ANZUP Annual Report 2021

Annual Report 2021

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

The Directors of ANZUP Cancer Trials Group Limited (“ANZUP”) are pleased to submit the Annual Report for 2021

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

ANZUP and its members would like to acknowledge and pay respect to the traditional owners of the lands on which we live and work across Australia. We would like to pay our respects to the elders both past and present, and all Aboriginal and Torres Strait Islander people, from whatever nation they may come. In particular, we acknowledge the Gadigal people of the Eora nation as the traditional owners of the lands and waters where our offices are located.

ANZUPtrials ANZUP anzuptrials

ANZUP Cancer Trials Group

ACN 133 634 956 ABN 32 133 634 956

FRONT COVER – ANZUP’S ENZAMET trial is awarded all three categories in ACTA’s Trial of the Year Awards

ANZUP ANNUAL REPORT 2021

Contents PAGE ANZUP 2020/21 Highlights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 Chairman’s Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Chief Executive Officer’s Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10 Organisational Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Governance Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Governance Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Thanks to Corporate and In-kind Supporters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 2021 ANZUP Membership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 ANZUP’s History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-17 Mission, Objectives, Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18-25 ANZUP’s ENZAMET Trial of the Year 2020 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26-27 Fundraising, Partnerships and Engagement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28-29 Below the Belt Research Fund . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30-31 Research Highlights – Committee Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32-41 2020 ANZUP ASM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42-46 Below the Belt #YourWay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47-49 Grants and Awards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50-51 Participating Centres . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52-53 Publications and Presentations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54-55 Financial Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56-77 Further Information and Contact Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78-80

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ANZUP ANNUAL REPORT 2021

AT A GLANCE

ANZUP 2020/21 Highlights MEMBERSHIP*

83%

1,820 members

2016

2017

2018

2019

2020

since 2016

2021

ANZUP & CO-BADGED TRIALS**

16 2018/19

2019/20

2020/21

ANZUP TRIAL PARTICIPANTS

4,690+

18

320

2020 VIRTUAL ASM DELEGATES

FROM OVER 340 SITES

CDW

WORKSHOPS

CONCEPTS

ATTENDEES

*As at 31 March, 2021

2018/19

2019/20

2020/21

5

6

4

32

31

24

115

229

115

**Active trials, including those in follow-up.

AT A GLANCE

ANZUP ANNUAL REPORT 2021

ANZUP 2020/21 Highlights CORPORATE SUPPORTERS

IN-KIND SUPPORTERS

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4

2020/21

2020/21

ANZUP TWITTER FOLLOWERS

WEB PAGE VIEWS

2018/19

184,028

2019/20

189,856

2020/21

201,496

2,722 2021

Y UR WAY

2,472 2020

2,139 2019

237

1,891 2018

CHALLENGES

1.2M+ 2020

ASM TWITTER IMPRESSIONS

$173,000

2020

RAISED

BELOW THE BELT

RESEARCH FUND GRANTS FELLOWSHIPS, SCHOLARSHIPS AND AWARDS

40

2018

49

2019

43

2020

(INCLUDING TRAVEL FELLOWSHIP, STUDY CO-ORDINATOR, YOUNG INVESTIGATOR AND BEST OF THE BEST)

*As at 31 March, 2021

1708 DONORS

72,783 KMS TRAVELLED

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ANZUP ANNUAL REPORT 2021

AT A GLANCE

Chairman’s Report At a glance I am privileged to provide this report on behalf of the ANZUP Board outlining ANZUP’s activities, progress against its Strategic Plan, and state of the Company over the last year.

ANZUP brings together a highly diverse and representative group of clinicians, researchers, and community representatives, to work with our partners and other stakeholders to improve outcomes for people affected by genitourinary cancers. We represent all relevant clinical and scientific disciplines, with guidance and input from an experienced and highly engaged Consumer Advisory Panel. We recognise the clinical needs because we experience them every day, either through our patients or personally. We are immersed in the science, either because of a dedication to learning and teaching or because we are involved in performing the research. We foster creativity, and this results in development of clinical trials to generate new evidence and to improve health policy and practice.

The last year has been difficult for everyone due to the COVID-19 pandemic. ANZUP was affected substantially. Our staff had to alter work practices rapidly, including setting up effective and safe systems for working from home. Our fundraising plans that had included face-to-face events such as the Melbourne and Sydney Pedalthons had to be scrapped. Our Annual Scientific Meeting could not proceed as planned in July 2020. Different regions and various health services responded to the pandemic in a wide variety of ways, with some suspending clinical research altogether. We could not continue our usual patterns of meeting together here or at international conferences, where relationships and new collaborations are often forged and strengthened. There was a very real risk of losing momentum and personnel, of our pipeline of creativity being blocked, of trials not progressing or being cancelled, and of financial hardship to ANZUP as a small company and a charity relying heavily on fundraising.

I am delighted to report that ANZUP met all of those challenges and flourished during this period. We are a not-for-profit company but we are allowed to accumulate some financial reserves. The Board has been managing this carefully for several years. This meant that we were well situated to continue most of our activities for a considerable period of time even if revenue ceased altogether. The Board has invested resources through Perpetual, and returns on those investments unsurprisingly were less than anticipated over this period, but were still above benchmarks. We were able to continue our policy of responsible and ethical investment. ANZUP was fortunate to receive Jobkeeper support, which was of great assistance in managing cashflow and allows us to have confidence we can meet known future liabilities.

Our very generous sponsors and partners continued to support us even though most of our usual activities did not go ahead as planned

Our objectives are to provide access to clinical trials where we can; to engage with a broad range of professional disciplines and to grow these links; to provide opportunities for participation in clinical research and to improve systems for doing so; to try to embed research as part of routine clinical care; to train future researchers, particularly clinician-researchers; and to add value to our trials by including related work such as basic and translational laboratory studies, quality of life research, health economic research, and other areas as applicable to each trial.

Our fundraising efforts underwent rapid transformation, resulting in a highly successful #YourWay campaign that continued to support our Below the Belt Research Fund, with 100% of funds being made available for that support. We were able to rethink and reschedule several of our key activities virtually, including Concept Development Workshops, and a very successful online Annual Scientific Meeting in November 2020.

AT A GLANCE

Throughout all of this ANZUP continued to have significant impact. Other groups in Australia and New Zealand, and in fact around the world, expressed amazement that our international DASL-HiCaP prostate cancer study was not only initiated during the height of the pandemic and lockdown in Australia, but accrued well ahead of predicted rates and was able to open sites rapidly. ANZUP changed many of the processes with its trials to allow for the pandemic, including provision for telehealth review of trial patients, shipping of study medication to the home, and other measures. This provided much-needed convenience and safety for our trial participants, allowed our site trial teams to continue working, and continued our momentum.

One of the highlights of the 2020 year occurred when the ENZAMET trial (ANZUP 1304), the subject of a plenary presentation at the 2019 ASCO meeting, swept the pool of awards from the Australian Clinical Trials Association, winning the 2020 ACTA Trial of the Year Award, the ACTA STInG Award for Excellence in Trial Statistics, and the Consumer Involvement Award. ENZAMET was the first trial in the history of the ACTA awards to win in all three categories. This is wonderful recognition of work that was of extremely high quality, directly informed and guided by our community, and has transformed clinical practice around the world. The study drug, enzalutamide, is now approved for this indication in multiple regions of the world including Australia, where the trial is cited in the registration documentation.

ANZUP the scientific organisation is guided by our Scientific Advisory Committee, comprising core members from various disciplines as well as the chairs of the various subcommittees.

ANZUP the company and charity is led by a very capable and engaged Board, comprising directors elected from the ANZUP membership and other directors appointed to the Board. This mix of expertise is difficult enough to find; we not only have that, but the extraordinary generosity of my fellow Directors in terms of the time and very practical input they contribute cannot be overstated. I am very grateful to them for their support, which is always reliable and always challenging in the most positive ways. ANZUP is supported and advised at every level of the organisation by our Consumer Advisory Panel, who provide advice on clinical needs, the patient perspective, our scientific strategy, our communications and documentation, our social media, our fundraising, and every other aspect of what we do. This is a talented and engaged group of people, and the 2020 ACTA Consumer Involvement Award is only one demonstration of how important and valuable they are to ANZUP. The ANZUP Strategic Plan is due for refreshment. We have made excellent progress against the deliverables in the Plan and its underlying operational components. I summarise some of them here, in reference to the specific goals outlined in the Strategic Plan.

ANZUP ANNUAL REPORT 2021

Goal 1. Continue to build on and develop high quality cutting edge clinical trials.

