UPdate Spring edition 2019

The Newsletter of ANZUP Cancer Trials Group Limited

SPRING 2019

Making Connections

MESSAGE FROM THE 2019 ASM CONVENOR: DAVID PRYOR Highlights from Brisbane While we were set a very high benchmark on the back of last year’s ASM, we managed to deliver another high quality and innovative program that had something for everyone.

A big thank you must go to the outstanding Convening Committee and Faculty.

The theme ‘Making Connections’ brought together a superb line up of international and national speakers from multidisciplinary backgrounds, all under the one roof. It was also a great opportunity for people to connect with their peers, catch up with old colleagues and make new friends.

Over the three days, we were treated to the most up to date scientific presentations from our impressive international faculty: Kelly Parsons, Phuoc Tran, Alison Birtle, Catherine Paterson and Betsy Plimack who shared their insights and experience with close to 400 attendees.

#ANZUP19

The ASM kicked off with an array of pre-conference meetings on Sunday including the ANZUP PCFA Nurses Symposium, the Translational Research Symposium and the MDT Masterclass. We are very grateful to all the chairs for their efforts in delivering such thought provoking sessions.

On Sunday we also held our annual Community Engagement Forum featuring presentations and panel discussions covering quality of life, treatment choices, survivorship, impacts on intimacy and the cost of cancer care. This forum gave the public the opportunity to engage with an experienced team of healthcare professionals and patient advocates, while learning about ANZUP and our clinical trials research program.

...another high quality and innovative program that had something for everyone.

MESSAGE FROM THE 2019 ASM CONVENOR: DAVID PRYOR

It was also a great opportunity for people to connect with their peers, catch up with old colleagues and make new friends.

The day concluded with another excellent ANZUPx session. Professor Jane Turner gave us a thought provoking talk on how we should prioritise the human connections in our day to day interactions with our patients and each other. This was followed

by Professor Declan Murphy entertaining us with his insights into how rapidly the field of oncology is advancing with tips on avoiding obsolescence as a cancer surgeon.

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The evening symposium challenged our audience to think about ‘The Art of Connecting’ with our peers through our passions and our community. We heard from our gifted faculty including Kelly Parsons, a urologist and award-winning author, Alasdair Foster, a photographer and Professor of Culture in Community and finally Dr Alison Birtle channelling her passion for musical theatre by treating us to a rendition of Send in the Clowns. All great examples of how connecting through creativity can help with the stresses of work and life demands while caring for our cancer patients.

#ANZUP19

We saw a good roll-up (post the conference dinner) to the Tuesday Breakfast session, ‘Is Social Media Worth the Risk for Healthcare Professionals’, ably chaired by Haryana Dhillon and featuring Henry Woo, Craig Gedye, Belinda Jago and social media expert Josh Britt. Attendees were also fortunate to hear from ANZUP Chair and ENZAMET Co-Chair Ian Davis share the practice changing ENZAMET results, as presented at the ASCO plenary session in June.

The Scientific Program on Monday and Tuesday involved close to 50 presentations, twitter engagement reached 2.8million #ANZUP19 impressions and over 1,600 tweets – with Haryana Dhillon, Ian Davis and Henry Woo as key social media influencers. Attendance was impressive with close to 400 delegates – all testament to the high quality, collegial, educational, entertaining ASM for which ANZUP has become renowned.

Thank you to every speaker, sponsor, chair, delegate, participant, committee member and organiser for your contribution. We look forward to seeing you in Adelaide for #ANZUP2020.

DAVID PRYOR Convenor

HELLO, WELCOME TO ‘UPDATE’ Contents: MESSAGE FROM THE ASM CONVENOR . . . . . . . . . . . Cover MESSAGE FROM THE CHAIR . . . . . . . . . 4 ASCO – ENZAMET . . . . . . . . . . . . . . . . . . 7 2019 ASM – TALKING UROLOGY . . . . . . 10 2019 ASM – CYCLING CHALLENGE . . . . 11 COMMUNITY ENGAGEMENT FORUM . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 ASM & BELOW THE BELT RESEARCH FUND AWARDS . . . . . . . . . 13 ASM BY NUMBERS . . . . . . . . . . . . . . . . . 17 ANZUP ASM 2019 HIGHLIGHTS . . . . . . 19 THANKS TO OUR ASM 2019 SPONSORS . . . . . . . . . . . . . . . . . . . 23 ANZUP CLINICAL TRIAL UPDATES . . . . 24 UPDATES FROM SAC & SUBCOMMITTEES . . . . . . . . . . . . . . . . 26

...all testament to the high quality, collegial, educational, entertaining ASM for which ANZUP has become renowned.

PROSTATE CANCER MASTERCLASS . . . . . . . . . . . . . . . . . . . . 34 BEST OF GU ONCOLOGY . . . . . . . . . . . 36 OTHER NEWS . . . . . . . . . . . . . . . . . . . . . 37 GRANTS & AWARDS . . . . . . . . . . . . . . . 38 UPCOMING EVENTS . . . . . . . . . . . . . . . 40

ANZUP UPdate Spring 2019 | 3

MESSAGE FROM THE CHAIR Welcome to this edition of UPdate, the newsletter of the Australian & New Zealand Urogenital and Prostate Cancer Trials Group Ltd (ANZUP)!

“Chicago, Chicago I will show you around – I love it Bet your bottom dollar you lose the blues in Chicago, Chicago” – Frank Sinatra Chicago is a great city. It has a rich history; amazing architecture; great music; delicious boutique local beers; distinctive food (“Chicago deep dish pizza” is not recognisable as pizza and will probably kill you but you will die happy); and it’s slightly nippy in winter by all reports. It’s also much more three-dimensional than most cities. Roads loop over and above/below others.

The famous “L” includes the elevated railroad running down the middle of several roads. The subway of course runs under the city. But it’s not until you go to a conference there that you discover there is also a whole system of busways running below ground and parallel to the main streets, specifically to support mass transit to the convention centre at McCormick Place. McCormick Place is apparently the only conference centre in the US large enough to hold the ASCO Annual Scientific Meeting, which attracts over 40,000 delegates every US summer. It stretches over several buildings and literally

IAN DAVIS, ANZUP CHAIR AND MARG MCJANNETT, ANZUP CEO, SITTING WITH THE ANZUP TEAM (ALL WEARING THEIR ANZUP CAPS!)

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kilometres, meaning it is almost physically impossible to attend consecutive sessions across tumour streams if they are opposite ends of the facility. But in 2019, why would you be anywhere other than the GU stream and the Plenary Session?

I had never before bothered to walk to the front of the main hall where the plenary sessions are held. It is a long way to the front of a room that can hold about 20,000 people, and there are screens and wifi throughout so that you can experience (almost) everything just by finding a seat near the back. The speakers are tiny dots in the distance but easily seen on the screen and heard. The plenary sessions are simulcast in another huge hall at the other end of the centre. You might as well save your energy and be able to make a quick getaway if needed.

I had never made the walk, that is, until this year. This year our perspective was from the front row, looking towards the back, and it was quite intimidating. Marg McJannett had reserved two rows front and centre by dint of decorating them with ANZUP caps. We stood and watched the hall fill with thousands of people, all of whom had come to hear Chris Sweeney who was standing just a little bit further towards the front, on the podium, to give an ASCO Plenary Presentation on the first international phase 3 clinical trial we have ever done: ENZAMET. This was a remarkable moment. Not just for the fact that ENZAMET was a positive study, that will influence clinical practice, and perhaps even more importantly might stop people treating metastatic hormonesensitive prostate cancer with inappropriate unproven combinations. It was the fact that we had turned an idea to a clinical trial reality that would lead to improved outcomes, the very definition of the ANZUP mission statement. We had done so by engaging people right across the spectrum of disciplines involved in this disease, including most importantly the people directly affected by it. We had designed questions that amazingly were not only still relevant at the time the trial read out at its first interim analysis, but were even more so than they were when we began. We had played a central role in setting up a global network of clinicians, researchers, and coordinating groups, that would see this project to completion and be the basis for many future trials.

ANZUP was on stage and in the public eye for all the right reasons, for the benefit of our patients. None of

MESSAGE FROM THE CHAIR this existed before, and would not exist today without the contribution of thousands of people, including the participants who so generously took part. The plenary, and the simultaneous publication in the New England Journal of Medicine, dominated social and other media for days.

