UPdate newsletter - Summer 2020

The Newsletter of ANZUP Cancer Trials Group Limited

UPdate Summer 2020

CHRISTMAS MESSAGE FROM THE CEO What a year it has been. With all the challenges put before us, our number one priority has remained to conduct high quality clinical trials research to generate evidence and improve treatments and outcomes for patients and their families affected by genitourinary cancers.

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

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

Our TheraP trial featured as an oral presentation at the ASCO 2020 virtual meeting in May, and ANZUP trials continued to feature at national and international meetings including ASCO GU, COSA and ESMO. Our UNICAB trial has brought on its first teletrial site at Goulburn Valley Hospital (Shepparton) under Border Medical Oncology (Albury). This marks an ANZUP first and we look forward to ever expanding the availability of our trials to rural and regional patients.

The achievement of our ENZAMET trial continues with it being awarded the Australian Clinical Trials Alliance (ACTA) Trial of the Year Award, the STInG Excellence in Trial Statistics Award and the ACTA Consumer Involvement Awards. A hat trick and an incredible achievement!

“Our ANZUP-led and co-badged trials continue to go from strength to strength�

Our ANZUP-led and cobadged trials continue to go from strength to strength.

Despite COVID-19 three trials opened for recruitment: DASL-HiCaP, ENZA-p and #UpFrontPSMA, and earlier in the year we held investigator meetings for each. ^ ACTA Virtual Awards

MARGARET MCJANNETT

ENZAMET also featured in ESMO’s Clinical Practice Guidelines for 2020. In addition, ENZAMET was named in the ASCO Annual Report on Progress Against Cancer earlier in the year as one of its Clinical Cancer Advances for 2020. ENZAMET contributed to registration of the agent for this indication by the FDA in December 2019, and has been incorporated into US and European treatment guidelines.

Our ASM due to be held in Adelaide in July, sadly had to be postponed. However, we were excited to introduce our #ANZUP2020 Mini ASM, in a two-day hybrid format working with local hubs and an interactive virtual meeting platform. With over 320 delegates attending the meeting we welcomed a superb international and national faculty. Popular sessions included the Nurses and Allied Health Session, MDT Master Games, ANZUP Symposium, ANZUP in Conversation, trial updates, ANZUPx as well as hosting virtual poster discussant rooms.

We continue to plan and hope that our 2021 ASM will see us back to a face-to-face meeting format. We are planning to hold the ASM in Adelaide from 18-20 July, ably led by our 2021 convener A/Prof Nick Brook. So save the date and we hope we can see you in person! You can read more about the #ANZUP2020 Mini ASM later in this edition.

We also hosted the 2nd Advanced Prostate Cancer Consensus Conference (APCCC), Asia-Pacific (APAC) virtual Satellite Symposium in October. This highly successful multidisciplinary meeting involved 25 key opinion leaders from 14 countries in the Asia Pacific region.

This symposium provided a forum to discuss and debate current questions on the clinical management of men with advanced prostate cancer and help ensure the decisions made are relevant and can be implemented in the Asia Pacific region.

Again due to COVID-19 we had to cancel both our Melbourne and Sydney Pedalthon events for 2020, but we decided to hold our inaugural virtual Below the Belt #YourWay Challenge. During the month of September, 237 challengers and 43 teams ran, walked, cycled and swam 72,783 kms across Australia, New Zealand, UK and beyond. The challengeraised an extraordinary $173,000 for ANZUP’s clinical trial research via the Below the Belt Research Fundand will support the important work of ANZUP clinicians and researchers.

As we reflect the year that was, and the challenges we all faced both personally and professionally, I would like to thank and acknowledge each and every one of you From our Board, led by Ian Davis and now retired Guy Toner, the SAC, subcommittee chairs, deputy chairs, our CAP, study chairs, site investigators and the hundreds of trial staff and members.

To our wonderful volunteers Lesley Tinkler and Jo Stubbs, who unfortunately we haven’t been able to see much this year, but hopefully will again in 2021. Our colleagues at NHMRC CTC and BaCT, our corporate supporters, sponsors and donors, thank you for all of your ongoing support and contributions. Finally, thank you to the many patients who participate in our trials and contribute to improving treatment and outcomes for the community.

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

MARGARET MCJANNETT CEO, ANZUP

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WELCOME TO UPDATE CONTENTS Christmas Message from the CEO

Cover

Message from the ANZUP Chair

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ENZAMET Announced as ACTA Trial of the Year 2020

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TheraP at ASCO 2020 6

Concept Development 8 Workshops ANZUP Clinical 9 Trial Updates Updates from SAC and Subcommittees

11

2020 Mini Annual Scientific Meeting

21

ANZUP #YourWay Challenge

33

APCCC APAC Satellite Symposium

38

Upcoming Events

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MESSAGE FROM THE ANZUP CHAIR Welcome to the final edition for 2020 of UPdate, the newsletter of the Australian & New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group Ltd. I usually fill this introduction to the newsletter with a description of everything ANZUP has done during the year. We celebrate how we have come together and we look forward to every upcoming opportunity to do it again. We thrive on this. Every year we seem to grow more, and take on more projects, and somehow continue to achieve even greater heights. 2020 has brought some unique challenges and I am proud and amazed by the way the ANZUP team and all of you have risen to them. Let me outline a few.

Cancellation of the Melbourne and Sydney Pedalthons and of our ASM could have spelled disaster for us: major reductions in revenue and profile, and more importantly the possibility of severe limitations in what we might be able to do to support our trials, our protocol development pathways, and our education and training initiatives. Instead, we have seen the amazing generosity of our sponsors and supporters: almost none of them asked for the funds to be returned, but instead looked for even more ways to support us.

Then the #YourWay campaign came seemingly out of nowhere to help us raise our profile and that of the diseases we work in and the trials we do, with amazing results you will read about in this newsletter. The ASM has been reinvented as our first virtual “mini-ASM,” which took place on 29-30 November and was a resounding success. It will never replace the sheer joy of getting together with all of you, but it is remarkable just what can be achieved by our fantastic team and by you, our members and contributors. Thank you all so much, and especially our great team headed by Marg McJannett!

these meetings productively by virtual means. This has resulted in a continuing pipeline of ideas and creativity, and perhaps new ways of working together. This year we had CDWs for our Translational committee and our Quality of Life and Supportive Care committee. There are positives here that we will continue to use even after COVID-19.

We had planned early in the year to bring together senior clinicians from around the Asia Pacific region to recapitulate our 2018 meeting where we discussed the local and regional implications of the Advanced Prostate Cancer Consensus Conference. That was to take place in Singapore, which now might as well be on the moon for all our chance of getting there. No problem, sez the ANZUP team, and a virtual meeting involving people living across 140 degrees of longitude was designed and executed flawlessly. Watch for a paper coming out of that soon.

Some things just could not happen. Our TheraP trial was slated for an oral presentation at ASCO, which would have been yet another feather in our cap and a demonstration once again of just how far ANZUP has come on the world stage. ASCO was very different this year but it did not stop the TheraP data from being presented, noticed by many, and discussed by a large number of people. The momentum from that trial will continue as we move ahead with new projects in that space.

However, not even a pandemic could stop us doing the trials that needed to be done. People around the world watched in amazement as we moved ahead with the

We usually meet on several occasions for face to face Concept Development Workshops. That wasn’t going to happen in a year when for some of us it was not possible to go past the end of your driveway. Once again, the team came through: we worked out ways of having

IAN DAVIS

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MESSAGE FROM THE ANZUP CHAIR large international DASL-HiCaP prostate trial, not only seeing it resourced and approved, but also opened at multiple sites in Australia and recruiting well above initial forecasts.

Oh, and it almost slipped my mind. You might remember ENZAMET? ASCO Plenary presentation in 2019? NEJM paper? Intense interest from clinicians, researchers, the community, and media? Helped get the drug registered for this indication in various places around the world? ENZAMET is now cited in US and European prostate cancer treatment guidelines.

