of bladder cancer trials.

For more details information about these trials, go to the ANZUP bladder cancer trials web page: http://bit.ly/ANZUPbladder

BCG+MM Status: Open & recruiting Location: Australia Activated sites: 12 Patients recruited: 309 Patients required: Stage one: 130 / Stage two: 370

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% of people with high-risk tumours, despite best current treatment.

Recent preliminary studies show promising results from adding mitomycin (MM), a chemotherapy drug, to current treatment with BCG (Bacillus Calmette-Guérin, 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 costeffective treatment for patients who suffer from this cancer.

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

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 and the National Health and Medical Research Council. We acknowledge Omegapharm and Merck Sharp & Dohme for providing the study drugs.

Current site locations for the BCG + MM trial are: NSW • Concord Repatriation General Hospital • John Hunter Hospital • Northern Cancer Institute, St Leonards • Southside Cancer Care Centre • The Tweed Hospital • Westmead Hospital VIC • The Alfred Hospital • Austin Hospital • Epworth HealthCare (Richmond) • Frankston Hospital • Royal Melbourne Hospital WA • Fiona Stanley Hospital

A LITTLE BELOW THE BELT 37

ANZUP trials - bladder

PCR-MIB Status: Open & recruiting Location: Australia wide Activated sites: 6 Patients recruited: 24 • Patients required: 30

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

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

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

We thank and acknowledge MSD for their funding and product support.

If a clinical trial proves that a treatment is more effective than existing options, it may become the new standard of care for patients in the future.

38 A LITTLE BELOW THE BELT

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

Participation in cancer trials is voluntary & patients can withdraw from a study at any time

Recruitment nearing completion for world first trial for bladder cancer

ASSOCIATE PROFESSOR ANDREW WEICKHARDT PRESENTING THE PCR-MIB CLINICAL TRIAL POSTER.

In 2016 ANZUP launched a world first bladder cancer trial where cancer has spread into the wall of the bladder. The current standard treatment for bladder cancer is chemotherapy and radiation but this study will investigate if it is safe and effective to add an additional new drug called ‘pembrolizumab’ to this standard therapy regimen.

Pembrolizumab is a new treatment that “takes the brakes off” the immune system, allowing it to attack cancers more effectively. Pembrolizumab belongs to a class of drugs called PD1 inhibitors, and at present is approved for use in Australia for the treatment of advanced melanoma in adults.

In some patients bladder cancer may spread deeper within the bladder but not more widely.

Chemotherapy given at the same time as radiation to the bladder may be an attempted cure for these patients. Yet one in three treated this way will still have a relapse. Potentially giving a PD1 inhibitor at the same time may activate the body’s immune system to fight the cancer.

This trial will recruit 30 patients at six different hospitals within Australia. Recruitment is almost complete with 23 patients now enrolled. In addition, a pre-planned safety and efficacy analysis was undertaken after the first 10 patients were enrolled and completed treatment. The results from this interim analysis demonstrated acceptable safety, and promising efficacy. There were no unexpected safety concerns. Follow up of these patients and additional patients will better determine the efficacy and safety of combining pembrolizumab with standard therapy.

Everyone involved in this trial are now eager to see the trial completed and undertake the follow up of patients.

If you or a member of your family would like to know more about the ANZUP led PCR MIB clinical trial, please discuss with your GP or specialist or refer to our website: https://www.anzup.org.au/content. aspx?page=bladdercancertrialdetails.

A LITTLE BELOW THE BELT 39

Spotlight on testicular cancer The testes are two small organs found inside the scrotum, the pouch of skin behind the penis. They are part of the male reproductive system and are responsible for making sperm and are involved in producing a hormone called testosterone. Testosterone is an important hormone during male development and maturation and aids development of muscles, deepening of the voice, and growth of body hair.

30

928

estimated diagnoses

estimated deaths

in Australia in 2020

will result from testicular cancer in 2020

What is testicular cancer?

Cancer that develops in a testicle is called testicular cancer or cancer of the testis. Usually only one testicle is affected, but in some cases both. About 90 to 95 per cent of testicular cancers start in the cells that develop into sperm - these are known as germ cells.

The five-year survival rate for men diagnosed with testicular cancer is close to 97.2 per cent. And in 2020, it is estimated there will be 30 deaths from testicular cancer.

Testicular cancer symptoms

Compared with other types of cancer, testicular cancer is rare. But testicular cancer is the second most common cancer in young men (aged 18 to 39) excluding non-melanoma skin cancer. However, this form of cancer is highly treatable, even when cancer has spread beyond the testicle.

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

It is estimated only 928 men will be diagnosed with testicular cancer in Australia in 2020. This equates to 1% of all cancers in men. For Australian men, the risk of being diagnosed with testicular cancer by the age of 90 is 1 in 192. The rate of men diagnosed with testicular cancer has grown by more than 50% over the past 30 years, however the reason for this is not known.

• Change in the size or shape of the testicle;

Germ cell tumours are the most common testicular cancers. Under a microscope there are two main types that are quite different when observed – seminoma and non-seminoma cells. Seminoma cells usually occur in men aged 25-45 but can also occur in men over the age of 60 or at any age. This form of testicular cancer develops more slowly than non-seminoma cancers. The faster developing, rarer form of testicular cancer occurs in younger men in their late teens and early 20s.

40 A LITTLE BELOW THE BELT

Less common symptoms include: • Feeling of heaviness in the scrotum;

• P ain or ache in the lower abdomen, the testicle or scrotum; • Back pain; • Feeling of unevenness; • T enderness or tenderness of the breast tissue (due to hormones created by cancer cells).

Spotlight on testicular cancer Causes of testicular cancer

Testicular cancer clinical trials

A couple of factors that may increase a man’s risk of testicular cancer include an undescended testicle as an infant, or family history, mainly having a father or brother who has had testicular cancer.

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

Testicular cancer treatment Treatment for testicular cancer depends on the type of cancer you have and how far it has spread. Your medical team will advise the best treatment for you. They will consider various points: • your general health

Several decades ago testicular cancer was a disease with a very poor prognosis. But now, because of new treatments, tested carefully in clinical trials, it is almost always curable even when it has spread. However, even though there are excellent treatments available, we still need to do more. This can only happen through understanding the science and by performing clinical trials to see which treatments are the ones most likely to help further improve outcomes. ANZUP is involved in clinical trials in testicular cancer through its clinical trials program.

Speak with your doctor if you would like to know more about testicular cancer clinical trials and also read about ANZUP’s trials on page 44.

• the type of testicular cancer • the size of the tumour • the number and size of any lymph nodes involved • if the cancer has spread to other parts of your body.

If testicular cancer does spread, it most commonly spreads to the lymph nodes in the pelvic and lower abdominal regions.

In almost all cases if testicular cancer is suspected, the affected testicle is surgically removed in an operation called an orchiectomy. A laboratory will then examine the tissue to confirm the type of cancer and the stage it is at.

After the surgery, you may not need any further treatment but you will be closely monitored. This is called surveillance. If additional treatments are required they may include chemotherapy or radiotherapy to eradicate any cancer cells that may have spread to other parts of the body. Others may need further surgery.

References https://www.cancer.org.au/about-cancer/types-of-cancer/testicular-cancer.html https://www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/cancer-summary-data-visualisation

A LITTLE BELOW THE BELT 41

Testicular Cancer Research Highlights

by Dr Ben Tran, Medical Oncologist, Peter MacCallum Cancer Centre and Walter and Eliza Hall Institute of Medical Research.

ANZUP Germ Cell Subcommittee Chair.

Testicular cancer is now highly curable, but that wasn’t always the case.

Up until the late 1970s, testicular cancer was a very aggressive disease with a very poor prognosis.

However, the development of cisplatin based BEN TRAN, ANZUP GERM chemotherapy, tested in CELL SUBCOMMITTEE CHAIR clinical trials, changed the face of testicular cancer, from a devastating disease in young men, to a highly curable disease.

Although testicular cancer patients now have mainly excellent outcomes, we can still do better. This is why ANZUP is involved in clinical trials in testicular cancer through its clinical trials program.

