ANZUP | A little below the belt | Issue 18, Summer 2023/24

Conducting clinical trial research to improve outcomes for bladder, kidney, testicular, penile and prostate cancers

AN ANZUP CANCER TRIALS GROUP PUBLICATION

ISSUE 18, SUMMER 2023/24

Donate today and make a real 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

$50k – $250k

Sponsor an Education Fellowship

Support an Ideas Generation Workshop

Kick Off a Pilot Study

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

Will allow us to hold face-to-face Ideas Generation Workshops to discuss new research ideas and concepts to consider developing into a future grant applications.

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 9054 3600

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.

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

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

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 the 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. We also acknowledge Maori as tangata ¯ whenua of Aotearoa New Zealand and as Treaty partners with the Crown as agreed in Te Tiriti o Waitangi.

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 03

Message from the Chair

06

Message from the CEO

09

Consumer Advisory Panel Update

11 The Ball’s in Your Court • • • •

ANZUP’s Community Engagement Forum Meet Tim Baker In the Media – Time Baker: In Praise of Prostate Cancer Nurses Finding Information and Asking the Right Questions

15 Friends of ANZUP

About the front cover:

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We would like to acknowledge and express our deep appreciation to Jasmine Sarin for her exceptional artwork design for ANZUP.

• Improving Access to Clinical Trials for Culturally and Linguistically Diverse (CALD) Populations • Communication and Consenting in Clinical Trials: Are We Talking the Same Language?

• Enhancing Diversity and Inclusivity in ANZUP Theranostic Prostate Cancer Clinical Trials • In the News – Diversity Fail in Drug Tests • From Immigrant Roots to Leading Medical Oncologist: Dr Andrea Apolo’s Unconventional Journey

The artwork truly embodies the core values of ANZUP, serving as a powerful symbol of unity, healing and community upliftment. Through the artwork, she beautifully conveys the essence of healers coming together to share knowledge and stories, celebrate diversity and foster collaboration. These visuals vividly depict the journey of individuals uniting to learn, share and enhance community well-being, perfectly encapsulating ANZUP’s mission.

As an award-winning Dharawal-born artist and graphic designer, Jasmine has worked with various organisations, delivering quality First Nations creative art projects. Her talent and dedication have left a lasting impact, blending cultural heritage with contemporary design.

In this edition of “A little below the belt”, we are proud to feature a section dedicated to cultural diversity in clinical trials, demonstrating ANZUP’s unwavering commitment to improving access to clinical trials for culturally and linguistically diverse populations. For more insights on this initiative, please refer to pages 16-25.

ANZUP Cancer Trials Group Limited Level 18, International Tower 3, 300 Barangaroo Ave, Sydney, NSW 2000 www.anzup.org.au anzup@anzup.org.au T: +61 2 9054 3600 ACN 133 634 956 ABN 32 133 634 956 @ANZUPtrials ANZUPtrials

Cultural Diversity in Clinical Trials

25 ANZUP at the American Society of Clinical Oncology Meeting 27 Below the Belt Research Fund

• 2023 Below the Belt Research Fund Recipients • Past Below the Belt Research Fund Recipients 32 Rude Food Cookbook 33

Synchrony Fellowship

• Overview • Winner of the 2023 Synchrony Fellowship Award 35

Do You Have a Story You Can Share?

36

Prostate Cancer

• Spotlight on Prostate Cancer • ANZUP at the European Society for Medical Oncology • DASL-HiCaP Reached Recruitment Target: A Milestone in the Fight Against Prostate Cancer • ANZadapt – A Simple but Radical Approach to Prostate Cancer Care • ANZUP Trials – Prostate • Co-badged Trials – Prostate 47

Bladder Cancer

• Spotlight on Bladder Cancer • Bladder Cancer Research Highlights: Unveiling the Potential of BCG+MM 51

Sydney Sock Project

52 Testicular Cancer • Spotlight on Testicular Cancer • Meet James Norrish – A Testicular Cancer Survivor and ANZUP Trial Participant • ANZUP trials – Testicular 58

Kidney Cancer

• Spotlight on Kidney Cancer • Treatment Choices and Decision Making 62 Penile Cancer • Spotlight on Penile Cancer • Shedding Light on Penile Cancer in Australia: An Interview with A/Prof Niall Corcoran

ANZUP

65

Trials in Follow Up

@ANZUPtrials

71

Below The Belt Events

ANZUP Cancer Trials Group

• Melbourne Pedalthon 2023 • Sydney Pedalthon 2023 • Get Involved Next Year

Editors: M in Liu, Daniel Glover, Nicole Tankard, Alice Clarke Graphic Design by Designcycle

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75

Community Fundraising

77 Thanks to our Partners, Corporate and In-Kind Supporters

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

Years ago we lived in the USA while I did some postdoctoral research. We lived in a lovely friendly suburb of Pittsburgh, surround by friends and neighbours who showed us some of the best of what Americans could be.

We were made welcome; my oldest daughter started school there; my wife, who was not able to work on our visa, found support and friendship wherever we turned. Every so often though there was a “what the...” moment, like the time we found out that Halloween pumpkins are definitely not for human consumption; that plum pudding for Christmas is considered on a par with nuclear waste; that most Americans don’t think it’s a good idea to go for a stroll in the snow on a subzero day; or finding out the hard way that Australian humour just is not understood by most Americans. But occasionally there was a conversation that made me realise that while we might think people understand, there can be huge gulfs in their experience that mean they really have no idea. And it’s not just an American thing.

An example: one of our neighbours asked me at a social get-together what it was that I did. I spent some time explaining to him about cancer and cancer research. It was very clear that, against all probability, this person had somehow never had any close personal experience of cancer in their lives. After about half an hour of conversation he leaned back, pondered for a moment, and then said, “Wow. Cancer sucks.” I said, “Yes it does.

It can ruin your whole day.” Him: “Yes, I guess it could” (see above re Australian humour).

Cancer sucks. It really does. We don’t know in many cases why it starts, which means it’s hard to know how to prevent those ones. We have improved treatments of various types now, but they are still not good enough for what we want and we have to do better. We don’t understand properly yet why some cancers respond well to treatment and others don’t, or how they acquire resistance to treatment.

And we don’t yet understand as well as we should the experiences of people affected by cancer.

That sounds a bit depressing! But it’s not all bad news. We’ve made great progress over the last century or so in understanding, treating, and preventing cancer. Whole new types of treatments have been developed that were only science fiction even just a few years ago.

The health care community understands now that it works far more effectively when it brings different experts together across various healthcare fields, including doctors, nurses, the huge range of allied health disciplines, scientists, and engages effectively with the wider community. We’ve begun to look at how we understand what needs people have for information, how best to communicate that information, and how we can better listen to and respond to people going through different types of challenges with the cancer and its treatment. It might seem obvious, but there is no “one size fits all” type of cancer or cancer treatment. It’s heading in the right direction, but there is still much to do.

There are some key things we need to do. We need to understand cancers better and why they behave the way they do. We obviously need better treatments, and we also need to know how best to use them, and how best to take advantage of what we already have.

We need better support for people affected by cancer.

We need to identify specific groups of people where outcomes might not be as good as they should be, and work to understand why and to make sure they are not disadvantaged. And we need to support the community of carers and researchers, including people in training, to make sure they are well trained and able to provide the care that is so badly needed.

You might not be aware of it, but every time a health professional recommends a treatment approach for you, it is based to some extent on evidence (or at least it should be!) You and your health care team need to know if what is proposed is effective, what the risks might be, what the alternatives are, and how each one stacks up against the other. Sometimes the evidence is weak or even absent; if that’s the case, you and your healthcare professional need to know and understand that. Unfortunately there are still situations where we have to extrapolate from what is known, or even make decisions without good supporting evidence. That’s an uncomfortable and potentially

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dangerous place to be. Sometimes though the evidence is clear, and if that’s the case it’s almost always because someone has performed a clinical trial to answer exactly those questions.

ANZUP is the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. We are a community of people involved in the care and research of the “below the belt” cancers of the genitourinary system: cancers of the prostate, kidney, bladder, testis, and penis. Collectively these cancers are very common in our community but are sometimes overlooked because they affect the “rude bits” and people might not be comfortable talking about them.

That means that for some of these cancers, we might not be as far down the road to improving outcomes as we should be, and ANZUP is determined to change that.

But I cannot close this introduction without telling you about one particularly important person: our CEO Marg McJannett, who came to us in 2010. ANZUP was little more than a toddler then, and we were struggling to gain traction and had a very shaky financial model. Marg had been Executive Officer at the Clinical Oncology Society of Australia, and many of us had known and worked with her for some time in that context. I can tell you it was a moment of enlightenment and joy when her application to be ANZUP Executive Officer came across my desk.

ANZUP is a cooperative cancer clinical trials group. We are immersed in the care of people with genitourinary cancers, and deeply involved in cancer research. We are constantly talking to our patients and their families, and receiving fantastic advice from our Consumer Advisory Panel. We perform investigator-initiated clinical trials, which means they are based on what the clinical needs are, where the science is and where it is heading, and what questions need to be answered and evidence generated. We’ve already performed clinical trials that have changed practice around the world, and we know there is still much to do.

Sometimes the research uncovers a better way of doing things; sometimes it tells us that the old way is better, or there is a better way of using the old approach, or that we should stop doing something we always thought we should be doing; whatever the outcome, these answers are critically important and are what move the field ahead.

You will find in this publication extensive information about all these cancers, and what ANZUP is doing to try to make a difference and to improve outcomes. You will see we have a host of other activities as well, ensuring we are all kept abreast of the latest scientific advances, treatments, outcomes of other trials, what hot topics are discussed at various meetings; and a huge range of activities for continuing education or for training upcoming clinician-researchers, who will continue our work into the future.

It’s a huge privilege for me to be involved in all of those.

One of the greatest parts about working with ANZUP is the people. We have a fantastic team in the ANZUP offices, supporting an amazingly diverse group of people involved in all the work we do. We are privileged every day to encounter and work with people affected by cancer, and to try to help them if we can. The extraordinary thing is that all of these people help us and the wider community as well: they selflessly participate in clinical trials, obviously hoping it will benefit them but knowing there is no guarantee of it, and understanding that they are making a huge difference for people who will come after them regardless of what the trial eventually shows.

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Marg is a nurse, and had worked for years providing outstanding clinical service. She was involved in setting up various clinical services, and had a keen interest in patient advocacy, education, and research. She spent considerable time working in the Sydney Melanoma Unit and the effects of her contributions are still evident in what that group has been able to achieve. Marg initially came on board at ANZUP only for three days per week, due to our financial constraints, but of course contributed far more than that. She oversaw the setting up of our structures. She built our networks across Australia, New Zealand, and internationally. She ensured we had continuous ongoing funding through Cancer Australia, and she set up every other major revenue stream we have had. This includes our annual Scientific Meeting, which we first held in 2011 and which is now the preeminent genitourinary cancer meeting in this part of the world. She registered ANZUP as a charity in all Australian states and territories and in New Zealand. She brought

in key people as our needs and resources grew, and established our Below the Belt Research Fund, which has supported dozens of investigators and research projects with well over $2M of resources going straight to where it is needed. Marg has helped us establish our internal governance and management processes: we have a stable and highly effective Board, and a management team that continues to produce great opportunities and outputs for everyone associated with ANZUP, and for the people we serve. Marg has continued to grow ANZUP to the point where we now have well over 2000 members, and a great portfolio of trials and other activities that you will see elsewhere in these pages.

also become one of my dearest friends. And secondly, as George Harrison said, all things must pass: Marg is retiring at the end of 2023, and as I write we are looking for a new ANZUP CEO. It’s very telling that in order to write the position description we had to deconstruct Marg into what will be at least two people – otherwise it would not be possible to find someone! It’s also very telling that she made this decision some months ago, but flatly refused to let anyone know about it at our Annual Scientific Meeting in July because ”she didn’t want it to be about her.” Yes Marg, no worries; and by the way we will be having an ASM in 2024 as well and it is definitely going to be about you at least a little bit.

The Board held a strategic retreat not long after Marg arrived. She left the room at the wrong time, and came back to find we had all agreed we would set her what then seemed like the impossible task of raising $1.5M in additional revenue over the next 12 months. In true Marg fashion, she achieved that and more. We also decided then that we really needed at least one prostate cancer trial in our portfolio. Within less than ten years we have had thousands of patients on ANZUP prostate cancer (and other) clinical trials, including one trial that won Trial of the Year in 2020, as well as awards for statistical quality and for community engagement; and most importantly has already saved thousands of lives.

So, as you read this fantastic publication, I would love you to take away a few messages:

Why am I telling you all this? Two reasons. Firstly, Marg has been a fantastic example of the culture of our organisation, with her warm personality, her incredibly generous contributions of her time and energy (I’m certain she never sleeps), and her ability to inspire other people to come on the journey with her, and she has

4. Y ou can help us, by raising awareness of these cancers and of the importance of clinical trials. You might also be interested in supporting us in other ways, and you can find out how to do that in this publication.

1. T hese cancers are important, they cause too much distress in our world, and we need to do better with them.

2. T he best way to do that is to do careful clinical trials to generate the evidence we need to be able to give the best advice to people making decisions about what treatment paths they will go down.

3. A NZUP is an extraordinary group made up of caring and dedicated people whose generosity of time, spirit, and resources never ceases to amaze me.

5. I am going to miss my dear friend. Marg, there are way too many things to count, I owe you so much, and “thanks” just seems so inadequate.

Please enjoy this edition of “A Little Below the Belt.”

IAN DAVIS CHAIR, ANZUP

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Message from the CEO, Margaret McJannett ANZUP is a cancer co-operative clinical trials group that brings together a world-leading multidisciplinary team of doctors, nurses, allied health care professionals, scientists, researchers, and community representatives, all working in areas related to urogenital cancer.

Our mission is to improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers through practice-changing multidisciplinary collaborative clinical trials. By performing clinical trials, we are able to generate new evidence for better treatments, or ways of providing other support.

In terms of conducting high-quality, multidisciplinary, practice-changing clinical trials, the past 12 months have been marked by significant achievements.

The ANZadapt trial is testing an innovative approach to treatment for people with castration-resistant prostate cancer (CRPC), which remains one of the most common causes of cancer-related death worldwide. The trial will test the idea of evolutionary therapy, also known as adaptive therapy. Hormone tablets, abiraterone and enzalutamide are approved in Australia to treat advanced prostate cancer. Small pilot studies have indicated that using hormone tablets sparingly, for just long enough to control the cancer, followed by a break in treatment and restarting them later, seems to improve how long hormone tablets can control the cancer. This study aims to find out if this pause/ restart strategy is better than taking hormone tablets every day continuously. This will lead to a personalised treatment schedule, different for each participant.

The study has been funded by a philanthropic grant awarded by the Anticancer Fund in Meise, Belgium and brings together a new collaboration between ANZUP and the Leiden University Medical Centre (LUMC).

ANZUP is partnering with the Hunter Medical Research Institute (HMRI) Clinical Trials Unit to coordinate the trial. The principal investigator of the ANZadapt trial is Associate Professor Craig Gedye.

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We successfully met our recruitment goals for the following ANZUP trials: DASL-HiCaP, EVOLUTION, and BCG+MM. Further details and insights can be found about DASLHiCaP on page 40, and BCG+MM on pages 49-50. These achievements underscore our dedication to advancing medical research and improving patient outcomes through impactful clinical trials.

In October 2023 Professor Louise Emmett was awarded an oral presentation for our ENZA-p trial at the European Society for Medical Oncology (ESMO) Congress in Madrid. The promising interim results mark an exciting leap forward in prostate cancer research. Explore further details about this study on pages 38-39.

Earlier this year, ANZUP delivered poster presentations for TheraP, P3BEP, BCG+MM, GUIDE and CLIMATE at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, the largest oncology gathering worldwide. For in-depth insights into this important event and ANZUP’s presence, please refer to pages 25-26.

Furthermore, our Pain-Free TRUS B trial was selected as the BJUI Global Prize 2023 for article of the year.

This prize is awarded to author/s of an article selected by a BJUI panel as the best paper in terms of quality and potential impact on practice.

ANZUP is committed to enhancing access to our clinical trials for all people affected by below the belt cancers. We recognise the challenges patients face in understanding medical jargon and complex consent forms. In our recent Community Engagement Forum, which took place during the 2023 ANZUP Annual Scientific Meeting (ASM), Associate Professor Craig Gedye introduced a novel approach: simplified brochures with plain language and relatable images, along with QR codes for explanatory videos.

While these innovations hold promise, further testing and patient feedback is essential. This conversation highlights the urgent need to bridge the communication gap in clinical trials, especially in the context of cultural and linguistic diversity in Australia.

We continue to convene our Idea Generation Workshops (IGW) across all the diseases we represent.

These workshops are designed to facilitate and support our members who have an idea that might be immature, in order to obtain advice on further development and input on the project’s scientific value, design, funding support and acceptability. All members are invited to submit concepts for discussion.

This is particularly valuable for junior or early career researchers. Concepts that are approved for further development have a working group assigned including members from our consumer advisory panel (CAP). The workshops also provide a supportive environment for “brainstorming” and “horizon scanning” to generate new ideas and opportunities. Some concepts are then recommended for applications for funding through ANZUP’s Below the Belt Research Fund mechanism.

In August we announced a new collaboration between ANZUP and The George Institute (TGI) for Global Health. TGI is affiliated with the University of New South Wales and has extensive experience in the conduct of national and international clinical trials investigating treatments for chronic and critical conditions. Together with ANZUP’s world-leading multidisciplinary members, including our community representatives, we will continue to build our capacity and capability to improve treatment and outcomes for people affected by genitourinary cancers.

To further develop and strengthen this partnership and with ANZUP’s expanding team and the current limited office space, we will be moving with TGI to their temporary new location at Barangaroo as we wait for new offices to be built at UNSW scheduled to be around late 2025. We look forward to the added opportunities for collaboration that our proximity to their team will provide as well as providing our growing team with facilities to continue their work in supporting ANZUP’s mission.

We held our ASM from 9 – 11 July 2023 in Melbourne with the theme “Bouncing Back”. We discussed how people and systems have adjusted and changed in response to the pressures of the pandemic, and also in relation to the impacts of these cancers. The diverse sessions included the highly successful new addition, The Perfect Pitch, the popular MDT Masterclass, the Translational and Supportive Care breakfast sessions, the always well-attended Nurses Symposium, the thought-provoking plenary sessions, the important ANZUP Trials in Action session, and the anticipated debates and poster presentations, among many other informative sessions. I am proud to report that this year’s ASM has a remarkable attendance of 446 delegates. It not only demonstrates the reputation ANZUP has earned for delivering high-quality, academically rigorous, educational, and entertaining ASMs, but also represents the highest number of delegates to date.

In terms of fundraising, we were delighted to welcome back riders, supporters and volunteers who joined us for Below the Belt Pedalthon. The Melbourne Pedalthon raised nearly $60,000 while the Sydney Pedalthon raised almost $80,000, and the funds are still rolling in!

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In 2024, ANZUP will launch a new community fundraising event called “Below the Belt Relay 181”.

ANZUP supporter and trial participant, James Norrish, along with his swim teammates, will undertake a marathon relay swim to raise funds and awareness for below the belt cancers. Join us and learn more about James’s inspiring story on pages 54-55.

A special note of appreciation goes to the countless patients who participate in ANZUP trials across Australia, New Zealand and internationally. Without every single one of you we would not be able to strive to achieve our mission: To improve the lives of people affected by below the belt cancers through practicechanging multidisciplinary collaborative clinical trials.

Every cent raised by the Below the Belt events goes straight into the hands of experts committed to improving the lives of people affected by bladder, kidney, testicular, penile, and prostate cancers through practice-changing multidisciplinary collaborative clinical trials.