And you might have heard the announcement on 1 December that ENZAMET was the winner of the prestigious Trial of the Year award from the Australian Clinical Trials Alliance (ACTA), as well as the ACTA STInG Excellence in Trial Statistics Award, and the ACTA Consumer Involvement Award. ENZAMET is the only trial ever to have won all three awards. I think we can safely say that our work has been recognised and has had true positive impact.

into effective public health policies and practice; does that sound familiar? I’ve been fortunate enough to stay well. Masks and distancing are a nuisance, but I have not had a cold all year. Much of my work can be done productively from home. Technology is a poor substitute for seeing and holding my family, but at least we have it. Many of us have learned more about what is truly important, what should be valued, and what parts of our former lives might be best discarded. We have relearned simple joys and the beauty of living in the moment. And when I could finally see my children and my granddaughter again, the happiness was almost unbearable. Almost.

“ENZAMET is the only trial ever to have won all three awards.

I think we can safely say that our work has been recognised and has had true positive impact.”

2020 has been a year characterised by uncertainty.

That’s often painful or difficult for us to manage. The unexpected and unpredictable can cause us harm, but it can also jolt us out of complacency, and it can lead to creativity and to new things that might not otherwise have been possible. And joy can still be found, sometimes because we do not know the future: this time last year I did not know that 12 months later I would be meeting my new grandson for the first time.

^ ACTA Virtual Awards In many respects 2020 has been a horrible year, starting with the bushfires and then the ongoing horror of the COVID-19 pandemic. So far we have all been barely touched by the pandemic, compared to elsewhere in the world, but even so it has turned our lives upside down, and we mourn for those we have lost. I live in Victoria and thankfully have not been infected yet, although I know people who have, and I have spent a total of four weeks in isolation / quarantine. I have been unable to spend the time I would usually spend with the people I love. It’s awful.

And yet: good can come out of this. We were heading for disaster, especially in Victoria; we collectively and through much sacrifice managed to beat the virus back to zero, even if only temporarily, and with good prospects for future control. It does not escape me that this is because of strong science and translation

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Last year I did not expect in 2020 to be reviewing my trial patients from a clinic where I had to pass screening to enter, then had to wear a mask and faceshield, wipe down everything including the keyboard and mouse mat, allow my stethoscope to sit idle around my neck, and try to do a clinical assessment on the end of the telephone. But I do, and it works, and life goes on, and we learn, and we get better at it, and some of these things might be good to continue eventually.

So, I won’t even try to forecast 2021. I do know that we will continue to thrive as a community, and that ANZUP will continue to do great work and to make a difference to people affected by genitourinary cancers. You will read in this newsletter more about that work, and the plans we continue to make in our eternal optimism.

Please enjoy this edition of UPdate.

IAN DAVIS Chair, ANZUP

ENZAMET ANNOUNCED AS ACTA TRIAL OF THE YEAR 2020 The ANZUP-led ENZAMET trial (ANZUP 1304) was announced as the winner of the 2020 ACTA Trial of the Year Award, the ACTA STInG Award for Excellence in Trial Statistics and the Consumer Involvement Award on 1 December 2020. A fantastic achievement and the first trial to be awarded all three categories.

ACTA is the national peak body supporting and representing networks of clinician researchers conducting investigator-initiated clinical trials within the Australian healthcare system. The awards are designed to celebrate Australia’s world-leading clinical trials expertise and promote the role, importance and value of clinical trials in Australia.

Professor Ian Davis, ANZUP Chair, accepted the Trial of the Year Award, saying, “The ENZAMET trial brought together a global community of clinician-researchers, scientists, and community representatives, all working with trial participants to improve outcomes for people affected by prostate cancer. We are honoured to accept these ACTA awards as recognition of what the wider ANZUP community has achieved so far. We know there is much more yet to do.”

Study Co-Chair Professor Chris Sweeney says of the win,

“It is not only gratifying to have a result that improves the care of patients with prostate cancer, but also very affirming that the ACTA committee has recognised ENZAMET with these awards.”

Many thanks also to Fred Wurzel, who was a patient on the ENZAMET trial, and said a few words at the awards ceremony.

This trial was only made possible because of the following: study co-chairs Professor Ian Davis and Professor Chris Sweeney, the principal investigators, co-investigators, study coordinators, clinical research associates, nurses and data managers, NHMRC Clinical Trials Centre, Cancer Trials Ireland, Canadian Cancer Trials Group, Dana Faber Cancer Institute, our Consumer Advisory Panel, the 83 trial centres both nationally and internationally, and most importantly the 1125 patients involved in the trial. Astellas Pharma

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

Findings from the ENZAMET trial have shown that hormone therapy with a drug called enzalutamide can improve the survival of some men with advanced, hormone-sensitive prostate cancer, and men with this sort of cancer who receive enzalutamide with standard treatment have a 33% improvement in overall survival and a 60% improvement in progression-free survival, compared to men receiving standard treatment alone.

ENZAMET continues to be recognised both nationally and internationally. Last year the trial featured in the ASCO main plenary session, and these practice changing results generated worldwide interest both through extensive media coverage and the medical community. In 2020 the achievements of this trial continued with ENZAMET featuring in ESMO’s Clinical Practice Guidelines for 2020. Other recognition includes being named in the ASCO Annual Report on Progress Against Cancer and as one of ASCO’s Clinical Cancer Advances for 2020.

TheraP INTERIM RESULTS PRESENTED AT ASCO 2020 We were very excited to see the interim results of our TheraP (ANZUP 1603) clinical trial presented at the ASCO Annual Scientific Virtual Meeting in May 2020.

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

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 enabling 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.

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The primary endpoint of the study was to compare the effects of the two treatments on change in PSA, a blood biomarker of prostate cancer. A favourable response, defined by reduction of PSA by 50% or more, occurred in 66% of men assigned to receive Lu-PSMA compared to 37% with cabazitaxel.

Results of the trial also demonstrated the treatment had less severe side effects than chemotherapy. Patient follow-up is ongoing with initial results suggesting the new treatment may delay progression of prostate cancer.

“This clinical trial provides compelling evidence that Lu-PSMA represents a new class of effective therapy for men with advanced prostate cancer. The ability to see what you treat by using the same molecule for both scanning and treatment is remarkable. This enables a personalised and patient-centred care where patients most likely to benefit can be carefully selected.”

Study Chair Prof. Michael Hofman Peter MacCallum Cancer Centre

TheraP INTERIM RESULTS PRESENTED AT ASCO 2020 “This is a great example of an academic clinical trial that has built on work done in Australia, supported by a large group of funders and stakeholders, performed by an outstanding group of clinicians and researchers, supported by the community, with amazing contributions from the trial participants, in a disease setting where we really need better outcomes. Just getting it done is a major achievement, but we have also shown that this new treatment can benefit some men with advanced 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 (now part of Advanced Accelerator Applications, the radioligand business of Novartis), Movember, The Distinguished Gentleman’s Ride, It’s a Bloke Thing and CAN4CANCER. The full interim results from the TheraP study are available online on the ASCO website here (and the video from the event is also available to view for ASCO members).

For additional study information and media coverage received visit http://www.anzup.org.au/therap

ANZUP Chair Prof. Ian Davis

“We are proud to partner with ANZUP on this cutting-edge clinical trial. Deaths from prostate cancer are avoidable, and research is key to saving lives. The interim findings from the TheraP trial demonstrate the tremendous value of Australian-based prostate cancer research towards a future free of prostate cancer.”

PCFA CEO Prof. Jeff Dunn AO

Prof. Michael Hofman

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CONCEPT DEVELOPMENT WORKSHOPS Concept Development Workshops (CDW) for each of the cancers ANZUP focuses on will be held during 2021.

The ANZUP concept development process:

Any ANZUP member is welcome to submit concepts to the multidisciplinary Concept Development Working Groups to review and receive feedback from medical oncologists, radiation oncologists, surgeons, nurses, statisticians, allied health, psycho oncologists and health economists.

Although concepts can be brought to the disease specific subcommittees as any time, CDWs are an increasingly important part of ANZUP’s core business and most new concepts are discussed at one in the first instance. The workshops provide a platform to give and receive invaluable feedback, enabling research to be further developed into high quality proposals.

MARK YOUR DIARIES 2021 CDW DATES: Quality of Life

12 March

Germ Cell

30 April

Renal Cell

23 April

Translational

7 May

BUP 28 April

Prostate

14 May

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ANZUP CLINICAL TRIAL UPDATES Throughout this year ANZUP has remained committed to continuing to work with our members, study chairs, sites and coordinating centres to help manage the impact COVID-19 has had on the conduct of our clinical trials.