We have opened or continued development of several trials during this period, including the DASL-HiCaP trial that is now recruiting in Australia, New Zealand, and Canada, with USA / UK / Ireland to follow soon. Other trials have continued development, with key agreements signed and collaborative links built to ensure their success. Our Concept Development Workshops have continued, with several promising ideas moving forward with a view to becoming active ANZUP trials; several of these have required setting up complex multi-party agreements.

2020 ACTA TRIAL OF THE YEAR AWARD

Goal 2. Increase awareness, participation and access to ANZUP trials.

ANZUP receives funding through Cancer Australia, of which part is contingent upon our ability to meet certain metrics, including numbers of trials, number of trial participants, number of sites including new sites, and engagement of rural, regional, and remote sites. ANZUP has been complimented on its ability to meet all those targets. We continue to build on this success, identifying new sites and new strategies to improve access and engagement.

Goal 3. Strengthen and build our capacity and capability to ensure we can deliver our Strategic Plan.

ANZUP has reviewed many of its processes and has developed and grown its capability to sponsor trials, ensuring that we keep “ownership” and control over these academic endeavours. We have also strengthened our office staffing, improving our ability to communicate internally and externally, track and monitor our trial activities, and ensure our processes are protected from external challenges such as COVID-19 or other changes in circumstances.

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ANZUP ANNUAL REPORT 2021

AT A GLANCE

Goal 6. Broaden ANZUP’s profile in the community locally, nationally and internationally.

THE #ANZUP2020 MINI ASM - EVENING SYMPOSIUM: “CREATING A CLINICAL PATHWAY IN THE FACE OF A PANDEMIC” - IAN DAVIS, CRAIG UNDERHILL, BERTRAND TOMBAL, NATASHA ROBERTS AND FRITHA HANNING.

Goal 4. Engage, collaborate and enhance mutually beneficial relationships.

We have continued to build on previous successes, including collaborations with other groups such as Prostate Cancer Foundation of Australia, the University of Sydney and the NHMRC Clinical Trials Centre, the Biostatistics and Clinical Trials Centre, Cancer Trials Ireland, and the Canadian Cancer Trials Group. New links forged with the Prostate Cancer Clinical Trials Consortium have enabled us to plan for trials to be run in the USA, something that previously was very difficult to undertake.

Goal 5. Increase engagement of the membership.

Our membership is now over 1800. We are aware that many of our members are not deeply engaged with ANZUP, but we are confident that opportunities are available for any member to participate at whatever level they feel comfortable. We aim to refresh the composition of our various leadership groups and to support younger researchers as they develop ideas and are mentored; these are the future leaders of the clinical and research communities and of ANZUP itself. ANZUP has been able to continue to provide a range of research grants, fellowships, and other awards, which have given support that would otherwise not have been available.

I have alluded above to various activities and events that have highlighted ANZUP and its activities. We have strengthened our communication capabilities, and continue to provide regular and very high quality information through various means, including the UPdate newsletter and ‘A little below the belt’ magazine. Other opportunities have come up to highlight our activities, including various media appearances by members, speaking invitations, input to advisory groups including government and advocacy, and most recently as the designated charity for Manu Feildel as he competed on Dancing with the Stars. Our aim is not publicity for its own sake, but to increase awareness of the diseases in which we work, and of the importance of clinical trials.

I would like to close by acknowledging our CEO Margaret McJannett and her team. These people are the quiet achievers behind all that we do, and you are probably often not even aware of how hard and how effectively they work.

Our survival and thriving through 2020 is a testament to their tenacity and commitment, their enthusiasm and energy, and the extremely high quality of everything they do. We are very fortunate to be so well supported.

We enter the 2021-2022 financial year not battered, bruised, and broken, but instead stronger, more resilient, more agile, and more confident than ever of our ability to perform at the highest level on the national and international stage. Final thanks go to all our members, for your contributions and support at every level; and to our patients and our families, who are the reasons we do all of this.

I commend to you this 2020-2021 Annual Report of ANZUP Cancer Trials Group.

Ian Davis Director and Chair of the ANZUP Board

‘A LITTLE BELOW THE BELT’ MAGAZINE

‘Our aim is not publicity for its own sake, but to increase awareness of the diseases in which we work, and of the importance of clinical trials’

AT A GLANCE

ANZUP ANNUAL REPORT 2021

Chief Executive Officer’s Report In 2020, ENZAMET featured in ESMO’s Clinical Practice Guidelines for 2020. ENZAMET was also named in the ASCO Annual Report on Progress Against Cancer earlier in the year as one of its Clinical Cancer Advances for 2020. This ANZUPled trial also 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.

What a year it has been! To say it has been a challenge is an understatement.

We were looking forward to a new decade and rolling out another year of innovative ANZUP programs including conducting our high quality investigator initiated clinical trials, supporting the development of a pipeline of new concepts, hosting our annual scientific meeting (ASM) as well as our Below the Belt Pedalthon fundraising events, to name a few.

Then came COVID-19, not only putting ANZUP’s plans into disarray, but the entire world. We rapidly needed to review, revise and repurpose almost everything we had planned including suspending our clinical trials as we implemented a number of strategies to ensure we met the objectives of the organisation.

Despite this curve ball, ANZUP managed to hit some significant milestones throughout the year.

Our ENZAMET clinical trial (ANZUP 1304) continued to have impact and be recognised worldwide. In 2019 the trial featured in the ASCO main plenary session, and these practice changing results continue to generate worldwide interest both through extensive media coverage and the medical community.

On 1 December 2020, ENAZMET scooped the pool at the ACTA Trial of the Year Awards Ceremony. ENZAMET was awarded the 2020 ACTA Trial of the Year Award, the ACTA STInG Award for Excellence in Trial Statistics and the Consumer Involvement Award. A fantastic achievement and the first trial to win all three awards! We acknowledge and thank the dedicated international team of researchers, staff, consumers, and most importantly, our trial participants.

Another achievement was our TheraP trial (ANZUP 1603), featured as an oral presentation at the ASCO 2020 virtual meeting on Friday 29 May 2020, with Michael Hofman presenting the interim results. TheraP is the first randomised trial comparing 177Lu-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. TheraP is a partnership between ANZUP and the Prostate Cancer Foundation of Australia (PCFA) with support from the Australian Nuclear Science and Technology Organisation (ANSTO), Endocyte Inc., a Novartis Company, Movember, The Distinguished Gentleman’s Ride, It’s a Bloke Thing and CAN4CANCER and the University of Sydney’s NHMRC Clinical Trials Centre providing central study coordination.

We are very grateful to all the investigators, trial coordinators, patients and their families for their participation.

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ANZUP ANNUAL REPORT 2021

AT A GLANCE

Our ANZUP Clinical Trials Portfolio continues to grow across the cancers we represent. As at 31 March 2021, we had 8 ANZUP-led active and recruiting trials, 2 co-badged trials, 6 protocols in development and several translational research projects. This included DASL-HiCaP, ENZA-p and #UpFrontPSMA that all opened in 2020 during the COVID-19 pandemic.

ANZUP continues to encourage and support concept development within our membership

DASL-HiCaP (ANZUP 1801) is an ANZUP-led randomised phase 3 trial adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in high risk, clinically localised prostate cancer. Study Co-Chairs are Prof Christopher 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. In April 2020, in the midst of COVID-19, the study opened across Australia and as at 31 March was open across 24 sites in Australia and New Zealand and recruited an impressive 94 patients. We anticipate the US, Canada, UK and Ireland will open during 2021.

ENZA-p (ANZUP 1901) is an ANZUP-led randomised phase II trial using PSMA as a therapeutic agent (Lutetium -PSMA) and prognostic indicator (PSMA-PET) in men with metastatic castrate-resistant prostate cancer treated with enzalutamide.

This study is being led by Prof Louise Emmett from St Vincent’s Hospital in Sydney. The study aims to recruit 160 patients across 13 Australian sites.

Our UNICAB trial opened its first teletrial site at Goulburn Valley Hospital (Shepparton) under Border Medical Oncology (Albury). This marks an ANZUP first and we look forward to further expanding the availability of our trials to rural and regional patients. #UpFrontPSMA is an ANZUP co-badged randomised phase II trial of Sequential 177Lu-PSMA617 and docetaxel versus docetaxel in metastatic hormone-naïve prostate cancer.

The study is being led by Prof. Arun Azad and aims to recruit 140 patients across 11 sites.

ANZUP brings together a world-class multidisciplinary team of oncology, surgical, medical, radiation, nursing, psychology and allied health professionals working in urogenital cancer. They take time out of their busy professional and personal schedules to help support ANZUP and make a difference to the lives of people affected by GU cancers.