We cannot expect this to happen every time we do a trial. You cannot expect that this will happen even once in your career. But we should definitely all take a moment to celebrate that we have collectively moved the field ahead by a significant step. And there is far more to come from this trial. And even further, I have not even mentioned all the other ones we are doing and plan to do, which you will read more about in this newsletter.

Yes, I’m with Frank on this one: “They have the time, the time of their life.” But great as Chicago is, it’s not Australia, is it? Fast forward a few weeks to Brisbane, 2023 July 2019, for the ANZUP Annual Scientific Meeting.

We’re starting to sound a bit like the International Olympic Committee, but this meeting just seems to go from strength to strength and every year brings something even a bit better than we saw before. How is that even possible? Once again we had a very strong scientific program, and I even saw some original data presented for the first time at our meeting. It was great to

see how much of the program linked to the conference theme of “Making Connections.” Our local speakers were extraordinarily good, not just in the scientific aspect of the program, but also in terms of engaging the audience. Our ANZUPx speakers Jane Turner and Declan Murphy left the audience spellbound. Our evening symposium looked at creativity, and included interviews with two of our international speakers and a local one. Our international faculty were (as always) involved to the maximum extent possible and generously gave of their time right up to the final session. The social media footprint from the ASM tells the story, with well over 2.7 million impressions from over 1600 tweets from 226 participants. As always, people physically far distant from the ASM were also able to contribute to the program through the social media storm. You will read more about the ASM in these pages.

It was the fact that we had turned an idea to a clinical trial reality that would lead to improved outcomes, the very definition of the ANZUP mission statement.

ANZUP UPdate Spring 2019 | 5

MESSAGE FROM THE CHAIR The ASM also hosted several other meetings, including the PCFA prostate nurses’ symposium, the prostate cancer survivorship CRE, the Community Engagement Forum, the Consumer Advisory Panel education session, the MDT Masterclass, the translational symposium, and numerous meetings of trial management and project development teams. We had great engagement with and support from our sponsors, and I don’t think the hardworking ANZUP team slept at all during the meeting. Thanks to all who helped make this possible and especially David Pryor and the convening committee for pulling everything together. Now the gauntlet is thrown down to Nick Brook and his team for the 2020 meeting where the conference theme will (of course, how could it not) be “Clear Vision.”

Phew. That’s two events. What about the rest? We’ve run five Concept Development Workshops this year, and there will soon be a special call for another funding initiative. We’ve set up new fellowships. We’ve given out the Below the Belt funding raised through Melbourne and Sydney Pedalthons, and of course the Sydney Pedalthon is coming up on 10 September 2019. We’ve run a prostate cancer preceptorship in Boston, with support from Astellas. We’ve welcomed new staff and farewelled others. We’re planning ahead for the Best of GU symposium in Adelaide, and for the GU Preceptorship in November. Followed by the Melbourne Pedalthon, and CDWs, and APAC APCCC, and the ASM, and… This organisation is really working hard collectively and continues to make great strides forward.

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Chicago and quite a few other places had better watch out, because we will be back.

Thanks to all of you for your interest and engagement in ANZUP. You are all collectively contributing to helping us get to where we need to go, even though it is a moving target and we will always need to do better and more for our patients. But for now: Chicago and quite a few other places had better watch out, because we will be back.

Please enjoy this edition of UPdate.

IAN DAVIS ANZUP Chair

ASCO – ENZAMET ENZAMET results presented at ASCO It certainly has been an exciting time here at ANZUP. On 2 June 2019 findings from the ENZAMET trial, led by ANZUP, were presented by Professor Christopher Sweeney at ASCO’s Plenary session at their Annual Meeting in Chicago. The ENZAMET trial was chosen as one of only four plenary sessions from over 6,200 abstracts received – a remarkable achievement. The ANZUP-led trial showed a 33% improvement in overall survival and a 60% improvement in progression‐free survival, for men with metastatic hormone sensitive prostate cancer who received enzalutamide in addition to standard of care therapy (androgen deprivation therapy, ADT), with or without docetaxel chemotherapy.

The results were also simultaneously published in the New England Journal of Medicine.

The ENZAMET project has been a great example of academic research: identification of an important clinical question leading to a carefully performed clinical trial, and outcomes that were always going to be informative whatever the result. We have also been able to generate a global network of clinicians, researchers, and coordinating centres, which will not only support the ongoing work for ENZAMET but that will push ahead with the next set of questions.

Professor Ian Davis, ANZUP Chair, ENZAMET Co-Chair

PROFESSOR CHRISTOPHER SWEENEY PRESENTING AT 2019 ASCO ANNUAL MEETING

PATIENTS FROM AUSTRALIA NEW ZEALAND CANADA

1,125 MEN LEFT: PROFESSOR CHRISTOPHER SWEENEY PRESENTING AT 2019 ASCO ANNUAL MEETING

USA IRELAND UK

TOOK PART IN THE STUDY

33%

83

OF MEN COULD LIVE A LONGER LIFE

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

AFTER 3 YEARS

GLOBAL SITES

80%

OF MEN WHO RECEIVED ENZALUTAMIDE AND HORMONE TREATMENT WERE ALIVE

72%

OF MEN WHO RECEIVED STANDARD TREATMENT WERE ALIVE

ANZUP UPdate Spring 2019 | 7

ASCO – ENZAMET ENZAMET is a large Phase 3 PROFESSOR CHRISTOPHER SWEENEY WITH OTHER PLENARY SESSION study that shows that giving SPEAKERS AT THE 2019 ASCO ANNUAL enzalutamide along with ADT to MEETING “hormone-naïve” men (who are just starting ADT) reduced the risk of death at 3-years by a third, relative to giving ADT with the standard anti-androgen drug.

Enzalutamide also significantly increased the time until the cancer showed signs of growing, either by symptoms, scans, or rising PSA. Before these findings, enzalutamide was given only to men with metastatic prostate cancer after ADT stopped working. This study now suggests that enzalutamide should be considered much earlier in the course of the disease, around the time of starting ADT when patients are diagnosed with metastatic cancer.

THE ENZAMET TEAM AT ASCO

The ENZAMET trial began in 2014 and recruited 1125 patients from 83 medical centres around the world. Men with metastatic prostate cancer starting first-line ADT were enrolled in the study. The average age of the men in the study was 69 years; 11% of men had metastatic disease outside of the bones and lymph nodes.

ENZAMET (ANZUP 1304, NCT02446405, CCTG PR17) is a global collaborative investigator‐initiated trial led

by ANZUP and sponsored by the University of Sydney, in collaboration with the Canadian Cancer Trials Group, Dana‐Farber Cancer Institute, and Cancer Trials Ireland (enrolling patients from Ireland and the United Kingdom). The University of Sydney NHMRC Clinical Trials Centre provided central study coordination.

Astellas Pharma provided drug and financial support but was not involved in study conduct or data analysis.

The positive findings from the ENZAMET trial will mean that once Enzalutamide is available, men with metastatic prostate cancer will have another treatment option.

The interest in the trial results was felt worldwide – with news, online and print coverage from around the world – from Channel Nine News in Australia, to France, Japan, Mexico, Ireland, USA, United Kingdom and everywhere in-between. It certainly has been a worldwind of a ride for ANZUP, and one that show no sign of stopping quite yet!

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It is great to see that ENZAMET has helped the field make another step forward in improving the outcomes of prostate cancer.

However, this is just the end of “Chapter 1”. I am excited to start on the next chapter with everyone as we define the quality of life, health economic and long term benefits. And then the biological studies will be another page turning chapter. It is such an honor to be writing this “good book” with all the ENZAMET investigators. Remember too, the ENZARAD book is also being drafted...

Professor Christopher Sweeney, ENZAMET Co-Chair

ASCO – ENZAMET ENZAMET MEDIA COVERAGE

3.5+ MILLION TWITTER IMPRESSIONS

8+

MILLION ONLINE NEWS REACH

4+

MILLION TV/ONLINE VIDEO REACH

2.5 MILLION FACEBOOK REACH

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2019 ASM – TALKING UROLOGY

Talking Urology sponsored by Ipsen Talking Urology started three years ago because I could not find a good (or even listenable) regular urology podcast discussing the literature and level 1 evidence that defines our everyday urological practice. I wanted to have something that would prepare us for robust evidence-based discussions in multidisciplinary meetings or chatting with our colleagues.