But we are pleased to report all trials have continued and a new trial was even opened.

We launched our latest theranostic trial ENZA-p (ANZUP 1901). This randomised phase 2 trial aims to compare the effectiveness of enzalutamide in combination with Lutetium-177 PSMA, versus enzalutamide alone, for the treatment of prostate cancer.

In addition, the UNICAB trial has taken on its first teletrial site at Goulburn Valley Hospital (Shepparton) under Border Medical Oncology (Albury). This marks an ANZUP first and we look forward to ever expanding the availability of our trials to rural and regional patients. We are also pleased to announce the DASL-HiCaP trial has opened its first international collaborative site with the inclusion of Auckland City Hospital in New Zealand. Thank you to all research teams and investigators for their efforts and to the participants for their involvement across all our trials.

ANZUP-led studies ENZA-p (ANZUP 1903)

BCG+MM (ANZUP 1301)

Study sites: 5

Study sites: 12

Recruitment: 13

Recruitment: 309

Target: 160 patients

Target: 500 patients

DASL-HiCAP (ANZUP 1801)

KEYPAD (ANZUP 1601)

Study sites: 22

Study sites: 15

Recruitment: 89

Recruitment: 42

Target: 1,100 patients across ANZ, US, Canada, UK and Ireland

Target: 70 patients

PCR MIB (ANZUP 1502)

P3BEP (ANZUP 1302)

Study sites: 6

Study sites: 25 ANZ

Recruitment: 24

Recruitment: 145

Target: 30 patients

Target: 500 patients

TIGER (ANZUP 1604)

UNICAB (ANZUP 1802)

Study sites: 4

Study sites: 11

Recruitment: 9

Recruitment: 17

Target: 60 ANZ and 420 patients internationally

Target: 48 patients

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As at 17 December 2020

ANZUP CLINICAL TRIAL UPDATES ANZUP co-badged studies #UpFrontPSMA Study sites: 5 Recruitment: 13 Target: 140 patients

NINJA (TROG 18.01) Study sites: 12 Recruitment: 81 Target: 150 patients

As at 17 December 2020

UPDATE YOUR MEMBER DETAILS NOW! Need to update your contact details or subscription preferences?

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.

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UPDATES FROM SAC AND SUBCOMMITTEES SCIENTIFIC ADVISORY COMMITTEE (SAC) The ANZUP Scientific Advisory Committee (SAC) had hoped to meet face to face at the ASM in July. Of course that could not happen in 2020 and the July and November meetings proceeded by Zoom videoconference. The SAC is designed to be multidisciplinary, and one of its strengths (and challenges) is to bring together the expertise, experience, ideas, and creativity of its diverse membership. The SAC spends much less of its time reviewing the conduct of individual trials, and much more thinking about strategic development, scientific direction, improving processes, engagement of our members, and building productive external links.

Our members are also key to ANZUP’s ability to communicate with its stakeholders and other groups with complementary interests to our own.

The SAC is informed and guided by input from its subcommittees: Bladder / Urothelial / Penile (BUP), Germ Cell, Prostate, Renal, Translational, and Quality of Life and Supportive Care. Membership of these committees is open to any interested ANZUP member.

If you are not a member and wish to be, please let us know and we will add you. You can contribute at any level you like, ranging from active involvement in the committee functions and trial management / leadership, through to simple interest and receipt of the minutes.

My hope is that every interested person feels that they are able and welcome to engage in these processes at whatever level you wish. These committees are the “engine room” of ANZUP and we want and need your ideas and energy.

Thanks as always to the members of the SAC, its subcommittees, the Consumer Advisory Panel, and the Board for its support.

IAN DAVIS Chair, Scientific Advisory Committee

IAN DAVIS

BLADDER, UROTHELIAL AND PENILE CANCER (BUP) As the year has progressed and we have adjusted to life with COVID-19, our trials have continued to recruit.

Below we provide an update on developments from the past two quarters, as well as current activity and any challenges and barriers we need to work to overcome.

Highlights include:

•

Current Trials BCG+MM •

Recruitment is now approaching 300 patients of a planned 500. To assist with recruitment, we are aiming to open additional sites for the study,

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•

including Nottingham University Hospital in the UK which is part way through the site initiation process and is due to start recruiting patients very soon. This will mark the addition of the first international site to the study.

Despite the current worldwide shortage of BCG, there have been no supply issues reported for BCG+MM at participating sites and MSD are opening a new BCG+MM supply centre to address global demand.

Therefore, it is important that all ANZUP members remind centres that the best way to conserve BCG stocks in Australia is to continue recruiting patients to this study.

BUP (CONTINUED) PCR-MIB

Trials in Development

•

WAter or Chemotherapy to prevent Urothelial carcinoma a pre-imPlantation (WACUP) (Sengupta)

•

• •

There are now 24 of a planned 30 patients enrolled on this study.

The aim is to complete recruitment before a large randomised Phase III study is opened by MSD later this year/early 2021, to avoid competing with this study.

Final analysis will occur once the last patient is recruited and completes 31 weeks of treatment.

Members are encouraged to send appropriate patients to centres where they could be recruited to this study to help complete recruitment.

• •

•

Below the Belt Funded Projects Circulating immune cell changes in patients treated with Pembrolizumab and chemoradiation for bladder cancer (Weickhardt, 2016) • •

Tissue biomarkers have been collected at sites and will be transferred centrally in early 2021 for analysis.

As yet, translational work on blood biomarkers has not begun. This will occur following completion of accrual of samples.

ACCEPT ANZUP Co-operative multi-centre cystectomy database (Hayne, 2017) • • • •

An abstract on 100 consecutive patients was presented at the ANZUP Mini ASM. St George Hospital and Nepean Hospital have recently received approvals and joined the project as participating sites.

Eastern Health and Royal Melbourne Hospital are also close to opening.

PIs at other sites will be contacted in the near future to seek an update on progress with opening the study.

EXERCYST: Exercise Medicine Prior to Open Radical Cystectomy: Feasibility and Preliminary Efficacy (Taaffe, 2017) • •

A total of 17 of a planned 20 patients have now been recruited.

Exercyst 2 trial is now under development for immediate post-operative exercise.

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There are now 25 out of 30 patients recruited to this study.

A grant application for the phase 3 larger study has beensubmitted in Q4 2020. Thank you to our Urology members who provided information via survey to help support this application.

The phase 3 Randomised trial has been submitted for funding under the new title: WATER Trial- Water irrigation versus intravesical chemotherapy After Trans-urEthral resection of low grade urothelial cancer of the bladder.

SUBDUE-1: SUB-urothelial Durvalumab InjEction-1 (Hayne) • • •

A protocol paper has been submitted.

Four patients have been recruited.

The dose of durvalumab has been escalated and no major immune-related safety issues have been reported.

Concept Submissions The Concept Development Workshops give members a unique opportunity to present new concepts, participate in lively discussion around gaps in research, and plan for future grant applications. ANZUP remains committed to supporting our membership while continuing to promote and encourage members to bring new concepts forward to ensure protocol development.

We encourage all members of the BUP Subcommittee to bring new concepts to the next Concept Development Workshop.

We would like to thank all BUP members for their commitment during this challenging year. We hope 2021 allows BUP concepts and trials to progress unimpeded so we can look forward to a productive year.

DICKON HAYNE & SHOMIK SENGUPTA Chair and Deputy Chair, BUP Subcommittee

DICKON HAYNE

SHOMIK SENGUPTA

QUALITY OF LIFE AND SUPPORTIVE CARE And that was 2020 – it literally zoomed by.