After 13+ years at ANZUP, this is my last CEO Update for our consumer magazine as I am transitioning to semi-retirement and moving to Queensland. I am incredibly proud of what ANZUP has achieved during this time. Together, we’ve made meaningful progress in the fight against below the belt cancers, advancing research, and providing vital support to patients and their families. I’d like to express my heartfelt gratitude to the ANZUP leadership team from the Board, Scientific Advisory Committee (SAC), Subcommittees and Consumer Advisory Panel (CAP).

It’s been an honour to work with the dedicated ANZUP membership, my extraordinary management team and the incredible community of supporters who have rallied behind our cause. While my time at ANZUP may be coming to a close, I’m confident that the organisation will continue to thrive and make a significant impact in the years to come. Thank you all for your unwavering commitment to our mission.

We extend our heartfelt gratitude to all those who participated, donated, and contributed to raising awareness and funds for ANZUP’s clinical trials research. Your support directly empowers our members to develop research projects that could lead to future ANZUP trials.

We’re truly fortunate to count on a dedicated membership, now exceeding 2,000 strong. This collective commitment drives our mission forward and fuels our continuous push for improved treatment and outcomes within our community. We’re profoundly thankful for the unwavering support of our donors, funders, and corporate partners who generously support our research initiatives.

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On behalf of the ANZUP team, I hope you enjoy this edition of our magazine, “A little below the belt”.

MARGARET MCJANNETT CEO, ANZUP

Consumer Advisory Panel (CAP) update

By Belinda Jago, CAP Chair

The ANZUP Consumer Advisory Panel (CAP) is a group of dedicated volunteers who have had a cancer diagnosis themselves or have cared for a family member/loved one with cancer. We champion clinical trial research as a key strategy for improving the treatments and outcomes for individuals affected by genitourinary cancers. We serve as the voices that assess the community’s perspective on the value of each clinical trial. Despite the challenges of recent years, with limited opportunities for face to face interactions, our enthusiasm remains unwavering. We have actively engaged in all ANZUP activities, consistently sharing our insights and feedback. In July 2023, a remarkable 11 out of our 12 CAP members were able to gather in person at this year’s Annual Scientific Meeting (ASM) held in Melbourne, under the theme “Bouncing Back”.

It was the first time for many of us to meet in person and we welcomed new CAP member Raewyn Manssen from New Zealand to her first ASM after she joined the CAP earlier in the year.

• O n Sunday, the CAP had a busy education program.

We began with a delightful catch up session, followed by engaging conversations on Artificial Intelligence within the context of translation research programs.

This topic is currently a focal point due to its significant impact on managing extensive datasets while ensuring data integrity.

• T he afternoon was all about the Community Engagement Forum “The Ball’s in Your Court”, facilitated by CAP member Leonie Young. We were privileged to have outstanding guest speakers on the panel, interviewed by CAP member Melissa Le Mesurier. Details of this entertaining and informative afternoon can be found on pages 11-14.

• O ver the next two days of the ASM, the CAP members also had the opportunity to serve as session chairs.

In all, it was an excellent meeting with very positive feedback from the CAP. As we headed home, we were a bit tired but incredibly enthusiastic about our roles and inclusion within ANZUP.

CAP MEMBERS AT THE ANZUP ASM 2023

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COMMUNITY ENGAGEMENT FORUM AT THE ANZUP ASM 2023

Other key activities in 2023 included: • T he CAP was represented at all of the Ideas Generation Workshops (IGWs) held this year, with a mix of face to face and Zoom attendance. The IGWs offer the CAP a great opportunity to put the community’s voice forward right from the beginning of the idea being presented, and we thank the membership for the positive feedback that we receive. We also look forward to seeing these “new ideas” progress over the coming months, where we will continue to have input through the various subcommittees and working groups, all of which have CAP representation.

• W e also had the opportunity to review 12 Below the Belt Research Fund Applications and the new Synchrony Fellowship Award with 17 applications.

We continue to use our well refined discussion and ranking system. These reviews are an important part of what we do as Consumer Advisors in research.

We always assess the potential impact and benefit of the research question under consideration for patients. It is noteworthy that we have such a strong alliance in which projects we would like to receive grant funding with the multidisciplinary team who review the applications from a scientific perspective.

We always look forward to hearing the outcomes of these research projects.

COMMUNITY ENGAGEMENT FORUM ‘THE BALL’S IN YOUR COURT’ 2023

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The CAP continues to support the membership, and we are actively involved in many discussions, demonstrating greater inclusion in grant applications and working groups for specific ideas. We really appreciate the respect and value given to our comments and suggestions. We are also grateful to be able to support the research of the talented and dedicated members of ANZUP who always strive to improve patient outcomes.

ANZUP’s continued growth and success, under the excellent leadership of Ian Davis as the ANZUP Chair and the CEO Marg McJannett, ably supported by a skilled and hardworking management team, present numerous interesting and rewarding projects for us to engage in.

We look forward to the opportunities that await us.

BELINDA JAGO CAP CHAIR

The ball’s in your court – ANZUP’s Community Engagement Forum “You have cancer.” Three words that can change your life in an instant. But what information do you need, what options do you have and how does life look after a cancer diagnosis?

Each year the program has a slightly different focus, but it always shows how ANZUP continues to look for ways, through clinical trials research, to improve outcomes for people affected by cancer.

ANZUP’s FREE Community Engagement Forum, The Ball’s in Your Court, is aimed at keeping you informed about below the belt research, clinical trials, and important associated topics.

The theme, The Ball’s in Your Court, encouraged some inspiring and quite unique conversations between researchers and health professionals. We also heard from cancer survivors who shared their stories of how, in their own unique ways, they found meaning from their diagnosis.

Meet the Facilitator Leonie Young N

G

Leonie was diagnosed with breast cancer in 1987 U and since that time has been YO LEONI E involved with patient advocacy and support for people affected by cancer. Leonie has been a stalwart supporter of ANZUP providing mentoring and support to our Consumer Advisory Panel since its inception and is now a member of the ANZUP Consumer Advisory Panel. She is the Peer Support Coordinator for the Wesley Hospital Choices Cancer Support Centre (Choices) in Brisbane and an inaugural member and immediate past Chair of the Breast Cancer Trials Consumer Advisory Panel.

This year, we held the forum on Sunday 9 July at Melbourne Convention Centre. We explored why ANZUP exists, the importance of clinical trial research, finding information, asking the right questions, being on the same page as your treatment team, and what life looks like after cancer.

We were delighted to feature Tim Baker, an acclaimed surf writer and journalist and prostate cancer survivor, and Joe Bakhmoutski, the host of the Simplify Cancer Podcast, ANZUP ambassador, and testicular cancer survivor. Discover their stories on pages 12 to 14.

Leonie Young

“I don’t always understand all the science and study details shared among the medicos on social media and at such conferences, but I do think it’s important that patients have a place at the table for such conversations.”

As a member of the ANZUP Consumer Advisory Panel, one of my roles is to help organise and facilitate the Community Engagement Forum, a regular event during ANZUP’s Annual Scientific Meeting. It offers a unique opportunity for members of the community to learn about research from the experts – those who undertake the research and those with a lived experience of cancer.

– Tim Baker, acclaimed surf writer, journalist, and prostate cancer survivor.

If you are interested in future forums, please register your interest via https://anzup.org.au/join-us-friends-of-anzup/

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Meet Tim Baker Tim Baker is an award-winning author, journalist, and storyteller specialising in surfing history and culture, working across a wide variety of media from books and magazines to film, video, and theatre. Some of R TIM BAKE his most notable books include “Occy”, a national bestseller and chosen by the Australia Council as one of “50 Books You Can’t Put Down” in 2008, and “The Rip Curl Story” which documents the rise of the iconic Australian surf brand to mark its 50th anniversary in 2019. Tim is a former editor of Tracks and Surfing Life magazines. He has twice won the Surfing Australia Hall of Fame Culture Award.

Tim was diagnosed with stage 4, metastatic prostate cancer in 2015 with a Gleason score 9. He was told he had just five years of reasonable health left, but eight years on, at 58, he’s still surfing, writing, and enjoying being a dad. His latest book, Patting the Shark, also documents his cancer journey.

Can you give us a little background on where you were at the time of your diagnosis?

Tim: I had recently turned 50 and had just come back from a work trip to the US where I was writing/co-directing a series of short online documentaries. Life was good. Two beautiful kids, a loving wife, a dream career as a surfing writer and a cosy home within walking distance to the beach. I remember thinking shortly before my diagnosis, everything is perfect, and I’m very grateful. I don’t need a wakeup call. Life had other ideas.

What were the symptoms and what led you to your diagnosis?

Tim: I’d noticed I was going to the loo more frequently and my wife had commented on it. I had some pain in my right femur which came and went over a few days and didn’t think too much of it, but it turns it that was a large metastasis in my thigh bone. Other than that, I felt perfectly fit and well, and was surfing regularly. Life was good.

Can you describe how you felt when you initially received your diagnosis?

Tim: I’ve described it as like getting smashed in the face with a baseball bat. I remember a kind of cognitive dissonance as the news sunk in - this can’t be happening.

This is happening. This can’t be happening. This is happening. It’s hard to describe, but the brain struggles to process the news it is being given.

12 A LITTLE BELOW THE BELT

The ball’s in your court

What treatment did you receive initially? How does that differ to what you do now?

Tim: I was put straight on hormone therapy (Androgen Deprivation Therapy, or ADT) and concurrent early chemotherapy as recommended by quite recent clinical trials at the time that showed a dramatic increase in survival times with the dual treatments. I now just have intermittent ADT, with regular breaks to reduce the side effects and this seems to be working quite well. I’ve had eight years of efficacy from the frontline ADT which I’m told is quite unusual and very pleasing.

You’ve spoken with a sense of vulnerability about your cancer journey so far, has that been a conscious effort or has it felt natural to you?

Tim: It was very much a conscious decision to try and make some meaning out of my diagnosis and advocate for change, particularly better provision of supportive therapies for people on ADT, which has hideous side effects. I was shocked to learn that the frontline treatment for the most common cancer in the country was, effectively, chemical castration and I had never heard this discussed.

I felt like I had to drag this out into the light and draw attention to the suffering it causes and the urgent need for better support for people who endure it. It was deeply uncomfortable, but it just felt like it needed to be done.

What advice would you give someone who is just starting on their cancer journey?

Tim: Be pro-active in adopting healthy, sensible, evidence-based lifestyle strategies like exercise, nutrition, stress reduction through a mindfulness practice like meditation. I believe we need to dismantle the false dichotomy between mainstream and what might be called complementary or natural therapies. As the Buddha says the answer’s in the middle way. Do what your oncologist recommends, but ask questions, inform yourself, and be pro-active about managing your own health. Get a care plan from your GP and seek referrals to an exercise physiologist, nutritionist, a sexual health specialist. If necessary, get a mental health care plan and find a good psychologist.

Finally, what is your involvement with ANZUP? Tim: I was presenting a session to represent the patient’s voice, in conversation with my occasional Melbourne oncologist Arun Azad at ANZUP’s Community Engagement Forum. It’s a wonderful opportunity to get my message out. I’ve benefitted from clinical trials that showed the benefits of early chemo, and I have participated in clinical trials for exercise (GAP4 Interval Study through University of Queensland) and medicinal cannabis (the Quest Initiative through Sydney University), and they have been entirely positive experiences. If there was a clinical trial suitable for me with an alternative to hormone therapy, I would jump at it in a heartbeat.

!

In the Media

The ball’s in your court

In praise of prostate cancer nurses

by Tim Baker

Attending my first cancer conference felt like a big deal.

The 2023 Annual Scientific Meeting of ANZUP Trials Group (Australian and New Zealand Urogenital and Prostate Cancer) brings together medical specialists, nurses, patient advocates, researchers and other stakeholders, in a three-day conference to discuss the latest advances in what’s sometimes cheekily referred to as “below the belt” cancer care.

It would have been easy to feel out of my depth amid the learned medical boffins and presentations on genome sequencing and PARP inhibitors and investigations into the tumour immune micro-environment – all of which sails clearly over my humble wordsmith’s head.

I met so many kindred spirits with similar ideas that I came away with a renewed sense that real change is not just possible but imminent, thanks to the goodwill and dedication of so many health care professionals determined to make life better for people like me.

Having sat through hours of presentations, and myriad informal chats, my bullet point take aways are this: • A prostate cancer diagnosis, especially advanced PC and the prescription of ADT, must trigger a care plan and ensure ongoing referrals to an exercise physiologist, nutritionist, and sexual health specialist, at the bare minimum.

But the warm welcome and inclusive culture of ANZUP makes it clear the patient voice is not just well and truly welcome here but actively listened to.

• P atients need to have the impacts of treatment, particularly ADT, better explained to them and the provision of tools and strategies to mitigate side effects needs to be a part of standard care.

Apart from my own presentation on pro-active and integrative cancer self-care, I found my natural allies among the Specialist Prostate Cancer Nurses (SPCN), who’s sessions were brimming with research and ideas around the kinds of supportive care people with prostate cancer desperately need. And nurses are, I believe, a vital link and powerful change agents, in seeing this come to pass.

• D iscussion and information around sexual health and the implications for intimate relationships and sexual function need to be front and centre from the time of diagnosis and reinforced at regular intervals (perhaps six-monthly) to ensure patients understand their options and the importance of tackling these issues early on for best outcomes.

As a prostate cancer patient, it was hugely encouraging to see all the work being done, not just on developing new and better treatment options, but on making PC patients’ lives better in the meantime. The focus on issues like exercise, nutrition, sexual function and coordinated survivorship care plans was enormously heartening.

• D iscussions of sexual health need to de-centre erections as the be-all and end-all of sexual function and cover themes of physical intimacy that don’t involve penetrative sex, what you might call “full body sensuality”, as a source of pleasure for patients and their partners.

I joined the early Sunday morning session, ANZUP Nurses & Allied Health Symposium, rather than enjoying a sleep in or hitting the fancy hotel breakfast buffet. I’m so glad I dragged myself out from under the doona on a cold Melbourne winter morning and resisted the lure of endless pan au chocolate. I may have been the only person in the room who wasn’t a specialist cancer nurse or researcher, but I was made to feel entirely welcome.

When we broke into smaller round table groups, with the ubiquitous butchers’ paper and marker pens at the ready for an “Ideas Generation Workshop”, we began with the customary introductions around the table. When it was discovered there was a “consumer” at the table (me!), there was much excitement and I was peppered with questions about my own experiences and views on gaps in the health care system and unmet needs of PC patients. It was an entirely supportive and affirming experience.

• T here needs to be a continual reinforcement that there is the potential for rich, joyful and meaningful life after even an advanced PC diagnosis. Simple lifestyle strategies like my own self-care mantra, M.E.D.S – meditation, exercise, diet, sleep – offers hope of maintaining and enhancing quality of life and mitigating side effects of treatment.

I’ll leave it to others better qualified than I to discuss advances in treatment options. But amid my enthusiasm for supportive and evidence-based complementary therapies, I would like to make clear my gratitude to medical science and hardworking specialists and researchers.

While I take some credit for my continued good health and rich quality of life, it is largely thanks to medical science that I am still here at all. https://www.pcfa.org.au/news-media/news/timbaker-in-praise-of-prostate-cancer-nurses/

A LITTLE BELOW THE BELT 13

The ball’s in your court

Finding information and asking the right questions During the 2023 ANZUP Community Engagement Forum, a meaningful dialogue unfolded between testicular cancer survivor Joe Bakhmoutski and Dr Ciara Conduit. Their conversation delved into the art of finding information and asking the right questions

Joe Bakhmoutski In 2016, Joe was diagnosed with testicular cancer. After his post diagnosis experience, Joe decided to help cancer patients, survivors and caregivers make sense of their experience through the now world renowned Simplify Cancer Podcast.

Today, Joe is a sought-after author and speaker with a message of hope and resilience. Joe is incredibly proud to launch his latest book “Finding Hope in Times of Uncertainty: A Guide to Thriving in the Challenging World of Today”.

Dr Ciara Conduit Ciara is a Medical Oncologist working within the genitourinary and melanoma services at Peter MacCallum Cancer Centre in Melbourne. She completed her physician training in both Tasmania and Victoria, including a Fellowship within the Early Drug Development Unit at Peter MacCallum Cancer Centre in 2020. Alongside her clinical role, Ciara is engaged in genitourinary research at the Walter and Eliza Hall Institute of Medical Research and previously also at the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group.

Dr Conduit: Cancer diagnosis can be overwhelming, and the decisions that follow can be daunting. As a survivor, could you share your thoughts on the significance of these decisions in your journey?

Joe: Of course. When I was diagnosed with testicular cancer, I remember feeling like my life was turned upside down. Suddenly, I had to make choices about my treatment, and it wasn’t as straightforward as I initially thought. My first experience with the urologist was more directive – I was told what surgery I needed.

Everything happened so quickly and I didn’t have to make any decisions.

14 A LITTLE BELOW THE BELT

But later, when I met my oncologist, he presented me with treatment options. Even though chemotherapy wasn’t possible, I could try radiotherapy. He explained the pros and cons and told me to take time to decide.

At first, it was surprising for me because I expected the expert to tell me what to do. I felt lost. But then I realised it’s a chance to take control and make my own decision.

It’s like being in a foreign place where you don’t know the language, and you have to figure things out. I want to think it through, ask questions, and decide what’s best, especially with my specialist’s help.

So, Ciara, are there any questions you think patients should be asking?

Dr Conduit: I don’t think there’s a magical question to ask. What I try to do with every new patient is understand what’s important in your life, your passions and your connections. By doing this, I can tailor advice to you. For example, if music is crucial and you’re a pianist, I’d consider how treatments like chemotherapy might impact that. So, ask the questions that matter to you.

Joe: You’re absolutely right. Is there anything that might be helpful when patients make decisions or try to find out more? There’s so much information online, but what sort of resources can we trust online?

Dr Conduit: I think it’s a good point. There is a lot of unhelpful information online that wouldn’t represent high level evidence supporting or in fact, against a particular treatment. You need to be careful about what you read, and your team can help directly towards that.

There are organisations like ANZUP that have valuable information for patients on the website. Additionally, for prostate cancer survivors, the Prostate Cancer Foundation of Australia offers comprehensive resources.

In terms of clinical trials, the trials team is an excellent resource. If you were to sign on to a trial at your local centre, you’ve not only got your doctor but also research nurses and trial coordinators. This is actually a whole extra team who can help you navigate some of this information as well.

Join Friends of ANZUP today and gain a glimpse into the significance of clinical trials research and how it impacts our development of below the belt cancer research.

What’s included?

• All the latest news in prostate, penile, testicular, kidney and bladder cancer trials conducted by ANZUP. • Discover the multiple ways you can get involved and raise awareness or funds such as via our range of Below the Belt events.

• Learn more about upcoming research and how treatment options from diagnosis and beyond are being improved through vital funding.

Sign up here Join Us – Friends of ANZUP – ANZUP https://anzup.org.au/join-us-friends-of-anzup/

A LITTLE BELOW THE BELT 15

Improving access to clinical trials for Culturally And Linguistically Diverse (CALD) populations Australia and Cultural Diversity

Access and Participation on Cancer Clinical Trials for CALD Communities Dr Abhijit Pal, a medical oncologist working as a staff specialist at Liverpool Hospital, recently presented some of the findings from his PhD. His study is looking at ways to improve the representation of patients from culturally and linguistically diverse backgrounds (CALD) on cancer clinical trials.

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HI

Due to the large number of Australians belonging to CALD groups, research into cultural diversity has been attracting a lot of attention from researchers and policymakers in Australia. This diverse group of people have been reported to experience health inequalities and unique circumstances such as language barriers, prejudice, discrimination, and racism.