Throughout the year ANZUP continued to encourage and support concept development within our membership – albeit in a slightly different way.

Our Concept Development Workshops (CDW’s), Advanced Prostate Cancer Consensus Conference (APCCC) and our ANZUP Annual Scientific Meeting (ASM) continued to grow and bring together multidisciplinary healthcare professionals to help develop, foster and promote GU cancer research.

We held four virtual CDW’s with 115 attendees and 24 concepts presented to our multidisciplinary members.

It was great to see how engaged and enthusiastic our members were in this new virtual format. These CDW’s are important as they encourage the growth and development of a pipeline of innovative ideas to be considered and prioritised with support from ANZUP over the next 12 months.

Our ASM was due to be held in Adelaide in July 2020 but sadly had to be postponed. However, we were excited to introduce our #ANZUP2020 Mini ASM, in a two-day hybrid format with local hubs and an interactive virtual meeting platform, attended by over 320 delegates.. We welcomed a superb faculty, including an impressive group of national and international speakers featuring Cristiane Bergerot, Alison Birtle, Ian Davis, Hary Dhillon, Louise Emmett, Robert Bristow, Felix Feng, Dickon Hayne, Silke Gillessen, Alicia Morgans, Tom Powles, Chris Sweeney and Bertrand Tombal Andrew Weickhardt to name a few. Popular sessions included the Nurses and Allied Health Session, MDT Master Games, ANZUP Symposium, ANZUP in Conversation, trial updates, the hotly anticipated ANZUPx sessions, as well as virtual poster discussant rooms. The outstanding faculty led discussions around the challenges and opportunities we face as we work together to improve access to clinical trials, particularly in light of the challenges of COVID-19.

AT A GLANCE

On Monday 26 October ANZUP hosted the 2nd Advanced Prostate Cancer Consensus Conference (APCCC), Asia-Pacific (APAC) Satellite Symposium - and the first time held virtually.

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. The meeting was a great success and focused on five topics discussed at APCCC viewed as most critical for the Asia-Pacific region, as well as discussion about the impact of COVID-19. The discussions are forming a paper due for publication in the BJUI in 2021.

Due to COVID-19 we had to cancel both our 2020 Melbourne and Sydney Pedalthon events and 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, and raised an extraordinary $173,000 for ANZUP’s clinical trial research via the Below the Belt Research Fund. These funds will support the important work of ANZUP clinicians and researchers during isolation and into the future.

Strategic & Business Planning: We are currently operating under the 2018-2020 Strategic Plan. The ANZUP Board, Governance, Finance & Audit, Fundraising and Partnership committees continued to meet regularly across the year (albeit via Zoom!) as well as the Scientific Advisory Committee (SAC) and SAC subcommittees, Consumer Advisory Panel (CAP) and the Trials Operations committees. These meetings help ensure our ANZUP activities are aligned with our overarching Mission and Strategic Plan.

The ANZUP Board looks forward to sharing our 2021– 2024 Strategic Plan later in 2021.

ANZUP ANNUAL REPORT 2021

Finances: ANZUP continues to receive valuable infrastructure funding from the Australian Government through Cancer Australia.

Whilst we value this financial and in-kind support from Cancer Australia independent funding is required for each clinical trial. It is therefore critical for ANZUP to continue to build greater financial independence and self-sufficiency through a number of fundraising avenues.

ANZUP remains committed to seeking out sustainable and innovative funding options to allow us to allow us to initiate trials and support our members in their concept and trial development in GU cancer.

ANZUP was in a strong financial position leading into 2020 and this foundation has enabled us to continue our research investment. We will remain prudent in the management of our budget and investment strategy, to ensure that we are able to continue our vital research into the future. A strong balance sheet enables ANZUP to support vital opportunities as they arise.

For further details on ANZUP’s finances, please see pages 56-77.

Data and quality: ANZUP works closely with the coordinating centres (NHMRC Clinical Trials Centre and the Centre for Biostatistics and Clinical Trials) to achieve robust processes on trial development and operations. Each organisation uses quality management systems, standard operating procedures (SOPs) and templates for accuracy and consistency. Data systems undergo vigorous planning, programming and checking processes prior to going live. Monitoring and formal audit processes complement these activities and annual training is provided to significant site staff ensuring data quality is maintained. All procedures and data systems comply with national and international guidelines on the conduct of clinical trials.

ANZUP also has an Independent Data and Safety Monitoring Committee (IDSMC) to evaluate the plausible benefits and risks associated with patient participation in ANZUP trials, and assess whether this justifies continuing the trials according to their original design. The IDSMC periodically reviews trial data and informs the ANZUP SAC Chair and relevant Trial Management Committee (TMC).

ANZUP MINI ASM HUB IN SYDNEY

The next generation of scientists and clinical researchers are very important to us, as they will pave the way for clinical trials to come.

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ANZUP ANNUAL REPORT 2021

AT A GLANCE

Staffing: Over the 2019/2020 reporting period, we have grown the ANZUP management team bringing a broader range of skillsets and experience to support our members and our expanding program of research activities.

I am very grateful to our dedicated team who work tirelessly to engage with and support our ANZUP members in their research endeavours. To our wonderful volunteers, Lesley Tinker and Jo Stubbs, who unfortunately due to COVID were unable to be as involved however we look forward to welcoming them back later this year.

Education and mentoring: On an ongoing basis ANZUP seeks opportunities to expand the education and mentoring of our membership. The next generation of scientists and clinical researchers are very important to us, as they will pave the way for clinical trials to come.

We host a variety of events in efforts to further their education and burgeoning clinical concepts.

Despite being virtual in 2020, our ANZUP ASM was still well-attended. It was one of the key events in Australia facilitating discussion on the latest updates in GU cancer research, treatments and supportive care with an outstanding international faculty comprised of experts in the field in attendance.

Our highly popular MDT Masterclass, part of the ASM program, is another key educational and mentoring experience for attendees. It incorporates a series of interactive care-based discussions across each of the major genitourinary cancers.

ANZUP’s Concept Development Workshops are another vital ANZUP activity aimed at educating and mentoring our membership. And despite COVID-19 we still held these virtually providing an opportunity for early-career researchers to receive mentorship whilst sharing ideas for emerging clinical trials.

Collaborations ANZUP is proud of the national and international partnerships we have forged in our efforts to improve treatment and outcomes for patients. We are grateful to all the investigators and trial staff at the 140 hospitals across over 10 countries that we collaborate with, as well as our colleagues at the NHMRC CTC and the Centre of Biostatistics and Clinical Trials (BaCT).

We thank our corporate supporters, sponsors and donors, for your ongoing support and generosity. With your help, ANZUP will find better treatments and outcomes for prostate cancer patients.

More than ever we remain extremely grateful to our committed membership for both their ongoing support and dedication to ANZUP, even in light of both the personal and professional adversity we all faced during the year.

In July 2020 we sadly farewelled our Deputy Board Chair A/Prof Guy Toner – who retired from the Board and clinical practice. Guy was pivotal in the initial establishment of ANZUP, having for many years chaired one of its predecessor organisations, ANZGCTG. Guy has been the quiet but effective force behind many of our initiatives, including the highly successful Below the Belt Research Fund and more recently the Discretionary Funding Initiative. Guy’s wise advice and mentorship has positively influenced clinicians and researchers all over the world. We thank and acknowledge Guy for the enormous contribution he has made both to ANZUP and the global GU oncology community.

We were delighted to welcome new Director, Prof Lisa Horvath, in the reporting period. Lisa is a medical oncologist and Research Director at Chris O’Brien Lifehouse. Lisa chairs ANZUP’s Prostate Cancer Subcommittee and is a member of the SAC. As we reflect on the year that was, and the challenges we faced both personally and professionally, I I would like to thank and acknowledge our extraordinary ANZUP Board, led by our Chair Prof Ian Davis, the SAC, Subcommittee Chairs, the CAP, Deputy Chairs, Study Chairs, Site Investigators and the hundreds of Trial Staff and members. ANZUP would not exist without you and we certainly wouldn’t have achieved what we have without your tireless efforts.

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

Thank you.