Lorna Pembroke discussed her PhD study, PROCOG, investigating the cognitive impact of prostate cancer In a time of global upheaval it is quite staggering to and treatments. Lorna’s study had previously been realise it was business almost as usual for ANZUP. considered by the prostate cancer subcommittee Given we were already avid users of tele- and videoand has subsequently been granted endorsement by conferencing, it was a relatively smooth transition to ANZUP. I know Lorna is seeking people who are willing Zoom for concept development workshops which meant to refer men to the study for a one-off assessment which work could continue. And how wonderful was it to be can be done via phone or videoconference. able to proceed with the mini-ASM in November, with some hubs enabling small groups to be together for Jasmine Yee sought input on a proposal investigating the meeting. I wanted to acknowledge our Victorian the feasibility and usefulness of body composition ANZUP family who were so amazing in coping with a measurement with a bioimpedence device. One of the very tough lockdown situation. I hope you all have plans things needing exploration in this context is whether the to enjoy the freedom you worked so hard to earn. I for reports provided can be used to facilitate engagement one am looking forward to a break from looking at little with lifestyle interventions such as exercise programs. boxes of people on the screen.

Noel Castan QOL Fellowship Concept Development Workshops As you will all be aware, Kath Schubach (Nurse In October, we held another concept development Practitioner) was awarded the Noel Castan Fellowship workshop. It was inspiring to have five new concepts during 2019. Kath has decided to focus her work on presented to the group, many in very early stages the quality of life amongst people with bladder cancer. of development which allowed the authors to gain It is exciting she now has agreement from the BCG + maximum input from the collective wisdom of the Mitomycin C trial management committee to use the group.

HQOL data from stage 1 of the trial to describe the quality of life of patients over time. This will be the first We were excited to hear about Catherine Paterson’s step in understanding how the disease, treatments, proposed mixed methods study of the unmet needs follow-up, and recovery impact the quality of patients’ and quality of life of men diagnosed with penile cancer. lives. Kath is well supported in her Fellowship by our This is a rare cancer, with apparently significant impacts Deputy Chair, Prof. Catherine Paterson. on many, many aspects of men’s lives. The study has the potential to provide major insights into how we can Subcommittee Meetings better support men affected by this cancer. It will be a world first, and help ANZUP to establish networks with During 2020 we have held regular subcommittee the clinicians treating penile cancers at the moment. meetings and while many of our members are focused on completing their BTB Pedalthon grants, we are Felicia Roncolato presented her concept proposing seeing increased input into ANZUP trials more generally. a phase II trial of oxybutynin for troublesome hot This input is increasing the range of psychosocial and flushes in men on ADT for prostate cancer. We are supportive care questions being addressed within the currently working on a proposal to access the data trials, aiming to better understand how we can support from existing, completed trial to explore the symptom patients throughout their treatments and beyond. clusters associate with hot flushes. This will be a big step forward in understanding how we might effectively ASM 2021 intervene to reduce these symptoms in men.

As you are all aware, it was necessary for ANZUP to postpone the ASM due to the COVID-19 restrictions.

We were delighted to have Cristiane Decat Bergerot join us for the mini-ASM as part of one of the ANZUP

in Conversation sessions. Her insights regarding the

patient experience, decision-making, and coping with GU cancers and their treatments were refreshing and provided a lot to think about. We are so pleased, that all things going well, Cris will join us as an international speaker for the ASM in Adelaide in July.

HARYANA DHILLON CATHERINE PATERSON

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QUALITY OF LIFE AND SUPPORTIVE CARE (CONTINUED) Future psychosocial and supportive care researchers?

While several of our members have welcomed new babies into their families this year (congratulations Camille Short on the safe arrival of Sascha and congratulations to Ben Smith on doubling output with the arrival of Edward), it will take some time before they may decide on a preference for quality of life and supportive care. So, we are doing our best to identify people with an interest in the area to be nurtured and supported as they develop research skills in this space. We also have several ideas suitable to be taken

up by fellows and/or trainees, this would be win-win in engaging their interest and getting some of our projects completed. Please do get in touch if you have people you know who would be interested.

Wishing you all a safe, restful, and uneventful few weeks over the summer holidays.

HARYANA DHILLON & CATHERINE PATERSON Chair and Deputy Chair, QoL and Supportive Care Subcommittee

RENAL CELL CANCER We would like to thank ANZUP as well as the investigators and trial teams for their continued efforts throughout a difficult and turbulent 2020. Below is an update of renal cell trials and other ongoing activity and developments.

KeyPAD trial and encourage cross-referral for suitable patients to support this important hypothesis.

The UNISoN study has the last few participants on treatment. An abstract has been accepted for ASCO GU 2021 for the preliminary results of Part 1. A translational research plan is being drafted that will be presented to the Translational Research Committee for review. A BIG THANK YOU to all the patients, their families, clinical trial coordinators and investigators involved in this trial and the BaCT team for coordination and data analysis. An analysis of the tumour response by RECIST in UNISoN was presented at the ANZUP mini ASM by Deepti Pandey, showing the challenges involved, and winning the best Coordinator talk at the meeting.

We are excited that ANZUP’s first tele-trial site for UNICAB at Goulburn Valley Health in Shepparton has launched.

The KeyPAD study continues to recruit, slowly but surely. We would like to thank all the KEYPAD investigators and trial teams for their continued efforts throughout a difficult and turbulent 2020. So far KEYPAD has recruited a total of 42 patients out of a total of 70 patients. The concept of inhibiting tumour associated macrophages with denosumab is increasingly relevant with many other studies testing this idea internationally. Please continue to promote the

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The UNICAB study is open across 11 sites in Australia and has recruited 17 of 48 patients to date.

After many years of development, the RAMPART study is open and recruiting in the UK, and ANZUP hopes to clear the remaining logistical hurdles to be able to open this trial here in Australia. People with large/ higher risk primary kidney cancers may be eligible to take immunotherapy monotherapy or combination versus observation. There are more steps to take but we hope to open the study in early 2021.

We’ve proposed a novel platform trying to test new ideas to run clinical trials in the CELEBRITY project.

Funding applications have been submitted but this remains in early stages of development. The idea is to make a clinical trial platform embedded in routine clinical practice using pre-existing resources. A number of emerging solutions will be tested, to see if these methods and technologies will enable us to share clinical trials to more Australians with kidney cancer.

The aim is to capture data for outcomes of most

RENAL CELL CANCER (CONTINUED) interest (e.g. survival), provide a platform for smaller sites to take part in ANZUP trials, and ultimately reduce workload for sites and improve patient outcomes.

Further grant applications are being prepared and we hope to be able to develop and launch this project soon.

We’d like to recognise and congratulate again Assoc Prof Andrew Weickhardt for the Below the Belt Research Fund grant: 68Ga-PSMA PET as a potential Imaging biomarker post tyrosine kinase inhibition of metastatic clear cell Renal Cell Cancer (PIRC) – a pilot study.

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

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

The RCC Subcommittee will also hold a Concept Development Workshop a few weeks later in April 2021. We encourage all RCC Subcommittee members, as well as our emerging researchers, trainees and recent graduate members, to attend and present a concept. The workshops continue to provide opportunities to brainstorm potential answers to tough clinical questions in kidney cancer research, as well as the development of paths towards fully-fledged kidney cancer trials. You can find ANZUP’s concept development template on the secure section of the ANZUP website.

We look forward to 2021 when we can further progress renal cell trials and concepts. We have learned this year that we as a global community can work together to solve challenging health problems. We look forward to continuing to work to the goals of preventing, treating and curing kidney cancer in partnership with our patients.

CRAIG GEDYE & DAVID POOK Chair and Deputy Chair, Renal Cell Subcommittee

We extend our thanks to subcommittee members who have referred new members to support membership growth. We encourage continued referral of new members - varying disciplines, trainees and different geographical locations - are all welcome.

ANZUP is planning a RCC Horizon scanning meeting for February 2021, where we hope to examine the current data, the gaps and the opportunities for ANZUP to lead to future developments.

CRAIG GEDYE

DAVID POOK

Find out more about ANZUP’s Concept Development Workshops and download the Concept Template

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PROSTATE CANCER After several years of sterling service chairing the ANZUP prostate subcommittee, Scott Williams has moved on to take on the Deputy Chair position on the SAC. On behalf of the ANZUP membership, we would like to acknowledge Scott’s leadership, and look forward to his ongoing contributions to the prostate powerhouse.

mixture of treatment de-intensification for the low risk patient group, and integration of PSMA PET into treatment planning for other men. The co-badged CHyPPR is exploring a shorter salvage radiotherapy schedule given over 4 weeks rather than the standard 6-7 week approach, potentially as a registry randomised trial. STAMPEDE-Oligo discussions between ANZUP and the UK are ongoing, particularly regarding the integration of DNA damage testing and integration of PARP inhibition.