AB

The 2021 census showed that 27.6% of the Australian population were born overseas and the top 5 languages spoken in the home, other than English, were Mandarin (2.7%), Arabic (1.4%), Vietnamese (1.3%), Cantonese (1.2%) and Punjabi (0.9%). The figures from the Australian Bureau of Statistics (ABS) revealed that over 300 separate ethnic backgrounds were identified in the 2016 census, with over 300 separately identified languages spoken in Australian homes.*

Dr Pal works in Liverpool, an area of southern Sydney that is extremely culturally diverse. One in two people are from a background JI T other than Australian and PA L speak a language other than English. His research aimed to survey the cancer clinical trials workforce in Australia to understand the challenges facing recruitment of CALD patients to cancer clinical trials.

DR

Australia is a multicultural society, with a population that includes many people born overseas, or who have a parent born overseas or speak a variety of languages.

Together, these groups of people are known as culturally and linguistically diverse (CALD) populations.

Dr Abhijit Pal

It is understood that patients with cancer from CALD backgrounds face challenges at every step of the patient journey from screening, diagnosis, standard of care and discussion about clinical trials.

“Inequity in cancer clinical trials has been a perennial issue and is becoming more noticeable this year. It is simply not fair that one sector of the community repeatedly does not get access to the wonderful advances that are being made every year in medical oncology through clinical trials – new anti-cancer therapies which offer better quality of life or longer survival are for everyone, not just a select few. We all need to do our part at the community, site and sponsor level to address this complex inequity and the many barriers that patients from CALD backgrounds face in being recruited to cancer clinical trials. At the very least, we need to measure properly and collect the correct data on CALD recruitment at site and sponsor level so we can benchmark the inequity for future years.”

– Dr Abhijit Pal

“Removing this hurdle and increasing representation is important because efficacy, toxicity and clinical outcomes of a studied treatment may be different in different populations. Also, many studies focus on screening, prevention, survivorship, and quality of life issues – topics that can best be understood through the inclusion of a diverse patient population.”

– Co-author of the study Dr Beth Glenn

Next Steps in Cancer Clinical Trials

High Translation Costs Hinder Minority Participation in Trials A recent study done at UCLA** theorised that the high translational cost of trial consent forms, in studies not funded by pharmaceutical companies which typically have budget to cover the cost of translation, may discourage investigators from recruiting patients for whom consent document translation would be required.

This would contribute to the disproportionately low rates of participants from traditionally underrepresented groups in clinical trials.

As trials evolve, the clinical trials teams should be required to report all the ethnicity, cultural and linguistic data, and also think more about future trial protocol development and how to collect information of patient populations systematically.

Crucially, interpreter services are pivotal in the delivery of clinical trials. Very few clinical trial sites and hospitals have specific CALD services. There is a clear need for more interpreters and interpreters trained in communicating clinical trials.

Dr Edward Garon, a senior author of the study, and colleagues evaluated potential differences in the two types of trials based on participant primary language and English proficiency, basing their findings on more than 9,213 participants in trials at UCLA Jonsson Comprehensive Cancer Centre between January 2013 and December 2018.

Improving access to clinical trials for patients from CALD backgrounds: • Provide more in-person interpreters • Provide more trained interpreters

The study showed that patients of limited English proficiency were represented approximately half as much in studies that did not have industry funding compared to those with pharmaceutical sponsorship.

• Develop translated patient resource materials • Trial navigators needed to help people get onto trials

“Results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency,” – Dr Maria Velez, a fellow in hematology and oncology at the David Geffen School of Medicine at UCLA and the lead author of the study.

Taking cultural differences into account can help make trials and resources more accessible, inclusive, and responsive to the needs of all people who require assistance. In contrast, poor identification and communication with CALD populations might lead to ineffective resource allocation and interventions.

ANZUP plans to review their clinical trials to assess if they are accessible to all, regardless of ethnicity and preferred language.

References * https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7830035/ ** https://www.miragenews.com/high-translation-costs-hinder-minority-1058761/

A LITTLE BELOW THE BELT 17

Communication and consenting in clinical trials: are we talking the same language?

At our most recent Community Engagement Forum, held at the ANZUP 2023 ASM, Melissa Le Mesurier and Craig Gedye had a great conversation about communication and consent. As a member of the Consumer Advisory Panel and cancer survivor, Melisa has firsthand experience with the difficulty of understanding the world of Medical Oncology, a world that has become second nature to ANZUP member Associate Professor Craig Gedye.

Melissa Le Mesurier Both professionally and personally, Melissa is passionate about medical research, consumer engagement and patient empowerment – something sparked when her (now adult) son was diagnosed with cystic fibrosis in 1996 and strengthened when she was diagnosed with bladder cancer in 2017. She is a Graduate of the Australian Institute of Company Directors and a Director of the Lung Foundation Australia.

18 A LITTLE BELOW THE BELT

A/Prof Craig Gedye Associate Professor Craig Gedye is a medical oncologist and cancer researcher. He works for CRA E IG GEDY people with melanoma, brain, prostate, bladder and kidney cancers. His research focuses on complexity and heterogeneity in cancer – why are cancers different between different people; why are cancers cells different to each other; what does this mean for each person’s treatment? This challenging problem spans projects across the research spectrum, from patient experience, through clinical trials, translational biomarkers and questions in basic science. Craig is privileged to lead several national cancer clinical trials for the ANZUP and COGNO cancer trials groups, chairs the ANZUP Renal Cell Cancer Subcommittee, is a member of the Mark Hughes Scientific Advisory Committee, HNEHLD Clinical Trials Ethics Subcommittee, COGNO Scientific Advisory Committee and ANZUP Cancer Trials Scientific Advisory Committee.

Melissa: Sometimes, you’re put in a situation and it’s like entering a foreign land.

I went from working in town every day, I was a busy mum with a busy life and suddenly I was in a whole new world. I remember I took a picture of myself in the paper hat and the paper gown thinking, how did I become this person?

No matter how hard you try in that situation, you’re not going to catch up with 20 plus years of uni and medical research knowledge. So how do you turn all the jargon into plain English? Craig’s got an interest in that area.

Craig, maybe you can tell us a bit about your clinical trial?

A/Prof Gedye: One of the things that I’m lucky to do is clinical trials and one of the things I have noticed is that we probably need to communicate information about trials a bit better. There is a standard mandated format for consent forms from NHMRC and they are complex and overwhelming. There is an information overload that includes a lot of complex terminology, and they can be lengthy and confusing. And at the end of it all we ask patients to sign their consent.

Melissa: It sounds like there could be a better role for communication in clinical education.

A/Prof Gedye: Exactly, you sign something shorter when you buy a house. So, we stopped, and we thought well, can we do something to if not replace it, at least supplement it. And these are very difficult conversations to have because we have always done things a certain way and we have always been legally bound to 17-page consent forms.

What we’ve tried to do is take insights from people who are doing clinical trials in different spaces. Some very clever people that I’ve worked with who’ve been doing clinical trials at the point of care when patients are very sick with serious infection. They have figured out ways of communicating to people who were very sick to say, we’ve got a simple thing we think could make the treatment work better.

We have created some simple brochures that can be printed out on an A4 sheet on any printer that explains not only the process of treatment during the trial but the expected outcomes we are conducting the trial for. The language is simple, relatable and includes images to help communicate easy to understand metaphors about the treatment process. There is even a QR code on the back that will play a video explaining the details of the trial using the same simple and relatable language.

These still have to go through our ethics review but one of the people who pushed me the hardest on this was the manager of our ethics service in Newcastle, who lived with a chronic illness herself and pointed out that we don’t do things well and that we needed to do better.

Melissa: One of the roles of the Consumer Advisory Panel is to look at proposals from the various scientists and researchers for these forms which you mentioned can be up to 40 pages long and look at it from a patient’s point of view. We look at the language, the terminology, and we have to ask questions like; what does this trial involve? But health literacy, which is how to navigate the system and understand medical information, is really low in Australia.

60% of people have very low health literacy. One in four people don’t have English as their primary language at home. Imagine struggling with the 40-page consent form while you’re unwell and your head is full of fairy floss because you’ve just been told this scary thing.

Do you think the new wave of communication that you’re proposing will help?

A/Prof Gedye: We need to test that in a trial. We have to actually ask patients to know if we’re helping. We will ask those questions as part of the trial and challenge ourselves to get feedback as we go along. The feedback about what actually works for people is so valuable. When we did the first version for the pilot trial, we were talking to the blokes that I worked for in Newcastle and we thought, weed killer analogies were probably going to be fine, which is what we had, but then someone pointed out that they didn’t like the idea of it being described that they had weeds rather than cancer. They felt the analogy was flippant considering how serious things were. So, we were challenged to ask ourselves what better and more relatable metaphors about the treatment types can we use.

The final thing that that I’m really hopeful we can do for this trial is, tap into Google Translate through people’s smart phones. If we’ve written these brochures well enough with grade 10 language, then we hope it’s possible that an automatic AI translation to another language will be easy.

That all still needs to be tested though.

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Enhancing diversity and inclusivity in ANZUP theranostic prostate cancer clinical trials During the 2023 ANZUP ASM hosted in Melbourne, Dr Martin Hong presented his research relating to participation rates of Aboriginal, Torres Strait Islander and culturally and linguistically diverse communities, in ANZUP Theranostic prostate cancer clinical trials.

Theranostics is a medical approach that combines treatment and diagnosis in one. It’s like having a smart medicine that not only helps you get better but also gives doctors information about your progress.

Dr Martin Hong Martin Hong is a Clinical Trials Fellow working at Liverpool Hospital in Sydney with a focus on early phase trials. Martin has recently received his fellowship in Medical Oncology from the Royal Australasian College of Physicians and has tumour stream interests in genitourinary DR MARTIN HONG and lung cancers. Martin is passionate about reducing inequities in healthcare access in culturally and linguistically diverse communities, particularly in clinical trials.

Dr Hong’s study focuses on ANZUP’s TheraP (ANZUP1603) and the upcoming ENZA-p (ANZUP1901) trials. While ANZUP has made significant strides in advancing prostate cancer research and treatment, the diversity information is not clear in ANZUP trials and has not been reported in the past.

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In most clinical trials, participants tend to be quite homogeneous. Recognising the importance of diversity, both globally and locally, there has been a concerted effort to enhance inclusivity and treatment options for all patients. Clinical trials play a crucial role in the treatment landscape, and their outcomes should ideally reflect the diversity of the real world patient population.

In 2017, a pivotal study performed by Dr Ben Smith* and his colleagues in South Western Sydney Local Health District (SWSLHD) revealed significant disparities in clinical trial participation among patients from culturally and linguistically diverse backgrounds, especially those whose primary language at home was not English**. Furthermore, the participation of Aboriginal and Torres Strait Islander patients in cancer clinical trials is unknown.

The primary objective of Dr Hong’s study was to review the participation of those two groups in ANZUP Theranostic clinical trials.

To provide some context, Cancer Australia mandates the collection of certain demographic data. One question asked was: Do you identify as Aboriginal or Torres Strait Islander, yes or no? Regarding the culturally and linguistically diverse background, the question was: What is your primary language spoken at home?

Results TheraP (ANZUP1603)

ENZA-p (ANZUP1901)

Total Participants

201

162

Aboriginal or Torres Strait Islander

1/201 (0.5%)

2/162 (1.2%)

Participants who speak a language other than English at home

23/201 (11.4%)

16/162 (9.9%)

Trial

A closer look at the data reveals that the majority of participants in both trials primarily spoke English at home. In TheraP, this accounted for 88.6% of participants, while in ENZA-p, the figure was at 90.1%. Italian was the most commonly spoken language other than English in TheraP, represented by five participants. In the case of ENZA-p, Serbian was the most frequently spoken non-English language, with three participants using it as their primary language at home.

Languages Spoken at Home TheraP (ANZUP1603)

In terms of the results, among the 201 participants in TheraP and the 162 participants in ENZA-p, only one patient in TheraP and two patients in ENZA-p identified as Aboriginal or Torres Strait Islander. Meanwhile, 23 participants in TheraP and 16 in ENZA-p reported speaking a language other than English at home.

ENZA-p (ANZUP1901)

Albanian

1 Armenian

1

Cantonese

1 Dutch

1

Croatian

1 Greek

1

Dutch

1 Hungarian

1

Farsi

1 Indonesian

1

German

1 Italian

1

Gujarati

1 Macedonian

1

Lebanese

1 Malay

1

Mandarin

1 Maori

1

Maori

1 Russian

1

Tagalog

1 Vietnamese

1

Chinese unspecified

2 Mandarin

2

Not stated/Unknown/ Not evaluable

2 Serbian

3

Spanish

3 English

146

Italian

5

English

178

While these findings are informative, they may not fully capture the cultural backgrounds of participants. To achieve a more comprehensive understanding of the cultural diversity within our participant pool, we must consider additional measures.

In summary, ANZUP clinical trials like many other cancer trials, have homogeneous trial patients.

Although we have collected information on what participants speak in terms of language, we need comprehensive information to gain a more accurate understanding of the cultural diversity among our participants.

Recognising this is the first step towards improving diversity in clinical trials, an endeavour ANZUP is committed to. It echoes the wisdom of Confucius, who said:

‘Study the past if you want to define the future.’

More information: * Dr Ben Smith is a Senior Research Fellow and Cancer Institute NSW Career Development Fellow. Ben’s research aims to ensure equitable access to high quality evidence-based psychosocial cancer care for all people living with cancer. He has a particular interest in fear of cancer recurrence, digital health interventions and underserved populations impacted by cancer, such as culturally and linguistically diverse (CALD) and First Nations communities. ** Smith, A. ‘Ben’, Agar, M., Delaney, G., Descallar, J., Dobell-Brown, K., Grand, M., Aung, J., Patel, P., Kaadan, N., & Girgis, A. (2017). Lower trial participation by culturally and linguistically diverse (CALD) cancer patients is largely due to language barriers. Asia-Pacific Journal of Clinical Oncology, 14(1), 52–60. https://doi.org/10.1111/ajco.12818

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In th

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s w e N

Article source: p62, ‘The Herald Sun’, Ian Davis, 4 March 2023

DIVERSITY FAIL IN DRUG TESTS

T

here is an overrepresentation in clinical trials in Australia of white, English-speaking, younger and middle class people – despite the fact that 37 per cent of people aged 65 and older (the largest cohort of Australians accessing medicines) were born overseas.

Drug companies recognise the importance of this problem. The pharmaceutical company Moderna, in the middle of a race to develop a Covid-19 vaccine in 2021, actively slowed down enrolment for its clinical trials to ensure participants reflected the whole community, because of concerns that the patients included in the trial might not reflect the diversity of the wider population.

This need to make clinical trials more representative of the global population was raised in Australia last year, when the National Health and Medical Research Council held a symposium targeting increased diversity in the translation of research. The discussion specifically included the need to provide access to clinical trials to people of different cultures, ethnic groups, socioeconomic groups, abilities, or ages.

It isn’t just about fairness in numbers.

It is also important to include a diversity of people in clinical trials because we know, for instance, that people from culturally and linguistically different groups, or those whose English might be poor, or those who live remote from a hospital, or those with fewer financial resources, often have poorer health than others in the community, These people cannot benefit from clinical trials if they cannot participate in them, and the community as a whole cannot benefit if the evidence from a clinical trial only applies to a fraction of the people in the community.

There are some good programs available to help clinicians better engage with culturally and linguistically diverse groups. The Australian Clinical Trials

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It is important to include a diversity of people in clinical trials.

is not the same thing at all as the central business district). As one of the fastest-growing regions in Victoria, Eastern Health’s catchment covers a diverse population:

IAN DAVIS Alliance is working to improve diversity in participation in clinical trials in Australia.

The Alliance’s Nicola Straiton was interviewed in 2022 by the ABC, stressing the lack of cultural and linguistic diversity among those trialling new drugs “could be limiting our understanding of the effectiveness of those treatments in different populations”.

While the focus of these groups is to target the cultural differences that prevent culturally and linguistically diverse groups from enrolling in clinical trials, I believe that there is a simpler way to attract these groups into trials of new drugs and devices: to ensure that clinical trials are performed right where these communities are located.

That might seem obvious, but many of Australia’s clinical trials are run out of centres that might be located in central city areas, distant from where people actually live and want to receive their health care. Nobody wants to travel. unnecessarily for their care, or to change their healthcare teams midstream, or to take on the cost and inconvenience of having to travel significant distances to receive what might be easily accessible for other communities.

We need to take our clinical trials to the community, not expect the community to go to where a hospital was built a century ago when the city was much smaller. Box Hill, the home of Eastern Health, is near the geographic heart of Melbourne’s population (which

OVER 20 per cent more people in the over-80 age group live here. compared to other areas of metropolitan Melbourne; 5.5 per cent of Victoria’s Aboriginal population in eastern Melbourne are located within the catchment; and ONE in four patients admitted to our hospitals come from a country. where English is not the predominant language, with the top five contributing countries including China, Greece, India, Italy, and The Netherlands.

Put simply, the area serviced

by Eastern Health is also a critical catchment area for outer Melbourne, large parts of Victoria, and even interstate patients, all of whom are currently disadvantaged for access to clinical trials.

Like all hospitals we conduct clinical trials, but we struggle to meet our current commitments, let alone meet future needs, because the space we currently have to run clinical trials at Eastern Health is only about 1-2 per cent of what is available at other health services.

People want all their care to be near where they live. Society’s current systems and services mean there is an unfair imbalance in people’s ability to access that care locally, and that cannot continue.

We need to ensure these services and access to clinical trial opportunities is available right here.

This will send an important message to our diverse community. we see you, you are important, and we want to meet your needs.

IAN DAVIS IS PROFESSOR OF MEDICINE AT MONASH UNIVERSITY AND EASTERN HEALTH

From immigrant roots to leading medical oncologist: Dr Andrea Apolo’s unconventional journey The 2023 ANZUP Annual Scientific Meeting welcomed a distinguished guest, Dr Andrea Apolo. From her journey as an immigrant to becoming a world leading Medical Oncologist and bladder cancer researcher, Andrea’s story defies convention, adding a unique and inspiring dimension to her accomplishments.

Dr Andrea Apolo Andrea B. Apolo, M.D. is a nationally and internationally recognised expert in bladder cancer research. She graduated DR ANDREA APOLO summa cum laude from Lehman College, City University of New York, with a Bachelor of Science degree in chemistry and biochemistry. She earned her medical degree at Albert Einstein College of Medicine in New York City. She completed a residency in internal medicine at New York-Presbyterian Hospital/ Weill Cornell Medical Center and completed a medical oncology fellowship at Memorial Sloan Kettering Cancer Center, also in New York City. In 2010 she was recruited to the National Cancer Institute’s Physician-Scientist Early Investigator Program to build a translational bladder cancer program. In 2014 Dr. Apolo received the Lasker Clinical Research Scholars Award and in 2021 was granted tenure at the National Institutes of Health.

Q: You are an extraordinarily successful researcher and an amazing medical oncologist. I wonder if you could take us through the path that you took to get to where you are now.

Dr Apolo: My story is a little bit unique in that my background as a medical oncologist is not traditional.

I don’t come from a family of doctors or scientists.

I come from a family of immigrants into the United States. My mother came to the United States when I

was four years old from Ecuador and as an immigrant she really struggled for a long time.

When we first came from Ecuador, I was very excited because my cousins were like, “It’s amazing there.

It’s going to be amazing. It’s the land of opportunities, it’s going to be wonderful.” But for us, it wasn’t. And my mom really struggled. She was a single mom and she worked in factories for very little pay.

Growing up in that environment was really difficult.