Margaret McJannett Chief Executive Officer, ANZUP

AT A GLANCE

ANZUP ANNUAL REPORT 2021

Organisational Chart Stakeholders: members, funders, community

Fundraising and Partnerships subcommittee

Finance and Audit Committee

BOARD Consumer Advisory Panel (CAP) Governance Committee

Translational Research

es

Trial operations (NHMRC CTC and BaCT)

mi

Independent Data Safety Monitoring Committee (IDSMC)

tte

Trial Management Committees

Bladder, Urothelial and Penile

om

Scientific Advisory Committee (SAC)

Quality of Life and Supportive Care

ANZUP CEO & Management Team

SAC

b su

c

Renal Cell

Prostate

Germ Cell

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ANZUP ANNUAL REPORT 2021

AT A GLANCE

Governance Structure ANZUP Cancer Trials Group Ltd is a collaborative, national and international, urogenital and prostate cancer, clinical trials, and research group. The organisational structure of ANZUP reflects its corporate governance and operational areas of responsibility.

Board The Board comprises the Directors of the Company and is responsible for financial management, corporate governance, reporting and compliance. The Board consists of five elected Directors and four Appointed Directors. The Board meets by teleconference approximately once every two months and face-to-face several times per year.

Governance Committee The purpose of the Governance Committee is to ensure that the Board fulfills its legal, ethical, and functional responsibilities through adequate governance policy development, recruitment strategies, monitoring of Board activities, and evaluation of Board members’ performance.

Finance and Audit Committee A committee of the Board. Its main objectives are to assist the Board in the discharge of its responsibility to exercise due care, diligence and skill; and to provide a formal forum for financial management, compliance and control.

Fundraising and Partnerships Subcommittee A subcommittee of the Finance and Audit Committee.

Its main objectives are to identify and pursue opportunities for additional revenue through fundraising and production of relevant marketing materials for ANZUP.

Management Team The Management team comprises the Chief Executive Officer (Margaret McJannett, 1 FTE), Executive Assistant (Alison Martin, 1 FTE), Marketing and Communications Manager (Lucy Byers, 1 FTE), Internal Communication and Projects Manager (Nicole Tankard, 1 FTE), Marketing and Communications Officer (Gillian Bailey, 0.8 FTE), Clinical Trials Project Manager (Nisha Rana, 1 FTE), Clinical Trials Project Manager (Thomas Cusick, 1 FTE), Head of Partnerships and Engagement (Julijana Trifunovic 0.7 FTE) and Database and Administration Coordinator (Nima Amatya, 1 FTE).The company’s registered office is in Sydney.

Consumer Advisory Panel (CAP) The ANZUP CAP reports to the Board. It comprises consumer/ community representatives who contribute at all levels of governance, from the Board and SAC and its subcommittees

through to specific trials and research projects. The CAP also provides a conduit for communication from ANZUP back to the community in order to promote clinical trial research. The CAP meets by teleconference quarterly and intends to meet face-to-face at least once per year where resources permit.

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

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

Operations Executive Committee This committee consists of representatives from ANZUP and each of its coordinating centres - the NHMRC Clinical Trials Centre at The University of Sydney and the Centre for Biostatistics and Clinical Trials. The committee is responsible for oversight of trials and group operations. This committee meets by teleconference approximately once per month.

Independent Data and Safety Monitoring Committee (IDSMC) The broad aim of the IDSMC is to evaluate the plausible benefits and risks associated with patient participation in ANZUP trials. The IDSMC comprises at least three members who are experienced in clinical research and are not conflicted with ANZUP. The committee oversees a number of ANZUP studies and co-opts others onto it when additional advice is required. The IDSMC advises the relevant Trial Management Committee (TMC) Chair(s), Group Chair and Scientific Advisory Committee Chair.

Trial Management Committees (TMC) Each trial has a TMC that meets approximately quarterly by teleconference to ensure oversight of the trial.

AT A GLANCE

ANZUP ANNUAL REPORT 2021

13

Governance Committee SCIENTIFIC ADVISORY COMMITTEE

FINANCE AND AUDIT COMMITTEE

Ian Davis – Chair

Joe Esposito – Chair

Scott Williams – Deputy Chair

Bernadette Crennan

Arun Azad

Martin Dowling

Nicholas Buchan

Ex-officio

Lisa Butler Haryana Dhillon Joe Esposito

Ian Davis

Margaret McJannett Glenn Murray

Craig Gedye

Katie Pancari (on maternity leave from May 2020)

Fritha Hanning

David Hurley (from May 2020)

Dickon Hayne

James Kench

FUNDRAISING AND PARTNERSHIPS SUBCOMMITTEE

Andrew Martin

Joe Esposito – Chair

Kathryn Schubach

Ray Allen

Shomik Sengupta

Bernadette Crennan

Martin Stockler

Ian Davis

Christopher Sweeney

Belinda Jago

Bertrand Tombal

Melissa Le Mesurier

Lisa Horvath George Hruby Belinda Jago Anthony Joshua

Guy Toner (until July 2020) Ben Tran

Ex-officio

Ex-officio

Lucy Byers

Margaret McJannett Thomas Cusick (from June 2020) Nisha Rana Felicia Roncolado Jane So (until January 2021) Shahlini Subramaniam Sonia Yip Alison Zhang

Margaret McJannett Juliana Trifunovic

CONSUMER ADVISORY PANEL Belinda Jago – Chair Ray Allen – Deputy Joe Esposito Les Land Melissa Le Mesurier Matt Leonard Colin O’Brien Michael Twycross Leonie Young

Ex-officio Ian Davis Margaret McJannett

SUBCOMMITTEE BUP (Bladder, Urothelial and Penile Cancer): Dickon Hayne – Chair Shomik Sengupta – Deputy Chair

ANZUP Fellows: Elizabeth Liow Jane So (until January 2021) Shahlini Subramaniam Sonia Yip Alison Zhang Margot Gorzeman – (AOPM)

Germ Cell: Ben Tran – Chair Fritha Hanning – Deputy Chair

Maryanne Ng – Program Manager (from 1 July 2020 to 18 September 2020)

Prostate Cancer: Lisa Horvath – Chair Jarad Martin – Deputy Chair

Isabella Pokorski – Clinical Trials Operations Lead (19 September 2020 to 31 December 2020)

Quality of Life & Supportive Care: Haryana Dhillon – Chair Catherine Paterson – Deputy Chair Renal Cell Cancer: Craig Gedye – Chair David Pook – Deputy Chair Translational Research: Arun Azad – Chair Anthony Joshua – Deputy Chair

ANZUP & CENTRE FOR BIOSTATISTICS & CLINICAL TRIALS (BaCT) Operations Executive Committee: Ian Davis – Chair Craig Gedye – UNISoN

ANZUP & NHMRC CLINICAL TRIALS CENTRE (CTC)

David Pook – UNICAB

Operations Executive Committee: Ian Davis – Chair

Thomas Cusick (from June 2020)

Guy Toner – Deputy Chair (until July 2020)

Alison Hall – Business Manager

Margaret McJannett – ANZUP CEO Dickon Hayne Thomas Cusick – Clinical Trials Project Manager (from June 2020) Nisha Rana – Clinical Trials Project Manager Martin Stockler – CTC Clinical Lead

Andrew Weickhardt – PCR MIB Carole Harris Margaret McJannett

Nisha Rana Komal Kanojia – Project Manager Deepti Pandey – Project Manager

14

ANZUP ANNUAL REPORT 2021

AT A GLANCE

Thanks to our Partners, Corporate and In-kind Supporters Corporate Supporters

In-Kind Supporters

We are very fortunate to have our corporate supporters and partners who enable ANZUP to better support our members and ultimately, patients and their families. Our 2020/2021 corporate supporters include:

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

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

AFI Branding, The Saturday Paper and FC Lawyers.

AT A GLANCE

ANZUP ANNUAL REPORT 2021

15

2021 ANZUP Membership Number of members

1,820

As at 31 March 2021 ANZUP had 1,820 members, a 5.5% increase since 1 April 2020.