The key to having a strong opinion on a point is to know your evidence. The prime focus of Talking Urology is the analysis of landmark papers with insights and discussion with the key authors of those papers. It was a natural extension of Talking Urology to chat to key opinion leaders and experts in their fields to give us the highlights of their plenary talks at the major meetings such as the ANZUP ASM in Brisbane, ASCO in Chicago or USANZ ASM in Brisbane.

At the ANZUP ASM we had nine interviews with the key experts and plenary speakers giving us the highlights of their talks. We chatted to Ian Davis about ANZUP’s extraordinarily successful ENZAMET phase 3 trial looking at the benefit of enzalutamide upfront in hormone naïve metastatic prostate cancer, which is the first study to allow concomitant docetaxel chemotherapy. Interviewers included myself, but more interestingly, other local urologists, oncologists and allied health professionals also chatted to speakers about their presentations.

We hope that these will make interesting podcasts that you can listen to in your car while driving to work highlighting the key messages presented at the ASM, straight from the mouths of the experts themselves.

Podcast links will be tweeted (follow @Talking_Urology), or can be accessed through www.talkingurology.com.au.

We will also showcase a number of the podcasts as videos on the ANZUP website – and they can be accessed here: https://www.anzup.org.au/content.aspx?page=asm-news.

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2019 ASM – CYCLING CHALLENGE Raising awareness of the Below the Belt Pedalthon Research Fund

There was a highly competitive ride off at the conference dinner with two heats and the high-energy final adjudicated by Ben Tran. After much tension and heart rate acceleration, Hayne’s Henchmen took out the 2019 championship title!

For the third year running, the excitement of the Below the Belt Pedalthon returned to the ASM with the stationary bike cycling challenge. The challenge saw close to 40 delegates roll up their sleeves (and even get into their Lycra) and form the teams:

Thank you to everyone who participated, either on a bike or cheering from the sidelines. The Below the Belt Research Fund can only continue to fund concept development and pilot studies if we raise awareness and support the Pedalthon events.

The teams cycled during morning tea, lunch or afternoon tea on Monday in the trade exhibition area with their pedal power tracked using the Body Bike Indoor Cycling app.

We look forward to seeing you again at #ANZUP2020 in Adelaide!

The challenge, as well as helping burn off the conference food, provided an opportunity to promote the 6th Sydney Pedalthon on Tuesday 10 September at Eastern Creek and the 3rd Melbourne Pedalthon in March 2020. All funds raised from the Pedalthon events go straight to the Below the Belt Research Fund to help progress concepts to clinical trials (see page 14 for more details about the research fund recipients and page 40 for information about the Sydney Pedalthon).

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COMMUNITY ENGAGEMENT FORUM ANZUP held the seventh Community Engagement Forum as part of the 2019 ASM in Brisbane on Sunday 21 July.

The annual free community forum provided an opportunity for the audience to engage with an expert team of healthcare professionals and patient advocates, whilst featuring presentations and panel discussions covering a variety of topics.

The forum began with Ian Davis providing a brief overview of ANZUP and an explanation of how ideas move from concept stage to clinical trials. Belinda Jago talked about consumer involvement at ANZUP followed by Shomik Sengupta who gave an excellent overview of ANZUP’s clinical trial research. Topics also included getting the right balance in life after cancer diagnosis with Haryana Dhillon, treatment impacts on sexuality and intimacy with Kath Schubach and Louise Emmett talked about clever proteins in prostate cancer with the TheraP trial.

The treatment choices and decision making question and answer session was a highlight to the audience.

David Pryor and his patient Darren Nolan, provided a most informative account of their shared decision making process in relation to participation on a clinical trial and Darren’s kidney cancer diagnosis.

An engaging panel discussion with audience participation was facilitated by Leonie Young and wrapped up another informative and interactive question and answer session.

“Excellent all round information regarding clinical trial research, their purpose, quality of life, nurse support and case studies regarding treatment choices and decision making” Attendee feedback The forum was promoted in print media (including The Saturday Paper) and online, as well as via PCFA, QLD support groups and QLD-based ANZUP members’ clinics.

The forum welcomed 100 attendees and 90% of the audience advised they were extremely satisfied with the overall content.

You can watch videos from the event here: https://www. anzup.org.au/content.aspx?page=asm-community.

of the speakers “The knowledge and experience convert difficult was excellent and their ability to ce”. scientific information to the audien “Great quality speakers, relevant material”.

and “ Useful, varied ation – updated inform ”. good speakers 12 | ANZUP UPdate Spring 2019

ASM AWARDS Congratulations to the 2019 winners ANZUP/AstraZeneca Travel Fellowships ANZUP ASTRAZENECA TRAVEL FELLOWSHIP RECIPIENTS

Congratulations to;

Alexandar Blazevski

Mo Li

Sachinka Ranasinghe

Emma Tan

Matthew Alberto

Elias Chandran

Elizabeth Liow

Bradley Reynolds

Jiasian Teh

Amer Amin

Wanyuan Cui

Aji Loganathan

Handoo Rhee

Natalie Vear

Angelyn Anton

Samantha Koschel

Ruchira Nandurkar

Tahlia Scheinberg

ANZUP Mundipharma Clinical Research Fellowship The ANZUP Mundipharma Uro-Oncology Clinical Research Fellowship valued at $60,000 supports an early/mid-career clinician or researcher of any healthcare discipline. This year’s Mundipharma Fellowship was awarded to Angelyn Anton.

TRIAL/STUDY COORDINATOR SCHOLARSHIP RECIPIENTS

Congratulations Arsha.

ANZUP Trial/Study Coordinator Scholarships Congratulations to;

Eileen Hozack

Alberta Abreu

Rhonda Huynh

Ashley Baring

Kamonwan Kongrak

Erin Cassidy

Taylor Major

Deborah Chang

Emma Newton

David Charman

Prue Pendlebury

Jenny Edmunds

Wendy Pritchard

Laura Galletta

Cindy Shaw

Luke Garcia

Cara Webb

Katrina Golden

Ray Yung

Mel Grant

Kristina Zlatic

ANGELYN ANTON

Astellas Young Investigator of the Year Award The Astellas Young Investigator of the Year Award recognises an outstanding early career researcher in prostate cancer clinical trials research with up to $10,000 to support his/her attendance at an international GU meeting and ANZUP ASM. Well done Arsha!

ANZUP UPdate Spring 2019 | 13

ASM AWARDS 2019 ANZUP Best of the Best Awards The Best of the Best Awards are given based on the content, degree of innovation, significance, and quality of oral or poster presentations given at the ASM, as judged by an independent panel.

Best of the Best Medical Student Award – congratulations to Ruchira Nandurkar Best Tweet #ANZUP19 – congratulations to Henry Woo 2019 AMGEN Best of the Best Oral Presentation Award – congratulations to Handoo Rhee 2019 AMGEN Best of the Best Oral Poster Award – congratulations to Kate Mahon

AMGEN BEST OF THE BEST ORAL PRESENTATION AWARD WINNER, HANDOO RHEE WITH DAVID PRYOR AND THERESE GRIDLEY FROM AMGEN

AMGEN BEST OF THE BEST ORAL POSTER AWARD WINNER, KATE MAHON WITH DAVID PRYOR AND THERESE GRIDLEY FROM AMGEN

BEST OF THE BEST ‘BEST TWEET WINNER’, HENRY WOO WITH DAVID PRYOR

AWARDS Below the Belt Research Fund Thank you to all 2019 Below the Belt Research Fund applicants. ANZUP received a large number of high quality applications, and after careful consideration, the review panel selected and announced the following successful applicants at the ASM.

ANDREW MOE RECIEVING HIS AWARD FROM GUY TONER

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Andrew Moe – SUBDUE – 1 SUB-urothelial DUrvalumab InjEction - 1 Our research group is aiming to create a new treatment for patients with bladder cancer.

Durvalumab is a medicine that targets the body’s immune cells to help combat bladder cancer. When given intravenously, durvalumab has proven effective at slowing advanced bladder cancer that has spread to other organs.

We will recruit patients with bladder cancer who are recommended to have their bladder removed.

Approximately two weeks before this major operation, we will perform an extra procedure to inject durvalumab into the bladder lining, using a camera (cystoscope).

A thin needle is used to inject durvalumab into the most superficial part of the bladder.

AWARDS To ensure that this injection is safe and well tolerated, we will follow-up these patients with regular surveys and blood tests before and after their bladder is removed.