At some point my mom realised she wasn’t going to be able to take care of me and she sent me back to Ecuador for a couple of years to finish elementary school. Then when I came back to the United States for middle school, I was 11, and that’s when I realised I can start working and help my mom.

I started working really young when I was 11, and then when I was 13 I got a second job. I started working in a restaurant as a hostess and a waitress.

Then I became a manager, and I was managing a full-service restaurant in Manhattan when I was 16 years old.

At the time I wasn’t really thinking about school in a serious way. Nobody in my family had ever gone to college. I just knew I wanted something more out of life, so I decided I wanted to go to college when I was 16 years old. And at that time, I was almost a senior in high school, and I had terrible grades.

A LITTLE BELOW THE BELT 23

Q: After completing medical school, you built a successful bladder cancer program. How did you make that transition from medical school to where you are now?

I told my guidance counsellor, I want to I want to go to college, and he said I could probably only get into a community college, which is a two-year college where I was living in New York at the time. But I ended up applying for a four-year university program through a special bridge program. I had to maintain a C average to stay in that program. That was my way of getting into a four-year city university.

I worked really hard in that first year. I was still working 50 hours at the restaurant and going to school full time. But I realised that I wasn’t going to be able to be successful if I continued working the way that I was working and getting into medical school was going to be difficult.

I did some research and I started applying to scholarships.

I typed up and mailed in applications to 11 different scholarships. Then slowly the rejection letters started coming in. I got one, two, three, four, and eventually nine rejection letters. I got accepted to a scholarship at the NIH, and it was a full scholarship for college. The NIH was my first exposure into biomedical research, and I fell in love with it.

In my last summer there I worked with a translational scientist at the NCI (National Cancer Institute) who saw patients and then also did laboratory research with mice models. He would see patients then he would go back to the lab and ask questions of his mice models and then go back into the clinic and see patients. That was really inspiring. I thought, If I ever get a chance to do something like that, that’s what I want to do. After that I was really lucky to get into medical school.

Throughout all of this I was experiencing imposter syndrome. I kept thinking to myself, how did I get into medical school? How did I get into a residency program?

They must have made a mistake. When I finally got into my fellowship program at Memorial Sloan Kettering, I thought they had made a mistake. I thought someone was going to come and tell me that I didn’t belong there. It was really difficult to deal with, but I learned how to be resilient and how to deal with challenges and move forward.

24 A LITTLE BELOW THE BELT

Dr Apolo: When I started at Sloan-Kettering, I was looking for a mentor and somebody that that was passionate about their work. And I found a fantastic mentor, Dean Bejan, who was working in bladder cancer. That’s why I started working in bladder cancer and I saw that there was a great need to do research in the field.

At that time the NCI had such a fantastic prostate cancer program, and they had a very strong kidney cancer program. I was working there as part of my tuition payback and they didn’t have a bladder cancer program, so they asked me to start one as I had been doing bladder cancer research. There was also not a lot going on in bladder cancer at that time. It was really an opportunity, but also a really hard transition going from fellowship to attending.

Q: What has been the most important asset in bringing your program together?

Dr Apolo: I think it’s a little bit of everything. It’s the people that have supported me and finding the right people to collaborate with. That’s really important because you can’t do everything yourself. But if you have a great idea and somebody else can help you with it, then you can really go a long way.

Q: How do you find balance between spending time with patients one on one in the clinic and dedicating time to thinking and research?

Dr Apolo: I’m very lucky that at the NIH we don’t have the same clinical demands that academic centres do. But I love being in the clinic and while I don’t have to see the number of patients that I see, I choose to have a very busy clinic schedule. I see consults for all GU tumours because I love being able to help people, even if most of my programs are bladder cancer. That’s where I get my ideas in terms of what to research next. I get to see what deficiencies are out in the clinical world.

Q: Given everything you have been through and everything you are working on now, how do you define success?

Dr Apolo: I used to think that a positive trial or a big paper was success. Now I think it’s the composite of all my work. Everything that I’ve done, put together and my contribution to medicine overall.

I think one of the most important things now, is teaching the next generation of scientists to do research and to carry it forward and being a mentor to them. That’s how you continue your legacy, through the people that you teach and the people that they go on to teach.

That to me is success.

ANZUP at the American Society of Clinical Oncology Meeting June 2023 Each year more than 40,000 oncology professionals from around the world come together for 5 days in June in Chicago USA for the American Society of Clinical Oncology (ASCO) Annual Meeting. This meeting allows the oncology community to stay up to date on new clinical cancer advances in every area of cancer research, gain real-time insights from worldrenowned faculty, and connect with one of the largest, most diverse audiences in global oncology.

The ASCO Annual Meeting is one of the most important conferences for presenting the latest, most practice-changing research in cancer care. Through this conference, the cancer community learns how to better care for, support, and treat people with cancer.

At the most recent ASCO Annual Meeting held from 3 – 7 June, ANZUP was in attendance to give five poster presentations, highlighting the research work of ANZUP.

This unique treatment involved two distinct parts. Firstly, a PET scan is used to ‘map’ the cancer. This is done by injecting a radioactive molecule called gallium-68 attached to a small molecule that rapidly localises to prostate specific membrane antigen (PSMA) on the surface of prostate cancer cells in the body. The result is the cancer cells ‘light up’, showing exactly where the disease is and enables identification of patients that may benefit from this new therapy. The second part is the therapy itself: the Lu-177 radionuclide is attached to a similar molecule used in the scanning process, and Lu-PSMA is administered to the patient, targeting the tumours and killing the cancer cells while minimising damage to surrounding tissue.

2. P3BEP (ANZUP 1302) Presented by Peter Grimison

1. Effects of [177Lu] Lu-PSMA-617 on overall survival in TheraP (ANZUP 1603) versus VISION randomized trials: An Exploratory Analysis Presented by Yu Yang Soon

TheraP is the first randomised trial comparing 177LuPSMA-617 (Lu-PSMA), a novel radioactive treatment, to the current standard-of-care chemotherapy called cabazitaxel for people with metastatic castrationresistant prostate cancer. These people had disease that had already progressed after standard chemotherapy.

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. 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’.

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3. BCG+MM (ANZUP 1301) Presented by Ian Davis

continuously which is the current standard of care.

This study will tell us if having these treatment breaks guided by mGSTP1 can improve how people feel during treatment while still treating the prostate cancer effectively.

5. CLIMATE (ANZUP 1906) Presented by Ciara Conduit

Non-muscle invasive bladder cancer is common and can cause substantial suffering. If the cancer is “high risk” then in over 30% of people it can turn into a more aggressive form of bladder cancer that requires treatment such as removal of or radiotherapy to the bladder within 5 years despite best current treatment.

This risk can be reduced by placing BCG bacteria into the bladder. Recent preliminary studies show promising results from also placing mitomycin, a chemotherapy drug, into the bladder along with BCG treatment. This large-scale, randomised trial will determine the effects of adding mitomycin to BCG on cure rates, survival, side effects, and quality of life.

4. GUIDE (ANZUP 1903) Presented by Lisa Horvath

The purpose of this study is to see if a prostate cancer marker in the blood (mGSTP1) can be used to guide chemotherapy treatment. Based on the level of this blood marker, some people may be able to have breaks in treatment rather than having chemotherapy

26 A LITTLE BELOW THE BELT

Testicular cancer is the most common cancer diagnosed in people aged between 15 and 39 in Western countries, however it can occur at any age.

Most people diagnosed with testicular cancer will have cancer confined to the testicle, without evidence of spread to other areas of the body. They are highly likely to fully recover following surgical removal of the testicle (orchidectomy) alone, and most will not require additional chemotherapy or radiotherapy. Sometimes, a person may choose to undergo preventive chemotherapy or radiotherapy, which reduces the risk of their cancer coming back; however, this may result in long-term side effects for some people. For this reason, most people in Australia are recommended “active surveillance,” which involves regular reviews with their doctor, computerised tomography (CT) scans and blood tests, but no chemotherapy or radiotherapy. With this approach, most people will be spared from unnecessary treatment and side effects.

However, a small number of these people will have recurrent cancer detected during active surveillance.

Reassuringly, these people are also highly likely to have a positive outcome following additional treatment.

A new blood test, micro-ribonucleic acid (miRNA), which evaluates a protein commonly found in testicular cancer is under investigation. Early studies have found that miRNA is detectable in blood samples of people who have known testicular cancer.

Below the Belt Research

Below the Belt Research Fund Overview

What is research funding?

The Below the Belt Research Fund was established to support ANZUP members in the development of investigator-initiated studies. The funds raised from Below the Belt events, and donations from our supporters, go directly towards clinical trial research via the Below the Belt Research Fund.

Research funding refers to the financial support obtained to conduct scientific research. It serves as a means for ideas and projects to advance with necessary financial assistance. The process of obtaining funding usually involves competitive applications for grants.

Securing these grants is crucial for researchers, as it enables them to conduct their studies effectively.

The fund provides much needed seed funding to support ANZUP members to progress new trial ideas to the point of becoming full scale studies.

Since 2015, ANZUP and Below the Belt events have raised over $2 million for cancer research. Seed funding has been awarded to 40 ANZUP members to help gather the evidence needed to turn an idea into a fully-fledged trial. Two important projects are prostate cancer trial DIPPER (read more on page xx) and testicular cancer trial CLIMATE (read more on page xx). These pivotal studies, supported Below the Belt Research Fund in 2020 and 2019 respectively, are currently in the process of recruiting patients.

Below the belt cancers - testicular, penile, prostate, bladder, and kidney - affect 90 new people every day in Australia and New Zealand. That’s why research to improve the treatments and outcomes of these cancers is crucial. All funds raised go straight into the hands of experts across Australia, New Zealand, and internationally who are committed to finding the answers we need.

In any research project, two key components play a vital role: the idea itself and its execution. The successful execution of research depends not only on the researcher’s dedication but also on the availability of proper infrastructure. This infrastructure encompasses research facilities, equipment, resources, and expert support required for the research.

Once a research project commences, expenses are incurred for researchers’ time and the necessary materials. Funding is essential to meet these monetary requirements.

In certain cases, when studies involve multiple participation centres, randomised controlled trials, or large sample sizes for experimental or observational studies, conducting the research within the institution’s resources may not be feasible. In such situations, external funding becomes necessary. Unfortunately, the lack of funding often leads to the stagnation of many promising ideas that could have evolved into highquality research projects.

A LITTLE BELOW THE BELT 27

Below the Belt Research

2023 Below the Belt Research Fund Recipients At the ANZUP Annual Scientific Meeting the 2023 recipients of the Below the Belt Research Fund were announced.

Dr James Buteau Nuclear medicine, University of Melbourne and Peter MacCallum Cancer Centre

a time-consuming process that can give different results between users. This limits routine use of the PET biomarkers in most medical centres. I will utilise artificial intelligence (AI) deep learning algorithms to create and validate a single-click solution to measure the PET biomarkers. This innovative approach could improve their access worldwide, and measure accurate PET biomarker values regardless of a centre’s expertise.

Implementing and Improving Access for the Predictive and Prognostic Biomarkers of Baseline PSMA and FDG PET of Patients with Prostate Adenocarcinoma Evaluated in TheraP Study (ANZUP 1603)

A/Prof Niall Corcoran

The ANZUP TheraP study was a landmark randomised controlled trial of Lutetium- 177-PSMA providing compelling evidence that this novel treatment improves outcomes for patients with metastatic castration-resistant prostate cancer. Together with lead investigators Prof. Michael Hofman, Prof. Andrew Martin, Prof. Ian Davis and the TheraP team, I was the first author of the imaging biomarker analysis (Lancet Oncology 2022). We demonstrated, for the first time, that high tumour uptake on the PSMA PET scan is a predictive biomarker for response to Lutetium- 177-PSMA. We also demonstrated FDG PET is a prognostic biomarker, which can identify patients with worse outcomes and could benefit from treatment intensification.

Penile cancer is a rare disease that affects approximately 1 in 100,000 men in Western countries. Despite its rarity, penile cancer can have a significant impact on patients’ quality of life and is associated with high rates of morbidity and mortality. Currently, there is a lack of comprehensive data on the risk factors and management of penile cancer in Australia.

In simpler terms, Lutetium-177-PSMA is a form of liquid radiation injected into a vein. This very targeted treatment finds and sticks to prostate cancer cells, while giving little radiation to normal organs. The PET scans are like a window into the future, done before giving the Lutetium-177-PSMA. PSMA PET scans help us understand how much radiation may be given to tumours depending on how “bright” they are. FDG PET scans reveal which tumours are growing fastest. This PET scan is a tool that can help find patients who have tumours that are more aggressive and may need more intense treatments.

In this project, I will address the main limitation of our prior work. Currently, specialised and expensive software is needed to measure the PET biomarkers.

Most medical centres need to use human contouring,

28 A LITTLE BELOW THE BELT

Urologist Western Health, Royal Melbourne, Peninsula Health Australian Penile Cancer Registry

To address this gap in knowledge, we are proposing the establishment of an Australian Penile Cancer Registry.

The aim of this registry is to establish a database that can clarify local risk factors and assess the effectiveness of current treatments in managing penile cancer.

This will be built upon an existing Victorian database with globally significant retrospective series and a proven publication record. As a national registry it will overcome barriers to access for interdisciplinary work and have a wider lens with more significant impact.

One of the key objectives of this registry is to improve our understanding of penile cancer, including its underlying biology and patterns of disease. By collecting and analysing data on patient demographics, tumour characteristics, and treatment outcomes, we hope to identify factors that may contribute to the development and progression of penile cancer.

In addition to providing valuable insights into the biology of penile cancer, the registry has the potential to inform clinical practice and improve patient outcomes. By evaluating the effectiveness of current treatments, we can identify areas for improvement and develop more targeted and effective therapies.

Below the Belt Research In conclusion, the establishment of an Australian Penile Cancer Registry has the potential to make a significant contribution to the field of penile cancer research.

By improving our understanding of penile cancer risk factors and management, we can ultimately improve outcomes for patients and reduce the burden of this disease on individuals and broader society.

A/Prof Craig Gedye Medical oncologist and cancer researcher, chair of the ANZUP Renal Cell Cancer Subcommittee Are ‘Dark Dimers’ Associated with Immunotherapy Benefit in Kidney Cancer?

Immunotherapy helps some people with advanced kidney cancers and works best if there are “targets” on the cancer. These immunotherapy targets come from changes in the DNA of the cancer cells called mutations. In kidney cancer some of the mutations are caused by a scrambling of the DNA message. The resulting ‘nonsense’ messages are the targets for the immunotherapy.

Nonsense mutations in other cancers can be caused when the DNA gets stuck together. These stucktogether mutations are common in skin cancers like melanoma, where they are caused by ultraviolet radiation.

Unexpectedly, these stuck-together mutations were found for the first time ever last year in kidney cancer.

It was only found in one lab, and this perplexing result needs to be rechecked.

Why stuck-together mutations should be in kidney cancer is a bit of a mystery, but notwithstanding, these stuck-together mutations might cause the ‘nonsense’ targets, they might be why some people with kidney cancer are helped by immunotherapy.

ANZUP has been grateful to deliver the UNISON and KEYPAD clinical trials of immunotherapy in people with kidney cancer. Some people on these clinical trials were helped, others unfortunately not. Most people on these trials kindly donated a sample of their cancer for later research projects.

We propose to test the cancer samples from the people in the UNISON and KEYPAD clinical trials, to doublecheck that the stuck-together mutations are indeed seen in kidney cancer, and to see if having more or less of the stucktogether mutations predicts who might benefit from immunotherapy or not.

Dr Ramesh Shanmugasundaram Current Appointments at St George: Urology Registrar and Clinical Research Fellow The MBC Trial – Assessment of the diagnostic utility of multi-parametric MRI Before Cystoscopy in patients presenting with a bladder mass: a multicentre prospective study Bladder cancer is a highly aggressive disease with poor outcomes despite advances in technology. For cancers that invade the muscle wall of the bladder (i.e., T2 disease), the 5-year survival even with radical treatment is only 60%.

Currently, T-staging is achieved via endoscopic resection of the tumour (TURBT). Unfortunately, Australian studies have shown that such endoscopic resections fail to sample the muscular layer in 41.9% of cases and in 39.7% of high-risk specimens, despite being the gold-standard for T-staging. Similar rates are seen in the international literature. These patients who are under staged have delayed treatment and poor outcomes. The early identification of T2 and T3 (i.e., muscle invasive) disease is critical to trigger early radical treatment and use of neo-adjuvant chemotherapy. CT scans and ultrasounds are completely unable to differentiate non-muscle invasive (T1 or lower) from muscle invasive (T2 or higher) disease. mp-MRI has the potential to improve the accuracy of clinical Tstaging. Previous MRI studies in bladder cancer have been limited by reserving the use of mpMRI to the post-resection setting, where the accuracy of MRI is confounded by postsurgical inflammation. Furthermore, no studies have assessed the use of novel MRI imaging sequences, such as diffusion kurtosis imaging, that have shown promise in detecting the grade and aggressiveness of other tumours.

In this study, we will assess: (i) t he accuracy of MRI in detecting muscle invasive bladder cancer that requires radical treatment. (ii) the ability of MRI to determine organ confined disease vs locally advanced disease >T3. (ii) the ability of MRI to discriminate bladder cancer from other masses seen on CT or U/S. (iii) To assess concordance between “kurtosis score” and histopathological grade of tumour. (iv) To assess concordance between “kurtosis score” and T-stage of tumour.

In future clinical trials it might help people decide whether to take one immunotherapy treatment or a combination of treatments. And understanding if stuck‐together mutations are truly in kidney cancer will help us learn how kidney cancer forms, and even how it might be prevented.

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Below the Belt Research

Past Below the Belt Research Fund Recipients Great ideas need funding. ANZUP has taken on the challenge of seeding new projects through the Below the Belt Research Fund. The launch of the Below the Belt Research Fund was announced at the 2nd annual Below the Belt Pedalthon at Eastern Creek in September 2015. Since then, Below the Belt Research Fund has supported ANZUP members to progress their ideas into fully-fledged trials.

Dr Chun Loo Gan Dr Chun Lu Gan, a medical oncologist at Royal Brisbane and Women’s Hospital, is a recipient of the 2022 Below the Belt Research Fund.

Currently, Dr Gan is running a study on kidney cancer called Predict RCC (Renal Cell Carcinoma) Trial. This study focuses on finding a much-needed biomarker for metastatic renal cell carcinoma (RCC) patients undergoing first-line systemic therapy.

Over the past years, the landscape of metastatic RCC treatment has changed significantly, with the emergence of many treatment options. However, the absence of a reliable biomarker has posed a challenge for researchers, leaving them with limited tools to tailor treatments for individual patients effectively.

The Predict RCC Trial centres around novel imaging techniques, specifically the PSMA (Prostate-Specific Membrane Antigen) and FDG (Fluorodeoxyglucose) PET scans.

“Thank you to ANZUP for the opportunity. We are very happy to get this study going.” Dr Gan and his team are optimistic that these advanced imaging techniques could potentially find valuable imaging biomarkers, guiding clinicians in making crucial treatment decisions.

30 A LITTLE BELOW THE BELT

Dr Weranja Ranasinghe Dr Weranja Ranasinghe, one of the urologists at Monash Health and Austin Health, was awarded the 2022 Below the Belt grant for his work in bladder cancer research.

About 80% of newly diagnosed bladder cancer patients have tumours limited to the bladder’s superficial layers. Aggressive cases are treated with BCG, an immunotherapy medication that activates the immune system to target cancer cells. However, BCG treatment fails in 30-45% of cases, leading to cancer progression. Identifying patients whose cancers won’t respond to BCG early is crucial.

Exaggerated inflammatory responses before BCG treatment may exhaust immune cells, hindering their effectiveness. This study aims to use genetic proinflammatory gene markers and immunostaining to identify non-responders.