ANZUP has subcommittees for each of its diseases, which includes the Germ Cell (Testicular Cancer) Subcommittee. The subcommittee has had a very productive year with trials ongoing as well as studies in the pipeline and the presentation of promising concepts that could lead to future trials.

Some highlights include the following: TIGER Trial This study aims to demonstrate how well standard-dose combination chemotherapy works compared to highdose combination chemotherapy in treating patients with germ cell tumours where the cancer persists after a first round of chemotherapy.

This trial is now open at 4 sites in Australia, with recruitment at 9 out of 60 patients. This study also aims to recruit 420 patients internationally.

iTestis Database iTestis is a user-friendly, multi-disciplinary, web-based testicular cancer database. Data collected within iTestis will provide better understanding of treatment patterns in Australia and identify how treatments for Australian patients can be improved. iTestis also has the capacity to be linked to tumour tissue from individual patients and through this linkage, there will be scope to answer some of the biological research questions that might lead to new treatment approaches. iTestis is continuing to expand, opening at multiple sites across the country,and gaining interest from cancer centres in other parts of the globe.

DR ROB HAMILTON, DR BEN TRAN AND DR FRITHA HANNING DISCUSSING ANZUP TRIALS - WHAT HAPPENS NEXT FOR OUR TRIALS, AT THE ANZUP ANNUAL SCIENTIFIC MEETING.

42 A LITTLE BELOW THE BELT

P3BEP Trial

PRESTIGE

The current gold standard practice for the treatment of germ cell tumours is the use of a chemotherapy combination called BEP which consists of three chemotherapy agents, Bleomycin, Etoposide and Cisplatin administered on a 3 weekly cycle. BEP is given with a drug called pegylated G-CSF (or pegfilgrastim) which stimulates white blood cell production.

Research in testicular germ cell tumours (TGCT) now focuses on helping TGCT survivors live long, healthy, and productive lives. The aim of some new clinical trials is finding ways to minimise treatment related complications, whilst maintaining the excellent outcomes.

The purpose of this study is to determine whether giving the same dose of BEP on a 2-weekly schedule will be more effective than a 3-weekly schedule and will be well tolerated. The 2-weekly schedule is called ‘accelerated BEP’.

This study has continued to recruit well despite the challenging circumstances presented by COVID-19 restrictions. Across ANZ, UK and US sites 144 patients have now been recruited.

In addition, blood and tissue from consenting P3 BEP trial participants will be collected for translational research studies.

Within the global TGCT academic community, there is interest in exploring primary Retroperitoneal Lymph Node Dissection* (RPLND) as an alternative to chemotherapy for curing selected men with advanced TGCT, namely those with disease just located in their retroperitoneum, with involved lymph nodes measuring 3cm or less.

While the short- and long-term effects of chemotherapy on health related quality of life (HRQoL) are well described in this group of cancer patients, there are minimal data regarding the impact of RPLND alone on HRQoL. Such data are necessary to inform a randomised study between chemotherapy and primary RPLND in this setting. Alternatively, if primary RPLND becomes increasingly used, data regarding HRQoL are necessary to properly inform the recommendation for surgery over chemotherapy in these young patients.

The PRESTIGE study aims to add to the literature, by describing the impact of primary RPLND on HRQoL, with particular attention to sexual function. PRESTIGE will also describe the peri-operative complications (i.e. the time between surgery and going home) and other surgical measures. Additionally, through collection of serum, PRESTIGE aims to explore whether the biomarker miR-371 has potential to assist in selecting patients most likely to be cured by primary RPLND alone and avoid chemotherapy.

Some other projects in the pipeline are as follows: Micro RNA Analyses There is an urgent need to develop markers that can better guide chemotherapy decision making and also identify patients at very low risk of recurrence where the intensity of CT scans during active surveillance could be reduced. One biomarker, miR-371, appears promising with high sensitivity and specificity for the detection of lingering testicular germ cell tumours, and subsequently, has the potential to satisfy both needs.

The PRESTIGE study examining the changes in HRQoL in patients undergoing primary RPLND aims to open in 2021 as well. However, given the extremely specialised nature of RPLND surgery, only a few sites around Australia will be participating.

To find out more about ANZUP’s testicular cancer trials go to page 44 or ask your GP or specialist if there is a clinical trial suitable for you. *remove lymph nodes at the back of the abdomen that may contain cancer cells.

The CLIMATE study aims to determine the clinical use of miR-371 in clinical stage 1 testis cancer. The CLIMATE study has been designed through the ANZUP concept development workshops, and will have sufficient funding to start in 2021. The aim will be to recruit approximately 200 patients with stage 1 testicular cancer over 2-3 years from 7-8 hospital sites.

A LITTLE BELOW THE BELT 43

ANZUP trials - testicular

ANZUP are currently running a number of testicular cancer trials.

For more detailed information about these trials, go to the ANZUP testicular cancer trials web page: https://anzup.org.au/content.aspx?page=trials-testicular

TIGER Status: Open & recruiting Location: Australia wide & Internationally Activated sites: 4 (Australia) Patients recruited: 9 • Patients required: 60 + 420 internationally

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

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

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

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

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

44 A LITTLE BELOW THE BELT

Up to 420 patients will be enrolled in Australia, New Zealand and other countries. Currently we have 9 patients enrolled and 4 sites open in Australia.

Please speak with your doctor if this is of interest to you or someone you know.

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

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

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

Current site locations for the TIGER trial are: NSW • Chris O’Brien Lifehouse VIC • Eastern Health • Peter MacCallum Cancer Centre QLD • Princess Alexandra Hospital

ANZUP trials - testicular

P3BEP Status: Active & recruiting Location: Australia wide & Internationally Activated sites: 61 Patients recruited: 145 • Patients required: Stage 1 (150) Stage 2 (350)

The current standard practice for the treatment of germ cell tumours is the use of the chemotherapy combination called BEP, which consists of three chemotherapy agents – Bleomycin, Etoposide and Cisplatin – administered on a three-weekly cycle. BEP is given with a drug called pegylated G-CSF (or pegfilgrastim) that stimulates white blood cell production.

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

Up to 500 patients will be enrolled in the study in Australia, New Zealand and other countries. Currently we have 61 sites open in Australia and New Zealand, and 144 patients enrolled.

We have also set up the trial in the US, in Ireland with the support of Cancer Trials Ireland and the Medical Research Council, Cambridge University, UK. This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

For more information, please go to the trials page on the ANZUP website: https://anzup.org.au/ aspx?page=testicularcancertrialdetails ANZUP collaborates with the University of Sydney through the NHMRC CTC to conduct P3BEP Trial.

This ANZUP investigator initiated study is being funded by a Cancer Australia grant.

Current locations for the P3BEP trial: NSW • Calvary Mater Newcastle • Chris O’Brien Lifehouse • Concord Repatriation General Hospital • Macquarie Cancer Clinical Trial • Nepean Hospital • Northern NSW Local Health District - The Tweed Hospital • Princes of Wales • Royal North Shore Hospital • Sydney Adventist Hospital QLD • Princess Alexandra • Queensland Childrens Hospital • Royal Brisbane & Womens Hospital VIC • Austin Health • Border Medical Oncology • Eastern Health • Peter MacCallum Cancer Centre SA • Flinders Medical Centre • Royal Adelaide Hospital WA • Fiona Stanley Hospital TAS • Royal Hobart Hospital NEW ZEALAND • Auckland Hospital • Christchurch Hospital • Palmerston North Hospital • Starship Hospital –Paediatric UK • Royal Preston Hospital • Beatson West of Scotland Cancer Centre • Bristol University Hospital • Velindre Hospital • Cambridge University Hospital Paediatric

• • • • • • •

University Hospital Southampton Royal Marsden Hospital St James Hospital - Leeds St Bartholomews Hospital Nottingham University Hospital Belfast City Hospital Derriford Hospital, Plymouth

USA • W ashington University School of Medicine • Rady Children’s Hospital • Augusta University Medical Centre • Vanderbilt University Medical Centre • L ucile Packard Children’s Hospital Stanford • M emorial Health University Medical Centre • U niversity of Mississippi Medical Centre • Geisinger Medical Center • Palmetto Health Richland • M ethodist Children’s Hospital of South Texas • University of Wisconsin Hospital • East Tennessee Children’s Hospital • M iller Children’s and Women’s Hospital Long Beach • Roswell Park Cancer Center • U SC / Norris Comprehensive Cancer Care • Broward HealthCare • Dana Farber Cancer Center • U T Southwestern Simmons Cancer Center • L A Biomedical Research Institute at Harbor- UCLA • Dayton Children’s Hospital • U niversity of Texas Science Center at San Antonio • Mayo Clinic • A dvocate Children’s Hospital – Oak Lawn • Carolinas Medical Center • U SC/ Norris Comprehensive Cancer Care

A LITTLE BELOW THE BELT 45

Spotlight on kidney cancer The kidneys are two bean-shaped organs, each about the size of a fist and are part of the renal system. They are located just below the rib cage, one on each side of your spine. Kidneys perform many crucial functions including filtering blood, removing waste as urine and the creation of hormones that help produce red blood cells.