The bladder is further assessed after its removal.

We plan to start on a very low dose, which we can gradually increase only when proven safe.

We hope that this treatment can be used in a larger trial, and long-term could become a standard treatment for high-risk bladder cancer.

BEN TRAN RECIEVING HIS AWARD FROM GUY TONER

Ben Tran – CLIMATE: Assessing the Clinical utility of miR-371 as a marker of residual disease in Clinical Stage 1 Testicular Germ Cell Tumour, following orchidectomy Testicular germ cell tumours (TGCT) are highly curable, even in the metastatic setting where platinum-based chemotherapy is highly effective. Patients diagnosed with clinical stage 1 (CS1) disease are most likely cured following orchidectomy, however, up to 50% do develop recurrence and require intensive courses of curative chemotherapy. A short, less toxic course of adjuvant chemotherapy can be used to reduce the risk of recurrence, but at a significant risk of over treating the large group of patients who will never recur. Additionally, CS1 patients undergo frequent computed tomography (CT) scans as part of active surveillance protocols aimed at detecting early recurrence, resulting in significant radiation exposure and subsequent long-term risks to a large group of young patients who will never recur.

There is an urgent need to develop biomarkers that can better stratify individual patient risk of recurrence to i) guide adjuvant chemotherapy decision making; and ii) identify patients at very low risk of recurrence where the intensity of CT scans during active surveillance could be reduced. miR-371 is a promising biomarker with high sensitivity and specificity for the detection of residual TGCT, and subsequently, has the potential to satisfy both needs.

CLIMATE is an innovative registry-based translational clinical trial in TGCT that will generate preliminary data demonstrating the clinical utility of miR-371 in CS1 disease. CLIMATE will enrol CS1 patients recommended for active surveillance, test for miR-371 at predefined timepoints and correlate these findings with recurrence, leveraging prospectively collected clinical data within iTestis, a national testicular cancer registry.

Carole Harris – What, where, when and how long?

Using PBS data to understand patterns of care and survival in Australian patients treated for metastatic clear cell kidney cancer There are now more treatment options for people with advanced kidney cancer. With more choices we need to know how best to use these therapies, in which combinations and in which order, so that every person with advanced kidney cancer experiences their best outcome.

One way to understand treatment in the real world is to use data that is already being collected. Australia has a universal health system, and as most medications are subsidised by the Australian Federal Government via the Pharmaceutical Benefits Scheme (PBS), we can learn which treatments people have for kidney cancer by looking at the data collected for administrative purposes. This data is available to researchers under carefully controlled conditions.

Our study will describe how medications are used across Australia to treat advanced kidney cancer: which drugs, in which order and for how long. We will understand how long people live with these therapies and if there are sequences of treatment that appear to work better. This study has the advantage that it can look at how cancer therapies are used and how effective they are at a population level.

Our future aim will be to use this “linkage data” method as the backbone of real-world clinical trials, where ANZUP members in every hospital in Australia can take part, not just those of us lucky to be in hospitals with many research

CAROLE HARRIS RECIEVING HER AWARD FROM GUY TONER

ANZUP UPdate Spring 2019 | 15

AWARDS resources. Real world clinical trials make small changes in the way we use standard treatments, and can have big impacts to improve patients’ outcomes.

KATE MAHON RECIEVING HER AWARD FROM GUY TONER

CRAIG GEDYE RECIEVING HIS AWARD FROM GUY TONER

Craig Gedye – AdapTax: feasibility, acceptability and safety of adaptively dosed docetaxel in men with metastatic castrate-resistant prostate cancer When prostate cancer spreads, injections that suppress the male hor-mone testosterone can control the cancer for some time, but it almost always starts to grow again later.

Chemotherapy on top of these hor-mone injections can regain control of the cancer, but again, only for a limited time of about one year. Cancers grow like weeds; some of the cancer cells can be controlled by weedspray but other parts of the can-cer aren’t affected and can flourish. These vulnerable and resistant cells of the cancer are often holding each other in balance; and when a treatment is used it can favour one group of cancer cells over another. This trial is designed to test the idea of taking a standard chemotherapy called docetaxel, and if it works to take breaks off the chemo, using it for long enough to control the cancer, but then stopping and saving it up until later to treat the cancer again (and again… and hopefully again, and again). While every man’s cancer is predicted to eventually become resistant to the chemo treatment, using an effective treatment in more sparingly is hoped to spread the benefit over a longer period of time, without any more side-effects.

Very early reports with other drugs sup-port this idea; this will be the first trial testing this idea with docetaxel. If this idea proves to be sound, it may improve the lives and survival of men with prostate cancer.

Kate Mahon – Randomised trial of biomarker-driven intermittent docetaxel versus standard-of-care (SOC) docetaxel in metastatic castration-resistant prostate cancer (mCRPC) In Australia last year, over 3,000 men died from prostate cancer and many more are living with this disease.

Chemotherapy in the setting of prostate cancer which has spread to other parts of the body improves symptoms and survival, however, chemotherapy is associated with significant side effects.

The standard way to deliver chemotherapy is to continue on a 3 weekly schedule while the cancer is still responding but this is often limited by an accumulation of side effects. Several small studies have suggested that some patients can safely have breaks in chemotherapy with less side effects and a better quality of life.

However, this is difficult to achieve with our current monitoring strategies. We have developed a new blood test which can accurately identify patients who are responding to chemotherapy. We plan to use this blood test to guide breaks in chemotherapy to provide more tolerable treatment and ultimately improve patients’ quality of life.

Shomik Sengupta - Genomic & immunological predictors of response to intravesical therapy

Many bladder cancers are treated with medications put into the bladder in order to prevent them the cancers from growing further into the bladder wall. In some cases, these treatments do not work as they are meant to. At present, we do not know when the treatments might fail. The aim of this study is to assess bladder cancer samples to identify changes within them that may predict whether the commonly used treatments SHOMIK SENGUPTA RECIEVING HIS AWARD FROM GUY TONER will work or not.

16 | ANZUP UPdate Spring 2019

ASM BY NUMBERS

392 DELEGATES

5

INTERNATIONAL SPEAKERS

75

+ 70 SESSIONS

73

PEOPLE ATTENDED COMMUNITY ENGAGEMENT FORUM

3

CROSSFIRE DEBATES

SUBMITTED ABSTRACTS

ANZUP UPdate Spring 2019 | 17

ASM BY NUMBERS

18

21

9

ANZUP/ASTRAZENECA TRAVEL FELLOWSHIPS

TRIAL COORDINATOR SCHOLARSHIPS

TALKING UROLOGY PODCASTS

40

16

CYCLING CHALLENGERS

SPONSORS

265

100

90+

115+

MDT MASTERCLASS ATTENDEES

COMMUNITY ENGAGMENT FORUM ATTENDEES

PCFA ANZUP NURSES SYMPOSIUM ATTENDEES

TRANSLATIONAL RESEARCH SYMPOSIUM ATTENDEES

#ANZUP19 Twitter

TOP INFLUENCER (BY MENTIONS) =

@HAGSIE 2.75M+ IMPRESSIONS 1,607 TWEETS 18 | ANZUP UPdate Spring 2019

WITH 403 TWEETS

145 NEW FOLLOWERS

GAINED DURING ASM

ANZUP ASM 2019 HIGHLIGHTS “This was the first ASM I have attended and the bar has been set extremely high for any future ASMs I attend.

The topics were diverse and informative.”

“The innovative ways many of the sessions were run make it a fun way to learn.”

“Great conference excellent speakers, very inclusive meeting.”

ANZUP UPdate Spring 2019 | 19

ANZUP ASM 2019 HIGHLIGHTS “Excellent and entertaining.”

“Fantastic meeting with true multi-disciplinary/ cross functional representation across those treating patients with GU cancers.”

20 | ANZUP UPdate Spring 2019

ANZUP ASM 2019 HIGHLIGHTS

“Jane Turner’s presentation was one of the best, very moving very relevant to the theme.”

“Once again a great program with good feel atmosphere.”

ANZUP UPdate Spring 2019 | 21

ANZUP ASM 2019 HIGHLIGHTS “One cannot help feeling so good meeting so many clever and passionate people.”

Join us at #ANZUP2020 in Adelaide SAVE THE DATE! It’s a pleasure to invite you to the ANZUP ASM in 2020, being held in Adelaide for the first time ANZUP goes from strength to strength with outstanding speakers and presentations, and I will be working with the 2020 Convening Committee to ensure #ANZUP2020 continues to raise the bar.