We convened our first subcommittee Zoom under the new regimen of Lisa Horvath and Jarad Martin, and had the usual animated and wide-ranging discussions over the relevant aspects of the ANZUP trial portfolio. Lisa Translational Substudies won much acclaim for somehow keeping the discussions contained to under one hour.

The ENZAMET trial is proving to be a gold mine for translational research, with planned studies in DASL-HiCaP genomics, cytokines and lipidomics planned for 2021.

An engaged translational group is meeting regularly, DASL HiCaP has hit the ground running, with 89 men and welcomes broader engagement. Other completed already randomised, and new sites coming on line at trials such as TheraP are also a great reservoir of an impressive pace. Anecdotally, the majority of men potential translational sub-studies, and any interested are being managed in the De Novo setting, and we investigators are encouraged to contact the relevant would remind clinicians that the trial is also open to study principle investigator to discuss. men experiencing high risk relapse within a year of prostatectomy.

Changing practice for the benefit of our patients is the guiding principle for ANZUP. We had an update Lu-PSMA Studies that based on the findings of ProPSMA, there has been significant progress potential MBS funding of Where TheraP led, several others are hot on the this disruptive technology in 2021. We look forward to heels. ENZA-p is now open for the metastatic Castrate continuing this tradition of success, and strengthening Resistant group, with 13 men already recruited. The ANZUPs reputation as the world’s premier collaborative ANZUP co-badged UpFront PSMA is available for trials group for genitourinary cancers.

Castrate Sensitive men with high volume metastatic disease at diagnosis, with 6 randomised.

LISA HORVATH & JARAD MARTIN Chair and Deputy Chair, Prostate Subcommittee New Concepts The lifeblood of ANZUP is the pipeline of new trial concepts which are originally presented at a concept development workshop, and then progressed through individual working parties with updates to the prostate subcommittee. Several evolving concepts were discussed including Primary 2 looking at the integration of PSMA PET and mpmMRI in the original diagnosis of prostate cancer with the aim of risk adapting diagnostic biopsy. In the post-operative salvage setting, two concepts are taking shape. DIPPER is looking at a

16 | ANZUP UPdate Summer 2020 LISA HORVATH

JARAD MARTIN

GERM CELL CANCER The second half of the year has again been very productive with a subcommittee meeting and a concept development workshop recently held. Our focus was to get a surgical study underway and receive funding for a stage 1 study looking at microRNA and fear of cancer recurrence. Below you can read if this occurred.

Ongoing activity in the Germ Cell Subcommittee include: 1. TIGER is now open at 4 sites in Australia, with recruitment at 9 patients. This study aims to demonstrate 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.

The open-label, randomised, stratified, 2-arm, multicentre phase 3 trial, led by Dr Darren Feldman from MSKCC, aims to recruit 420 patients internationally, with 60 patients to be recruited from Australia and New Zealand. Members are encouraged to refer relapsed patients to TIGER where possible.

2. iTestis is continuing to expand, opening at multiple sites across the country, with data for over 300 patients on the database. 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.

development of a Stage 2 seminoma surveillance protocol.

5. Liz Connolly recently presented “A Review of the Australian Experience of High Dose Chemotherapy and Stem Cell Transplants for Germ Cell Tumour” at MOGA and again at the ANZUP ASM. This is fantastic local data demonstrating the excellent survival in Australian germ cell tumour patients who have received high dose chemotherapy for refractory disease.

In the pipeline, the following continue to be a focus for the Germ Cell Subcommittee for 2021.

1. Micro RNA analyses appear to be a promising biomarker for testicular cancer, both seminoma and non-seminoma. The CLIMATE study has been designed through the concept development workshop, and will have sufficient funding to start in 2021. The aim will be to recruit ~200 patients with stage 1 testicular cancer over 2-3 years from 7-8 sites and correlating miR-371 with recurrences.

2. The use of primary RPLND in stage 2A/B seminoma and marker negative non-seminoma is gaining momentum. The PRESTIGE protocol examining the changes in HRQoL in patients undergoing primary RPLND is being circulated and we aim to open this study in 2021 as well.

The Germ Cell Concept Development workshop was held on 13 November and resulted in a lot of productive discussion. The concepts presented included: • PRESTIGE- Primary RPLND Study Primary 3. P3BEP has continued to recruit well despite the retroperitoneal lymph node dissectipn (RPLND) for challenging circumstances. 144 patients have now clinical stage II (CSII) testicular germ cell tumour been recruited across ANZ, UK and COG sites. Blood (TGCT) and tissue from consenting P3BEP participants will be • CLIMATE- miR 371 cohort study collected for translational research studies. Members are • National audit results of high-dose chemo/ASCT reminded to consider the study for their patients either • Chemo/Cog Data Analysis at their site or at others where the trial was open.

• Nationwide Tumour Board for Testis Cancer • Hypogonadism Study 4. The ANZUP surveillance guidelines for both stage 1 and advanced disease (following curative Hopefully next year we are not faced with as many chemotherapy) are now available on the ANZUP challenges and are able to progress some of the studies website and are pending eviQ review. Please that are in the pipeline as well as some of the concepts contact Ben Tran if you are interested in leading the above. We encourage you to join our subcommittee meetings and the concept development workshops.

Here’s to a busy, productive 2021 – hopefully with a few face to face meetings!

BEN TRAN & FRITHA HANNING Chair and Deputy Chair, Germ Cell Subcommittee

17 | ANZUP UPdate Summer 2020 BEN TRAN

FRITHA HANNING

TRANSLATIONAL RESEARCH The past two quarters, since the last update, has seen another busy period. In addition, the first Translational Research Subcommittee (TRS) meeting was held. This led to a lot of robust discussion. Below are noteworthy updates and next steps.

ANZUP aims to make translational research a key focus and strength of the organisation moving forward.

Therefore the TRS will facilitate overall translational research activity for ANZUP-led trials. We encourage any ANZUP members who are actively involved in translational research to not miss the opportunity to be part of this subcommittee.

Translational research plans are in place for ANZUP prostate cancer studies. For the non-prostate cancer trials more work is currently required to form a translational research plan. In addition, international trials e.g. ENZAMET and ENZARAD, have established a Translational Research Trial Executive Committee (TEC), which includes representation from the regions, and will not come under the direct responsibility of the TRS.

ANZUP holds face-to-face Concept Development Workshops (CDWs) to promote and encourage members to bring new concepts forward for development. The CDWs are designed to facilitate and support members who actively contribute in teleconferences and across research activities and have an idea/concept they would like to put forward for discussion. And if supported, this concept could further develop into a future grant application.

At present the TRS is considering an initial Concept Development Workshop be held as an educational event. If you are interested in topics such as single cell/ whole genome sequencing and analysis, as well as discussion about opportunities for collaboration, please let us know.

As always, we are grateful for the patients and families who enrol on our trials and donate bio-specimens that support our translational research. We could not conduct our activities without these high-quality samples. We would also like to acknowledge the participating sites thoroughness in obtaining correlative Results from the TheraP trial have established samples from our ANZUP trials. Bio-specimen collection 177 Lu-PSMA as a new standard of care option in continues as part of existing trials, including ENZA-p metastatic castration-resistant prostate cancer (mCRPC). and DASL-HiCaP, BCG+MM, P3BEP, KEYPAD, UNISoN Funded by PCFA, TheraP demonstrated that Lu-PSMA and PCR-MIB. had superior PSA response rates (PSA RR) and PSA-progression-free survival (PSA-PFS) compared to All ANZUP members are reminded you are welcome cabazitaxel. Despite these practice-shaping results, to participate in any of the subcommittees at whatever outcomes from Lu-PSMA are variable and identifying level you wish. If you would like to join the Translational molecular predictors is a priority.

Research Subcommittee please let the ANZUP secretariat know so you can be added.