In 2020 it is estimated:

2.9%

men

of all newly diagnosed cancers in Australia

are almost twice as likely to be diagnosed as women

4,100+ diagnoses

of kidney cancer in Australia

What is kidney cancer?

Kidney cancer generally refers to renal cell cancer, which develops in the lining of the small tubes in the kidney. There is usually just a single tumour in one kidney, but sometimes there may be more than one tumour, or tumours in both kidneys. Kidney cancer can be subdivided into several different types, based on the appearance of the cancer cells under a microscope as well as other genetic factors. About 90% of kidney cancers are renal cell cancer, and the most common subtype is clear cell renal cancer.

Other types of kidney cancers include: • Urothelial cancer of the renal pelvis and ureter starting in either the ureter (the long tube that connects the kidney to the bladder) or the renal pelvis (the top part of the ureter, where it connects to the kidney). The renal pelvis and ureters are lined with transitional cells, which can develop into cancer cells.

These cancers behave more like bladder cancers than kidney cancers and are treated like bladder cancer.

46 A LITTLE BELOW THE BELT

• W ilms tumours usually occur in children rather than adults; about 90% of kidney cancers in children are Wilms tumours. These tumours are often not detected until they are quite large, but most are found before they have spread to other organs.

• R enal sarcomas, which are rare, begin in the blood vessels or other types of tissue in the kidney.

Other types of tumours in the kidneys are benign – that is, they do not spread (metastasise) to other parts of the body.

Kidney cancer has become increasingly more commonly diagnosed and survival rates continue to improve. This cancer is the 7th most diagnosed cancer in Australia and in 2020 it is estimated there will be 4,193 new cases of kidney cancer diagnosed (2,755 males and 1,438 females). Kidney cancer is rare in people under 40 but risk does increase with age. Also, men are almost twice as likely to be diagnosed with kidney cancer as women.

Spotlight on kidney cancer In 2020, it is estimated there will be 917 deaths from kidney cancer (616 males, 301 females) and the fiveyear survival rate for Australians diagnosed with kidney cancer is 79%, although most people with kidney cancer localised only to the kidney can be cured.

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

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

Symptoms may include: • blood in the urine (haematuria); • p ain or a dull ache in the side or lower back that is not due to an injury; • a lump in the abdomen; • rapid, unexplained weight loss; • constant tiredness; • fever not caused by a cold or flu.

If you are experiencing some of these symptoms, please see your doctor.

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

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

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

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

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

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

Treatment options Treatment will depend on the type of kidney cancer, the stage of the cancer and your general health. The main treatment for kidney cancer is surgery alone or with radiotherapy and will depend on the stage of the cancer. All treatment has benefits and side effects, which need to be discussed with your cancer care team.

Treatment for kidney cancer is provided by a multidisciplinary team, comprising a group of doctors and other health professionals with expertise in kidney cancer. This team will regularly meet and discuss the patient’s medical history, organise appropriate tests, assess the test results, and together determine the most appropriate treatment care plan.

Clinical trials One treatment option is taking part in a clinical trial.

A trial will help confirm whether novel medicines are safe and effective to introduce as new treatment for kidney cancer. During a trial your health and progress is monitored extremely closely and as a participant in a trial you may also gain access to a treatment option that is not yet available to the wider public.

If you have already had one or more forms of cancer treatment and are looking for a new treatment option, there are clinical trials for you to consider. Or, if you have just been diagnosed with cancer, the time to think about joining a trial is before you have any treatment.

Read more about the ANZUP kidney cancer trials on page 50.

Reference: https://www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/cancer-summary-data-visualisation

A LITTLE BELOW THE BELT 47

Kidney Cancer and Immunotherapy

By ANZUP member Angela Mweempwa FRACP, Medical Oncology Phase 1 Fellow, Peter MacCallum Cancer Centre Immune treatments like nivolumab, ipilimumab and pembrolizumab are drugs that have shown promise in the treatment of many cancers including the common form of kidney cancer, “clear cell” renal cell cancer.

Many studies have excluded people with rare forms of kidney cancer, which lumped together are called “nonclear cell” kidney cancer. About one quarter of people with kidney cancer have the non-clear cell cancer type.

While it is known that another class of medicines for kidney cancer, small molecule tyrosine kinase inhibitors, don’t work as well for rare kidney cancer, it made little scientific sense to exclude rare kidney cancer from immune treatments.

There is also an urgent unmet need for effective therapies for patients with rare kidney cancer, as people typically experience a more aggressive disease course, leading to a more limited prognosis compared to patients with the clear cell subtype.

So the UNISoN trial was designed to look at whether new immune treatments can help people with non-clear cell kidney cancer. The UNISoN study tested immune treatments in two stages. In the first part of the trial, one immune treatment called nivolumab was given by itself to 85 participants. If nivolumab was not helpful, participants had the option to move to the second part of the study. Forty-four participants entered the second part of the study, where another type of immune treatment called ipilimumab was added to nivolumab.

The total duration of treatment was 12 months for both drugs. Recruitment for the study ran 40% faster than expected and was effective at 19 sites across Australia.

The UNISoN trial will help us answer several important questions in this population of patients:

ASSOCIATE PROFESSOR CRAIG GEDYE PRESENTING THE UNISON TRIAL POSTER.

Both nivolumab and ipilimumab act by working with the immune system to fight cancer. These types of drugs are helpful in other types of cancer such as clear cell kidney cancer, melanoma and lung cancer. Based on experience in different cancer types, immune treatments are also known to cause the immune system to attack normal cells. This can lead to side effects, but they are often easily controlled.

All the participants on the UNISoN trial have completed the first part of treatment with nivolumab.

Outcomes such as how effective the treatment was and the frequency of side effects have been looked at in a ‘Part 1 analysis’ and will be reported soon.

For everyone involved in the trial, it is exciting as the results will help us understand whether immune treatments work in non-clear cell kidney cancer.

In addition, there are profound real-world applications of the potential findings from UNISoN. Patients with rare kidney cancer generally experience only modest responses to treatment. In many settings, there are no reimbursed treatment options for patients with nonclear cell kidney cancer. UNISoN offers high quality, randomised evidence that will undoubtedly guide the management of patients with rare forms of kidney cancer. We are eagerly anticipating the results from UNISoN, which are expected in 2021.

• D o immune treatments help people with rare kidney cancer?

• I s nivolumab alone effective?

• I s the combination of ipilimumab and nivolumab effective in people failed by nivolumab alone?

Clear cell kidney cancer

Non-clear cell kidney cancer

75%

25%

48 A LITTLE BELOW THE BELT

Highlights • N on-clear cell kidney cancer is rare and useful treatments are lacking • UNISoN tested two types of immune treatments nivolumab and ipilimumab • Outcomes have been reviewed in ‘Part 1 analysis’ • Results from UNISoN will be reported in 2021

A pilot study for Kidney Cancer

by Associate Professor Andrew Weickhardt

The Below the Belt Research Fund has supported many members in the development of investigator-initiated studies. This year, it has provided much needed seed funding to support five ANZUP members to A/PROF ANDREW progress new trial ideas to WEICKHARDT the point of becoming full scale studies. We would like to congratulate Andrew Weickhardt on his pilot study.