Dr Ranasinghe said, “Below the Belt grant has given us the opportunity to fund this research and work on these personalised therapies, which will help patients in future, and identify which treatment works for patients with different bladder cancers.”

Below the Belt Research Dr Megan Crumbaker Dr Megan Crumbaker received the Below the Belt Research fund in 2021 for a study she is conducting along with Professor Anthony Joshua at St. Vincent’s Hospital in Sydney.

This study investigates high dose testosterone in combination with carboplatin in people with metastatic castrate-resistant prostate cancer.

Dr Crumbaker said, “We’ve already completed the study in 20 people and found some promising efficacy data with the first cohort we’ve done, and it looks to be a pretty safe combination. But we wanted to expand out to more regional centres to be able to offer a trial to other areas around New South Wales.”

Getting the grant has enabled the team to expand the study to other regional sites. Currently, they have successfully opened at Cost Harbor in Port Macquarie, and there are plans to open in Orange soon.

“It’s been a really great opportunity to conduct this research, and also to be able to loop in some more regional sites to give access to trials to these patients that oftentimes have to travel to more metropolitan sites to access something like this.” Said Dr Crumbaker.

A/Prof Andrew Weickhardt Associate Professor Andrew Weickhardt, a recipient of the 2020 Below the Belt Research Fund, is conducting a study at the Olivia NewtonJohn Cancer and Research Centre and St Vincent’s Hospital in Sydney.

Associate Professor Weickhardt is investigating the use of PSMA PET (Prostate-Specific Membrane Antigen Positron Emission Tomography) scans in patients with metastatic kidney cancer.

Although PSMA PET scans are commonly used to detect prostate cancer, preliminary research suggests they may also detect kidney cancer with angiogenic vessels. The study seeks to determine if PSMA PET scans correlate with conventional CT scans and if they reveal additional disease sites, such as in the bone.

This study also explores if the extent of disease on these PSMA PET scans changes with the use of an oral tyrosine kinase inhibitor.

Recruiting at two sites and aiming for 20 patients over the next year, the study has already shown promising results, adding value to CT scans. Associate Professor Weickhardt hopes to expand to other sites across Australia to enhance recruitment and further the investigation.

Associate Professor Weickhardt went on to say, “We’ve been fortunate enough to receive the Below the Belt Research Fund and look forward to sharing the mature results in the next 12 to 24 months.”

A LITTLE BELOW THE BELT 31

Get ready to embark on a flavourful journey like no other!

Our Rude Food Cookbook is coming! Featuring a collection of recipes from renowned chefs and dedicated cancer researchers.

These dishes have been expertly crafted to represent all things below the belt as their creators explain the significance of clinical trials research while giving a subtle nudge to below the belt (testicular, penile, prostate, bladder and kidney) cancers.

Whether you prefer it soft or hard, we’ve got your ‘copy’ covered!

Stay tuned for details on how to get your hands on both versions.

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Synchrony Fellowship Overview Thanks to the generosity of the Synchrony Foundation we were able to establish the Synchrony Fellowship which aims to advance prostate and other urogenital cancer research by offering targeted support to address or answer a specific clinical question.

The spirit of the award will address the following core elements: 1. I nvestment in people. It is anticipated that a substantial proportion of the award will be utilised as salary support.

The aim is to provide the funded researcher with salary to both enable the project to be completed as well as forge a longer-term academic profile in prostate cancer.

2. W ork on existing data. Recognising the two-year funding window, utilising existing data sources will be ideal. Multiple resources exist within ANZUP for such work, including secondary analyses of high impact clinical trials that can be used to inform contemporary studies and clinical practice.

3. C apacity building. Opportunities should be taken to utilise the award to develop capacity for subsequent research.

This may be in the form of building unique data or tissue repositories that have high potential to inform clinical practice, or analytic pipelines of high relevance to subsequent ANZUP researchers.

This award provides salary support for the researcher as well as some direct research costs depending on the project.

Winner of the 2023 Synchrony Fellowship Award Dr Edmond Kwan Genitourinary Medical Oncology Fellow, BC Cancer – Vancouver Postdoctoral Research Fellow, Vancouver Prostate Centre, University of British Columbia Honorary Adjunct Senior Lecturer, Faculty of Medicine, Nursing and Health Sciences, Monash University, Australia

Project title: Multimodal ctDNA analysis and novel imaging to inform precision use of PSMA radioligand therapy: an integrative biomarker analysis of the phase 2 TheraP trial Prostate-specific membrane antigen (PSMA) is a protein that is abundantly present on the surface of most prostate cancer cells. Recently, a new treatment modality known as radioligand therapy has enabled clinicians to deliver targeted radiation therapy for patients with PSMAexpressing advanced prostate cancer. Lutetium-PSMA-617 (LuPSMA) has been shown to be effective in patients where other treatments are no longer controlling cancer growth. However, it is unclear how best to use LuPSMA in situations where intravenous cabazitaxel chemotherapy is also a valid option. Importantly, neither treatment benefits all patients, and both can potentially result in significant short- and long-term life-altering side effects.

A LITTLE BELOW THE BELT 33

Dr Edmond Kwan is an Australian medical oncologist and clinician scientist that will spearhead an ambitious new project to discover better ways of identifying patients who will or will not benefit from LuPSMA and cabazitaxel. He will do this by analysing plasma circulating tumour DNA (ctDNA) and PET imaging data generously donated from 200 participants in the ANZUP TheraP study, a world-first randomised clinical trial conducted across 11 centres in Australia comparing LuPSMA versus cabazitaxel chemotherapy.

Plasma ctDNA represents small fragments of DNA shed into bloodstream from dying prostate cancer cells. Dr Kwan hopes that by studying genetic mutations detected in ctDNA of participants in the TheraP study, and integrating these data with PET scan images, scientists may be able to provide vital clues that can help patients with prostate cancer make difficult life-changing treatment decision.

Currrently, Dr Kwan is embedded as a postdoctoral research fellow in the laboratory of Dr Alexander Wyatt, a senior scientist at the Vancouver Prostate Centre, University of British Columbia in Canada.

There, he continues to finetune his translational research skills, closely supported by a team of dedicated scientists working to better understand how cancer genomics can inform optimal patient care. In July this year, Dr Kwan returned to Australia briefly to attend the 2023 ANZUP Annual Scientific Meeting, where he was awarded the inaugural ANZUP Synchrony Fellowship. During the award ceremony, he reflected on what the Synchrony Fellowship means to him, and his overarching vision for the project.

“I am honoured to be the inaugural recipient of the ANZUP Synchrony Fellowship. Without this award, I may not have had the protected research time dedicated to furthering my passion for finding better treatments for patients suffering from prostate cancer,” Dr Kwan said.

“This proposal will bring together an international group of highly talented and devoted scientists and clinicians working together to find biomarkers that will predict benefit from either LuPSMA or cabazitaxel therapy. I’d like to thank the Scientific Advisory Committee as well as the Consumer Advisory Panel, and of course, our generous donor for making this all possible.”

In 2024, Dr Kwan will return to Australia to carry out the critical next phase of this project. Together with his team, they will embark on preforming comprehensive genomic and epigenomic characterisation of ctDNA from 300 baseline, on-treatment, and end of treatment blood samples from TheraP study participants. Applying custom computational algorithms and tools, they will endeavour to predict the response and long-term survival for patients on each therapy and identify mechanisms of resistance that are inevitable for the vast majority of patients over time. When asked about his own future, Dr Kwan expressed immense excitement for the road ahead.

“I am over the moon to be returning home to begin the next phase of my professional career. It was always my intention to come back to Australia and give back to my mentors and friends in the medical, scientific and ANZUP community that have supported me along the way. The fact that this project is a home grown one makes it that much sweeter.”

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DO YOU HAVE A STORY YOU CAN SHARE? Making your voice heard can assist others with sharing their experiences and opinions, ultimately raising awareness about below the belt cancer types and the treatment or support options available to patients, carers, family, friends, colleagues, or health care professionals.

Please send any information to anzup@anzup.org.au A LITTLE BELOW THE BELT 35

Spotlight on prostate cancer The prostate is a walnut-sized gland located in front of the rectum, behind the base of the penis, and below the bladder. It surrounds the urethra, the tube-like channel that carries semen and urine through the penis. The main function of the prostate is to make seminal fluid, the liquid in semen that protects, supports, and helps transport sperm.

25,485 estimated new diagnoses in Australia in 2023

95%

five year survival rate after diagnosis

3,507 estimated number of deaths in 2022

What is prostate cancer?

Prostate cancer begins when healthy cells in the prostate change and grow uncontrollably, forming a tumour. A tumour can be benign or cancerous.

A cancerous tumour is malignant, meaning it can grow and spread to other parts of the body. A benign tumour means the tumour can grow but will not spread.

Prostate cancer is slightly unusual when compared with other cancer types. This is because many prostate tumours do not spread rapidly to other parts of the body. Some prostate cancers grow at a very slow rate and may not cause problems or symptoms for years, or sometimes ever. Even when prostate cancer has spread to other parts of the body often it can be managed for a long time. So people with prostate cancer, and even those with advanced prostate cancer, may live with good health and quality of life for many years. However, if the cancer cannot be well controlled with existing treatments, it can cause symptoms like fatigue and pain and sometimes can lead to death.

An important part of managing prostate cancer is monitoring it for growth over time, in order to find out if it is growing slowly or rapidly. Based on the pattern of growth, your doctor can then decide the best available treatment options and when to give them.

Prostate cancer is the most common cancer diagnosed in Australia. By the age of 85, it is estimated one in six

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people will be diagnosed with prostate cancer.

It is more common in older people, with 63 per cent of cases diagnosed in people over 65 years of age.

In 2023, it was estimated that 25,487 new cases of prostate cancer will be diagnosed in Australia.

The five-year survival rate for people 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.

In 2022, deaths from prostate cancer were estimated to be 3,507.

Prostate cancer symptoms Symptoms are not usually seen with early prostate cancer. Advanced prostate cancer symptoms can include: • Frequent urination, particularly at night; • Pain on urination; • Blood in the urine; • A weak urine stream; • Pain in the pelvis or back • Weak legs or feet If the disease becomes more widespread and found in the bones, it can cause unexplained pain, fatigue and weight loss.

Spotlight on prostate cancer Causes of prostate cancer

Treatment may take various forms and may not be recommended straight away. Options include:

Some of the risk factors for prostate cancer:

1. W atchful waiting where you might be monitored in case symptoms develop or change.

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

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.

• 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 • T here is also an association with high testosterone levels.

3. Surgery might be 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.

Treatment options If you do not have a family history of prostate cancer, you may want to consider tests for early detection after discussing the risks and benefits with your general practitioner (GP).

4. R adiotherapy can take two forms: a. external beam radiation therapy – where a machine outside the body directs radiation towards the prostate gland

If you have a family history of prostate cancer, your GP should discuss the option for annual PSA testing.

Your general practitioner (GP) will assess your symptoms, conduct a physical examination and arrange blood tests if needed. Your GP should also discuss your needs (including psychological, physical, social and information needs) and suggest sources of reliable information and support.

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 optimal course of treatment and take into consideration: • the stage of the disease • the location of the cancer • the severity of symptoms • your general health and wishes.

b. i nternal radiation therapy (brachytherapy) – where small radioactive ‘seeds’ are placed inside the prostate.

5. 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).

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

Clinical trials 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 people with advanced prostate cancer. Please talk with your doctor to see if there is a clinical trial suitable for you.

ANZUP is currently running a number of prostate cancer trials. You can read about ANZUP prostate cancer trials from page 43 or for more information, go to the ANZUP prostate cancer trials web page: https://anzup.org.au/clinical-trials/recruiting-trials/?_cancer_type=prostate

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.pcfa.org.au/awareness/general-information/general-information-resources/

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ANZUP Trial Highlights

ANZUP’s Phase 2 ENZA-p study (ANZUP 1901) interim results show a 58% reduction in the rate of PSA progression

THE TEAM AT ESMO 2023

At the recent European Society of Medical Oncology (ESMO) Annual Scientific Meeting in Madrid in October, ANZUP announced interim results of their Phase 2 ENZA-p (ANZUP 1901) study, which compares the effectiveness of enzalutamide in combination with Lutetium-177 PSMA, versus enzalutamide alone for the treatment of metastatic prostate cancer. ENZA-p enrolled 162 patients from 15 sites across Australia and was the first study of its kind in the world to combine these therapies.

The interim results from our ENZA-p trial showed the rate of progression was slowed by 58% for people who received enzalutamide in combination with Lutetium-177 PSMA, versus enzalutamide alone.

The data showed that the group who received LuPSMA therapy plus enzalutamide had, on average, 13 months progression free survival (the length of time that someone lives with a disease without it getting worse) compared with 7.8 months for those who received enzalutamide.

“The ENZA-p trial results are an exciting leap forward, building on other work by ANZUP in Lu-PSMA therapy by evaluating the use of complementary combination therapies. We are pleased to see the results are strongly positive and demonstrate that adding 177Lu-PSMA-617 to enzalutamide prolongs both depth and duration of treatment response in these people with high risk metastatic prostate cancer.

An enormous thanks to the patients, families and trial teams across Australia. With your dedication and ongoing support will help change and improve treatments for patients with prostate cancer in the future,” says Study Chair Professor Louise Emmett.

PROF. LOUISE EMMETT

Prostate cancer remains the most common cancer in Australian and the leading cause of cancer relatedmortality in developed countries.

PROF. LOUISE EMMETT

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Prostate specific antigen (PSA) is a protein made by both normal prostate cells and cancerous prostate cells.

PSA is found in the blood and can be measured with a blood test. The test results will show the level of PSA in your blood as nanograms of PSA per millilitre (ng/mL) of blood. The most common test to indicate if you have issues with your prostate, is a PSA blood test.

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

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 (Lu-PSMA for short) is a relatively new treatment in advanced prostate cancer. Lu-PSMA is a radioactive molecule that attaches to the surface of prostate cancer cells throughout the body.

The ENZA-p trial is an Australian collaborative investigator-initiated trial led by ANZUP in collaboration with Prostate Cancer Research Alliance (PCRA): An Australian Government and Movember Foundation Collaboration, Cancer Australia, Endocyte – a Novartis Company, Australian Nuclear Science and Technology Organisation (ANSTO), Australasian Radiopharmaceutical Trials Network (ARTnet), St Vincent’s Hospital Sydney and NHMRC Clinical Trials Centre University of Sydney. Astellas provided drug and financial support.

Research posters at ESMO ANZUP also showed two posters at ESMO, sharing their research with other clinicians and experts from around the world.

KEYPAD:

cells. This study is designed to assess the effects and safety of the combination of two drugs; pembrolizumab and denosumab. The study is currently in follow up and this poster showed some findings were encouraging.

The study was presented by Dr Carole Harris.

ENZAMET: Our ENZAMET study was a large, international randomised trial determining if treatment with enzalutamide can improve survival and quality of life in people starting hormone treatment for newly diagnosed prostate cancer that has spread beyond the prostate.

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

It involved 1,125 participants from Australia, New Zealand, Canada, the US, Ireland, and the UK. In June 2019 ANZUP reported that the ENZAMET clinical trial met its primary endpoint of improved survival at the planned first interim analysis. People with metastatic hormone sensitive prostate cancer (mHSPC) received enzalutamide or non-steroidal anti-androgen therapy (NSAA: bicalutamide, nilutamide, or flutamide) in addition to standard of care therapy (androgen deprivation therapy, ADT), with or without docetaxel chemotherapy. The ENZAMET trial showed a 33% improvement in overall survival and a 60% improvement in progression-free survival, for people who received enzalutamide. This translated into 80% chance of survival at 3 years with enzalutamide versus 72% with NSAA. The research looked into the effects of enzalutamide on overall survival plus or minus early docetaxel, in participants aged less than 70 years versus greater than or equal to 70 years. The study was presented by Professor Lisa Horvath.

The commonest kind of advanced kidney cancer is called clear cell kidney cancer. Immune therapies have been shown to be effective in about a quarter of patients with advanced clear cell kidney cancer after the standard tablet treatment has failed. This study will test if a drug (denosumab) usually used to treat osteoporosis (thinning of the bones) or cancer that has spread to the bones, can be added to the immune therapy to increase the ability of the body’s immune system to attack kidney cancer PROF. LISA HORVATH

About ESMO: ESMO is the leading professional organisation for medical oncology. With more than 30,000 members representing oncology professionals from 168 countries worldwide, ESMO is the society of reference for oncology education and information.

DR CAROLE HARRIS

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ANZUP Trial Highlights

DASL-HiCaP reached recruitment target: a milestone in the fight against prostate cancer

In April 2020, right at the beginning of the COVID-19 pandemic, our DASL-HiCaP trial opened and recruited its first patient.

Earlier this year the trial reached its recruitment target of 1,100 patients from around the world – Australia, New Zealand, Canada, the US, Ireland, and the UK – a great achievement!

“The ability of the DASL-HiCaP team to adapt in real time and meet the needs of study conduct while also meeting the challenges and unknowns of a pandemic was remarkable,” said Professor Christopher SweeneyDASL-HiCaP Co-Chair.

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

Prostate cancer remains the most common cancer in Australia and the leading cause of cancer-related mortality for people in developed countries.

The phase 3 study aims to demonstrate that the addition of the new potent oral hormonal therapy, darolutamide, to the standard radiation therapy and testosterone suppression improves the outcomes of people with localised high-risk prostate cancer.

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Outcomes of the trial will be measured in terms of whether the addition of darolutamide decreases the risk of spreading prostate cancer to other parts of the body, as well as improving quality of life and potentially decreasing the risk of prostate cancer death.

“At ANZUP we remain committed to running our clinical trials and delivering the best standard of care for those people impacted by genitourinary cancers.

COVID-19 presented challenges to each and every one of us across the globe, as it had with the day to day running of our trials, and the safety of our patients and site personnel remained our top priority.”

“We know clinical trials are the only way to find out the safety and effectiveness of new treatments and whether they should become the new gold standard for treatment in the future. It is very pleasing to see our DASL-HiCaP trial reach recruitment, and help us move closer to our goal of improving outcomes for those people with high risk, clinically localised prostate cancer,” said ANZUP Chair, Professor Ian Davis.

ANZUP Trial Highlights

ANZadapt – a simple but radical approach to prostate cancer care In 2023, it is estimated that over 25,000 new cases of prostate cancer will be diagnosed in Australia. ANZUP member Associate Professor Craig Gedye is leading a clinical trial into new ways of treating prostate cancer. In recognition of September as Prostate Cancer Awareness Month, Associate Professor Gedye spent time with Dr Ginni Mansberg on 2GB’s Healthy Living show to talk about the important prostate cancer trial ANZadapt.

A/Prof Craig Gedye Associate Professor Craig Gedye is a medical oncologist and cancer researcher. He works for people with melanoma, brain, prostate, bladder and kidney cancers. He is the chair of the ANZadapt trial, which is currently recruiting participants.

Dr Ginni Mansberg Ginni Mansberg is a well known celebrity doctor in Australia, with nearly 30 years of experience as a Sydney GP. Her special interest in menopause inspired her bestselling book, ‘The M Word, How to Thrive in Menopause.’ She is also a co-founder of the Asia Pacific HPV Coalition.

Dr Mansberg: Why is there more prostate cancer diagnosis than ever in Australia today?

A/Prof Gedye: The fact is that Australia’s population is getting much bigger and growing older. There are actually fewer people on average being diagnosed with prostate cancer while the individual case numbers are going up. We’re all living longer which allows more time for these types of things to develop.