22 | ANZUP UPdate Spring 2019

Our theme for 2020 will be ‘Clear Vision’ and the conference will be from 19-21 July 2020 at the Adelaide Convention Centre.

Reserve this date in your diary now, and we will share with you more details about the speakers and program as they are confirmed.

I very much look forward to welcoming you to Adelaide next year.

NICK BROOK #ANZUP2020 Convenor

THANKS TO OUR 2019 ASM SPONSORS PLATINUM SPONSORS

GOLD SPONSORS

SILVER SPONSORS

MDT MASTERCLASS

BRONZE SPONSORS

TRAVEL FELLOWSHIPS

TALKING UROLOGY SPONSOR

COFFEE CART SPONSOR

EVENING SYMPOSIUM SPONSOR

INTERNATIONAL SPEAKER SPONSORS

NURSES SYMPOSIUM SPONSORS

ASM APP SPONSOR

BEST OF THE BEST AWARDS SPONSOR

TRADE EXHIBITORS

ANZUP UPdate Spring 2019 | 23

ANZUP CLINICAL TRIAL UPDATES BCG MM (ANZUP 1301)

TheraP (ANZUP 1603)

Study sites: 13 sites open to recruitment

Study sites: 11 sites open to recruitment in Australia

Recruitment: 235 patients randomised

Recruitment: 199 patients randomised

Target: 500 patients

Target: 200 patients

KEYPAD (ANZUP 1601)

TIGER (ANZUP 1604)

tudy sites: 14 sites open to recruitment in S Australia with 2 more expected in 2019

Recruitment: 31 patients randomised

Target: 70 patients

Pain-free TRUS B (ANZUP 1501)

Study sites: 4 sites open

Recruitment: 5 patients randomised

Target: 420 patients internationally and 60 ANZ

UNISoN (ANZUP 1602)

Study sites: 9 sites open and recruiting

Study Sites: 19 sites open

Recruitment: 404 patients randomised

Recruitment: 84 patients randomised in Part 1 & 32 patients randomised in Part 2

Target: 420 patients

Target: 85 patients Part 1 and 48 patients Part 2

P3BEP (ANZUP 1302)

UNICAB (ANZUP 1802)

Study sites: 42 sites open and recruiting 19 (ANZ), 10 (UK) and 13 (US)

Study sites: 5 sites open, 10 sites in total anticipated to participate

Recruitment: 98 patients randomised

Target: 150 patients Stage 1

350 patients Stage 2

PCR MIB (ANZUP 1502)

Study sites: 6 sites open to recruitment in Australia.

Recruitment: 19 patients randomised

Target: 30

24 | ANZUP UPdate Spring 2019

Recruitment: 0

Target: 48 patients

ANZUP CLINICAL TRIAL UPDATES ANZUP Studies soon to open ENZA-P (ANZUP 1903)

ANZUP Co-badged Studies FASTRACK II (TROG 15.03)

Study sites: 12 anticipated to participate

Study sites: 8 sites open and recruiting

Recruitment: 0

Recruitment: 54 patients randomised

Target: 160 patients

Target: 70 patients

STUDY STATUS: Submitted to Lead HREC August 2019, currently awaiting approval.

#UpFrontPSMA (ANZUP 1904)

Study sites: TBD

Recruitment: 0

Target: 140 patients

STUDY STATUS: Preparing submission to Lead HREC early September

DASL-HiCaP

Study sites: close to 100 anticipated

NINJA (TROG 18.01)

Study sites: 10 sites are anticipated to participate across Australia. Currently 3 sites are open

Recruitment: 13 patients so far

Target: 150 patients

NMIBC-SI Evaluation

Study sites: 17 sites open

Recruitment: Patients enrolled field test 1: 220 (closed - completed) Patients enrolled field test 2: 136

Target: 450 patients overall

Recruitment: 0 Target: 1,100 patients across Australia, New Zealand, US, Canada, UK and Ireland STUDY STATUS: Submitted to Lead HREC August 2019, currently awaiting approval.

ANZUP ANZUP UPdate UPdate Summer Spring 2018 2019 | 25

UPDATES FROM SAC & SUBCOMMITTEES Scientific Advisory Committee (SAC) The ANZUP Scientific Advisory Committee (SAC) met in Brisbane just prior to the ASM, on Saturday 20 July 2019. Usually the SAC meeting at the ASM is open to all members but on this occasion, in part due to the timing, we held our usual closed meeting. The SAC meetings usually go for two hours and have a very full agenda. The SAC agreed at recent strategy meetings that we should spend more time discussing strategic issues rather than details of oversight of particular trials. That certainly happened on this occasion: the entire meeting was spent talking about strategy and high level plans. We had excellent engagement from everyone who attended, and a number of clear actions resulted. Ongoing areas of emphasis for the SAC will be: • Review of the ANZUP research strategy and priorities • A ssessment of clinical needs and evidence gaps based on diseases and on disciplines

• N ew models for trials, including teletrials, novel designs, targeting of specific populations of particular need • O ngoing improvement in systems for identification and development of new concepts • Better engagement of members and stakeholders Thanks as always to the members of the SAC, its subcommittees, the Consumer Advisory Panel, and the Board for its support.

All ANZUP members are reminded that you are welcome to participate in any of the subcommittees at whatever level you wish. If you are not currently on a subcommittee mailing list and you wish to be, please let me or the ANZUP secretariat know so that we can add you.

IAN DAVIS Chair, ANZUP Scientific Advisory Committee

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Update your member details now at www.anzup.org.au/member/updateprofile.aspx to stay up to date on all the latest ANZUP news and events.

26 | ANZUP UPdate Spring 2019

Bladder, Urothelial and Penile Cancer (BUP) Recent News The broadened scope of the subcommittee is already having impact, with discussion & preliminary plans underway for ANZUP studies in upper tract urothelial (UTUC) and penile cancers, as outlined below. The rarity of these diseases certainly pose challenges for study design, but conversely also means that good quality research is urgently needed to inform clinical care.

Currently open studies continue to accrue well, overcoming a few challenges along the way: 1. T he BCG-mitomycin study, comparing sequential BCG & Mitomycin to standard BCG for high-risk non-muscle invasive bladder cancer (NMIBC), has recruited 235 of a planned 500 patients. The management of these patients has been made difficult by restrictions in the supply of BCG, and this may also affect availability of study treatments. It is important to have discussions at each site between clinicians, pharmacy staff and suppliers to ensure BCG supplies for patients who need it. Enrolment in the BCG-mitomycin trial requires fewer does of BCG per patient certainly in Arm B of the study, and thus maybe helpful in preserving scarce supplies.

2. T he PCR-MIB study is assessing the effects of adding Pembroluzimab to chemo-radiotherapy for muscleinvasive bladder cancer. Having overcome some initial barriers, the study has now recruited 19 of 30 participants. Blood samples are being collected for Below-the-Belt (BtB) funded translational substudy.

A number of potential future studies are at various stages of development and/or discussion: POUT-2 is a study of adjuvant immunotherapy for resected UTUC that has been developed by the Institute for Cancer Research in the UK. Discussions are continuing with the aim of ANZUP opening the study in Australia & New Zealand.

ACCEPT multicentre cystectomy database is collecting data from West Australian centres, with ethics and governance review underway to open at other sites interstate. It is hoped this database will not only provide much needed audit of cystectomy practices but also enable implementation and evaluation of interventions such as Enhanced Recovery pathways.

Water irrigation for low/intermediate risk NMIBC is currently being assessed in a BtB funded single centre pilot study, with plans for a subsequent ANZUP trial to compare it to post-resection chemotherapy.

The 2019 BtB grants included funding for a Phase I study of sub-urothelial injection of Durvalumab and a pilot study of translational markers of NMIBC response to therapy. It is hoped these studies can lead onto subsequent ANZUP studies.

This year’s ANZUP ASM also included scientific presentations on the need for survivorship studies in penile cancer, and the consumer engagement forum brought forward a motivated and interested penile cancer survivor who has provided significant impetus to plan further work in this area.

SHOMIK SENGUPTA Deputy Chair, Bladder Subcommittee

AT THE 2019 ASM

ANZUP UPdate Spring 2019 | 27

Germ Cell Recent news 1. TIGER study is open at multiple sites in Australia and recruiting patients. This is one of the most important studies in germ cell cancer for some time, comparing TIP versus TICE (high dose with stem cell rescue) as first salvage for platinum refractory disease.