68Ga-PSMA PET as a potential Imaging biomarker post tyrosine kinase inhibition of metastatic clear cell Renal Cell Cancer (PIRC) – a pilot study Immunotherapy and tyrosine kinase inhibitors (tablet targeted therapies) have revolutionised the treatment of advanced clear cell renal cell cancer (ccRCC), the most common type of kidney cancer. Computed tomography (CT) scans are used to determine where the cancer is and how it is responding to treatments.

CT scans have limitations, however, only showing us tumour deposits physically and not reflecting how active they are.

A new type of positron emission tomography (PET) scan, targeting “prostate specific membrane antigen” (PSMA), appears very useful in diagnosing the extent

of ccRCC spread before treatment and to see if the treatment is working. This is likely because RCC deposits have many small blood vessels, with the PSMA protein being found in these blood vessels, and not because it is related to the prostate.

Many tablet targeted therapies affect cancer blood vessel development, and as such, this project seeks to understand whether a PSMA PET scan is useful in visualising patients’ tumours after they have been treated with these therapies.

Additionally, we want to understand if tumours that remain active on PSMA PET might be sensitive to another tablet targeted therapy, potentially allowing us to tailor the right treatment, to the right patient, at the right time.

A LITTLE BELOW THE BELT 49

ANZUP trials – kidney

ANZUP are currently running a number of kidney cancer trials.

For more details information about these trials, go to the ANZUP kidney cancer trials web page: http://bit.ly/ANZUPkidney

KEYPAD Status: Open & recruiting Location: Australia wide Activated sites: 15

The most common kind of advanced kidney cancer is called clear cell kidney cancer. This trial aims to improve survival rates for people with this cancer.

Patients recruited: 42 • Patients required: 70

Renal cell carcinoma (RCC) is the 7th most diagnosed cancer in Australia and the 14th most common cancer in Western populations. Approximately 90% of kidney cancers are renal cell carcinomas (RCC). At the moment the five-year survival rate for Australians diagnosed with kidney cancer is 78.5%, although most people with kidney cancer localised only to the kidney can be cured.

ANZUP collaborates with the University of Sydney through the NHMRC CTC to conduct the KEYPAD Trial.

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

NSW • Calvary Mater Newcastle • Northern Cancer Institute • Concord Repatriation General Hospital • St George Hospital • Border Medical Oncology Research Unit • St Vincent’s Hospital Sydney

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

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

It is hoped that by combining pembrolizumab with denosumab, will stimulate the immune system, so that the immune therapy will work better in the tumours.

We thank and acknowledge Amgen and MSD for providing product and funding to support our KEYPAD Trial.

We are currently running the KEYPAD trial at the following locations:

QLD • Royal Brisbane & Women’s Hospital • Sunshine Coast University Hospital • Icon Cancer Care • The Townsville Hospital SA • Flinders Medical Centre VIC • Eastern Health • Monash Health Clayton • Ballarat Oncology and Haematology Services WA • Fiona Stanley Hospital

50 A LITTLE BELOW THE BELT

ANZUP trials – kidney

UNICAB Status: Open & recruiting Location: Australia wide Activated sites: 11 Patients recruited: 17 • Patients required: 48

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

All patients will take cabozantinib orally every day, until the medication is no longer effective. There is no placebo (inactive treatment), which means that everyone who takes part in the trial will receive the active cabozantinib drug.

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

Cancer trials can be undertaken in different settings. Depending on the trial, it may occur in a hospital, a clinic or the patient’s home.

We are currently running the UNICAB trial at the following locations: NSW • Border Medical Oncology • Calvary Mater, Newcastle • Campbelltown Hospital • Macquarie University • St. George Hospital QLD • Royal Brisbane & Women’s Hospital SA • Adelaide Cancer Centre • Flinders Medical Centre VIC • Goulburn Valley Hospital, Shepparton (teletrial) • Eastern Health • Monash Medical Centre, Clayton ANZUP collaborates with the Centre for Biostatistics and Clinical Trials (BaCT) to conduct the UNICAB Trial.

We thank and acknowledge Ipsen for providing product and funding to support our UNICAB Trial.

A LITTLE BELOW THE BELT 51

Spotlight on penile cancer

What is penile cancer?

Penile cancer symptoms

The penis is part of the male reproductive and urinary systems. Penile cancer is a disease where (cancer) cells form in the tissues of the penis. Most penile cancers are squamous cell carcinomas (cancer that begins in flat cells lining the penis).

Colour changes, bumps or thickening of the skin can be signs of penis cancer. Other symptoms can include discharge or bleeding.

The stats* Penile cancer is rare. In 2020 there will be an estimated 136 cases of penile cancer diagnosed and an estimated 24 deaths from this disease. In 2012–2016, on average, 73.8% of males diagnosed with penile cancer survived 5 years after diagnosis. And it is estimated that in 2020 males will have a 1 in 1,391 (or 0.0719%) risk of being diagnosed with penile cancer by the age of 80.

136 men

It is estimated will be affected by penile cancer in Australia in 2020.

These and other symptoms may be caused by penile cancer. Other conditions may cause the same symptoms. Check with your doctor if you have any of the following problems: • Redness, irritation, or a sore on the penis • A lump on the penis

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

Other risk factors for penile cancer include: • Being age 60 or older • H aving phimosis (a condition in which the foreskin of the penis cannot be pulled back over the glans) • Having poor personal hygiene • Having many sexual partners • Using tobacco products

52 A LITTLE BELOW THE BELT

Spotlight on penile cancer Who treats penile cancer?

Based on your treatment options, you might have different doctors of various specialties on your treatment team. These doctors could include: • A urologist: a surgeon who specialises in diseases of the male genitals and urinary tract • A radiation oncologist: a doctor who uses radiation to treat cancer • A medical oncologist: a doctor who uses chemotherapy and other medicines to treat cancer • A psychologist trained in sex therapy: a specialist who can help patients and their partners discuss their feelings around intimacy and sexual well-being

How is penile cancer treated?

Thinking about taking part in a clinical trial Progress in treating penile cancer has been hindered by its rarity so it is difficult to recruit enough patients to penile cancer clinical trials.

Clinical trials are carefully controlled research studies that are done to get a closer look at promising new treatments or procedures. Clinical trials are one way to receive state-of-the art cancer treatment, management and care that is not yet available to the wider public. Clinical trials are also the best way for a multidisciplinary team to learn better methods to treat this rare form of cancer.

If you would like to learn more about clinical trials that might be right for you, start by asking your doctor or contact ANZUP.

Surgery is the main treatment for most men with penile cancers, but sometimes radiation therapy may be used, either instead of or in addition to surgery. Other local treatments might also be used for early-stage cancer.

Chemotherapy may be given for some larger tumours or if the cancer has spread.

As well as medical treatment for penile cancer it is also important to adjust to living with the diagnosis.

A specialist nurse, psychologist, social worker, a GP and support groups can all help and provide ways of coping.

Although penile cancer is a relatively rare disease, its consequences are profoundly life changing for the men who develop it.

Evidence supports the view that factors such as embarrassment, fear, the potential impact on sexuality and a cancer sited in a sexual organ all impact on patients’ help-seeking behaviours, resulting in a delay in presenting to a healthcare professional.

References *https://www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/summary ** What are the unmet supportive care needs of men and their loved ones affected by penile cancer? A systematic review of the empirical evidence. Presenter and lead: Associate Professor Catherine Paterson https://www.anzup.org.au/docview.aspx?id=1029

A LITTLE BELOW THE BELT 53

What are the barriers and facilitators to interdisciplinary models of person-centred supportive care in the context of penile cancer? A mixed methods study A/Prof Catherine Paterson, Dr Henry Yao, Prof Shomik Sengupta, Dr Justin Chee, Prof Ian Davis and Mr Wayne Earle (Patient Representative)

Globally, penile cancer is an uncommon malignancy with reported incidence of 0.84 cases per 100,000 globally.