The good news is though, that because of improving knowledge and treatment, a lot more people are living longer with prostate cancer. Up to 95% of men diagnosed today with prostate cancer will live for 5 years after diagnosis. That is an improvement from only about two thirds in the early 1990s.

Dr Mansberg: What are some of the symptoms of prostate cancer?

A/Prof Gedye: Often the symptoms can be changes in the “water works” which can be quite subtle. Trouble urinating, urinating more often, getting up in the middle of the night to urinate and sometimes more worrying symptoms like blood in the urine.

Dr Mansberg: Can you tell us more about the controversial screening process?

A/Prof Gedye: I always like to look at this from a “third option” perspective. Public health people often say that we are detecting too many cancers that are not important and we are putting a lot of people through treatment that they don’t need. People that treat cancer patients are saying that we are missing out on opportunities to treat people and to treat people early. The reality is that the PSA blood test is a good test in many ways, but it is not perfect. What we need is a much better test to detect the right cancers, the cancers that are important that are going to cause troubles for patients. We need a test that is going to be able to distinguish between those and those that are much milder. The reality is that prostate cancer is more likely to develop as you get older, and you may not even be aware of it.

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Dr Mansberg: How has treatment for prostate cancer changed over the years?

A/Prof Gedye: Quite a lot. It really depends on the situation that each person finds themselves in. that is why it is really important to understand perspectives from everyone involved with prostate cancer care.

Sometimes a prostate cancer is slow and “sleepy”.

These types of cancers should be left alone without any immediate treatment, just careful surveillance with a urologist. Some cancers are important and should be removed with surgery. There are also some even more aggressive prostate cancers that should be treated with radiation alone and not with surgery.

It is really important for someone with a prostate cancer diagnosis to speak to all of the doctors and nurses involved in their care to find out what is the best decision for them.

Dr Mansberg: Do “sleepy” cancers ever change and become more important?

A/Prof Gedye: Absolutely and that is why careful surveillance is a must. There are a lot of urologists who are very good at this. With the benefit of new kinds of MRI scans that help us look at the prostate gland, they can make the decision to act at the right time.

Dr Mansberg: Can you tell us more about the ANZadapt trial?

A/Prof Gedye: ANZadapt is being run by ANZUP and funded by The Anti-Cancer Fund, a charity from Belgium.

The trial currently open in 10 hospitals across Australia and another 6 hospitals in the Netherlands. We are testing a simple but very radical idea.

Cancer constantly evolves. This evolution may even be accelerated by treatments such as radiation, chemotherapy, targeted or hormonal therapy. One therapeutic strategy to mitigate this evolutionary change

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is called ‘adaptive therapy’. Adaptive therapy can be considered when using an effective but non-curative treatment. Treatment is used sparingly, for just long enough to control the cancer and maintain quality of life, but paused as soon as control is achieved. ‘Adapting’ the treatment to each patient aims to increase the duration of benefit, by using treatment-sensitive cancer cells to compete with, and control, treatment-resistant cancer cells. By changing the goal of therapy from “achieve the deepest/quickest short-term biochemical/radiological response” to “delay inevitable treatment resistance” we hope to prolong each patient’s life and quality-of-life as much as possible.

We started with a small pilot clinical trial at Calvary Mater in Newcastle which was funded by the Below the Belt research fund. The aim of this study was to confirm or extend the outcomes of another small trial done in the United States. We used this pause and go treatment idea on 20 patients who volunteered to participate.

We were able to keep the patients just as well with no worse symptoms or side effects. It seemed, compared to historical treatment methods, that we were able to keep the cancer controlled for quite a lot longer. ANZadapt is the next step, and it is a really important trial because it is a randomised trial. Half of the participants will take the tablet every day, and the other half will be asked to adopt the pause and go treatment method. The trial has just started and we are in the early stages of recruitment and it will take some time to complete.

If we’re right, it will take an existing treatment and make it better which will change the way we treat prostate cancer.

Maybe even more importantly this approach could translate to other treatments and other cancers. We might be able to use existing treatments with better effects and keep people alive for longer.

If you have a prostate cancer diagnosis and would like to learn more about this trial, please visit https://anzup. org.au/clinical-trial/anzadapt/

ANZUP trials prostate Principal Investigator: Associate Professor Craig Gedye

ANZadapt ANZUP 2101 Status: Open & recruiting Location: Australia wide Activated sites: 9 Patients recruited: 12 • Patients required: 84

Cancer constantly evolves. This evolution may even be accelerated by treatments such as radiation, chemotherapy, targeted or hormonal therapy. One therapeutic strategy to mitigate this evolutionary change is called ‘adaptive therapy’. Adaptive therapy can be considered when using an effective but non-curative treatment. Treatment is used sparingly, for just long enough to control the cancer and maintain quality of life, but paused as soon as control is achieved.

‘Adapting’ the treatment to each patient aims to increase the duration of benefit, by using treatmentsensitive cancer cells to compete with, and control, treatment-resistant cancer cells. By changing the goal of therapy from “achieve the deepest/quickest short-term biochemical/radiological response” to “delay inevitable treatment resistance” we hope to prolong each patient’s life and quality-of-life as much as possible.

Mathematical models suggest substantial benefits may be possible. In a pilot clinical trial of adaptive abiraterone in castrate-resistant prostate cancer in the US, patient survival almost doubled compared to contemporaneous and historical controls.

These provocative findings must be tested in a prospective randomised clinical trial. We hope that the ANZadapt trial will provide the evidence to change practice and improve survival in people with metastatic castration-resistant prostate cancer.

For more information please go to the trials page on the ANZUP website: https://anzup.org.au/clinical-trial/anzadapt/ Active sites: NSW • Calvary Mater Newcastle • GenesisCare Northern Cancer Institute St Leonard’s • Border Medical Oncology Research Unit • Chris O’Brien Lifehouse – Sydney Local Health District • Sydney Adventist Hospital QLD • Mater Cancer Care Centre, Mater Misericordiae Ltd • Sunshine Coast University Hospital SA • Royal Adelaide Hospital – Central Adelaide Local Health Network Inc. WA • Fiona Stanley Hospital Pending Sites: • ICON Cancer Centre, Adelaide

The ANZadapt Trial is an investigator-initiated trial sponsored and led by ANZUP. This trial has received funding from a philanthropic grant awarded by the Anticancer Fund (ACF) in Belgium. This trial is a collaboration between ANZUP, the Hunter Medical Research Institute (HMRI) Clinical Trials Unit and the Leiden University Medical Center (LUMC).

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ANZUP trials - prostate

DIPPER

Principal Investigators: (From left)

Associate Professor Matt Roberts and Professor Louise Emmett

ANZUP 2002 Status: Open & recruiting Location: Australia wide Activated sites: 5 Patients recruited: 0 • Patients required: 110

While removal of the prostate is an effective treatment for many individuals with prostate cancer, around one third of people will experience return of their cancer (recurrence).

Commonly, this is diagnosed when a blood test called prostate specific antigen, or PSA, becomes elevated.

Provided there is no spread of cancer seen on scans, a ‘watch and wait’ surveillance approach, or radiotherapy are both reasonable treatment pathways in individuals deemed to be at low risk of further spread.

However, no-one knows yet what is the best treatment in this situation. While radiotherapy can be effective, it can result in side effects, and these can affect quality of life. It might be possible that personalised selection of individuals for surveillance using blood tests and newer imaging tests, such as PSMA PET scans, might identify a group of people who do not need additional radiation or other treatments and might be able to have similar outcomes for the cancers without the side effects.

The DIPPER trial will compare cancer control and quality of life outcomes for individuals receiving either radiotherapy or surveillance following recurrence of their cancer after personalised patient selection, utilising the new imaging test and other clinical information.

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The DIPPER trial is an investigator-initiated trial sponsored and led by ANZUP. This trial has received funding through ANZUP’s Discretionary Funding.

This trial is a collaboration between ANZUP and The George Institute for Global Health who are providing operational, statistical and data management services.

For more information please go to the trials page on the ANZUP website: https://anzup.org.au/clinical-trial/dipper/ Active sites: NSW • Royal North Shore Hospital – Northern Sydney Local Health District • St Vincent’s Hospital – Sydney VIC • Peter MacCallum Cancer Centre QLD • Royal Brisbane & Women’s Hospital • Redcliffe Hospital

ANZUP trials - prostate

GUIDE

Principal Investigator: Associate Professor Kate Mahon

ANZUP 1903 Status: Open and recruiting Location: Australia wide Activated sites: 8 Patients recruited: 6 • Patients required: 120

The purpose of this study is to see if a prostate cancer marker in the blood (mGSTP1) can be used to guide chemotherapy treatment. Based on the level of this blood marker, some people may be able to have breaks in treatment rather than having chemotherapy continuously which is the current standard of care. This study will tell us if having these treatment breaks guided by mGSTP1 can improve how people feel during treatment while still treating the prostate cancer effectively.

Current locations for the GUIDE trial:

GUIDE is an investigator-initiated study sponsored and led

by ANZUP. The study is funded by ANZUP Discretionary Funding Initiative, ANZUP Below the Belt Research Fund and Chris O’Brien Lifehouse Philanthropic Fund.

VIC • Goulburn Valley Health • Frankston Hospital • Peninsula Health • St Vincent’s Hospital – Melbourne

For more information please refer to https://anzup.org.au/clinical-trial/guide/

AUSTRALIA NSW • Border Medical Oncology • Chris O’Brien Lifehouse • Concord Repatriation General Hospital • Dubbo Base Hospital • St Vincent’s Hospital – Sydney

“The GUIDE study is investigating how we can use a blood marker to optimise chemotherapy treatment in metastatic prostate cancer.

Using this marker, we aim to personalise chemotherapy to minimise side effects and improve quality of life while ensuring that treatment is still effective.”

Associate Professor Kate Mahon, GUIDE Principal Investigator

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Co-badged trials - prostate Principal Investigators:

NINJA

(From left)

Professor Jarad Martin and Dr. Mark Sidhom

Status: Open & recruiting Location: Australia and New Zealand Activated sites: 22 Patients recruited: 277 • 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.

Current locations for the NINJA trial:

This study will include 474 people. Currently we have active sites across Australia and New Zealand with 120 patients currently enrolled.

VIC • Peter MacCallum Cancer Centre (Parkville)

This trial is open and recruiting. If you are interested in participating in the trial, please refer to https://anzup.org.au/clinical-trial/ninja/ 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.

NSW • Blacktown Hospital • Calvary Mater Newcastle • Campbelltown Hospital • GenesisCare Hurstville • GenesisCare Maitland • GenesisCare Newcastle • Liverpool Hospitals • Illawarra Cancer Centre • St George Hospital • Westmead Hospital

QLD • Princess Alexandra Hospital SA • Genesis Care South Australia • Royal Adelaide Hospital WA • 5D Clinics • Genesis Care Fiona Stanley Hospital • Sir Charles Gairdner Hospital NEW ZEALAND • Waikato Hospital NZ

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Spotlight on bladder and urothelial cancer What is bladder cancer?

The bladder is a hollow organ in the pelvis that holds urine before it is eliminated by the body during urination. This function makes the bladder a crucial part of the urinary tract. The urinary tract is also made up of the kidneys, ureters, and urethra. The renal pelvis is a funnel-like part of the kidney that collects urine and sends it into the ureter. The ureter is a tube that runs from each kidney into the bladder. The urethra is the tube that carries urine out of the body.

The prostate gland is also part of the urinary tract.

The bladder, like other parts of the urinary tract, is lined with a layer of cells called the urothelium.

This layer of cells is separated from the bladder wall muscles, called the muscularis propria, by a thin, fibrous band called the lamina propria.

Bladder cancer starts when healthy cells in the bladder lining – most commonly urothelial cells – change and grow uncontrollably, forming a mass called a tumour.

Urothelial cells also line the renal pelvis and ureters.

Cancer that develops in the renal pelvis and ureters is also considered a type of urothelial cancer and is often called upper tract urothelial cancer. In a lot of cases, it is treated similarly to bladder cancer.

A tumour can be cancerous or benign. A cancerous tumour is malignant, meaning it can spread and grow to other parts of the body. A benign tumour means the tumour can increase in size but will not spread. Benign bladder tumours are quite rare.

Types of bladder cancer Bladder cancer takes different forms*: • urothelial 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 • squamous cell carcinoma begins in the thin, flat cells that line the bladder • adenocarcinoma is a rare form which starts in mucusproducing cells in the bladder. * other rarer variants are also found

Bladder cancer may be limited to the lining of the bladder (non-muscle invasive bladder cancer, NMIBC), invade the bladder wall (muscle invasive bladder cancer, MIBC) or spread further to lymph nodes or other organs (advanced or metastatic bladder cancer).

Among Australia’s 15 most common malignancies, bladder cancer remains the only one with survival rates that have worsened over the past 30 years.

Bladder cancer was the 11th most commonly diagnosed cancer in Australia in 2023, with an estimated 3,121 new cases. In addition, it was estimated there would be 1,043 deaths in Australia from bladder cancer but from 2014 - 2018 on average, 55.8% of people diagnosed with bladder cancer survived 5 years after diagnosis.*

Bladder cancer can be treated effectively if found early and before it spreads outside the bladder.

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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 Environmental risk factors are thought to be more important than genetic or inherited susceptibility when it comes to bladder cancer. Some factors that can increase the rise of bladder and urothelial cancer include: • smoking; • older age; • family history; • diabetes treatment using the drug pioglitazone; • workplace 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 early-stage 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 67-68.

The worsening bladder cancer survival rates over the past 30 years 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. Early identification and referral can lead to timely diagnosis. In addition, the hope is that novel approaches are identified through clinical trials and help reverse the trend of deteriorating survival rates in bladder cancer.

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

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ANZUP Trial Highlights

Below the belt cancer research highlights: unveiling the potential of BCG+MM 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.

Studies show promise in enhancing treatment by adding the chemotherapy drug mitomycin (MM) to current treatment with BCG (Bacillus Calmette-Guérin, a strain of modified bacteria which stimulates an immune response to early cancer cells).

The ANZUP investigator-initiated study BCG+MM assesses the impact of adding mitomycin on cure rates, survival, side effects, and quality of life, offering a potentially cost-effective solution for patients.

This study has achieved a significant milestone by successfully enrolling 501 patients from across Australia and one site in the UK. With the recruitment phase now concluded, Professor Dickon Hayne, the study chair, along with the dedicated team, are shifting their focus towards the crucial phases of data collection and comprehensive analysis

Professor Dickon Hayne Professor Dickon Hayne is a urologic surgeon who leads urological research and education in urology, at the University of Western Australia. He is Head of Urology for the South Metropolitan Health PROFESSOR DICKON HAYNE Service in WA and is the lead clinician for the Urological Tumour Collaborative of the WA Cancer and Palliative Care Network (WACPCN). Dickon Chairs the Bladder Urothelial and Penile (BUP) Cancer Sub-committee of ANZUP, is a Scientific Advisory Committee (SAC) member, leads the BCG+MM, ZipUp and SUBDUE trials and is widely engaged in ANZUP’s other subcommittees, trials and activities. His major clinical and research interests are urological cancer, in particular bladder cancer.

Q: Could you provide us with an overview of the BCG+MM trial’s objectives and key aspects?

Prof Hayne: The trial compares a standard treatment for high-risk non muscle-invasive bladder cancer (HR NMIBC) using BCG immunotherapy with a new treatment combining BCG with the chemotherapy agent mitomycin.

The drugs are put in the bladder with a catheter weekly and then monthly over a year.

The trial is randomised meaning half the patients get BCG and half get BCG+mitomycin, but who gets which is determined by chance. This removes bias and allows us to be sure any findings from the study are real.

This is one of the largest randomised controlled trials completed in this space with 501 patients recruited and we are really excited to have completed accrual.

Q: Regarding the BCG+MM trial, how do cure rates, survival, side effects, and quality of life currently appear?

Prof Hayne: I wish I could tell you or indeed knew the results of the study myself! The results can only be looked at when the last patient in the study has been followed up for 1 year (May 2024).

We do know that both treatments are safe because an independent drug safety monitoring committee has been checking on things throughout the duration of the trial. We will definitely be publishing the results once they are known.

If BCG+MM performs better than BCG alone, this may change global practice in the initial treatment of HR NMIBC.

A LITTLE BELOW THE BELT 49

Q: In your opinion, what are the most pressing challenges in the field of bladder cancer research and treatment?

Prof Hayne: In the HR NMIBC setting, we need better and alternative treatments to BCG. BCG though effective is toxic and we still have a global shortage affecting supply. Several new treatments are emerging, but they need to be properly tested in large high quality clinical trials.

With muscle-invasive bladder cancer (MIBC), we need to have better centralisation of care in ‘high volume centres’.

Surgery to remove the bladder (cystectomy) is an effective treatment but research shows that results are better when more cases are treated in any particular centre.

If you are offered surgery to remove the bladder, ask your surgeon how many cases they do per year and how many are done in their centre.

Internationally recognised guidelines state that centres should do at least 10 ideally 20 cases per year.

50 A LITTLE BELOW THE BELT

PROFESSOR DICKON HAYNE

Q: What are some common misconceptions about bladder cancer, and how can individuals better understand the disease to detect it early and receive effective treatment?

Prof Hayne: Bladder cancer is much more common than many people realise. It is more common in men, but women tend to have worse outcomes after diagnosis and treatment. The numbers of male deaths from bladder cancer are very similar to male deaths from malignant melanoma which is a cancer many more people have heard of.

Smoking is the most common identifiable cause but other factors such as family history and exposure to chemicals are other causes.

Blood in the urine is the most common symptom of bladder cancer.

If you see blood in the urine even once, your doctor should refer you to a urologist to consider a cystoscopy.

This is a simple local anaesthetic test that takes 5 minutes and can easily find or rule out a bladder cancer.

If bladder cancer is found early, it is much easier to cure.

Show your support of below the belt cancer research and buy a pair (or three)!

AVAILABLE NOW on the Sydney Sock Project website sydneysockproject.com/collections/anzup

Show us how you choose to wear your socks on social media using the hashtag #SSPANZUP

Spotlight on testicular cancer The testicles are part of the reproductive system. There are normally two testicles, and they are located under the penis in a pouch called the scrotum. They can also be called gonads or testes.

The testicles produce sperm and testosterone. Testosterone is a hormone that plays a role in the development of masculine characteristics and the reproductive organs.

31

1000

estimated diagnoses

estimated deaths

in Australia in 2023

from testicular cancer in 2022

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.

Testicular cancer is not a common cancer but it is the second most common cancer in young men (aged 20 to 39) excluding non-melanoma skin cancer. The average age at diagnosis is 37 years old. However, this form of cancer is highly treatable, even when cancer has spread beyond the testicle.

The most common testicular cancers are germ cell tumours. There are two main types, seminoma and nonseminoma. Seminoma usually occurs between the ages of 25 and 45 years and tends to develop more slowly than non-seminoma cancers. Non-seminomas are more common in younger people, usually in their late teens or early 20s.

It is estimated that 1,000 people were diagnosed with testicular cancer in 2023. The average age at diagnosis is 37 years old.

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In 2022 a total of 31 deaths from testicular cancer were estimated. In 2014 - 2018, on average 97.3% of those diagnosed with testicular cancer survived 5 years after diagnosis.

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

Less common symptoms include: • Feeling of heaviness in the scrotum; • Change in the size or shape of the testicle; • Pain or ache in the lower abdomen, the testicle or scrotum; • Back pain; • Feeling of unevenness; • Tenderness or tenderness of the breast tissue (due to hormones created by cancer cells).

Self-checking is so important – because if found early, testicular cancer is one of the most curable cancers.

Spotlight on testicular cancer Causes of testicular cancer A couple of factors that may increase a person’s risk of testicular cancer include an undescended testicle as an infant, or family history, mainly having a close relative who has had testicular cancer.