5.5%

members

since last year

Membership distribution

BY STATE/TERRITORY IN AUSTRALIA:

AUSTRALIA/ NEW ZEALAND TOTAL

NT: 11

1,761

QLD: 254 WA: 99 SA: 108

NSW: 610 VIC: 522

NEW ZEALAND:

102

ACT: 33

TAS: 22

REST OF THE WORLD: US: 15 Canada: 8 Ireland: 5 Singapore: 4 Malaysia: 3 Belgium: 2 India: 2 Indonesia: 2 China: 1 Denmark: 1 Hong Kong: 1 France: 1 Japan: 1 Korea: 1

Germany: Philippines: Spain: Switzerland: Turkey:

1 1 1 1 1

REST OF THE WORLD TOTAL

59

Building our multidisciplinary membership Clinical Trials Coordinator 337

Radiation Therapist

13

Medical Oncologist

290

Statistician

12

Trainee

282

Pharmacist

11

Registered Nurse

233

Consumer Advocacy

9

Urologist

189

Epidemiologist

8

Radiation Oncologist

136

Radiologists

6

Scientist

74

Health economics

6

Allied Health

48

Endocrinologist

6

Nuclear medicine

41

Surgeon

6

Students

32

Medical Physics

3

Psychologist

23

General Practitioner

2

Fellows

20

Psychiatrist

2

Pathologist

15

Anaesthetist

1

Supportive care

15

Medical Oncologist Clinical Trials Coordinator

Trainee

Registered Nurse

Urologist Radiation Oncologist

16

ANZUP ANNUAL REPORT 2021

AT A GLANCE N

20

14

I NA UG UR

AL P

ED

AL

O TH

ANZUP’s History 2008-2012

2013-2017

warded infrastructure funding from A Cancer Australia

ANZUP completes its first trial (EVERSUN) and presents results at ASCO GU

Official launch of ANZUP in Sydney

Inaugural Pedalthon fundraiser Sydney

First Annual General Meeting

Launch of Below the Belt Research Fund

hase II study of accelerated BEP P (testicular cancer trial) reaches recruitment target

Inaugural ANZUP GU Preceptorship in Prostate Cancer ANZUP and PCFA announce new partnership to raise $1.5 million for prostate cancer trial

irst face to face Scientific Advisory F Committee meeting

ANZUP reaches 1,000 members

ST

AS

AT OR M

IA LS 2

IG

ZA EETING FOR EN

TR

ANZUP’s global ENZAMET trial reaches recruitment target of 1,100 patients Sydney Pedalthon raises more than $1 million in four years

M

FIR

P ZU

T ES

AN

I NV

irst stand-alone Annual F Scientific Meeting (ASM) Sydney

014

irst Trainee Day (renamed F MDT Masterclass in 2014)

UP/COSA ASM AN Z

U PRE PG ZU N A

CEPTOR SH IP

20 1 5

-

AT A GLANCE

EB CEL ANZUP

RAT

E

ANZUP ANNUAL REPORT 2021

17

RS EA 0Y 1 S

P RE S MET ZA EN

ENTATION

AT A

SC O

2

01 9

2018-2020

PR OS TAT EM

ASTERCLASS IN B

TO OS

2020-2021

A NZUP celebrates 10th anniversary year

New ANZUP trials open – ENZA-p and DASL-HiCaP

I naugural Melbourne Pedalthon First virtual ASM held

H osted the first Asia Pacific Advanced Prostate Cancer Consensus Conference (APCCC) Satellite Symposium

First virtual fundraising event - #YourWay

‘ Is there a trial for me?’ campaign launched with Breast Cancer Trials Australia

ENZAMET wins ACTA Trial of the Year TheraP results presented at ASCO

R ude Food campaign launched

First tele-trials site opens

A NZUP reaches 1500 members (12 March) E NZAMET trial one of four ASCO Plenary Presentations I naugural 2019 Prostate Masterclass held in Boston

20

2

C 0A

L TRIA TA

OF THE YEAR A WA RD S

E NZAMET trial highlighted by ASCO’s annual report as a major advance in the progress against cancer

-

-

T heraP, UNISoN & Pain-Free TRUS B trials recruit their final patients

M AN U

FE

ILD E

L-#

YOURWAY

N

18

ANZUP ANNUAL REPORT 2021

ACHIEVEMENTS

Achievements

Mission, objectives, priorities Our mission: Our objectives:

To conduct clinical trial research to improve treatment of bladder, kidney, testicular, penile and prostate cancer.

To develop, foster and promote prostate and urogenital cancer research by; • p roviding access to clinical trials for all appropriate Australian and New Zealand patients • i ncreasing involvement of and collaboration with various professional disciplines in clinical and preclinical research • providing opportunities for clinical research • b uilding systems to simplify and streamline clinical research of the highest quality • f ostering a culture of research amongst all clinicians involved in the care of patients with urogenital cancers • p roviding training opportunities for the next generation of clinical researchers • p roviding for translational studies in prostate and other urogenital cancers, including tissue banking from clinical trials for further studies

ANZUP strategic priorities: our goals 2018-2021: Goal 1. Continue to build on and develop high quality cutting edge clinical trials Goal 2. Increase awareness, participation and access to ANZUP trials Goal 3. Strengthen and build our capacity and capability to ensure we can deliver our Strategic Plan Goal 4. Engage, collaborate and enhance mutually beneficial relationships Goal 5. Increase engagement of the membership Goal 6. Broaden ANZUP’s profile in the community - locally, nationally and internationally

ACHIEVEMENTS

Goal

1

ANZUP ANNUAL REPORT 2021

Continue to build on and develop high quality cutting edge clinical trials

ANZUP is composed of a multidisciplinary group of members. They are either involved in the treatment and research of genitourinary cancers, or have been diagnosed with, or have personal experience of, these cancers. This varied membership ensures ANZUP develops robust, high quality clinical trials. These trials are diverse and are spread across each of the tumour types ANZUP represents, and employ many treatments including radionuclear medicine, immunotherapy and online psychotherapy resources.

The monthly trial updates are an avenue used to build on the ANZUP clinical trial process. They are distributed to all members to encourage improved patient recruitment to ANZUP trials, and hopefully instigate cross-referrals.

Differing communication tools are utilised that allow ANZUP to provide regular updates about trial recruitment status. These include sessions held at the Annual Scientific Meeting, the trial specific e-newsletters, as well as the Trials Management Committees (TMC) meetings.

The Principal Investigators (PI) on numerous ANZUP trials have specialised in a variety of areas including urology, surgery, radiation oncology ,medical oncology, nursing and psychology. It is a continual process ensuring the trial lead investigators come from a cross-section of disciplines, in efforts to have all-inclusive input into the research undertaken. ANZUP is also striving to ensure junior researchers across all disciplines attend and contribute at events and workshops. Junior researchers are encouraged to contribute by encouraging them to attend our Best of GU meetings, MDT Masterclasses, and the Prostate Preceptorship.

ANZUP and the international partners involved in ANZUP’s ENZAMET and ENZARAD trials undertake a biannual International Trials Steering Committee meeting. This meeting is facilitated by ANZUP. This meeting allows relationships to be built or maintained with the international clinical trial community and also provides a platform to examine the GU clinical trials landscape, identify gaps in research and discuss new concepts.

Each subcommittee undertakes regular analysis and reports on concepts submitted, trials in development, current trials, and the pipeline, at quarterly teleconferences.

The Concept Development Workshops, run across each of the five cancers ANZUP represents and all subcommittee members are encouraged to use these events to submit, ruminate and review new concepts.

Concept development

2018/19

2019/20

2020/21

Total workshops

5

5

5

Total attendees

115

229

131

Total concepts presented

32

43

27

ANZUP’s Scientific Advisory Committee (SAC) is at the centre of the organisation and allows members to discuss novel trial ideas and develop proposals into established protocols.

19

20

ANZUP ANNUAL REPORT 2021

ACHIEVEMENTS

Goal

Increase awareness, participation and access to ANZUP trials

ANZUP continues to increase awareness, participation and access to ANZUP trials through many different approaches.

Our subcommittee membership has continued to grow across all cancer types.

Total Members Subcommittee

Mar 2018

Mar 2019

Mar 2020

Mar 2021

Prostate

442

493

531

579

BUP

302

335

367

395

Germ Cell

190

209

230

246

Renal

274

305

331

349

Regular attendees are encouraged to both promote and ask their colleagues and trainees to join and participate in the subcommittee meetings. External meetings are also used to promote ANZUP and highlight the benefits of ANZUP membership. This has been done at ANZUNS, the USANZ New Zealand Section Meeting, COSA and the Asia Pacific Advanced Prostate Cancer Symposium.

For the year, the number of rural/regional sites participating in ANZUP trials totals 14 with 12 patients recruited. ANZUP often invites rural members and their patients to share content for the clinical newsletter UPdate and consumer magazine, ‘A little below the belt’. More than 400 cancer centres receive this publication, and of these 28 are rural/regional sites.

ANZUP and the National Cancer Cooperative Clinical Trials Groups have provided funding for the Australasian Teletrial Model. This model was developed by the COSA Regional and Rural Group, and utilises telehealth to improve clinical trials accessibility.

The model benefits regional, rural and remote patients, and connects centres within the same city to increase the access and recruitment to highly specialised clinical trials.

And this includes rare cancer trials. In response to COVID-19, telehealth expanded across Australia and New Zealand from March 2020.