Treatment of penile cancer can be divided into the management of a primary penile tumour, and the management of regional A/PROF CATHERINE PATERSON lymph nodes. There are a range of treatment options for the management of primary penile tumour depending on the stage of disease, with the main treatment option being surgical removal.

54 A LITTLE BELOW THE BELT

Although, in the case of precancerous changes or earlystage malignancies, non-surgical treatments such as topical chemotherapy or laser therapy may be applicable.

Despite the use of penile sparing therapy, all treatments can be disfiguring and this has a profound negative impact on the patient’s sexual function, quality of life (QOL), social interactions, self-image and psychological well-being.

Different forms of treatment are associated with their own individual challenges for patients, complications, unique psychological burden, and unmet supportive care needs. The rarity of penile cancer represents a significant challenge to the patient, partner and healthcare professional, at each step along the cancer care continuum, from diagnosis to treatment, and into survivorship. Evidence underscores that men can experience high unmet physical, psychological and sexual needs with each facet impacting and being intertwined with the other at varying degrees.

Evidence identifies the need for the rearrangement of clinical services to develop new approaches and standardised ways to identify and address the profound unmet supportive care needs of men diagnosed with penile cancer and their partners. What is clear, is that we need interdisciplinary clinical teams (specialist nurses, psychologists, urologists, medical oncologists, plastic surgeons and sex therapists) working together to promote a person-centred model of rehabilitative care from diagnosis and into survivorship. However, to date, no research has been undertaken in Australia to understand the experiences of care delivery, or the barriers and facilitators to interdisciplinary models of patient centred supportive care.

This study aims to: 1) a ssess the experiences of unmet supportive care needs, quality of life, anxiety, depression, distress and person-centred care in men affected by penile cancer, and their partners, and 2) t o understand the barriers and facilitators of interdisciplinary models of person-centred supportive care delivery; 3) t his study will help to inform future work in developing a pilot randomised controlled trial to test a future person-centred supportive care intervention.

To date, the delivery of supportive care for patients and their families affected by penile cancer internationally remains suboptimal. Evidence demonstrates that often patients and their partners require multiple interventions that focus on improving quality of life and addressing what matters most to them. Currently in Australia, researchers and healthcare professionals don’t know what does matter.

MR WAYNE EARLE

References • Sewell, J., et al., Trends in penile cancer: a comparative study between Australia, England and Wales, and the US. Springerplus, 2015. 4(1): p. 420.

• Hakenberg, O., et al. European Association of Urology: Penile Cancer. 2018 02.10.2020]; Available from: https://uroweb.org/ guideline/penile-cancer/.

• Mortensen, G.L. and J.K. Jakobsen, Patient perspectives on quality of life after penile cancer. Dan Med J, 2013. 60(7): p.

A4655 • Paterson, C., et al., What are the unmet supportive care needs of men a affected by penile cancer? A systematic review of the empirical evidence. European Journal of Oncology Nursing, 2020: p. 101805.

• Dräger, D.L., C. Protzel, and O.W. Hakenberg, Identifying psychosocial distress and stressors using distress-screening instruments in patients with localized and advanced penile cancer. Clinical Genitourinary Cancer, 2017. 15(5): p. 605-609.

Help us raise $50,000 for Penile Cancer Research Now imagine the same penis has penile cancer. All the laughter stops abruptly, very very abruptly. This is the news that about 100 men are given every year in Australia and it can be a death sentence - the five-year survival rate at every stage is only about 50%.

There are many synonyms and funny names for the penis as men feel obliged to entitle an item that commands so much of their attention during their lives.

Prick, cock, dick, old fella, wife’s best friend, donger, willy, and (the classic) tallywhacker.

The outcome of this study aims to help improve the lives of men diagnosed with penile cancer and their partners. The research team aims to drive forward service improvements, produce information to help patients and their families, and help clinical teams choose the most appropriate model of person-centred supportive care. This study will provide the much-needed information to leverage funds to inform a future supportive care intervention trial.

Treatments range from minor surgery, chemotherapy, radiation, circumcision and the real biggie, amputation (penectomy).

All stages of this terrifying disease require a plethora of specialists – a patient may need oncologists, nurses,

urologists, psychologists, sex therapists and plastic surgeons. And in addition to the obvious physical damage, there are a great many potential negative psychological effects – depression, sexual malfunction, loss of quality of life and difficulty with social interactions, self-image and mental well-being.

A major problem in Australia is the complete lack of any research into the interaction needed between the various services, the patients and their partners and families to ensure the best possible physical and mental outcomes.

Want to help? Visit https://www. belowthebelt.org.au/research-appeal for more information or to support this important research.

A LITTLE BELOW THE BELT 55

ANZUP trials in follow up

Trials in follow up Once a clinical trial is finished, researchers scrutinise all the information collected during the course of the study.

Reviewing all the data allows researchers to decide whether the results mean the new drug or device should continue to the next phase of clinical trial, or, when applicable, seek approval for broader use by the appropriate authorities.

Once a new drug or device has been proven to be effective and safe, it may become part of standard treatment for the condition or disease.

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

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

ANZUP now has nine trials in follow-up across four of the below the belt cancer types – bladder, testicular, prostate and kidney cancer.

ANZUP Trials 1. BL12 – Bladder Cancer This study was designed to look at whether NabPaclitaxel improves survival and is less toxic, with improved quality of life, compared with Paclitaxel in people with advanced or metastatic urothelial cancer, in the setting where the cancer has grown or come back during or within 12 months of completion of platinum based chemotherapy.

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

Recruitment to this study ceased on the 7th April 2017 and sites are being closed out. As part of this process,

56 A LITTLE BELOW THE BELT

sites are required to submit documents and begin the process of archiving all trial records for 15 years from the end of the trial. And once it becomes available, the final trial publication will be submitted to the Human Research Ethics Committee.

2. ENZAMET – Prostate Cancer Enzalutamide is a new hormone treatment taken as tablets. Previous trials have proven that enzalutamide improves survival and quality of life in men with prostate cancer that has stopped responding to standard hormone treatments and chemotherapy.

This large, international randomised trial was undertaken to determine if treatment with enzalutamide can improve survival and quality of life in men starting hormone treatment for newly diagnosed prostate cancer that has spread beyond the prostate. The trial was led from Australia

by ANZUP in collaboration with the NHMRC Clinical Trials Centre. It involved 1,125 men from Australia, New Zealand, Canada, the US, Ireland, and the UK. This landmark Australian led clinical trial, ENZAMET, has now shown that hormone therapy with a drug called enzalutamide can improve the survival of some men with advanced, hormone-sensitive prostate cancer.

Findings from the ENZAMET trial, led by ANZUP, have shown that men with this sort of cancer who receive enzalutamide with standard treatment have a 33% improvement in survival compared to men receiving standard treatment alone and a 60% improvement in the time it takes to detect the cancer growing again. These results were much better than it was thought they might be when the trial began.

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

Enzalutamide is a new hormone treatment taken as tablets.

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

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

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

4. Pain Free TRUS B – Prostate Cancer A prostate biopsy involves taking small pieces of the prostate through a needle so that it can be looked at through a microscope. A Trans Rectal Ultrasound (TRUS) guided biopsy is the usual method and involves insertion of a thin needle through the wall of the rectum into the prostate using the guidance of an ultrasound probe. An injection of a local anaesthetic (lignocaine) around the prostate is the standard method of reducing the discomfort of a prostate biopsy.

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

This is a phase 3 double-blind placebo-controlled randomised trial of methoxyflurane with peri prostatic local anaesthesia to reduce the discomfort of trans rectal ultrasound-guided prostate biopsy.

This study has accrued a total of 420 participants across Australia and New Zealand and has now completed recruitment.