We will shortly commence planning for correlative samples collected for TheraP. By testing circulating We look forward to a productive 2021 for the biomarkers in pre-treatment blood samples collected Translational Subcommittee and continued translational on TheraP, we hope to better understand why some research activity for ANZUP. men respond and others do not benefit from Lu-PSMA therapy. This will help us to better use this new ARUN AZAD & ANTHONY JOSHUA agent and result in improved outcomes for men with Chair and Deputy Chair, Translational Subcommittee advanced prostate cancer. Results from this world-first study will be presented at ASCO GU 2021.

18 | ANZUP UPdate Summer 2020 ARUN AZAD

ANTHONY JOSHUA

CONSUMER ADVISORY PANEL (CAP) As 2020 draws to a close it will certainly be a year that we remember, especially for the Melbourne CAP members who were locked down for months! As hard as it was at the time, we are extremely grateful we have all remained COVID healthy. On a global scale, being in Australia/NZ seems the best place to be and we are now looking forward to enjoying the warmer months ahead, spending time with family and friends, albeit still with some restrictions.

The CAP had its last meeting for the year in early November and 2 additional guest presentations were added to the agenda.

Lorna Huang presented her concept ‘Characterising prostate cancer patients undergoing hormone therapy: Is there a group of men more at risk of cognitive changes? A cross-sectional study.’ Lorna was seeking feedback from the CAP regarding the patient surveys that underpin the study and to consider how recruitment to the study could be improved.

Lucy Byers, ANZUP Marketing and Communications Manager, also presented a summary of the recently completed and successful #YourWay campaign. It was great to see that all of the CAP contributed to this event in some way through participation, fundraising, donating and promotion. We hope to see this event continue in the future.

Despite a slower start to the year and missing our annual face to face education session and ASM, we have just spent the last couple of days attending the Virtual Mini ASM #ANZUP2020. This was a fabulous way to finish off the year COVID style and included many excellent presentations. Well done to our CAP member Melissa Le Mesurier who co-chaired the ANZUP Symposium and a special thanks to Scott Williams and Dickon Hayne for acknowledging the commitment and work the CAP willingly does to support ANZUP’s research activities from a consumer perspective. We are looking forward to the ASM 2021 in Adelaide.

matched the rankings of the other panel members. This gives the CAP confidence that our ranking is the voice of the community rather than as an individual.

Patient Information and Consent Form Reviews (PICF) were recently completed by the CAP for: ZipUp The CAP believes the trial protocol is straight forward.

We are also of the opinion that if we were in the same position as the cohort of patients being invited to participate in this study, we would all be agreeable to put ourselves forward. Improving scanning techniques for staging purposes to ensure the most appropriate treatment for patients was considered very important by the CAP. UNICAB Master Teletrial PICF The CAP reviewed the original UNICAB PICF back in 2018 (not then recruiting as a teletrial). This PICF had been adapted for use in a teletrial model that has been developed rapidly to deal with COVID-19 restrictions and social distancing. It is very pleasing from a community point of view, that despite the terrible effects COVID-19 has had more broadly, it has certainly sped up the process for developing the teletrial models. This hopefully results in much better access for trials, especially for those living in regional and rural areas.

CAP members have attended the recent concept development workshops, disease specific subcommittees and continue to provide articles for ANZUP‘s consumer magazine and UPdate newsletter.

CAP member Melissa Le Mesurier attended her first Fundraising and Promotions (Partnership) Subcommittee meeting after her recent appointment and Leonie Young and Ray Allen, other CAP members, were nominated to attend the Translational Research Subcommittee to offer CAP representation.

The CAP was also involved as a team in reviewing the research applications received for the Below the Belt Research funding grants. A new review process was put in place following feedback from CAP member Colin O’Brien to ANZUP. Draft CAP grant review guidelines were hastily written. These guidelines will be finalised in the New Year. With these guidelines the CAP then reviewed and discussed the applications, and provided our rankings. These were then collated and very closely

19 | ANZUP UPdate Summer 2020 BELINDA JAGO

RAY ALLEN

CAP (CONTINUED) ACTA Trial of the Year Awards – Consumer Involvement Award I was delighted to be able to accept the Consumer Involvement Award on behalf of ANZUP and the CAP. The ENZAMET trial was one of the first PICF’s the CAP reviewed back in 2013. It has certainly been a very positive journey for the trial, the patients who participated on the trial, for the CAP to have been involved with this, and of course for ANZUP. A big thank you to the ANZUP Chair Ian Davis and ANZUP CEO Marg McJannett who have been ever present and supportive of the CAP since our inception in 2012. It has been a very positive experience for the CAP to be part of ANZUP. We have certainly been very busy contributing this year. Sometimes you may feel a little zoomed out

20 | ANZUP UPdate Summer 2020

but this format has really enhanced the CAP meeting experience as we would not have had all these meetings face to face without restrictions.

We continue to look forward to being able to contribute to ANZUP’s activities. The CAP is currently a great team and we all enjoy working together. So here’s to 2021 – we are well versed in taking on whatever opportunities or challenges we are faced with.

In closing we thank the ANZUP Board, the Executive team and the membership for supporting and engaging with the CAP. We look forward to 2021 being even bigger and better. Wishing you all a very safe and healthy Christmas and New Year.

BELINDA JAGO & RAY ALLEN Chair and Deputy Chair, CAP

v ANZUP CAP

2020 MINI ANZUP ANNUAL SCIENTIFIC MEETING The 2020 ANZUP Mini ASM was held on Sunday 28 November and Monday 29 November 2020.

On behalf of the ‘mini’ organising committee for the 2020 ANZUP Mini ASM I’d like to thank everyone who presented, attended and helped to organise ANZUP’s first hybrid ASM – be it through our virtual platform or in person in one of the hubs that were held across the country.

As you would all be aware, due to COVID-19, in early 2020 ANZUP made the difficult decision to postpone our face-to-face ANZUP ASM in Adelaide, and move it back a year to July 2021. After that decision, we held many discussions with members and sponsors and decided to hold a Mini ASM.

Our ANZUP Symposium hosted a panel of both international and national speakers who explored Creating a clinical pathway in the face of a Pandemic – a very interesting and topical discussion.

ANZUP trial updates and next steps, a virtual poster discussant room and ANZUP awards including the Below the Belt Research Fund Awards and Best of the Best rounded off a very full agenda.

And the Mini ASM was completed with a final and ever entertaining and thought-provoking ANZUPx session given by our final international speaker, Alison Birtle.

I’d like to take this opportunity to thank you for your attendance, either virtually or at a local hub, and also for your ongoing support of ANZUP. This The Mini ASM provided a platform to discuss and meeting is only made possible by the dedication of present the latest updates in GU cancer treatment, each and every member of our ANZUP community. research and supportive care and to learn more about The convening committee of Ian Davis and Lisa existing and planned ANZUP trials.

Horvath have displayed an extraordinary commitment to developing another world-class educational, The program kicked off with a Nurses and Allied Health inspirational and captivating program. I am grateful to Session In the face of a pandemic: Navigating a clinical the ANZUP subcommittee chairs for their review of the trial where a panel explored the challenges of treating submitted abstracts and concepts. My thanks also to patients and the lessons learnt during a pandemic. This the ANZUP management team and in particular, Marg was a great session with some insightful conversations McJannett. And finally, this meeting is only possible which are being collated into a research paper. thanks to the support of our sponsors including Cancer Australia, who provide key infrastructure funding to We also saw the return of the ever popular MDT Master ANZUP. Games. The afternoon was convened by Craig Gedye, Carole Harris and Nicky Lawrence. The panels were ANZUP continues to go from strength to strength and I broken up by disease type. Each then endeavoured to strongly urge all members to actively engage, whether educate the audience with real-life clinical challenges it is through attendance at the ASM’s, proposal and and audience polling. development of new trials, recruitment for current trials, or involvement in the subcommittees. People On the Sunday evening we hosted a ‘virtual’ welcome continue to be diagnosed with genitourinary cancers, drink session and held the first two highly anticipated so even though we are making a difference there is ANZUPx talks – featuring Andrew Weickhardt and more work to be done. With your help, ANZUP has the Catriona McNeil. Since its inception 3 years ago, opportunity to place Australia and New Zealand at the ANZUPx has never failed to disappoint - and this year, forefront of the world of GU Oncology. even virtually, was no different.