In addition, personal history may contribute to testicular cancer. If you have had cancer in one testicle you are more likely to develop cancer in the other testicle. It is also found that infertility may be another possible cause.

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 • the type of testicular cancer

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

Testicular cancer clinical trials 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 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. You can also read about ANZUP’s trials on the following pages.

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

• 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.

Understanding testicular cancer, the treatments available and possible side effects can help you decide your treatment pathway. You may also want to talk to your doctor about how treatment for testicular cancer may affect your fertility.

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.

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

AALITTLE LITTLEBELOW BELOWTHE THEBELT BELT 53 53

Meet James Norrish – a testicular cancer survivor and ANZUP trial participant James Norrish is a vibrant young man from the Northern Beaches of Sydney who has played sports to a high level, including playing first class rugby.

Back in March of 2023, James was diagnosed with testicular cancer after discovering a lump. Coming out the other side relatively unscathed, he reflected on the experience and the support that was given to him while participating in an ANZUP clinical trial. James has an ambition to raise awareness and funds for clinical trials, kickstart the conversation around testicular cancer and encourage others to get checkups.

and ‘Am I going to get really sick?’

I remember a thousand questions storming through my head and started blowing them out to Matt Winter, my Urologist, who answered them one by one. He brought out a big ANZUP textbook. He told me to read it and take photos of the most informative pages, which gave me comfort. I went from ‘Am I going to die?’ to ‘Life is going to carry on and I will be okay.’

But the follow-up scans were genuinely harrowing. I was fine “GRAB LIFE BY THE BALL!” – JAMES NORRISH before, but as I sat on the table, all my worries came back. My brain convinced me I was going to be in trouble. I asked them Can you provide a snapshot of your life before your to call me the second the results come though. I cried diagnosis? What were you doing, and how did your with relief, realising I had been worrying subconsciously. diagnosis change things?

My oncologist, Gavin Marx, helped me return to the I was 27 when I found the lump, and I was leading my mindset of feeling lucky. He told me that it was very normal life. I had just completed a full preseason for normal to feel the way I did during the first scan. That the Shute Shield, so I was feeling fit, really strong and helped massively. healthy. I actually didn’t have anything to worry about, I What treatment did you receive initially? And what is was just enjoying life and living it up. I was going to the the trial that you are on? gym, training, having fun on the weekends, going back to work on Mondays, doing it all over again. Then all of a sudden, the world got turned upside down with an influx of appointments.

What were the symptoms and what led you to your diagnosis?

I didn’t have a single symptom. I didn’t feel down, I didn’t feel sick and I didn’t feel tired. It was sheer coincidence.

A friend mentioned his testicular pain and he was going to get it looked at. About a week later, while adjusting myself, I felt something hard and found a lump.

I was very close to playing the ‘she’ll be right’ card, but the conversation with my friend prompted me to get checked the next day and it kicked off the whole process.

How did you feel when you initially received your diagnosis?

James: My heart kind of sank, and my stomach did a little bit of a front flip, I didn’t feel sad, I just felt a little bit grim. I immediately turned to questions like ‘Am I going to die?’, ‘What is life going to look like from here?’

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James: The initial treatment was a radical left orchiectomy, which is essentially the removal of my left testicle. Now, I’m enrolled in a surveillance program designed by ANZUP. This is why I have such a soft spot for this organisation, and why it was a no-brainer to raise money for their research.

They’ve made my life so easy. Without their research, we wouldn’t know that it’s okay to not do chemotherapy straight away after testicular cancer. We wouldn’t know what those options are and how to weigh them up.

The study I’m on is called CLIMATE, and it’s not solely about me, it’s related to research that can benefit future patients.

They’re conducting additional blood tests beyond the standard ones. In the future, this could be the blood test that helps understand the likelihood of a recurrence of testicular cancer.

What advice would you give someone who is just starting on their cancer journey?

James: Taking charge of what you can control is the best way to avoid going off the rails. For me, it meant seeking help, seeing a psychologist, understanding my own head, eating good food and, of course, staying active. Controlling the controllables kept me in a good headspace. If you’re not comfortable discussing it with friends or family, there are services available, such as helplines and support groups, to help you navigate the situation.

Apart from controlling what you can, one of the big things that got me through was picturing the day I didn’t have cancer. I pictured celebrating with mates and having a party when it was all over. I aimed to get back to playing footy, telling myself it wouldn’t define me. I’d get fit and strong enough to hit the footy field again.

Visualising those things kept me going.

So, to anyone out there, do your best to control what you can, reach out for help and picture what life will be like when it’s all done.

Life will be sweet at some point.

charity to support. Gavin didn’t even take a breath before he said ‘ANZUP. It’s got to be ANZUP.’ Everything I had been through started to click. I remember seeing the ANZUP magazine, the ANZUP recommendations and the ANZUP surveillance program - it all just clicked in my head.

So, that made me send an email the next day, where I was then introduced to the ANZUP CEO, Margaret. We had an initial discussion and it kicked off this process from there.

Why should people get involved?

James: I can’t tell you the number of conversations I’ve had that have brought to my attention how common it is. I’ve had a friend whose mate had testicular cancer, a different mate’s dad who had testicular cancer and then I’ve got another friend whose brother has just been diagnosed with testicular cancer.

The chances are that somebody you know will be affected by urogenital cancer in their lifetime and you’d want them to have a better outcome. ANZUP’s research has played a significant role in providing people, like myself, with an optimistic outlook.

I encourage everyone to help raise awareness and get involved in the event. It doesn’t take a lot. You don’t have to be the hero who donates $10,000, or the one who swims 10 km. Simply give what you can and do what you can. Every dollar counts, every metre counts, and you can be a part of something to genuinely make a difference.

The work ANZUP does is vital. It has and will continue to help so many young Australians.

They’re doing incredible work and will continue to do so, but this relies on funding.

Similarly, what is your message to those who aren’t regularly checking for irregularities?

James: Whether you check or not, they’re there. Whether you actively search for them but prefer to ignore the signs, they’re still there. I’m a big advocate for catching things early. I nabbed it early and lost a nut, but it hasn’t thrown me off, everything’s ticking along, and I’m not in any real strife.

The reality is that in Australia 1 in 181 people will be diagnosed with testicular cancer in their lifetime. But you can make a massive difference by doing monthly checks.

What is your involvement with ANZUP now?

James: I’m working with ANZUP to launch a community relay fundraising event called ‘Below the Belt - Relay 181’ in 2024. My mates and I will be swimming the first 100km and asking for support from the community to jump in the pool combining to swim a further 81km.

Stay tuned for more information about:

My journey with ANZUP started when I visualised how I could help and realised I wanted to do something. I remember my first or second appointment with Gavin, I told him I wanted to do something to raise awareness and money. But I didn’t know the right research group or

A LITTLE BELOW THE BELT 55

ANZUP trials - testicular

Principal Investigator: Associate Professor Ben Tran

CLIMATE ANZUP 1906 Status: Open & recruiting Location: Australia and New Zealand Planned sites: 12 Patients recruited: 96 • Patients required: 200

Testicular cancer is the most common cancer diagnosed in people aged between 15 and 39 in Western countries, however it can occur at any age. Most people diagnosed with testicular cancer will have cancer confined to the testicle, without evidence of spread to other areas of the body. These people are highly likely to be cured following surgical removal of the testicle (orchidectomy) alone, and most will not require additional chemotherapy or radiotherapy. Sometimes, a person with testicular cancer may choose to undergo preventive chemotherapy or radiotherapy, which reduces the risk of their cancer coming back; however, this may result in long-term side effects for some people.

For this reason, most people in Australia are recommended “active surveillance,” which involves regular reviews with their doctor, computerised tomography (CT) scans and blood tests, but no chemotherapy or radiotherapy.

With this approach, most will be spared from unnecessary treatment and side effects. However, a small number of these will have recurrent cancer detected during active surveillance. Reassuringly, these people are also highly likely to have a positive outcome following additional treatment.

A new blood test, micro-ribonucleic acid (miRNA), which evaluates a protein commonly found in testicular cancer is under investigation. Early studies have found that miRNA is detectable in blood samples of people who have known testicular cancer.

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CLIMATE is an investigator-initiated research project led by ANZUP in collaboration with the Walter and Eliza Hall Institute for Medical Research (WEHI). This study has been co-funded by the ANZUP Cancer Trials Group Discretionary Funding Initiative and WEHI. For more information please go to the trials page on the ANZUP website: https://anzup.org.au/clinical-trial/climate/ Current locations for the CLIMATE trial: NSW • Chris O’Brien Lifehouse – Sydney Local Health District • Southside Cancer Care Centre • St Vincent’s Hospital – Sydney VIC • Eastern Health • Epworth Hospital • Peter MacCallum Cancer Centre QLD • Royal Brisbane & Women’s Hospital NEW ZEALAND • Te Whatu Ora Southern – Dunedin Hospital

Principal Investigator: Associate Professor Peter Grimison (ANZ)

P3BEP

ANZUP trials - testicular

ANZUP 1302 Status: Active & recruiting Location: Australia wide & Internationally Activated sites: 102 Patients recruited: 282 • 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”.

For more information, please go to the trials page on the ANZUP website: https://anzup.org.au/ clinical-trial/p3bep/ 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 • Chris O’Brien Lifehouse • Nepean Hospital • Prince of Wales Hospital • Calvary Mater Newcastle • C oncord Repatriation General Hospital • Macquarie Cancer Clinical Trials QLD • Princess Alexandra Hospital • Royal Brisbane & Women’s Hospital • Queensland Children’s Hospital SA • Royal Adelaide Hospital • Flinders Medical Centre

TAS • Royal Hobart Hospital VIC • Peter MacCallum Cancer Centre • Border Medical Oncology • Austin Health • Box Hill Hospital WA • Fiona Stanley Hospital NEW ZEALAND • Auckland Hospital • Christchurch Hospital • Starship Hospital – Paediatric • Palmerston North Hospital • C hristchurch Children’s Haematology Hospital UK • Royal Marsden Hospital • University Hospital Southampton • St James’s Hospital – Leeds • Cambridge University Hospital Paediatric • Royal Preston Hospital • Beatson West of Scotland Cancer Centre • Belfast City Hospital • Nottingham University Hospital • St Bartholomew’s Hospital • Bristol University Hospital • Velindre Hospital • Derriford Hospital, Plymouth • Northern General Hospital • Aberdeen Royal Infirmary • University College Hospital, London • The Christie USA • Memorial Sloan Kettering Cancer Center • L ucile Packard Children’s Hospital Stanford • U SC / Norris Comprehensive Cancer Care • W ashington University School of Medicine • Rady Children’s Hospital • Geisinger Medical Center • University of Texas Science Center at San Antonio • Carolinas Medical Center • Advocate Children’s Hospital – Park Ridge • Advocate Children’s Hospital – Oak Lawn

• Mayo Clinic • Driscoll Children’s Hospital • Wake Forest University Health Sciences • UT Southwestern Simmons Cancer Center • Dell Children’s Medical Center • Augusta University Medical Center • Vanderbilt University Medical Center • Memorial Health University Medical Center • University of Mississippi 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 • Broward HealthCare • Dana Farber Cancer Center • L A Biomedical Research Institute at Harbor– UCLA • Dayton Children’s Hospital • Loma Linda University Medical Center • University of Iowa • Presbyterian Hospital New Mexico • Saint Mary’s Hospital • Hackensack University Medical Center • P rovidence Sacred Heart Medical Center and Children’s Hospital • U niversity of Minnesota/Masonic Cancer Centre • T ufts Children’s Hospital • D artmouth-Hitchcock Medical Center • C hildren’s Hospital of Alabama • A nn & Robert H. Lurie Children’s Hospital • N YU Winthrop Hospital • K aiser Permanente Downey Medical Center • C hildren’s Healthcare of Atlanta - Egleston • C hildren’s Hospitals and Clinics of Minnesota • G olisano Children’s Hospital of Southwest Florida • Y ale University • J ohns Hopkins University/Sidney Kimmel Cancer Center • U niversity of Alberta Hospital • B I-LO Charities Children’s Cancer Centre • M assachusetts General Hospital Cancer Center • R utgers Cancer Institute

A LITTLE BELOW THE BELT 57

Spotlight on kidney cancer People usually have two kidneys, located in the abdomen above the waist on either side. These bean-shaped organs are each about the size of a small fist and are located closer to the back of the body than to the front.

Each kidney works independently so the body can function with less than one complete kidney.

The kidneys filter blood to remove excess minerals, salts and impurities, as well as extra water. Blood pressure, red blood cell production, and other bodily functions are controlled by hormones produced by the kidneys.

In 2023 it is estimated:

4,682

diagnoses

of kidney cancer in Australia

What is kidney cancer?

Kidney cancer has become increasingly more commonly diagnosed and survival rates continue to improve. This cancer is the 7th most diagnosed cancer in Australia, with an estimated 4,682 new cases in 2023. Kidney cancer is rare in people under 40 but risk does increase with age.

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.

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most diagnosed cancer in Australia

Other types of kidney cancers include: • Urothelial carcinoma. This is also called transitional cell carcinoma. It constitutes 5% to 10% of the kidney cancers diagnosed in adults. Urothelial carcinoma begins in the area of the kidney where urine collects before moving to the bladder, called the renal pelvis. This type of kidney cancer is treated like bladder cancer because both types of cancer begin in the same cells that line the renal pelvis and bladder.

• Wilms tumour is most common in children and is treated differently from kidney cancer in adults. About 1% of kidney cancers are Wilms tumors. A different approach to treatment is used for this type of kidney cancer. This type of tumour is more likely to be successfully treated with radiation therapy and chemotherapy than the other types of kidney cancer when combined with surgery.

• Sarcoma of the kidney is rare. This type of cancer develops in the soft tissue of the kidney, i.e. the thin layer of connective tissue surrounding the kidney, called the capsule; or surrounding fat. This form of kidney cancer is usually treated with surgery.

However, sarcoma commonly comes back in the kidney area or spreads to other parts of the body. After the first surgery additional surgery or chemotherapy may be recommended.

Spotlight on kidney cancer In 2022, it is estimated there will be 912 deaths from kidney cancer and the five year survival rate from 2014 - 2018, for Australians diagnosed with kidney cancer was 80.7%, although most people with kidney cancer localised only to the kidney can be cured.

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

• Inherited conditions – About 3–5% of kidney cancers occur in people with particular inherited syndromes, such as von Hippel-Lindau disease, Birt-Hogg-Dubé syndrome, and hereditary papillary RCC.

Kidney cancer symptoms

• Exposure to toxic substances at work or in the environment – After regular exposure to certain chemicals, such as arsenic, cadmium or some metal degreasers, the risk of kidney cancer may be higher.

In its early stages, kidney cancer often does not produce any symptoms. Many are diagnosed with the disease when they see a doctor for a different reason.

Symptoms may include:

Treatment options

• blood in the urine (haematuria); • pain or a dull ache in the side or lower back that is not due to an injury;

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 multidisciplinary cancer care team.

• 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.

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

Treatment for kidney cancer is provided by a multidisciplinary team, comprising a urologist, urologic oncologist, medical oncologist and radiation oncologist. 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.

• Obesity – Excess body fat may alter certain hormones that can lead to kidney cancer.

Clinical trials

Causes of 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.

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 more kidney cancer patients. 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.

• 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.

If you have already had one or more forms of cancer treatment and are looking for a new treatment option, you may be suitable for a clinical trial. 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 kidney cancer trials: https://anzup.org.au/clinical-trials/kidney-cancer-trials/

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

A LITTLE BELOW THE BELT 59

Treatment choices and decision making Associate Professor David Pook and his patient, Juliet De Nittis, engaged in a discussion about Juliet’s battle with kidney cancer and her participation in a clinical trial under the guidance and support of David.

Who is Juliet De Nittis?

I am a success story. I would not be here today without the immunotherapy treatment I received from an ANZUP clinical trial.

“I firmly believe a clinical trial saved my life” Juliet says.

There is no good day to hear ‘you have cancer.’ But for Juliet it was the worst possible timing.

On the eve of her daughter’s 16th birthday, she was diagnosed with kidney cancer.

Juliet put on a brave face to avoid upsetting her daughter, her heart was silently breaking.

Doctors only gave her a year or two to live, at the most.

As more results came back, that was reduced to just 8 months. “It was a shock,” Juliet says. “I wanted to live.”

While Juliet had stomach and back pain, for many, kidney cancer has no symptoms at all. And the disease is increasingly common.

Juliet’s type of kidney cancer was aggressive and considered untreatable. It covered her whole kidney and had already spread to her lungs.

The opportunity to be on the ANZUP’s UNISoN trial gave her some hope to cling to. For the trial, Juliet took an immunotherapy drug, nivolumab, which primed her immune system to recognise and destroy her cancer cells.

‘Now, incredibly, after 2 years of immunotherapy treatment and another year of treatment free, my cancer is still in remission, stable and the latest scan unbelievably revealed: “Lungs Clear!!”; my expiry date has expired!’

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About A/Prof David Pook Associate Professor David Pook specialises in the treatment of prostate, kidney, bladder, and testicular cancers.

He is the principal investigator on multiple international clinical trials treating urological cancers with experimental drugs including novel combinations of immune therapy.

He is a clinical research fellow in the Prostate Cancer Research Group at Monash University where he helps develop prostate cancer models which can be used to test novel treatments. He is also the Deputy Chair of the ANZUP Renal Cell Cancer Subcommittee.

Q: What treatment plan did you put in place for Juliet?

A/Prof Pook: Juliet was an easy one, but not for a good reason, as she had non-clear cell kidney cancer.

The standard treatment was palliative care, which was not an option. The ANZUP UNISoN clinical trial had opened for non-clear cell rare cancer, so we offered this to Juliet.

Q: Juliet, when you were given this information, what went through your mind when David was explaining it all?

Juliet: I think like anyone would if you have a chance if there is some hope you take it. That was the first thing I thought, if it would work or not at least you are a part of a process for the next person that it might work for them.

A/Prof Pook: Can I just make a comment here. Juliet said that it might not work for you, but it might for the next patient. This is the reason a lot of us do medicine.

Juliet came to the clinic, and she was scared and worried that her cancer has spread. Juliet was going through the worst time of her life, and she was still thinking about other people.

Q: What information did you look at when you were trying to decide what to do?

Juliet: I did what most did. I went to google search, which can be incredibly depressing. I found asking David and the trials coordinators for information helped. I then read all the information and wrote down many questions to ask, so I felt prepared. I also felt part of the decision-making process.

Q: What has your experience of the trial been like?

Juliet: I decided to take part in the UNISoN trial and given a new immune treatment to see if it helped me.

When I discussed my options with my specialist, David, he said because of the type of cancer I had, if we had nothing to treat me with, I would be dead.

The medical staff, all of them; doctors, study coordinators, and incredible, competent, endlessly patient, fabulous nurses and auxiliary staff at Monash Clayton Clinical Trials Centre are brilliant, kind, and professional – vitally important and have helped me and fellow patients through our trial experience.

I was completely surprised by the success I have had. You wish for it, but you cannot allow yourself to truly belief it!

Q: What advice would you give other people in a similar situation?

A/Prof Pook: If anyone is thinking about participating in a clinical trial, you should ask your clinician any of your concerns, questions, and queries. It is also important to get a good picture of what the standard treatments options are, and to ask your clinician if there are any clinical trials suitable for you.

Juliet: First, I would ask the question ‘is there a trial suitable for me?’ I felt extremely lucky that there was a trial suitable for me, as it was an incredible opportunity to have the best outcome you can have.

I joined the trial not just with the hope the treatment may help me in some way but also to contribute to research for future cancer patients, and with enormous gratitude for previous cancer patients who have participated in trials that have led to my current treatment.