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

This randomised study has compared Lu-PSMA, with a type of chemotherapy called cabazitaxel, which is the standard treatment for advanced prostate cancer when other treatments have stopped working. Half the participants received Lu-PSMA and half received cabazitaxel. This trial enrolled 200 participants in Australia.

ANZUP was able to report interim results of the TheraP clinical trial at the American Society of Clinical Oncology (ASCO) Annual Scientific Virtual Meeting on Friday 29 May 2020.

A favourable response, defined by reduction of PSA by 50% or more, occurred in 66% of men assigned to receive Lu-PSMA compared to 37% with cabazitaxel. Results of the trial also demonstrated the treatment had less severe side effects than chemotherapy.

Patient follow-up is ongoing with initial results suggesting the new treatment may delay progression of prostate cancer.

TheraP is a partnership between ANZUP Cancer Trials Group and the Prostate Cancer Foundation of Australia (PCFA) with support from the Australian Nuclear Science and Technology Organisation (ANSTO), Endocyte, It’s a Bloke Thing, Movember and CAN4CANCER.

6. UNISoN – Kidney Cancer In this clinical trial ANZUP will test whether new immune treatments can help people with rare kidney cancer (‘nonclear cell’ cancer).

Non-clear cell kidney cancer represents approximately 25% of people with kidney cancer; and because it is rare there are no treatments currently reimbursed in Australia.

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

Nivolumab and ipilimumab have been used alone or together in many cancers, so the side-effects are well known and should be manageable. Immune treatments help some people with cancer, especially those with melanoma, common (clear cell) kidney cancer, lung and bladder cancer.

Unfortunately they are much less effective in other cancers (like pancreas, prostate and brain cancers). Nivolumab and ipilimumab have not been tested in people with non-clear cell kidney cancers, so ANZUP is delighted to ask this question, and hopes to help people with this rare disease.

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

Co-badged Trials 7. proPSMA – Prostate Cancer Prostate cancer is the most commonly diagnosed cancer in Australian men. If detected early, when disease has not spread, there is a high chance of cure. Relapse, however, is not uncommon despite careful selection of patients prior to surgery or radiotherapy. This, in part, reflects a failure to detect disease spread at baseline due to limited accuracy of current scanning techniques. More accurate scanning may improve outcomes by redirecting patients with disease spread from unsuccessful local treatments to more appropriate management.

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ANZUP trials in follow up This clinical trial will investigate a new type of scan which provides whole body images of prostate cancer spread.

Early experience suggests that this new technology, called PSMA PET/CT (prostate specific membrane antigen positron emission tomography/computed tomography), is superior to current scanning techniques.

PSMA PET/CT has capacity for wide availability at relatively low cost. Performing a single better test rather than several less accurate scans will also be cheaper, improve patient experience and expose patients to lower amounts of radiation.

10. NMIBC-SI - Bladder Cancer

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

Results of this trial will be used to support funding of this new technology in Australia and internationally.

Although treatments can significantly reduce the risk of recurrence and progression, there are both benefits and harms that are likely to vary between treatment options.

However, little is known about the impact of these treatments on patients’ quality of life.

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

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

This study aims to evaluate the use and satisfaction with the e-TC website in men who have finished treatment for testicular cancer and are feeling stressed, down or worried about their cancer coming back. Men were recruited through clinicians at participating centres and online via search engine and social media advertising. The study has now closed to recruitment with 40 participants having taken part.

9. FASTRACK II – Kidney Cancer 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 led by TROG and Co-badged by ANZUP Cancer Trials Group and is now closed to recruitment and is in follow up.

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Non-muscle invasive bladder cancer (NMIBC) makes up approximately 70-80% of all bladder cancer diagnoses. NMIBC is bladder cancer that has not yet invaded through the wall of the bladder. Treatment is generally intended to reduce the risk of the bladder cancer recurring or progressing to muscle invasive disease. Treatment involves endoscopic resection to the bladder tumours followed by potential intravesical chemotherapy or immunotherapy.

Phase I of the project involved qualitative research to develop a draft Non-Muscle Invasive Bladder Cancer Symptom Index (NMIBC-SI). The second phase of the project aims to evaluate the psychometric properties of the NMIBC-SI. This was conducted across two field tests: • F ield Test 1 was a cross-sectional study design asking participants to complete the draft NMIBC-SI questionnaire either on paper or lectronically. 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 used a prospective longitudinal study design to evaluate the clinical validity of the final version of the NMIBC-SI. Participants were asked to complete the NMIBC-SI along with comparative questionnaires at different time-points during their treatment. The purpose of Field Test 2 is to assess the reliability, validity and responsiveness of the final version of the NMIBC-SI to ensure it is fit for purpose in clinical research.

ANZUP iwas running this trial in collaboration with Cancer Australia and Cancer Council NSW. This study is being sponsored by the University of Sydney.

Below the Belt Research Fund

ANZUP’s 2020 Below the Belt Research Fund Recipients

BELOW THE BELT RESEARCH FUND RECIPIENTS PRESENTING ON THEIR PROJECTS AT THE ANZUP ANNUAL SCIENTIFIC MEETING.

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

Clinical trials are essential for discovering new treatments for diseases, as well as new ways to detect, diagnose, and reduce the chance of developing the disease.

Clinical trials can show researchers what does and doesn’t work in humans that cannot be learned in animals or in the laboratory, and at the same time test for any potential side effects.

Clinical trials are expensive, often costing millions of dollars. ANZUP receives some funding from the Australian Government, and this provides useful support but comes nowhere near covering our basic costs. And importantly, government infrastructure support funds cannot be used to run clinical trials. Every clinical trial we do needs to have its own funding. This is why ANZUP has fundraising events.

Some of our fundraising goes to support researchers who do not have other means to support their research. And other funds raised through the Below the Belt events supports ideas that are not yet fully fledged clinical trials but might evolve into them. This is one way we continue to grow ideas for future work.

The Below the Belt Research Fund has supported many members in the development of investigator-initiated studies. This year, it has provided much needed seed funding to support five ANZUP members to progress new trial ideas to the point of becoming full scale studies. We would like to congratulate the recipients and below you can read about four of these studies.

PRIMARY 2: A prospective, multicentre, randomised study of Ga-68 PSMA /CT + mpMRI vs mpMRI alone for prostate cancer diagnosis.

Louise Emmett and Michael Hofman MRI is now routinely utilised for the diagnosis of prostate cancer in Australia. However, it still misses about 15-20% of important cancers, and about half of the biopsies undertaken after MRI are negative, because MRI is not completely accurate. PSMA PET is a new technique that is helpful in staging men who have already been diagnosed with prostate cancer. The PRIMARY trial currently underway - is assessing the value of PSMA PET in men who are suspected of having prostate cancer, and are undergoing both an MRI and a prostate biopsy.

This trial proposes to randomise men between MRI + biopsy (if required) - the current standard of care in Australia, and MRI /PSMA + biopsy (if required). The study hypothesis is that PSMA MRI will both reduce unnecessary biopsies and improve accuracy of prostate cancer diagnosis, compared to using MRI alone.

Also, a health economics analysis to assess cost to the community and QOL for men with prostate cancer is an important component of this trial.

To date, the study has enrolled 230/309 men, and the results are looking promising for combination of PSMA and MRI to be more accurate than MRI alone in diagnosing important prostate cancers. There is the potential for imaging to play a much bigger role in diagnosis of prostate cancer and for the number of biopsies required to be safely reduced.

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Below the Belt Research Fund De-Intensification of Post ProstatEctomy Radiotherapy (DIPPER) incorporating clinical and imaging-based risk stratification: Part 1 – Pilot study (additional site)

The potential exists for re-irradiation to be delivered to a higher dose and with less risk of toxicity by harnessing the unique potential of the MRL to deliver treatment more accurately.

If this treatment is feasible on the MRL, the intention is to broaden this to a national study to explore in more detail the optimal dose for this treatment.