The CAP is involved across all ANZUP research projects including the Scientific Advisory Committee, subcommittee meetings, Concept Development Workshops and the Annual Scientific Meeting. The membership of the Consumer Advisory Panel (CAP) is reviewed annually to ensure an optimal mix of individuals.

In the past community links have been reinforced when consumers are invited to attend the Community Engagement Forum. This free community forum provides information and the opportunity to discuss the importance of clinical trials, heighten the profile of ANZUP as well as the impact a ‘below the belt’ cancer can have on a person and their family. We also record these community forums to share with a wider group. Unfortunately this event could not be held this year due to COVID-19 restrictions.

Social media is another avenue used by ANZUP to educate and engage with the wider community about ANZUP activities, events and clinical trials. ANZUP and Below The Belt each have their own Twitter, Facebook and Instagram accounts, and ANZUP also has a LinkedIn and YouTube account.

Social Media Followers ANZUP Twitter followers @ANZUPtrials

1,666

2,065

2,384

2,722

2017/2018

2018/2019

2019/2020

2020/2021

ANZUP Facebook followers @ANZUPtrials

1,927

1,979

2,234

2,150

2017/2018

2018/2019

2019/2020

2020/2021

ANZUP Instagram followers @ANZUPtrials

ANZUP launched its first tele-trial site with the UNICAB trial at Goulburn Valley Health, Shepparton on 26 November 2020.

192

510

450

464

2017/2018

2018/2019

2019/2020

2020/2021

ACHIEVEMENTS

Goal

ANZUP ANNUAL REPORT 2021

Strengthen and build our capacity and capability to ensure we can deliver our Strategic Plan

ANZUP continues to review, revise and develop its systems, procedures and governance principles to safeguard the delivery of our strategic plan. The organisational structure of ANZUP reflects its corporate governance and operational areas of responsibility. The board, comprised of the Directors of the Company is responsible for corporate governance, financial management, , reporting and compliance, and ongoing revision of organisational policy. This ensures we develop a sound quality management system to deliver our strategic plan.

ANZUP’s Concept Development Workshops have been streamlined with the use of templates. Our subcommittees and broader membership are consulted regularly to ascertain if new or revised tools might further aid collaboration to widen our scope as well as our capabilities.

As the number of ANZUP studies continues to expand and the membership steadily increases, we recognise the importance of clearly defined decision making processes and delegation of duties. The quality and integrity of ANZUP operations are underpinned by documented processes and policies.

Delivery of our strategic plan is made possible by continued fundraising. It is an invaluable component of ANZUP’s activities. The Partnerships and Engagement role was appointed in August 2019. This role continues to be the business driver for the three year fundraising plan and is helping broaden cost effective, sustainable, and regular revenue streams through many forms of fundraising.

Our Below the Belt Research Fund ensures all the money raised through the Sydney and Melbourne Pedalthons, and the Below the Belt #YourWay Challenge, is used to support future ANZUP trials. The Below the Belt Research Fund has to date raised close to $1.9 million. The ASM also supports the financial sustainability of ANZUP. ANZUP continues to grow the ASM by developing and delivering a high quality scientific program. In 2020 we had to adapt the format of the ASM due to the impact of COVID-19, the need for social distancing and the inability of all delegates and speakers to travel. A virtual meeting with one face to face hub was held and it again showcased ANZUP’s research activities and attracted 320 delegates.

2016

2017

2018

2019

2020

297

335

390

392

320

International speakers

4

6

7

5

9

Submitted abstracts

57

78

53

73

49

Fellowships, scholarships and awards

40

47

42

39

55

Delegates

21

22

ANZUP ANNUAL REPORT 2021

ACHIEVEMENTS

Goal

Engage, collaborate and grow stakeholder relationships

Engaging, collaborating and broadening ANZUP stakeholder relationships is done through various means.

Crucially, the funding agreement with the Australian Government through the Cancer Australia Support for Clinical Trials continues to support ANZUP’s infrastructure.

Donors, volunteers, philanthropists, corporate partners and other key stakeholders remain an important focus for ANZUP and especially the Partnership and Engagement role. ANZUP will continue to build, manage and retain these crucial relationships.

Collaborative links have allowed ANZUP to function at a high capacity. This is demonstrated by the four co-badged trials with other Cancer Cooperative Trials Groups (CCTGs) and our membership of the Executive Officers Network (EON) and Clinical Trials Consumer Network (CTCN). The CTCN shares information between the groups’ Consumer Advisory Panels (CAPs) and EON strengthens links between groups by the sharing of ideas and resources. .

In 2020/21 ANZUP collaborated with the NHMRC Clinical Trials Centre (CTC) at the University of Sydney to conduct 10 clinical trials. In addition, ANZUP collaborated with the Centre for Biostatistics and Clinical Trials (BaCT) to conduct 4 clinical trials. These established affiliations ensure robust processes on trial development and operations.

ANZUP’s key relationships include:

Key Relationships • A ustralia & New Zealand Urological Nurses Society (ANZUNS) – represented on the ANZUP SAC by Kath Schubach • Australian Clinical Trials Alliance (ACTA) • Cancer Australia • Cancer Councils • Cancer Nurses Society of Australia (CNSA) • Clinical Oncology Society of Australia (COSA) • Colleges (e.g. RACP, RANZCR, RACS) • Kidney Health Australia • Medical Oncology Group of Australia • Movember • National Cancer Cooperative Trials Groups • Prostate Cancer Foundation Australia (PCFA) • T ROG (Trans Tasman Radiation Oncology Group) Cancer Research • U rological Society of Australia & New Zealand (USANZ)

International Partnerships and Collaborations • Alliance for Clinical Trials in Oncology • Canadian Cancer Trials Group (CCTG) • Cancer Research UK • Cancer Trials Ireland (CTI) • Children’s Oncology Group (COG) • Dana-Farber Cancer Institute • E uropean Organisation for Research and Treatment of Cancer (EORTC) • Medical Research Council (MRC) UK • National Cancer Institute US • Prostate Cancer Clinical Trials Consortium (PCCTC) • Prostate Cancer Foundation New Zealand (PCFNZ) ANZUP’s multidisciplinary membership continues to be the most important stakeholder relationship. For members, ANZUP provides an annual calendar of education and networking opportunities. In 2020/21 this included the Concept Development Workshops and the ASM, Educational workshops and events, grant opportunities, scholarships, fellowships and awards allows ANZUP to support fellows, trainees and junior researchers on an ongoing basis. Such events and opportunities encourage the next generation of researchers to engage with experts in their field, hone their skills, add to their knowledge, further investigate their research areas, and be a contributor to the trial development process. Our collaboration with PCFA to improve access to and funding for prostate cancer trials has cemented another key relationship.

Regular email, print and social media updates are continually distributed and shared with the ANZUP membership. Being an ANZUP member provides the means to stay up to date with the latest GU clinical trials research, networking and the opportunity to attend educational sessions.

ACHIEVEMENTS

Goal

ANZUP ANNUAL REPORT 2021

Increase engagement of the membership

ANZUP’s membership continues to increase and diversify.

This has meant ANZUP regularly reviews ways in which we can optimally support and provide opportunities for our multidisciplinary membership. Importantly, communication strategies are often tailored to the requirements of our members. This can include subcommittee participation, trial development, trial management, trial news, as well as educational and fundraising events across different channels including print, email, and social media updates.

Opportunities to engage and communicate with corporate and philanthropic groups continue to be investigated.

ANZUP has ongoing relationships with philanthropic and charity groups including the Paul Ramsay Foundation, Perpetual IMPACT Philanthropy, the Nordia Foundation, Roy Morgan Research Ltd, Ian Garrow, the Lin Huddleston Charitable Foundation, the Macquarie Group Foundation, PCFA and PCFNZ, Movember and the Melbourne Racing Club Foundation.

Members are further supported via our Concept Development Workshops. Each of the major cancers ANZUP represents have their own standalone workshops.

The workshops are facilitated by the chairs of each subcommittee. The workshops provide educational and mentoring opportunities for members across each of the four tumour streams but most importantly encourage the development of emerging clinical trial concepts so they can then be transformed into fully developed clinical trials.

Regular communication about fundraising opportunities, activities and the Below the Belt events is made possible through the use of corporate and community database.

Media coverage around ANZUP clinical trials has been increased after establishing links with respected medical journalists and broadcasters. This was achieved with the announcement of the TheraP trial results at ASCO GU in February 2021 leading to a lot of media coverage.

ANZUP is also active across many social media platforms, with profiles on Twitter, Facebook, Instagram, LinkedIn and YouTube. ANZUP’s Twitter account continues to have a highly engaged clinical following with a steady stream of activity.