2. i Testis continues to recruit patients, looking for additional sites. This is a testicular cancer registry, supported by ANZUP, that hopes to engage as many sites and clinicians as possible. Please contact Ben Tran if you are interested in participating. Data collection support can be provided.

3. P 3BEP continues to recruit well. Over 80 patients are now recruited across ANZ, UK and COG sites! Well done to Peter Grimison and team on successfully driving this study!

4. T he ANZUP surveillance guidelines for patients with advanced disease who have completed curative chemotherapy is now available on the ANZUP website.

Coming up 1) M icro RNA analyses appear to be a promising biomarker for testicular cancer, both seminoma and non-seminoma. Ben Tran is leading an ANZUP effort,

FREE to Join!

which will serve as a parallel study to both SWOG 1824 and AGCT1531, two international studies which have only recently started recruiting patients. The focus will be on patients with stage 1 testicular germ cell tumours.

2) P lanning is underway for a surgical study for testicular germ cell tumours. The use of RPLND in stage 2 Seminoma and Recurrent Node-only Non-Seminoma has been reported by several groups internationally.

We’re hoping to start an ANZUP study that will help address PROMs in this patient population.

3) H aving a survivorship plan is increasingly recognised as an important component of ongoing care for testicular germ cell tumour patients. Jeremy Lewin is leading an effort in generating a clinically useful survivorship plan that can be implemented across Australia.

4) H ypogonadism is a complex issue in testicular cancer survivors. It can be a result of both primary or secondary, with secondary causes often under appreciated and perhaps more common. Feasibility studies using iTestis are underway to determine the proportion of survivors with secondary hypogonadism.

And if the population is sufficient a small pilot study using novel agents to address this will be designed.

BEN TRAN Chair, Germ Cell Subcommittee

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

Friends of ANZUP provides: • Information about the benefits of clinical trials and how to access them • Support from people who understand the challenges • Biannual community magazine, ‘A Little Below the Belt’ • Invitation to Community Engagement Forums Please refer consumers to “Friends of ANZUP” and help us achieve our mission to improve the outcomes and treatment for those living with prostate, kidney, bladder and testicular cancers. Find out more at: http://www.anzup.org.au/friendsofanzup.aspx

28 | ANZUP UPdate Spring 2019

Renal Cell It’s been another busy few months for the renal cancel subcommittee, including many of us attending and participating in the #ANZUP19 ASM in Brisbane in July.

The RCC Subcommittee also held a successful face-to-face Concept Development Workshop in May with close to 20 attendees and two promising concepts presented. ANZUP is now running three kidney cancer studies and the subcommittee plans to open a fourth study this year.

The UNISoN study continues to recruit patients quickly and will complete accrual well ahead of schedule. This is a fantastic effort and demonstrates to our collaborators in the pharmaceutical industry our ability to run trials efficiently and provide results quickly. This is important as we continue to design and discuss future trials with our partners.

The KeyPAD study continues to recruit and will evaluate the effectiveness of this promising combination of PD-1 antagonist pembrolizumab with the RANKL inhibitor denosumab and test the hypothesis that addition of RANKL inhibition will block tumour immuno-suppression and increase effectiveness of anti-PD1 immunotherapy.

The UNICAB study has now opened across three sites in Australia and we are expecting 48 participants. We are eagerly awaiting our first patient on this trial. UNICAB is an exciting phase II trial of cabozantinib in patients with metastatic or unresectable non clear-cell renal cell carcinoma who have progressed on, or are not candidates for immunotherapy. The timelines for this study were very tight and our team did an incredible job in opening the first site (Ashford Cancer Centre) in April which was less than 15 months from when the trial idea was first presented to Ipsen (the company who has the license for cabozantinib in Australia and is funding the study). This study was also designed as a partner to the UNISoN study, as patients can be enrolled on UNICAB if they progress on UNISoN. The study also provides a treatment option for patients who have medical conditions that do not allow them to be treated with immunotherapy.

Translational Research Recent News 1. We had a very successful and well-attended Translational Research Symposium at the ANZUP ASM recently held in Brisbane. Our international speakers Betsy Plimack and Phuoc Tran gave outstanding talks and were ably complemented by our line-up of local speakers including Niall Corcoran, Ben Tran, Mitchell Lawrence, Ian Vela, Lisa Horvath and Lisa Butler.

Thank you to all our speakers for another fantastic Symposium and we look forward to once again showcasing the best of our translational research at next year’s ASM. 2. Biospecimen collection continues as part of existing trials including TheraP, UNISoN, BCGMMC, P3BEP and KEYPAD.

Coming up 1. With ENZAMET reading out mid-year, we are actively planning for translational studies based around the precious bio-specimens that were collected as part of this practice-shaping trial.

We will soon be announcing a call for scientific proposals to be reviewed by the ENZAMET translational research sub-committee.

2. With TheraP imminently completing accrual, we will soon begin the process of retrieving bio-specimens collected as part of what we hope will be another practice-shaping trial.

ARUN AZAD Chair, Translational Research Subcommittee

CRAIG GEDYE Chair, RCC Committee

ANZUP UPdate Spring 2019 | 29

Quality of Life & Supportive Care Recent News

Supportive Care Breakfast

The Annual Scientific Meeting is rapidly fading into the hazy past, but I wanted to recap on some of the exceptional supportive care and quality of life activities that formed part of this marvellous event.

Monday’s supportive care breakfast provided an opportunity to really come to grips with the challenge of implementing innovations into practice. Sonia Stratchen presented the work she led to implement a care plan for men on androgen deprivation in her region. What was clear from her presentation is that implementation requires substantial effort, dedicated time, and engagement of all stakeholders. With international speakers, Catherine Paterson and Mark Lazenby, able to discuss the differences in implementation approaches in USA and UK. There was a significant level of enthusiasm in the room to explore how to implement this care plan across the country. If you are interested in going a working group to explore this approach please get in touch with us through the ANZUP Office.

ANZUP PCFA Nurses Symposium It was wonderful to be part of such a vibrant discussion with nurses attending ANZUP, with presentations from Natasha Roberts reporting preliminary results of her ANZUP Janssen Nursing Fellowship investigating patient experiences of participating in ANZUP Clinical trials generating some interesting insights for consideration about how we approach and support people taking part.

Stay tuned for the publication!

Gay Corbett presented her work developing resources to support patients experiencing psychosexual challenges after a cancer diagnosis. This is work has developed through the concept development workshops, which Gay participated in during March 2018. It is a wonderful reminder of both what can be achieved by someone with a passion for a problem and the time it takes to develop research projects and resources.

Tam Bui, a PhD candidate and medical oncologist, shared some of the preliminary data from her PhD project exploring the troubling issue of scanxiety, the anxiety experienced by patients in the lead up to investigations and receiving their results. The room wasn’t surprised to hear the high level of distress patients reported in the lead up to their diagnostic scans. Tam also collected data on the experience of diagnostic test anxiety in nurses, thank you to everyone who completed this survey to generate some useful data where there is a major gap at this time. Tam will be looking at interventions to support patients and the whole healthcare team to manage test anxiety better.

30 | ANZUP UPdate Spring 2019

ASM 2020 Planning for next year’s annual scientific meeting has already commenced. We are very pleased Amanda Hutchinson has agreed to represent our subcommittee on the conference organising committee. If you have suggestions and ideas for the program, speakers, and innovative topics please get in touch with Amanda.

Coming up Toward the end of September we will be holding our next Supportive Care and QOL Subcommittee meeting to discuss the status of projects under our remit. So again, please get involved to help us progress the work so important to our patients.

HARYANA DHILLON Chair, QoL and Supportive Care Subcommittee

Prostate Cancer The prostate subcommittee continues to grow and has seen some exciting achievements over the past few months, as well as a number of new studies on the horizon, putting ANZUP very much on the map in prostate cancer clinical trial research.

In early June 2019, we were very excited to see the ANZUP-led ENZAMET trial first interim analysis feature in a plenary session at ASCO in Chicago. One of only four plenary sessions chosen from over 6,000 abstracts submitted.

This study closed to enrolment in 2017, with patients recruited from Australia, New Zealand, the USA, the UK, Ireland and Canada. The first interim analysis showed a survival benefit of 33% for those in the enzalutamide arm.