I hope you enjoyed the 2020 Mini ANZUP ASM, and We also held the first of our two ANZUP in look forward to welcoming you to the 2021 ANZUP Conversation panel discussions hosted by Joseph ASM in Adelaide from Sunday 18 July to Ischia and Renu Eapen. The first of our stellar Tuesday 20 July. international line up on the panel were Silke Gillessen and Tom Powles - and this was truly a highlight.

HENRY WOO The Monday morning saw the next ANZUP in Convenor, 2020 Mini ASM Conversation sessions featuring more of our great internationals: Chris Sweeney, Alicia Morgans, Felix Feng and Cristiane Bergerot. There was lively, and sometimes controversial discussions around the GU highlights of 2020.

21 | ANZUP UPdate Summer 2020

HENRY WOO

HIGHLIGHTS FROM #ANZUP2020 ASM

“Very engaging speakers and great to hear some international perspectives on the COVID-19 pandemic”

Nuses & Allied Health Session

Sydney Hub Hub attendees in Sydney, Melbourne & Perth

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“Attending the Hub in Sydney was excellent, great to mix with real people”

MDT Master Games, “The MDT Master sponsored by Janssen

Games sessions were informative, interesting and a great learning opportunity”

“ANZUP in Conversation was a real highlight”

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ANZUP Symposium, sponsored by Astellas

“The ANZUP Symposium was very engaging and interesting” Virtual poster room, sponsored by AstraZeneca

ANZUP Trials

“Amazing coordinators, great study cases, very relevant to current landscape, very engaging” 24 | ANZUP UPdate Summer 2020

v Best of the Best winner Richard De Abreu Lourenço

Twitter Participants

Best of the Best Awards, sponsored by Ferring Pharmaceuticals

^ Best of the Best oral presenter Hui Ming Lin

Behind the scenes

Bring on #ANZUP21 in Adelaide!

Watch Nick Brook’s video here

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ASM BY NUMBERS

320 DELEGATES 3

9

ANZUPx SESSIONS

INTERNATIONAL SPEAKERS

20

11

SPONSORS

PROFESSIONS

49

ABSTRACTS

20+

SESSIONS 26 | ANZUP UPdate Summer 2020

12

TRIAL COORDINATOR SCHOLARSHIPS

ASM BY NUMBERS (CONTINUED)

8

ANZUP IN CONVERSATION INTERVIEWS

5

BELOW THE BELT RESEARCH FUND AWARDS

#ANZUP2020 TWITTER

1.2M+

450+

IMPRESSIONS

TWEETS

TOP INFLUENCER @HAGSIE 130 TWEETS & 420K+ IMPRESSIONS #ANZUP2020 APP

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DOWNLOADS

4,500+

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UNIQUE VIEWS 27 | ANZUP UPdate Summer 2020

ASM AWARDS Congratulations to all 2020 winners ANZUP Delegate Scholarships Congratulations to: Mohammed Al-Zubaidi

Anthony Joshua

Xuan Rui Ong

Kuok Liang (Albert) Tan

Dominic Bagguley

Nathasha Karunaratna

Deepti Pandey

Arsalan Tariq

Elizabeth Connolly

Lawrence Krieger

Nicholas Ralph

Renea Taylor

Niall Corcoran

Mitchell Lawrence

Bradley Reynolds

Pravin Viswambaram

Richard De Abreu Lourenço Hui-Ming Lin

Matthew Roberts

Thomas Whish-Wilson

Michael Fernando

Andrew Morton

Shanen Sandhu

Samer Yousef

Howard Gurney

Visalini Nair-Shalliker

Tahlia Scheinberg

Cynthia Hawks

Ruchira Nandurkar

David Smith

Michael Hofman

Jonathan O’Brien

Jo-Lynn Tan

Trial Coordinator Scholarships

2020 Best of the Best Awards

Congratulations to: Akrita Kaur

Sponsored by

Brandan Holt Cindy Ren Duncan Colyer Emma Newton

Congratulations to:

Kate Fluck Lara Kenyon

Best of the Best Nursing Allied Health Award

Lisa Walker

Cynthia Hawks

Lorna Eggers

Best of the Best Oral Presentation

Pavi Krishanth

Richard de Abreu Lourenço

Rachel Doyle

Best of the Best Poster Award

Stephanie Kaladis

Dominic Bagguley Best of the Best Student/Trainee/ Fellow Award Pravin Viswambaram Best of the Best Trial Study Coordinator Award Deepti Pandi

28 | ANZUP UPdate Summer 2020

AWARDS Thank you to all 2020 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 Mini ASM 2020.

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

Matthew Roberts - De-Intensification of Post ProstatEctomy Radiotherapy (DIPPER) incorporating clinical and imaging-based risk stratification: Part 1 – Pilot study (additional site).

MRI is now routinely utilised for the diagnosis of prostate cancer in Australia. However, it still misses about 15-20% of important cancers, and about half of the biopsies undertaken after MRI are negative, because MRI is not completely accurate. PSMA PET is a new technique that is helpful in staging men who have already been diagnosed with prostate cancer.

The PRIMARY trial - currently underway - is assessing the value of PSMA PET in men who are suspected of having prostate cancer, and are undergoing both an MRI and a prostate biopsy.

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

This trial proposes to randomise men between MRI + biopsy (if required) - the current standard of care in Australia, and MRI /PSMA + biopsy (if required). The study hypothesis is that PSMA MRI will both reduce unnecessary biopsies and improve accuracy of prostate cancer diagnosis, compared to using MRI alone. Also, a health economics analysis to assess cost to the community and QOL for men with prostate cancer is an important component of this trial.

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

29 | ANZUP UPdate Summer 2020

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

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

AWARDS Alex Tan - PRIUS MR: Prostate Re-Irradiation Using SABR and MRI Guidance.

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

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

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

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

Anis Hamid - MEMENTO: Biomarker discovery in metastatic hormone sensitive prostate cancer (MEtastatic Prostate Cancer MEthylation and Transcriptional biOmarker Study).

In recent years, we have learned that changes in prostate cancer genes can influence the risk of developing metastatic prostate cancer. This study aims to improve our understanding of how genes are controlled in metastatic prostate cancer, and specifically how gene control might determine how men respond to standard treatments (such as hormone therapy and chemotherapy).

By way of examining cancer biopsies taken at the diagnosis of metastatic prostate cancer, we will test for an important genomic feature called DNA methylation – a process involved in ‘silencing’ genes. We believe DNA methylation will provide important information about why some cancers are more aggressive than others and why men may respond to treatments

30 | ANZUP UPdate Summer 2020

differently. We will use DNA methylation information from the tumours and compare it to information of how men diagnosed with metastatic prostate cancer responded to standard treatments. We then hope to use this as a strong foundation to design larger studies to test DNA methylation in prostate cancer clinical trials, to prove that it is an important test in the clinic to identify the risk of aggressive disease and to tailor the optimal treatment choice for patients. Ultimately, this study aims to build on our scientific knowledge of prostate cancer in order to improve ‘precision care’ of men with metastatic prostate cancer.

Andrew Weickhardt - 68Ga-PSMA PET as a potential Imaging biomarker post tyrosine kinase inhibition of metastatic clear cell Renal cell Cancer (PIRC) – a pilot study.

Immunotherapy and tyrosine kinase inhibitors (tablet targeted therapies) have revolutionised the treatment of advanced clear cell renal cell cancer (ccRCC), the most common type of kidney cancer. Computed tomography (CT) scans are used to determine where the cancer is and how it is responding to treatments.

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

A new type of positron emission tomography (PET) scan, targeting “prostate specific membrane antigen” (PSMA), appears very useful in diagnosing the extent of ccRCC spread before treatment and to see if the treatment is working. This is likely because RCC deposits have many small blood vessels, with the PSMA protein being found in these blood vessels, and not because it is related to the prostate.

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

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

ANZUP IN CONVERSATION For the past three years at the face-to-face ANZUP ASM we featured ‘Talking Urology.’ Joseph Ischia chatted with key opinion leaders and experts in their field who featured at the ANZUP ASM to give both highlights of their presentation at the ANZUP ASM as well as updates from key meetings around the world.

Sponsored by

This year, with the impact of COVID-19 leading to the ANZUP ASM and most other key meetings going virtual, we needed to think ‘outside the box’ - and ANZUP in Conversation was born.