Matthew Roberts This clinical trial will use modern PET scanning (PSMA PET/CT) in men who have a rising PSA level after prostate surgery to select those who can potentially avoid or minimise additional (radiation, hormone) treatments safely. Previous studies reported that these men who have a negative or confined PSMA PET have good treatment responses to limited radiation treatment without hormones compared to men whose cancer has spread. Some men with a negative PSMA PET who were not treated did not progress over 3 years, suggesting that some men can be spared treatment altogether.

The purpose of this trial is to determine if some men with low risk cancer who can be safely monitored, then avoid treatment side effects without compromising disease control.

This trial will be limited to men who are deemed as “Low Risk” for spreading cancer using criteria from the European prostate cancer guidelines. If the PSMA PET result is negative, the trial will randomly choose close surveillance and delayed treatment or standard radiation treatment. If the PSMA PET result is positive and confined, men will receive standard radiation treatment to the prostate and the other half will receive additional hormone treatment. If positive and spread outside the prostate area, selected treatments and responses will be monitored for some years.

PRIUS MR: Prostate Re-Irradiation Using SABR and MRI Guidance Alex Tan This study aims to demonstrate the feasibility of using the next generation of radiotherapy machine with an onboard MRI scanner (known as an MR-linac, or MRL) to give further radiation to the prostate in men who have previously received prostate radiation and now have a recurrence in the prostate gland. The efficacy and tolerability of this approach has been demonstrated in a number of small series using a conventional radiation machine, but the dose and method of delivery have varied significantly and thus the results are difficult to generalise or apply clinically.

Controlling the recurrent cancer this way can spare men the toxicity of hormone therapy which, while usually effective, carries a raft of side effects that can significantly impact quality of life.

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MEMENTO: Biomarker discovery in metastatic hormone sensitive prostate cancer (MEtastatic Prostate Cancer MEthylation and Transcriptional biOmarker Study) Anis Hamid In recent years, we have learned that changes in prostate cancer genes can influence the risk of developing metastatic prostate cancer. This study aims to improve our understanding of how genes are controlled in metastatic prostate cancer, and specifically how gene control might determine how men respond to standard treatments (such as hormone therapy and chemotherapy).

By way of examining cancer biopsies taken at the diagnosis of metastatic prostate cancer, we will test for an important genomic feature called DNA methylation – a process involved in ‘silencing’ genes. We believe DNA methylation will provide important information about why some cancers are more aggressive than others and why men may respond to treatments differently. We will use DNA methylation information from the tumours and compare it to information of how men diagnosed with metastatic prostate cancer responded to standard treatments. We then hope to use this as a strong foundation to design larger studies to test DNA methylation in prostate cancer clinical trials, to prove that it is an important test in the clinic to identify the risk of aggressive disease and to tailor the optimal treatment choice for patients. Ultimately, this study aims to build on our scientific knowledge of prostate cancer in order to improve ‘precision care’ of men with metastatic prostate cancer.

68Ga-PSMA PET as a potential Imaging biomarker post tyrosine kinase inhibition of metastatic clear cell Renal Cell Cancer (PIRC) – a pilot study Andrew Weickhardt You can read more about this study on page 49.

SAVE THE DATE 1 - 30 SEPTEMBER 2020

Y UR WAY SAVE THE DATE 1 - 30 SEPTEMBER 2020

1-31 May 2021

N OR WALK TO RAISE AWARENESS Do it anytime, anywhere and with anyone #YourWay W THE BELT CANCER RESEARCH

elow the Belt #YourWay and invite you in September to any km’s as you can.

www.belowthebelt.org.au/yourway

or in the great outdoors.

Whatever you choose we are doing THIS SEPTEMBER CYCLE, RUN OR WALK TO RAISE AWARENESS low the belt cancer research. both yourBELOW mind andTHE bodyBELT CANCER RESEARCH ANDKeeping FUNDS FOR We are delighted to announce our new campaign – Below the Belt #YourWay and invite you in September to

, with a friend orride alone.

Do walk it every day or orrun some daysasinmany km’s as you can. #YourWay, #YourWay #YourWay New Zealand. What’s Your Way? You can do it at home, at the office, or in the great outdoors. Whatever you choose we are doing

this to raise awareness and much needed funds for below the belt cancer research. Keeping both your mind and body healthy.

it as a team, with prostate your family, and with work colleagues, with a friend or alone. Do it every day or some days in e belt (bladder, Do kidney, penile, testicular) cancer September. It’s #YourWay. Open to all in Australia and New Zealand.

How can you get involved?

o this fantastic new campaign as we will be postponing the Do it #YourWay and help raise $100,000 for below the belt (bladder, kidney, penile, prostate and testicular) cancer #YourWay instearesearch. d.

*For for our Pedalthoners, encourage you to sign up to this fantastic new campaign as we will be postponing the uture clinical trials below the we belt cancers.

G OUT MORE

ERE.

rWay

Below the Belt Pedalthon in Sydney until 2021. Cycle #YourWay instead.

Improve your fitness, raise awareness and help fund future clinical trials for below the belt cancers.

Support comes in all shapes and sizes.

IF YOU ARE INTERESTED IN FINDING OUT MORE REGISTER YOUR HERE. Whatever you areINTEREST interested in

doing to support ANZUP, let us know and we will help support you on the journey.

Fight Cancer Below the Belt, #YourWay

Participate in a fitness challenge – Get involved with a fun run, triathlon, walkathon the options are endless! – and represent ANZUP.

Sponsor a fundraiser – Donate to a friend or family member participating in a sports festival.

Donate In Memoriam – Honour your loved one with a contribution in their name or asking for donations in lieu of funeral flowers.

Hold an event – Be it a morning tea, a raffle, a barbie, trivia night, or book club, we can support you to run your own fundraising event.

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

Give in Lieu of a Gift – Donate towards a special occasion in lieu of a traditional gift. For example, a wedding, birthday or retirement celebration. If it is your special occasion, why not ask for donations instead.

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Good2Give now makes donating to ANZUP at work, easy.

ANZUP registers with workplace-giving platform Good2Give.

Good2Give is a not-for-profit workplace-giving platform that makes it easy for businesses, their employees and customers to support the communities and causes they care about. Their innovative technology solutions help businesses, donors and charities connect.

Workplace giving enables businesses to connect with its purpose-driven employees, by providing them with a way to support the causes they care about like ANZUP. Do you, or anyone you know work at any of the below Good2Give registered companies? If so, please consider ANZUP when donating through the workplace-giving platform. Not only is it tax effective but many of the listed organisations match your donation.

• AAMI

• MLC

• APIA

• NAB Bank

• Aurizon

• NRMA

• Australia Post

• Pandora

• Baker and McKenzie

• PWC

• Bank of Melbourne

• Qantas

• Bank of Queensland

• REA Group

• Bank SA

• South 32

• BT Financial Group

• St George

• Bupa

• Stockland

• Citi

• Suncorp Bank

• Country Road

• Sydney Water

• Deutsche Bank

• The Reject Shop

• DXC. Technology

• Toyota

• GIO Workers Compensation

• Unilever

• Hanes • Herbett Smith Freehills • JB Were

• Vita • Vodaphone • Westpac • Witchery

For more information about how you or your organisation can help ANZUP through Good2Give please email donate@anzup.org.au

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Get inspired and host your own event A great idea is just the beginning… here are a few key dates and events to get you started when planning your own fundraising event:

January

April

Organise an Australia Day BBQ and raise awareness for cancer research.

Testicular Cancer Awareness Month

February

May

Sign up to the Below the Belt #YourWay Challenge.

Participate in, or sponsor Below the Belt #YourWay

March

June

World Kidney Day is the 11th May 2021

Help support ANZUP with the pre tax appeal.

Y UR WAY

How does your donation make a difference?

All contributions, large or small, get us closer to finding better treatments for cancer.

Clinical trials are a costly exercise, but the outcomes are so worthwhile. This is where your donated funds go:

$500 – $1000

$5000 – $10000

Sponsor a travel fellowship

Support a concept workshop

Will support the attendance of an ANZUP multidisciplinary member at a conference or scientific meeting.

Will allow us to hold a face-to-face Concept Development Workshop to discuss new research ideas and concepts to consider developing into a future grant applications.