A fantastic achievement.

Another exciting development is another of our ANZUPled studies, TheraP, having reached its final patient recruitment – a full five months ahead of time. TheraP has garnered significant national and international interest, showcasing the strength of Australian research teams in the global sphere of clinical trial research, and we very much look forward to sharing the first interim analysis with you in 2020.

Continuing on as an exciting ANZUP initiated activity is the concept development workshop, the most recent of which was held in May. Eleven study ideas were presented, with a view to developing a path

forward to a fully-fledged prostate cancer clinical trial.

The multidisciplinary nature of the event means that a holistic analysis of trial concepts are conducted, from psycho-oncology and survivorship to molecular biology and biomarker studies. The workshop is a truly outstanding and educational event, with a vision to finding the answers to the tough clinical questions in prostate cancer research.

We also have a number of exciting new studies in progress, including ENZA-p and DASL-HiCaP. ENZA-p is ANZUP-led randomised phase II trial using PSMA as a therapeutic agent and prognostic indicator in men with metastatic castrate-resistant prostate cancer treated with enzalutamide (ANZUP 1901). This study is being led by A/Prof Louise Emmett from St Vincent’s Hospital in Sydney. The study aims to recruit 160 patients, across 12 sites – with the view to open the study by the end of 2019.

DASL-HiCaP is also an ANZUP-led randomised phase 3 trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in high risk, clinically localized prostate cancer. Study Co-Chairs are Prof. Chris Sweeney and A/Prof. Tamim Niazi, and the study aims to recruit 1,100 patients from close to 100 sites across Australia, New Zealand, US, Canada, UK and Ireland. We are planning to recruit the first patient to DASL-HiCaP by the end of 2019.

SCOTT WILLIAMS Chair, Prostate Cancer Subcommittee

ANZUP UPdate Spring 2019 | 31

Consumer Advisory Panel (CAP) This spring edition of UPdate always gives me great pleasure in being able to report back on the CAP ‘s attendance at the Annual Scientific Meeting, which is a highlight for the CAP as this is our only face to face meeting as a group each year. Once again #ANZUP19 was a fantastic meeting for us starting with our CAP Education session on the Sunday morning. We were also delighted to welcome Tuan Hoang, Melissa Le Mesurier and Michael Twycross as potential new CAP members who joined the rest of the team at #ANZUP19. It was a great opportunity for them to meet the current CAP and get a much better feel for what our role is at ANZUP is all about. We thank the many members who take the time to consider potential CAP members amongst their patient groups and referring them to us.

Together we enjoyed presentations from Ian Davis, Leonie Young, Scott Williams, Ben Tran, Jaclyn Verghis & Nima Amatya with Lucy Byers and Marg McJannett facilitating our final session with a group discussion on what the CAP can do to assist in promoting clinical trial research in the community. We thank everyone for the time that they take in preparing for our sessions, we had a great morning and learned a great deal more.

The Sunday afternoon was spent attending the Community Engagement Forum where we also have CAP members presenting and facilitating what was once again a very successful program, with the full report on page 12.

ANZUP is well known for having an engaged CAP who interact well with the membership and this only happens through being offered these many opportunities. We thank the ANZUP Board for supporting our attendance at this meeting and to the Marg and her team for organising our great program. We go home rather exhausted but enthused with more information than we came with and the knowledge that we are valued for the contribution that we make.

I was thrilled to be offered a patient advocate scholarship for ASCO June 2019 in Chicago with a very apt theme of Caring For Every Patient, Learning From Every Patient.

Being able to attend this meeting offered me a very memorable experience being able to network with other patient advocates and listen to the research being presented , but 2019 will always remain special as I was able to attend the Plenary session (full report page 7) along with a large contingent of ANZUP members and supporters, where Chris Sweeney presented the very positive results of the #ENZAMET trial. We had front row seats in an auditorium holding thousands of people and was a privilege to be there as part of what was rightly a very proud moment for ANZUP. The CAP reviewed the ENZAMET patient information and consent forms back in 2014, and the results of this trial is what we always hope to see. This is why we volunteer with ANZUP to help promote and be involved in clinical trial research from a patient perspective and try to encourage people to consider clinical trials when assessing their treatment options. Our aim is for the wider community to “think treatment – think trials”.

Sunday evening saw the CAP head out for a group dinner where we were also joined by some of the ANZUP team. This is a great opportunity for everyone to get to know each other in a relaxed environment before we head into the next 2 days of the scientific meeting. The CAP also plays its part in the next 2 days with the opportunity to chair and present at a couple of the sessions. We participated in the bike challenge and thank Michael for riding off in a semi final at the dinner. He is encouraging us to participate more seriously next year!

CAP REPRESENTATION AT ASCO

32 | ANZUP UPdate Spring 2019

Consumer Advisory Panel (CAP) CAP members have also: • A ttended the Concept Development Workshops with feedback from the CAP in the main being very positive. They are an interesting day and it’s important to have a consumer voice at these workshops. We also provided some feedback after the CDW’s to ensure that a small lay summary is provided for all the concepts submitted so the CAP can review just prior to these meetings to ensure that we can participate fully and provide relevant input.

• H ad the opportunity to review Patient Information and Consent Forms for the ENZA-p and the DASL-HiCaP studies and look forward to seeing these trials open to patient recruitment in the near future.

• B een part of the panels to review the applications for the Below the Belt Research Fund Awards with 15 plus studies to be considered and the ANZUP Mundipharma Clinical Research Fellowship. This is really interesting work to read the many research ideas coming through to ANZUP.

Farewell John Stubbs In closing the CAP update we want to formally acknowledge that John Stubbs retired from the ANZUP CAP in April this year and thank him for his 10 years of valued service to ANZUP and the CAP where the group has benefitted from his many years of experience as a committed patient advocate. John is still actively involved in a number of groups so I’m sure that you will still see him around.

There’s never a dull moment being part of the ANZUP CAP and I thank the team for their valued contribution.

I am forever grateful for the CAP’s willingness to “review” whatever needs to be done, even at short notice.

BELINDA JAGO Chair, CAP

Community Engagement Forum videos Each year during the ANZUP ASM, we hold a forum to provide the public with information on ANZUP and the importance of clinical trials in improving treatment for people diagnosed with prostate, bladder, kidney, penile or testicular cancer.

On Sunday 21 July 2019 we held the forum at the Hilton in Brisbane. You can watch the videos from the forum here: https://www.anzup.org.au/ content.aspx?page=asmcommunity ANZUP UPdate Spring 2019 | 33

PROSTATE CANCER MASTERCLASS

At the beginning of June, five clinicians and I attended the inaugural ANZUP Prostate Cancer Masterclass, held at the Dana-Farber Cancer Institute in Boston, USA. Still buzzing after post-plenary celebrations of the ANZUPled ENZAMET study at the American Society and Clinical Oncology (ASCO) Annual Scientific Meeting, we strapped ourselves in for 2 ½ days of high-octane learning, culminating in a comprehensive review on current best practice and emerging clinical evidence in prostate cancer management.

With a program meticulously crafted and facilitated

by Professor Christopher Sweeney, we knew we were in for a treat. What eventuated was a slew of top-class speakers, many of whom were international thoughtleaders in the field. The presenters brought with them a passion that was captivating, but equally down-toearth and approachable when the situation called for it.

The intimate small group environment, which could be perceived as potentially confronting, was anything but.

Instead, it formed the catalyst by which robust debate and discussion amongst colleagues was encouraged and diverse viewpoints allowed to blossom.

The group benefited from exposure to unique perspectives on how current evidence influences the way we care for our patients. Such discussions are essential,

34 | ANZUP UPdate Spring 2019

as it is only through appreciating the practicalities of how treatments impact patients can we even begin to design the innovative clinical trials that will answer the questions of tomorrow. As young investigators embarking in what we hope to be long and fulfilling careers, we were encouraged to think critically, have a healthy dose of scepticism and never be afraid to “challenge the dogma” of long-held potentially erroneous viewpoints that can threaten to derail our research and plague our pursuit of better outcomes for our patients.

Far from being “all work and no play”, drinks on our final night at the “Top of the Hub” overlooking the stunning Boston skyline were an absolute highlight.