The biannual publication of a consumer magazine, ‘A little below the belt’ is another external communication strategy which is distributed digitally and via print to cancer centres.

ANZ, key stakeholders, members, donors and supporters all receive this publication. The Below the Belt events, now held virtually, and the pedalthons in both Sydney and Melbourne (unfortunately postponed this year due to COVID-19), also raise community awareness of clinical trials, urogenital cancers and the Below the Belt Research Fund.

23

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ANZUP ANNUAL REPORT 2021

Goal

ACHIEVEMENTS

Broaden ANZUP’s profile in the community – locally, nationally and internationally

Since the commencement of ANZUP in 2008, our profile has rapidly increased at a local, national and international level.

Heightened community engagement and awareness of both ANZUP and our clinical trial portfolio on a local and national level has often been made possible by the commitment of the CAP. Also, without the CAP, it would be difficult for ANZUP to fully understand the consumer viewpoint on clinical trials. ANZUP implements key strategies to engage and educate the broader community on clinical trial research and outcomes. The CAP membership is reviewed each year to ensure it is made up of the right combination of individuals. ANZUP ensures trial information is readily accessible, in lay terms, for the general public to view.

ANZUP also developed the ‘Friends of ANZUP’ initiative.

The consumer membership group provides updates on ANZUP activities, information and invitation to events and clinical trial updates. Through ‘Friends of ANZUP’, members can select to receive an invitation to the annual Community Engagement Forum as well as a hardcopy of the consumer magazine, ‘A little below the belt’.

The ANZUP website is an essential communication tool and acts as the face of ANZUP. It allows us to maintain our profile with our membership, as well as the broader community.

The mobile-friendly website is regularly updated to ensure the most current information is made available. The website has several sections for different audiences. There is a members’ only section containing resources and meeting materials. Another area of the website has trial information for healthcare professionals and trial information in lay language for patients and carers. In addition to these areas, the website provides details of ANZUP’s awards and events, access to ANZUP publications, as well as donor/supporter information. The website The ANZUP profile continues to be disseminated to a wider audience through celebrity endorsement. The Below the Belt #YourWay Challenge saw several Australian celebrities champion the ANZUP cause, using their social media following as a vehicle to communicate with the wider community and previously untapped audiences.

The Below the Belt Bulletin was developed as new supporter collateral and was distributed to ANZUP’s donors. This e-newsletter advises donors of our current clinical trials and the research being undertaken. It also provides information about how they can continue to be involved with ANZUP. But most importantly, this bulletin provides an avenue to acknowledge and thank our donors for their support.

ANZUP continues to maintain its relationship with the International Trials Steering Committee. The committee provides a scientific overview of the conduct, analysis and reporting of trials ANZUP are involved in at an international level. The committee considers, reviews, and proposes revisions to the study design protocol, reporting and analysis plan.

Internationally, even with the revised mini-ANZUP ASM, high profile and notable international faculty joined the meeting.

Leading global clinicians were chosen specifically due to their experience with ANZUP represented cancers, their involvement in ANZUP clinical trials, as well as their skillset and ability to impart their knowledge to the ASM attendees. The Australian and New Zealand audience are able to listen to these impressive global clinicians speak, whilst they share their experience and highly respected views. At the 2020 mini ASM, 9 international speakers virtually presented to 320 delegates.

REGISTRATIONS AND ABSTRACTS OPEN

ABSTRACTS CLOSE 15 AUGUST 2021

ANNUAL SCIENTIFIC MEETING ADELAIDE CONVENTION CENTRE AND ONLINE 17-19 OCTOBER 2021

Program highlights include: • Leading international and Australian experts • Up-to-date management and research for prostate and other genitourinary cancers • ANZUP PCFA Nurses Symposium • Translational Research Symposium • ANZUP in Conversation with International guests • Overviews of current and planned ANZUP trials • ANZUP MDT Masterclasses with expert panels • Always entertaining ANZUPx • The topical and engaging crossfire debate • Community Engagement Forum: A little below the belt • Travel fellowships available for ANZUP members • Face to Face and virtual attendance options available

#ANZUP21 www.anzup.org.au/asm2021

Our outstanding international faculty includes: Prof Alison Birtle – Consultant Clinical Oncologist and Honorary Clinical Senior Lecturer, Lancashire Teaching Hospitals, UK Prof Matthew Galsky – Director of Genitourinary Medical Oncology, Mount Sinai Hospital, US Prof Chris Parker – Clinical Oncologist Consultant at The Royal Marsden Hospital, UK Prof Heather Payne – Clinical Oncologist Consultant at University College Hospital, UK A/Prof Sima Porten – Urologist at University of California, San Francisco, USA Prof Christopher Sweeney – Medical Oncologist at Dana-Farber Cancer Institute, US (member of the ANZUP Scientific Advisory Committee) Prof Bertrand Tombal – Chairman of the Division of Urology and Professor of Urology at the Université catholoique de Louvain (UCL), Cliniques universitaires Saint-Luc, Brussels, Belgium (member of the ANZUP Scientific Advisory Committee) A/Prof Eli van Allen – Genitourinary medical oncologist and Associate Professor at Dana Farber Cancer Institute and Harvard Medical School, USA

26

ANZUP ANNUAL REPORT 2021

ACHIEVEMENTS

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 worldleading 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 Christopher 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, 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 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.

ACHIEVEMENTS

ANZUP ANNUAL REPORT 2021

only trial ever e th is T E M A Z N “E ree awards. to have won all th ly say that our I think we can safe cognised and work has been re tive impact.” has had true posi is, Professor Ian Dav ANZUP Chair r, ai h -c o C T E M A ENZ

“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.” Belinda Jago, Chair, Consumer Advisory Panel

“It was a privilege to accept the Statistics in Trials Interest Group (STInG) award on behalf of all those who made a contribution to the statistical excellence of ENZAMET. It’s great that the efforts that went into the statistical planning, execution, reporting and interpretation is being acknowledged in this prestigious way. Those actions helped to deliver a convincing result about two years ahead of schedule, and the rapid dissemination of results via very high impact channels...”

Andrew Martin, Statistics NHMRC Clinical Trials Centre (CTC)

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ANZUP ANNUAL REPORT 2021

AT A GLANCE

Fundraising, Partnerships and Engagement Thanks to the support from our committed and passionate supporters and donors, we continue to help improve the lives of people affected by below the belt cancers through clinical trials research.

Although the last 12 months have been difficult for many people, we are very grateful to all the individuals, families, volunteers, corporations, workplaces and other organisations that supported us and continued to remain committed to help ANZUP reach our goals.

In January 2021 ANZUP launched a penile cancer research appeal to raise not only funds, but also awareness.

The appeal aims to fund research to gain further understanding of the interaction needed between the various services, the patients and their partners and families to ensure the best possible physical and mental outcomes.

ANZUP is also working on ongoing communications and case studies to go to selected media outlets to educate and raise awareness about this cancer.

The generous and ongoing support from the community not only raises awareness for ANZUP but invests in worthwhile projects, novel trials all the way to full scale clinical trials, to make a difference to the lives to people diagnosed with below the belt cancers, their families and future generations.

Penile Cancer Appeal 2021

ACCEPT STUDY PI PROF DICKON HAYNE

Special donations In July 2020 ANZUP was delighted to receive funding from the McCusker Foundation for the ACCEPT study. The support will assist with the development of the first national secure online database for radical cystectomy patients. The study will help analyse outcomes, provide further information, improve best practice and standards in bladder cancer treatment.

ANZUP is extremely grateful to the McCusker Foundation for their support.

Penile cancer is a rare but significant male cancer with a complete lack of any research in Australia. As part of ANZUP’s Bladder, Urothelial and Penile (BUP) subcommittee and disease portfolio, ANZUP is dedicated to finding more answers and to gain a comprehensive picture of how this disease can best be treated now and into the future.

AT A GLANCE

Community Events The general community supports ANZUP in many generous ways, including events.

On International Women’s Day, 8 March, Mary Kate on Newtown boutique in Sydney hosted a charity fashion night celebrating women working in research and in particular ANZUP’s cancer researchers.

ANZUP ANNUAL REPORT 2021

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Trusts, Foundations and Philanthropy ANZUP would like to acknowledge the generous support of the following trusts, foundations, individuals and families who have supported ANZUP during the past year.

• The McCusker Charitable Foundation • Lin Huddleston Charitable Foundation

This year’s theme was #ChoosetoChallenge. ANZUP’s female members were celebrated for their commitment and achievements in clinical trials research. Funds were raised on the night, and also online, with a percentage of sales from Mary Kate’s website throughout the month of March.