$50k – $250k

Kick off a pilot study Will allow us to invest in a pilot study to test the feasibility of promising drug therapies, surgical methods, post-operative care and palliative care options.

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/donate or by calling ANZUP on +61 2 9562 5042.

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Below the Belt #YourWay

Y UR WAY

43

237 CHALLENGES

4

1708 DONORS

EVENT SUPPORTERS

72,783 KMS TRAVELLED

RAISED

TEAMS

20

EVENT SPONSORS

$173,000

25

PIECES OF MEDIA COVERAGE

45%

AMBASSADORS & INFLUENCERS

747,000 IMPRESSIONS ON SOCIAL MEDIA

55%

MALE

FEMALE

YOUR WAY SONG BY PROFESSOR DICKON HAYNE PUBLISHED ON SPOTIFY 64 A LITTLE BELOW THE BELT

6

Below the Belt #YourWay

Y UR WAY During the month of September, 237 challengers and 43 teams ran, walked, cycled and swam 72,783 kms across Australia, New Zealand, UK and beyond, and raised an extraordinary $173,000 for ANZUP’s Below the Belt Research Fund.

The Below the Belt #YourWay Challenge originated from the song, Your Way donated to ANZUP by Dickon Hayne, who penned and recorded the song with his two daughters Zoe and Natasha. The #YourWay Challenge empowered the community to support ANZUP via digital channels, and gave participants the choice of what, where, when and how they undertook the challenge over 30 days of September.

There were plenty of laughs and competitive mini challenges but everyone was dedicated to the challenge and to raise awareness and much needed funds for below the belt cancer research. And at the same time, keeping both mind and body healthy.

TONY AND BELINDA JAGO

“This cause is close to my heart.

Currently, I’m a collaborator in a worldfirst bladder cancer therapeutic trial, only made possible with a $50,000 Below the Belt start-up grant.

We can’t wait to share our progress!”

“I had challenged myself to walk a minimum of 150kms and I’m very happy to report that I’m on target to achieve my stretch goal of 200kms.

Tony has joined in the challenge as well and we have walked the streets of Lysterfield and lucky for us our 5km zone allows us to walk in the lovely Lysterfield National Park as well. I also gratefully thank all the family and friends who have chipped in and sponsored this event. Raising funds is vitally important to help ANZUP run clinical trials to answer questions that may help improve outcomes for #belowthebelt #cancers. We could not do this work without your support.”

- Andrew Moe

- Belinda Jago, ANZUP CAP Chair

We were delighted to have many ANZUP members participating and not only raising amazing funds, but also clocking up extraordinary kms and even leading smaller #YourWay events.

The incredible Dickon Hayne not only inspired the challenge with this song, but he was the team captain for the Fiona Stanley Fremantle Hospital Group who were the highest fundraisers raising an incredible $15,800 with several activities contributing to the challenge.

ANDREW MOE AND BUB

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Below the Belt #YourWay

- Manu Feildel (Chef & #YourWay Ambassador)

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Blog posts from participants

Below the Belt #YourWay

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Below the Belt #YourWay

“We, the Underhill family, wanted to be involved as a family to walk/run together as a way of staying fit in lockdown in regional Victoria. Sadly, several members of our family have died of cancer and we wanted to raise awareness and money for this important cause. We know how important clinical trials are to improving cancer outcomes. And we thought the team name was a bit of a laugh! Go Team Undies!”

BRAVING ALL SORTS OF CONDITIONS TO RAISE MONEY FOR #YOURWAY2020 – CHRIS STEER

- Craig Underhill and Team Undies

“Thank you to everyone that donated to the 2020 Below the Belt #YourWay challenge”.

“As a long-time supporter of the Pedalthon and an Ambassador of the Below the Belt events I think it’s a wonderful evolution to the #YourWay challenge in response to the events thrown at us in 2020. Now more than ever it’s really important that people find their own way to stay healthy and active, and also to continue to raise awareness for the amazing work the ANZUP team are doing”.

– Manu Feildel

– Jonny Harrison

My Camino Podcast ANZUP’s Board Director and testicular cancer survivor Joe Esposito and ANZUP’s volunteer Jo Stubbs kindly joined Dan Mullens on his My Camino Podcast where they talked about raising awareness and funds for below the belt cancers.

Listen to the podcast by going to https://podcasts.apple. com/au/podcast/this-week-were-encouraged-to-joinbelow-belt-cancer/id1201172784?i=1000490437753 TAKING THE DOG FOR A WALK AS PART OF THE #YOURWAY CHALLENGE – HARYANA DHILLON

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Below the Belt #YourWay

Fundraising heroes Congratulations to all our challengers who raised vital funds for clinical trials. We would like to give a special thank you to our top fundraising team and individual heroes:

Top Fundraisers Teams 1. FSFHG Team - $14,145 2. Sydney Opera House to Manly Beach Walk - $7,595 3. GenesisCare - $7,083 4. The Young and the Rest of Us - $6,816

Overall Champions • T he Below the Belt #YourWay Champion: Neil Cartledge • M ost kilometres walk / run - male: Michael Twycross, 278.29 km • M ost kilometres walk / run - female: Nicole Tankard, 1,000.55 km • M ost kilometres cycled - male: Neil Cartledge, 2,226.08 km • M ost kilometres cycled - female: Kristy West, 515.13 km • M ost kilometres - kids: Alana Harrison, 64 km

5. Just the 2 of Us - $6,146

• M ost kilometres swimming - male: Bill McJannett, 14.56 km

Individuals

• M ost kilometres by team: Novartis - 3 Cyclists: 7,183 km

1. Belinda Jago - $4,610

• Most creative indoor challenge: Jacqueline Smith

2. Dickon Hayne - $3,937 3. Margaret McJannett - $3,503 4. Andrew Weickhardt - $3,253

CONGRATULATIONS to all the Below the Belt #YourWay winners.

5. Jacqueline Smith - $3,171

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Below the Belt #YourWay

Thanks to our #YourWay Sponsors and Supporters GOLD SPONSORS

SILVER SPONSOR

BRONZE SPONSORS

SUPPORTERS

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Below the Belt #YourWay

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Below the Belt #YourWay

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Below the Belt #YourWay

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Below the Belt #YourWay

“Well hasn’t 2020 been a year of constant change, challenge and opportunity. Never before have we had to pivot so much to survive. ANZUP did this beautifully with the #YourWay challenge and supporters did that with enthusiasm, engagement, fundraising and raising awareness.

As Race Director for the Pedalthon events and several other charitable cycling events, it’s been a year of change. We need to stay true to what we believe.

Having been touched personally with below the belt cancer in my family, my truth is to see a world with improved outcomes for patients, to see continued and improved personalised treatments, higher success rates and less to no side effects.

In 2021, I look forward to reconnecting on the race track and to see below the belt cancers given the funding they deserve, see your smiles and hear your laughter as you passionately ride your bikes for a cause greater than the bike itself”.

– Kent Williams, Entoure.

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Thanks to Corporate Supporters and In-Kind Supporters Corporate Supporters

In-Kind Supporters

We are very fortunate to have our corporate supporters and partners who enable ANZUP to better support our members and, ultimately, patients and their families. Our 2019/2020 corporate supporters include:

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

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

Active Display Group, AFI Branding, The Saturday Paper and FC Lawyers.

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Y UR WAY

SUPP RTING ANZUP CANCER TRIALS

Fight Cancer Below the Belt Join us in the fight to improve the treatment and outcomes of those with below the belt cancers.

#YourWay Challenge

Research Appeal

Pedalthon

Join us in 2021 fom 1- 31 May and do it #YourWay

Our current appeal is for essential penile cancer research

Sydney: Thursday 9 September Melbourne: Sunday 14 November

www.belowthebelt.org.au

ANZUP Cancer Trials Group Level 6, Lifehouse Building, 119-143 Missenden Road, Camperdown NSW 2050 Tel: +61 2 9562 5042 Email: anzup@anzup.org.au www.anzup.org.au