On the morning of our last day together, the Boston skies opened, offering a picturesque backdrop of which to tour the grounds of the world renowned Brigham and Women’s Hospital, Boston Children’s Hospital and Harvard Medical School. We listened in awe as Professor Sweeney recounted the coveted history of the area where countless luminaries had toiled and dedicated their lives to making the medical discoveries that would forever

PROSTATE CANCER MASTERCLASS

shape cancer care for decades to come. Truly a fitting finale to an unforgettable few days in Boston.

They say that “good company, lively conversation and the endearments of friendship fill the mind with great pleasure”. To my five new friends (Patti Bastick, Steve McCombie, Handoo Rhee, Andrew Schmidt and Alison Zhang), what a blast! Thanks for making the trip an absolute joy every step of the way. Special thanks also to our dear leader, ANZUP CEO Ms Margaret McJannett, who worked tirelessly to ensure every aspect of our visit ran smoothly from start to finish. Don’t know what

we would do without you there Marg! Finally, none of this would have been possible without the support and generosity of Astellas Oncology.

To the wider ANZUP community, I cannot speak highly enough of this program. If you get the opportunity to attend down the track, don’t hesitate to apply! It would be fantastic to get some of our Radiation Oncology and Nuclear Medicine colleagues to join us next time around.

EDMOND KWAN

ANZUP UPdate Spring 2019 | 35

Best of GU Oncology Evening Symposium The Best of GU Evening Symposium will feature highlights from the 2019 ASM representing cutting edge research and treatment in prostate and urogenital cancer.

Date: Wednesday 6 November 2019 Venue: Coal Cellar + Grill, Hilton, Adelaide Time: 6.30pm – 9.30pm Symposium Chair: Prof. Henry Woo Speakers: A/Prof. Catherine Paterson, Dr. Alison Birtle, A/Prof. Louise Emmett and A/Prof. Nick Brook

Registration is FREE for USANZ or ANZUP members* and places are strictly limited so secure your spot now.’ For more information and to register visit https://www.anzup.org.au/content.aspx?page=bestofgu

36 | ANZUP UPdate Spring 2019

OTHER NEWS Macquarie Bank Charity Morning Tea On Thursday 8 August, close to 100 Macquarie Group employees attended a Charity Morning Tea organised by Giving@Macquarie to raise funds for ANZUP. A/Prof Louise Emmett gave the attendees a short presentation on ANZUP and what we do, and how clinical trials work.

The group was then invited to morning tea, and make a donation to ANZUP. It was great to see so many people interested in ANZUP and want to learn more about what we do.

The morning tea raised over $5,800 including dollar for dollar matching from Macquarie.

A great effort all round!

Thanks again to the Macquarie Group for making this great event possible!

ANZUP Trivia Night in Sydney a success!

On a windy chilly evening in late August Sydney, ANZUP hosted a trivia night with 65 people attending.

A great night was held by all – the ‘Trials and Trivulations’ team were the trivia champions for the evening!

The night was a huge success – raising over $5,300 for our Below the Belt Research Fund.

Thanks to all our sponsors – the Lord Dudley, Lisa McGuigan wine, Lion, Flight Centre, Gin Lane and Baby Coffee Co.

ANZUP UPdate Spring 2019 | 37

OTHER NEWS Hello and Good Luck

Welcome Abi

Good luck Lucy Lucy Byers our Marketing and Communications Manager is going on maternity leave to have her second baby (and another girl) and will return in May 2020. We wish Lucy, Alex and Grace all the best and welcome Evie Rose Patricia Byers who came into the world on Father’s Day.

Abigail Gatling joined the ANZUP team in August 2019, stepping into the role of Marketing & Communications Manager while Lucy Byers is on her maternity leave.

Abi most recently comes from Queensland University of Technology in sunny Brisbane, where she has been managing industry partnerships, events and communications. She has previously worked with AHPRA and the Asthma Foundation. Welcome to Sydney & ANZUP, Abi!

Welcome Joolz Julijana Trifunovic has joined the ANZUP team to lead fundraising and philanthropy initiatives. Joolz has been fundraising for almost 25 years and has helped raise over $32 million for numerous not for profits including the Children’s Medical Research Institute and ANZGOG more recently.

She brings a wealth of knowledge and experience to this new role.

GRANTS AND AWARDS The Noel Castan Fellowship ANZUP is very proud and excited to launch the Noel Castan Fellowship at the 2019 Annual Scientific Meeting (ASM) in Brisbane. The ASM theme “Making Connections” highlights the need to improve access to high quality information for patients and caregivers, while encouraging links between the various health disciplines, researchers and cross-border collaborations.

The aim of the Noel Castan Fellowship is to build ANZUP’s research capacity and increase the translation of information collected from our trials, which will contribute to better understanding of how to optimise patient care.

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

Learn more about the fellowships here: https://www. anzup.org.au/content.aspx?page=noelcastanfellowship

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

Anita Castan

38 | ANZUP UPdate Spring 2019

GRANTS AND AWARDS

ANZUP/PCFA Partnership Grant Call for prostate concepts With the renewal of our Memorandum of Understanding for our PCFA ANZUP Partnership Grant for a further three years, we are now calling for prostate cancer concepts.

The aim is to encourage members to consider submitting their ideas/concepts for broader feedback from a multidisciplinary panel including senior investigators, statisticians, consumers and trainees with the aim of becoming an ANZUP sponsored Protocol.

A shortlist of applicants will be required to present their concepts on Tuesday 26 November 2019 in Melbourne at the Park Royal Melbourne Airport.

ANZUP encourages and supports those concepts that are: • Investigator Initiated ; • Multidisciplinary;

If you have a concept you would like to submit please complete the ANZUP Concept Outline Form (and learn more about Guidelines for ANZUP Concepts here) and return it to anzup@anzup.org.au

by Friday 25 October 2019.

Funding will be available to support attendance of the successful shortlisted applicants.

If you have any further queries,

• M ulticentre (ie ideally across mutliple ANZUP sites (4-6 minimum);

please don’t hesitate to contact

• I nclusive where appropriate of Quality of Life, Translational Research or Health Economic components;

Margaret McJannett.

Ian Davis, Scott Williams or

• Capable of leading to changes in practice.

ANZUP UPdate Spring 2019 | 39

FREE REGISTRATION FOR ANZUP MEMBERS

REGISTRATION OPEN

Ride and support your research fund Tuesday 10 September 2019 Join us in the race to defeat prostate, bladder, kidney, penile and testicular cancers Will you be lining up in 2019 for an action packed day at Sydney Motorsport Park?

The Below the Belt Pedalthon welcomes all levels of cyclists to ride as many laps as you can around the iconic Sydney track, with entertainment, awards, prizes and a post-race lunch.

Help us raise much needed funds to help progress YOUR ideas to clinical trials and ultimately improve treatments and outcomes for those living with below the belt cancers.

All funds raised from the Pedalthon go directly to the Below the Belt Research Fund.

Interested in riding or forming a team? Email the Pedalthon team at pedalthon@anzup.org.au

Together we can fight cancer below the belt www.belowthebelt.org.au 40 | ANZUP UPdate Spring 2019

#BTBPedal19 #SYDPedal19

UPCOMING EVENTS

2019 SEPTEMBER

SEP/OCT

OCTOBER

OCTOBER

10

27-1

17-20

24-26

SYDNEY PEDALTHON

ESMO

RANZCR ASM

BARCELONA

AUCKLAND

NZ SECTION MEETING (USANZ) CHRISTCHURCH NZ

NOVEMBER

NOVEMBER

NOVEMBER

6

12-14

29-30

2019 ANZUP BEST OF GU

COSA ASM

ANZUP PRECEPTORSHIP (PROSTATE)

ADELAIDE, VENUE TBC

ADELAIDE

SYDNEY

2020 FEBRUARY

13-15

15

ASCO GU

MELBOURNE PEDALTHON

SAN FRANCISCO

MAY/JUNE

MARCH

JULY

29-2

19-21

2020 ASCO ANNUAL MEETING

ANZUP ANNUAL SCIENTIFIC MEETING

CHICAGO

ADELAIDE CONVENTION CENTRE

ANZUP UPdate Spring 2019 | 41

EARLY BIRD REGISTRATIONS OPEN FEBRUARY 2020 ABSTRACTS & CONCEPTS OPEN FEBRUARY 2020

SAVE THE DATE

ANZUP ANNUAL SCIENTIFIC MEETING 19-21 JULY 2020 ADELAIDE CONVENTION CENTRE

#ANZUP2020