JULIET AND HER DAUGHTER

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Spotlight on penile cancer The penis is the external genital organ. It is composed of three chambers of spongy tissue that contain smooth muscle and many blood vessels and nerves. The corpora cavernosa makes up two of the chambers located on both sides of the upper part of the penis. The corpus spongiosum is located below the corpora cavernosa and surrounds the urethra. The urethra is the tube through which semen and urine exit the body at an opening called the meatus.

What is penile cancer?

Penile cancer symptoms

Penile cancer is a rare type of cancer and occurs on the foreskin, on the skin of the penile shaft, or the glans (head) of the penis. It occurs mostly in uncircumcised people (who still have foreskin around the head of the penis). Circumcision is the removal of the foreskin and may reduce the risk of penile cancer.

People with penile cancer may experience a variety of symptoms. Symptoms may include: • a growth or sore on the head of the penis (the glans), the foreskin or on the shaft of the penis that doesn’t heal in a couple of weeks • b leeding from the penis or under the foreskin • a hard lump on or under the foreskin

The stats*

• a n odorous discharge under the foreskin

Penile cancer is rare. In 2023, an estimated 174 new cases of penile cancer will be diagnosed. In 2014 - 2018, on average, 74.5% diagnosed with penile cancer survived 5 years after diagnosis. In 2022, the estimated agestandardised incidence rate of penile cancer is 1.2 cases per 100,000 people.

• c hanges in the colour of the skin on the penis or foreskin • t hickening of the skin on the penis or foreskin that makes it hard to pull back the foreskin • p ain in the shaft or tip of the penis • s welling at the tip of the penis • a rash on the penis or a constant red patch of skin that does not resolve • l umps in the groin due to swollen lymph nodes.

174 people

Are estimated to be affected by penile cancer in Australia in 2023.

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

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Spotlight on penile cancer Causes of penile cancer The cause of penile cancer is not known in most cases.

However, there are several risk factors.

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: • not being circumcised • smoking tobacco • increasing age • certain skin conditions such as psoriasis • HIV/AIDS • premalignant lesions/conditions • exposure to ultraviolet (UV) radiation.

Who treats penile cancer?

Based on your treatment options, you might have different doctors of various specialties on your treatment team. For penile cancer, the multidisciplinary team often includes a surgeon, a doctor called a urologist who specialises in urinary tract problems, a medical oncologist, and a radiation oncologist. Your healthcare team may also include a variety of other health care professionals, oncology nurses, social workers, pharmacists, counsellors and psychologists, dietitians, and others.

How is penile cancer treated?

Surgery is the main treatment for most people 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.

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.

Although penile cancer is a relatively rare disease, its consequences can have profound effects for the people who experience it.

Evidence supports the view that factors such as embarrassment, fear, the potential impact on sexuality and a cancer in a sexual organ all impact on patients’ seeking help, resulting in a delay in going to a healthcare professional. See your doctor early and ensure you talk about treatment and the effects on sexual health and fertility.

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Shedding light on penile cancer in Australia: an interview with A/Prof Niall Corcoran A/Prof Niall Corcoran Associate Professor Niall Corcoran is a urological surgeon and research scientist with clinical appointments at Royal Melbourne and Frankston.

He is a principal research fellow in the Department ASSOCIATE PROFESSOR of Surgery, University of NIALL CORCORAN Melbourne, where he holds the prestigious Movember – Distinguished Gentleman’s Ride Clinician Scientist Award through the Prostate Foundation of Australia’s Research Program. He is also the Research and Education Lead in GU oncology at the Victorian Comprehensive Cancer Centre and chairs the Prostate Cancer Optimal Care Pathway expert working group through the Victorian Cancer Agency. His study ‘Australian Penile Cancer Registry’ was awarded the 2023 Below the Belt Research Fund.

Q. Can you tell us a bit about penile cancer in Australia?

A/Prof Corcoran: Penile cancer is a rare malignancy with an estimated incidence of 1 in 100,000 men in Western countries. The disease is characterised by a wide range of clinical presentations, from localised and curable tumours to advanced and aggressive forms with high morbidity and mortality rates. Despite its clinical significance, there is a paucity of comprehensive data on the epidemiology, risk factors, and management of penile cancer in Australia.

Q. What is the scope of the research that you have you are undertaking in this area?

A/Prof Corcoran: To address this gap in knowledge, we are proposing the establishment of an Australia Penile Cancer Registry. The registry will serve as a centralised and standardised database of clinical and pathological information on patients with penile cancer, including demographics, tumour characteristics, treatment modalities, and outcomes.

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Q. How has the Below the Belt Research Fund enabled your work?

A/Prof Corcoran: The below the belt funding has enabled establishment of the registry which will allow for the identification of patterns and trends in the incidence, prevalence, and outcomes of penile cancer in Australia and facilitate the evaluation of the effectiveness and safety of different treatments and management strategies.

This will be built upon an existing Victorian database with globally significant retrospective series and a proven publication record. As a national registry, it will overcome barriers to access for interdisciplinary work and have a wider lens with more significant impact.

Q. What do you hope to achieve as a result of the Below the Belt Research Fund and your research?

A/Prof Corcoran: The establishment of an Australian Penile Cancer Registry will help to improve our understanding of penile cancer and reduce the burden of this disease on patients and society. The proposed registry will fill a critical gap in knowledge and provide a valuable resource for researchers and clinicians in Australia.

The proposed registry will provide a unique opportunity to advance our understanding of penile cancer biology and improve patient outcomes by identifying modifiable risk factors and optimising treatment approaches. By bringing together clinicians, researchers, and patients, the registry will facilitate collaboration and knowledge exchange and promote the development of evidencebased clinical guidelines and best practices.

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. DASL-HiCaP (ANZUP 1801) – Prostate Cancer The purpose of this study is to see if a new tablet drug, darolutamide, combined with the current best treatments, can improve outcomes for people 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 people with advanced prostate cancer.

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 thank and acknowledge Bayer for providing funding and product fo the DASL-HiCaP Trial.

The trial is now closed to recruitment, and enrolled 1,106 people from Australia, New Zealand, Canada, US, Ireland, and the UK.

2. ENZA-p (ANZUP 1901) – Prostate Cancer Enzalutamide is a potent hormone therapy that prevents testosterone from reaching prostate cancer cells, thereby stopping cancer growth. It is already widely used in people 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.

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.

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 people benefit from 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 people in this trial were randomly allocated to receive Lu-PSMA and enzalutamide, and the other half were randomly allocated to receive enzalutamide alone. There are 160 participants enrolled in this trial across Australia.

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ANZUP trials in follow up 3. ENZAMET (ANZUP 1304) – Prostate Cancer

4. ENZARAD (ANZUP 1303) – Prostate Cancer

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

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

This large, international randomised trial was undertaken to determine if treatment with enzalutamide can improve survival and quality of life in people 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 people from Australia, New Zealand, Canada, the US, Ireland, and the UK. In 2020 the ENZAMET trial won all three of the Australian Clinical Trials Alliance (ACTA) Awards. The ENZAMET trial was awarded the 2020 ACTA Trial of the Year Award, the ACTA STInG Award for Excellence in Trial Statistics and the Consumer Involvement Award.

This landmark Australian led clinical trial, ENZAMET, has now shown that hormone therapy with a drug called enzalutamide can improve the survival of some people with advanced, hormone-sensitive prostate cancer.

Findings from the ENZAMET trial, led by ANZUP, have shown that people with this sort of cancer who receive enzalutamide with standard treatment have a 33% improvement in survival compared to people 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.

The ANZUP investigator initiated studies were financially supported by Astellas, who also provided enzalutamide.

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Enzalutamide is a new hormone treatment taken as tablets. Previous trials have proven that enzalutamide improves survival and quality of life in patients with prostate cancer that have 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 people starting radiation and hormone therapy for prostate cancer that does not seem to have spread beyond the prostate.

The trial has been led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. The trial accrued 802 people from 69 sites across Australia, New Zealand, Canada, the US, Ireland, and the UK. Recruitment closed on 30th June 2018.

The ANZUP investigator initiated studies were financially supported by Astellas, who also provided enzalutamide.

5. EVOLUTION (ANZUP 2001) – Prostate Cancer The aim of this study is to see if combining ipilimumab and nivolumab (drugs that activate the body’s own immune response to kill cancer cells), with Lu-PSMA (a type of treatment called radionuclide therapy that can be used to treat prostate cancer by bringing radioactive atoms into the cancer cells), can further improve the anticancer effects of Lu-PSMA. It is thought that ipilimumab and nivolumab and Lu-PSMA may work together to treat prostate cancer. Lu-PSMA can potentially kill cancer cells and break up the tumour into small pieces that may be recognised by your immune system while ipilimumab and

ANZUP trials in follow up nivolumab help activate the immune system to find and attack the cancer. This new treatment combination may lead to shrinkage or stabilisation of previously progressing tumours and therefore hopefully stop or reverse the growth of the cancer.

The EVOLUTION Trial is an investigator-initiated trial sponsored and led by ANZUP. This trial has received funding in partnership with the Prostate Cancer Foundation of Australia, Bristol Myers Squibb and Novartis. This trial is a collaboration between ANZUP, the NHMRC Clinical Trials Centre at the University of Sydney and the Australasian Radiopharmaceutical Trials Network (ARTnet) with support from MIM Software Inc. and ANSTO. The EVOLUTION trial is now closed to recruitment and enrolled 93 people from across Australia.

6. TheraP (ANZUP 1603) – 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.

7. BCG+MM (ANZUP 1301) – Bladder Cancer 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 cost-effective treatment for patients who suffer from this cancer.

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.

The BCG+MM trial is now closed to recruitment, and enrolled 501 patients from across Australia and one site in the UK.

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 people 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.

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ANZUP trials in follow up 8. PCR-MIB (ANZUP 1502) – Bladder Cancer

10. RAMPART (ANZUP 1606) – Kidney Cancer

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.

Removing the kidney (or part of a kidney) by surgery is currently the best treatment if you have kidney cancer.

The current standard treatment after surgery is ‘active monitoring’. This means no further treatment, but having regular checks so that if the cancer does come back further treatment options can be considered as early as possible.

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.

9. KEYPAD (ANZUP 1601) – Kidney Cancer 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.

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.

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 were 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, it will stimulate the immune system, so that the immune therapy will work better in the tumours.

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

Surgery, together with ongoing regular follow-up and observation, is the standard approach for people diagnosed with kidney cancer that has required removal of the kidney (or part of a kidney) by surgery. For some people the cancer may return which is when other treatment is offered. We are aiming to find out whether taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) can prevent or delay kidney cancer coming back.

The RAMPART study is now closed in Australia after enrolling 36 patients across Australia.

11. UNISoN (ANZUP 1602) – 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.

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Trials in follow up 12. UNICAB (ANZUP 1802) – Kidney Cancer 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.

We thank and acknowledge Ipsen for providing funding and study drug for the UNICAB Trial.

13. TIGER (ANZUP 1604) – Testicular Cancer 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 colonystimulating 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.

Up to 420 patients were enrolled in Australia, New Zealand and other countries.

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.

Co-badged Trials 14. proPSMA – Prostate Cancer Prostate cancer is the most commonly diagnosed cancer in Australian people. 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.

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

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

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

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Trials in follow up 15. 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.

16. NMIBC-SI – Bladder Cancer 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.

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.

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: • Field 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.

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

17. #UpFrontPSMA – Prostate Cancer 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.

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. #UpFrontPSMA is now closed to recruitment, and enrolled 130 patients across Australia.

For more information on our trials in follow up, go to our website https://anzup.org.au/clinical-trials/follow-up/

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120 2,756 8,543.6 $60,000 ALMOST

RIDERS

LAPS

KMS

Melbourne Pedalthon

RAISED

Melbourne Pedalthon 2023 After a pandemic pause, the third Melbourne Pedalthon was held on Sunday 26 March 2023 at Sandown Racecourse.

We were fortunate to have speeches from Councillors Sean O’Reilly and Richard Lim from the Greater Dandenong Council and Melbourne comedian Michael Shafar.

The event was a huge success with nearly $60,000 being raised. 100% of donations support ANZUP Cancer Trials Group to improve the lives of people affected by bladder, kidney, testicular, penile, and prostate cancers through practice-changing multidisciplinary collaborative clinical trials.

COUNCILLOR SEAN O’REILLY

COUNCILLOR RICHARD LIM

Riders and teams included the local community, medical and pharmaceutical colleagues, their patients, corporates, and cycling clubs. We were delighted to have Michael Milton, OAM, our Pedalthon ambassador.

Michael is an Australian Paralympic skier, Paralympic cyclist, and para-triathlete with one leg. With 6 gold, 3 silver, and 2 bronze medals he is the most successful Australian Paralympic athlete in the Winter Games.

MICHAEL SHAFAR

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Melbourne Pedalthon

Fundraising heroes Congratulations to Andrew Weickhardt our 2023 Melbourne Pedalthon fundraising champion on the day for raising an incredible $2,994!

Congratulations to the highest fundraising team Eastern Cycling Club – Thornton who raised over $4,452 – well done to the team!

Champion of the track Congratulations to 2023 Below the Belt Champions (most number of laps), BBTT 1 who completed 144 laps in 3 hours!

Other winners Congratulations to all the other winners of the day: • Best Dressed Individual: Shomik Sengupta • Fastest Lap by Individual Male: Lance Friedman • Fastest Lap by Individual Female: Simona Infantino • Most Laps Individual: Brady Bantick • Sprint Challenge: Glen Newnham • Highest Fundraising Team: Eastern Cycling Club – Thornton • Highest Fundraiser: Andrew Weickhardt • Below the Belt Champions (most number of laps): BBTT 1

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Thanks to Sponsors and Supporters A big thank you to our sponsors and supporters for their generous contributions. Special thanks to Platinum Sponsor Bristol Myers Squibb and venue partner Melbourne Racing Club (MRC) Foundation. We’re also grateful to our supporters for sustaining our riders throughout the event.

ALMOST

120+ 1,843 7,250 $80K RIDERS

LAPS

KMS

Sydney Pedalthon

RAISED

Sydney Pedalthon 2023 The Sydney Pedalthon made its return on Tuesday 31st October 2023 at the iconic Sydney Motorsport Park.

The day was full of energy and competitive spirit. We witnessed grit, determination, and cycling prowess, as well as a lot of fun.

ANZUP Chair Professor Ian Davis, as well as the esteemed ANZUP researchers, Professor Lisa Horvath and Associate Professor Kate Mahon, gave great insight into the work that goes on behind the scenes in our mission to improve outcomes for people living with below the belt cancers.

We’re excited to share that the event saw an incredible turnout, with over 120 registered riders participating. Our combined entry fees, donations and sponsorships have raised almost $80,000. This surpassed our most recent Melbourne Pedalthon, and the funds are still rolling in!

A special thank you goes out to Michael Milton, OAM, our Pedalthon ambassador, who joined us once again, following the 2023 Melbourne Pedalthon.

Our heartfelt gratitude extends to every rider, supporter, and volunteer who made this day truly exceptional. Your dedication and commitment have contributed immensely to our goal of raising vital funds for testicular, prostate, penile, kidney, and bladder cancer research!

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Sydney Pedalthon

Fundraising Heroes

Other Winners

A thunderous round of applause for Peter Lean, our 2023 Sydney Pedalthon fundraising champion, who raised over $4,000!

Congratulations to all the other winners:

Congratulations to the highest fundraising team, The Breakfast Point Men’s Shed, who raised over $12,000 – an outstanding achievement by the entire team!

• Fastest lap – Female: Jennifer Brittain

• Most Number of Laps – Female: Jennifer Brittain • Most Number of Laps – Male: Dome Deli • Fastest lap – Male: Jamie Kennell-Webb • Sprint Challenge: Jamie Kennell-Webb • Queen of Mountain: Loise Austin • King of Mountain: Duncan Begg • Best Dressed Individual: David Grimes • Fundraising Challenge Winner: John Bush (who raised an amazing $3,006.88, claiming the title of the top fundraiser from September 25th to October 1st)

Champion of The Track Hats off to VELO2073, the 2023 Below the Belt Champions (most number for laps). As a team of 5, they conquered 116 laps in just 3 hours! That’s 23.2 laps per rider. Congratulations on this incredible achievement!

Thanks to Sponsors and Supporters We would like to thank our Silver Sponsors Gallagher and Janssen, as well as our drink station sponsor Perpetual. Your support is invaluable in making this event a tremendous success.

Last but certainly not least, we would like to thank our incredible supporters who played a crucial role in sustaining our riders throughout the event.

THANK YOU TO OUR 2023 SILVER SPONSORS

THANK YOU TO OUR 2023 WATER SPONSOR

THANK YOU TO OUR 2023 SUPPORTERS

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Fundraising for ANZUP

Community fundraising Breakfast Point Men’s Shed

City2Surf

John Bush and the Breakfast Point Men’s Shed team have been great supporters of ANZUP since 2018 at our Pedalthon events and local community events to raise funds and awareness for below the belt cancer.

The City2Surf was back in Sydney on Sunday 13 August 2023. Bringing 80,000+ people together from all walks of life to run, jog, walk or stroll the iconic 14km course from Sydney CBD to Bondi Beach.

On 29th September 2023, the Men’s Shed with the support of Ashfield Bunnings Warehouse put on a community sausage sizzle. The event achieved an impressive fundraising total of $3006.88 for below the belt cancer research.

In the previous year, Steven Guy joined as a walker and fundraiser, raising an impressive $1,441.50 for ANZUP’s research on below the belt cancers. Sadly, Steven’s battle with kidney cancer, which he bravely fought since 2019, ended in 2023.

A heartfelt thank you goes out to the Breakfast Point Men’s Shed for their exceptional dedication in raising both awareness and funds for the 2023 Sydney Pedalthon. Your efforts are truly commendable.

This year, Alyce Comey, a close friend of Steven Guy, showed her support for the ANZUP by participating in the City2Surf event in memory of Steven. Her dedication resulted in a fundraising total of $667. We sincerely appreciate her efforts in contributing to below the belt cancer research.

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Fundraising for ANZUP

Community fundraising Sydney Rams Tenpin Bowling Club On September 26th, the Sydney Rams Tenpin Bowling Club came together for an unforgettable Charity Bingo night. This special event was dedicated to raising funds for ANZUP in memory of our dear friend and long-time supporter, Steven Guy, who passed away earlier this year.

Through cash donations and other fund-raising activities on the evening, a donation of $1,750 has been made to ANZUP on behalf of The Sydney Rams.

Thank you for your generosity Sydney Rams Tenpin Bowling Club. Let’s continue Steven Guy’s legacy of support for ANZUP.

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Bribie Island Bowls Club The Bribie Island Bowls Club launched an inspiring Charity Month in September 2023, dedicated to driving critical medical research and support for major cancers and diseases. We’re grateful that ANZUP’s Below the Belt Research Fund has been selected as one of the foundations to receive support.

The event featured compelling guest speakers who shared their personal stories, inspiring us all to make a difference.

Throughout Charity Month, a remarkable total of $17,500 was raised to share amongst the five foundations. A generous donation of $3,500 was presented to ANZUP, bringing us one step closer to the mission of improving the lives of people affected by bladder, kidney, testicular, penile and prostate cancers.

Thanks to our Partners, Corporate 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 2023 corporate supporters include:

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

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Join us in the fight to improve the treatment and outcomes of those with below the belt cancers

Find out more at www.belowthebelt.org.au ANZUP Cancer Trials Group Level 18, International Tower 3, 300 Barangaroo Ave, Sydney, NSW 2000 Tel: +61 2 9054 3600 Email: anzup@anzup.org.au www.anzup.org.au 78 78 AA LITTLE LITTLE BELOW BELOW THE THE BELT BELT