During the Mini ASM Joseph Ischia and Renu Eapen hosted two ANZUP in Conversation sessions featuring a stellar line up of international guests: Silke Gillessen, Tom Powles, Chris Sweeney, Alicia Morgans, Felix Feng and Cristiane Bergerot.

These ‘Graham Norton’ style sessions proved a huge hit at the Mini ASM, and we were lucky enough to also interview many of the key internationals who featured in not just this session but ANZUPx and the ANZUP Symposium as well.

You can watch these ‘conversations’ on the ANZUP website here.

< Chris Sweeney and Lisa Butler Tom Powles and Andrew Weickhardt >

< Silke Gillessen and Ben Tran Cristiane Bergerot and Amanda Hutchinson >

< Alicia Morgans and Ian Davis Rob Bristow and Lisa Horvath >

< Alison Birtle and Dickon Hayne Felix Feng and Jarad Martin >

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THANK YOU TO OUR 2020 ASM SPONSORS Thank you to our generous sponsors for the 2020 Mini Annual Scientific Meeting.

Platinum Sponsors

Gold Sponsors

Silver Sponsors

Bronze Sponsors

Delegate Scholarships

MDT Masterclass

Symposium Sponsor

ANZUP in Conversations Sponsor

International Speaker Sponsors

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Best of the Best Awards Sponsor

App Sponsor

Virtual Poster Room Sponsor

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

Watch the #YourWay highlights reel on YouTube here.

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

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

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

“This cause is close to my heart.

Currently, I’m a collaborator in a world-first bladder cancer therapeutic trial, only made possible with a $50 000 Below the Belt start-up grant. We can’t wait to share our progress!”

- Andrew Moe David Pook >

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

Louise Emmett and her team ‘Sydney Opera House to Manly Beach’ walked all day and clocked up an incredible number of kilometres whilst enjoying the scenic adventure.

Rottnest Island event ^ Andrew Weickhardt and Dave Pook competed in the Zwift cycling community.

“Under lockdown the only way is virtual hill climbs - so far >7000m elevation climbed upwards on the bike - Mont Ventoux, Mt Evans and others.”

- Andrew Weickhardt

BELOW THE BELT #YOURWAY The Ladies of Lifehouse team >

The Ladies of Lifehouse - Lisa Horvath, Kate Mahon and Catriona McNeil - joined The Bay Run enthusiasts and walked 12km for #YourWay. ANZUP member Shomik Sengupta and his team rode, walked and ran until they were ‘Sweaty Down Under’.

Belinda Jago didn’t let lockdown hinder her efforts and was the highest fundraiser raising $5,455 and exceeding her walking goal of 150km to 347km.

Michael Twycross ended up running an incredible 343kms. v Michael Twycross

“I had challenged myself to walk a minimum of 150kms and I’m very happy to report that I’m on target to achieve my stretch goal of 200kms. Tony has joined in the challenge as well and we have walked the streets of Lysterfield and lucky for us our 5km zone allows us to walk in the lovely Lysterfield National Park as well. I also gratefully thank all the family and friends who have chipped in and sponsored this event. Raising funds is vitally important to help ANZUP run clinical trials to answer questions that may help improve outcomes for #belowthebelt #cancers. We could not do this work without your support.”

- Belinda Jago (Chair, ANZUP CAP)

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BELOW THE BELT #YOURWAY < Team Undies Other ANZUP members who participated in the #YourWay Challenge included: Matt Leonard, Natasha Roberts, Mario Guerrieri, David Blakey, Michael Ng, Cynthia Hawks, Bradley Reynolds, Peter Grimison, Megan Crumbaker, Sarennya Pathmanandavel, Tom Ferguson and Pravin Viswambaram. v Hary Dhillon

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

Go Team Undies!”

- Craig Underhill and Team Undies Kev’s Crew - Kath Schubach, her husband Ross and niece Laura, rode and walked for Kev.

v Kev’s Crew

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BELOW THE BELT #YOURWAY

Manu Feildel ^

^ Tom Ferguson

Thank you to everyone who supported the Below the Belt #YourWay Challenge. For those who missed out – the challenge will be back in 2021.

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

More information coming soon.

“As a long-time supporter of the Pedalthon and an Ambassador of the Below the Belt events I think it’s a wonderful evolution to the #YourWay challenge in response to the events thrown at us in 2020.

Now more than ever it’s really important that people find their own way to stay healthy and active, and also to continue to raise awareness for the amazing work the ANZUP team are doing.”

- Jonny Harrison, Sydney Pedalthon Ambassaor

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- Manu Feildel, Chef & #YourWay Ambassador

THANK YOU TO OUR #YOURWAY SPONSORS AND SUPPORTERS Thank you to our generous sponsors for the 2020 Below the Belt #YourWay Challenge.

Gold Sponsors

Silver Sponsor

Bronze Sponsor

Supporters

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ADVANCED PROSTATE CANCER CONSENSUS CONFERENCE (APCCC): ASIA-PACIFIC (APAC) SATELLITE SYMPOSIUM In advanced prostate cancer, fast and effective drug development has resulted in many treatment options and these all require careful decision-making for each patient. Clinicians face the progressively challenging task of selecting from multiple potentially effective treatments that are also costly and possibly toxic. Further developments in novel nextgeneration imaging methods, biomarkers, molecular characterisation, and genetic testing have led to many questions and areas for which there is little evidence to support clinical decision-making.

On Monday 26 October 2020 ANZUP hosted the 2nd Advanced Prostate Cancer Consensus Conference (APCCC), Asia-Pacific (APAC) Satellite Symposium virtual meeting - a meeting developed to help ensure the treatment decisions made are relevant and can be implemented in the Asia Pacific region.

The meeting involved 25 multidisciplinary clinicians from 14 countries: Australia, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Turkey and Vietnam. Participants were selected based on their expertise in the management of advanced prostate cancer in their respective region.

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

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

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

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APAC APCCC 2020 did not set out to develop a revised set of consensus recommendations, but used in-meeting and post-meeting polling to gain insights into key issues relevant to the Asia-Pacific region.

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

Key issues for the Asia-Pacific region which continue to influence management of advanced prostate cancer include: • differences in access to and cost of therapeutic agents, including the availability of generics • differences in access to and cost of novel imaging technologies and indications for use • toxicity profile of chemotherapy among Asian populations • later stage at diagnosis of prostate cancer among some Asian populations – while not discussed specifically during the meeting, this was presented as background context and was highlighted as an issue which is at risk of being further exacerbated by the pandemic.

We are in the process of preparing a paper from the discussions to be submitted for publication in the BJUI. ANZUP hopes this symposium continues as an ongoing series of meetings to provide a platform to discuss the real-world application of evidence to the management of patients in the Asia Pacific region. The commitment and interest of all involved demonstrates the importance of working together to consider topics applicable and significant to the region.

UPCOMING EVENTS 2021 MARCH

MARCH

FEBRUARY

MARCH

11 - 13

12

19 - 20

23 - 24

ASCO GU Symposium

Quality of Life Concept Development Workshop

ANZUP Preceptorship

TROG ASM

APRIL

APRIL

APRIL

MAY

23

28

30

7

Renal Cell Cancer Concept Development Workshop

BUP Concept Development Workshop

Germ Cell Cancer Concept Development Workshop

Translational Concept Development Workshop

MAY

MAY

JUNE

JULY

14

1 - 31

4-8

18 - 20

Prostate Cancer Concept Development Workshop

#YourWay Challenge

ASCO Annual Meeting

ANZUP ASM Adelaide

SEPTEMBER

AUGUST

SEPTEMBER

SEPTEMBER

25 - 27

1

9

17 - 21

MOGA ASM

Corporate Supporter Meeting

Sydney Pedalthon

ESMO Conference

NOVEMBER

OCTOBER

NOVEMBER

NOVEMBER

9

3

14

16 - 18

APCCC

ANZUP Best of GU Evening Symposium

Melbourne Pedalthon

COSA ASM

39 | ANZUP UPdate Summer 2020

#ANZUP21 ABSTRACTS & CONCEPTS OPEN FEBRUARY 2021 EARLYBIRD REGISTRATIONS OPEN FEBRUARY 2021