• The Nordia Foundation • Roy Morgan Research Ltd • Mrs Alison McKendrick and family

New fundraising collateral and supporter materials The new Below the Belt Bulletin was launched in June 2020 providing donors and supporters with the latest information regarding research projects, events and funding.

A new suite of marketing materials and branded merchandise have been developed to educate and raise awareness about ANZUP and why funding is critical for below the belt clinical trial research.

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ANZUP ANNUAL REPORT 2021

AT A GLANCE

Below the Belt Research Fund Every cent we raise through the Below the Belt events goes directly towards clinical trial research via the Below the Belt Research Fund.

In 2020, ANZUP’s Below the Belt Research Fund provided much needed seed funding to support five ANZUP members to progress new trial ideas to the point of becoming full scale studies. These research grants were announced at the virtual 2020 Mini ASM.

LOUISE EMMETT

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

MATTHEW ROBERTS

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 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

This clinical trial will use modern PET scanning (PSMA PET/CT) in men who have a rising PSA level after prostate surgery to select those who can potentially avoid or minimise additional (radiation, hormone) treatments safely.

Previous studies reported that these men who have a negative or confined PSMA PET have good treatment responses to limited radiation treatment without hormones compared to men whose cancer has spread. Some men with a negative PSMA PET who were not treated did not progress over 3 years, suggesting that some men can be spared treatment altogether.

The purpose of this trial is to determine if some men with low risk cancer who can be safely monitored, then

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.

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.

AT A GLANCE

ALEX TAN

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 reirradiation 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

ANZUP ANNUAL REPORT 2021

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ANDREW WEICKHARDT

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

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

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.

By way of examining cancer biopsies taken at the diagnosis of metastatic prostate cancer, we will test for an important genomic feature called DNA methylation – a process involved in ‘silencing’ genes.

We believe DNA methylation will provide important information about why some cancers are more aggressive than others and why men may respond to treatments differently. We will use DNA methylation information from the tumours and compare it to information of how men diagnosed with metastatic prostate cancer responded to standard treatments. We then hope to use this as a strong foundation to design larger studies to test DNA methylation in prostate cancer clinical trials, to prove that it is an important test in the clinic to identify the risk of aggressive disease and to tailor the optimal treatment choice for patients.

Ultimately, this study aims to build on our scientific knowledge of prostate cancer in order to improve ‘precision care’ of men with metastatic prostate cancer.

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.

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ANZUP ANNUAL REPORT 2021

RESEARCH HIGHLIGHTS

Research Highlights

Research Highlights Scientific Advisory Committee: Ian Davis and Scott Williams The ANZUP Scientific Advisory Committee (SAC) was established and is constituted to ensure ANZUP receives strategic guidance from a broad and diverse range of disciplines, crafts, and individuals. The SAC oversees the scientific direction of ANZUP, provides the Board with strategic advice, and contributes practical input at the level of the committees, workshops, and specific protocols and concepts. The SAC executive comprises the ANZUP Board chair, Board deputy chair, SAC chair, subcommittee and Consumer Advisory panel chairs, ANZUP CEO, and ANZUP clinical trials project manager. The SAC executive provides for rapid and effective responses when decisions need to be made quickly and without the opportunity for consultation with the full SAC. Decisions by the SAC executive are discussed and ratified at the next full SAC meeting.

The SAC has evolved its agenda over time to allow it to spend more time on strategic matters and less on operational or trial-specific issues. This has allowed ideas to flow more freely and be taken up in our structures and processes. An example this year was a decision to recommend appointment of a new SAC member representing nuclear medicine, and we are grateful that Prof Andrew Scott has accepted the Board’s

CHAIR, IAN DAVIS

DEPUTY CHAIR, SCOTT WILLIAMS

nomination into this role. ANZUP also welcomes Prof Lisa Butler as the scientific representative replacing Prof Pam Russell, who retired from the SAC early in 2020.

Prof Martin Stockler stood down from his role as deputy chair of the SAC, with thanks for his contributions; Martin’s SAC membership continues as clinical epidemiology representative, and we welcome Prof Scott Williams as the new deputy chair. The membership of the SAC is reviewed by the Board annually.

Meetings of the SAC were held virtually during 2020.

The planned face-to-face open meeting, usually held at the Annual Scientific Meeting, was unable to proceed.

SAC functions effectively with the virtual format but face to face interactions are of great value, and we look forward to resuming these in 2021 when it is possible and safe to do so.

ANZUP welcomes and invites all its members to become involved in its scientific processes, including participation in its committees, workshops, educational and training events, career development initiatives, and the Annual Scientific Meeting. We look for opportunities to increase engagement of our members and we encourage ideas about how to do so more effectively.

RESEARCH HIGHLIGHTS

ANZUP ANNUAL REPORT 2021

Bladder, Urothelial and Penile Cancer (BUP) Subcommittee: Dickon Hayne and Shomik Sengupta ACCEPT ANZUP Co-operative multi-centre cystectomy database (Hayne, 2017) An abstract on 100 consecutive patients was presented at the ANZUP Mini ASM in November 2020.

To date three sites have begun contributing patient data, with 158 patients entered onto the database.

CHAIR, DICKON HAYNE

DEPUTY CHAIR, SHOMIK SENGUPTA

As the year progressed and we adjusted to life with COVID-19, our BUP cancer trials continued to recruit. We would like to take this opportunity to provide an update on the past year’s activities and developments.

Currently recruiting ANZUP trials BCG+MM As of 31 March 2021, recruitment is at 336 patients of a planned 500. To assist with recruitment, we are aiming to open additional sites for the study, including Nottingham University Hospital in the UK, which was been delayed due to COVID-19. Once opened, this will mark the first international site to the study.

There continues to be a worldwide shortage of BCG, which although during the year didn’t impact our recruitment, MSD are due to open a new BCG+MM supply centre to address global demand. MSD have further increased current trial supply to keep pace with the excellent ongoing recruitment to the study.

PCR-MIB There are 25 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 in 2021, to avoid competing with this study.

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

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.

Translational work on blood biomarkers will commence upon completion of accrual of samples.

The Exercyst Trial: Exercise Medicine Prior to Open Radical Cystectomy: Feasibility and Preliminary Efficacy (Taaffe, 2017) We are delighted to report that all of the planned 20 patients have now been recruited.

Exercyst 2 trial is now under development for immediate postoperative exercise.

Concepts WACUP This phase 3 randomised trial was submitted for grant funding for a larger study, under the new title: WATER Trial- Water irrigation versus intravesical chemotherapy After Trans-urEthral resection of low grade urothelial cancer of the bladder.

There are now 26 out of 30 patients recruited to this study.

SUBDUE-1 This trial looks at feasibility and toxicity of a sub-urothelial injection of durvalumab as a potential new primary treatment for non-muscle invasive bladder cancer. The trial recruits patients already scheduled for cystectomy and involves administration of the drug into the bladder wall with a dose escalation protocol.

ANZUP has been heavily involved in the development of the study, which is running only at Fiona Stanley Hospital and is sponsored by South Metro Health Services. AstraZeneca is providing durvalumab but no other support for the study. The trial is funded by a Below the Belt grant and another local grant (Spinnaker) in WA has been obtained for translational work.

So far 7 patients have been recruited to this study.

During the year a protocol paper was submitted to BJUI.

ZipUp This study which will investigate the role of zirconium girentuximab PET in the imaging of urothelial cancer is on-track to open Q2 2021.

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ANZUP ANNUAL REPORT 2021

RESEARCH HIGHLIGHTS

Concept Development Workshops The Concept Development Workshops (CDWs) are designed to facilitate and support members who have an idea/concept they would like to put forward for discussion and, if supported, to further develop into a future grant application.

We held our first ever Zoom Concept Development Workshop on Thursday 30 April 2020 and had 4 concepts presented and over 30 people attend.

We hope to move past the hurdles of the last year and look forward to the progression of BUP concepts and trials and another productive year ahead.

Renal Cell Cancer Subcommittee: David Pook and Craig Gedye Research Committee for review. 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.

CHAIR, CRAIG GEDYE

DEPUTY CHAIR, DAVID POOK

We would like to thank everyone, including 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 throughout the year.

The UNISoN study has the last few participants on treatment. An abstract was accepted for ASCO GU 2021 for the preliminary results of Part 1. Part 2 of the study will be presented at ASCO 2021 with the final survival analysis being presented at ASCO GU 2022. A translational research plan is being drafted that will be presented to the Translational

The KEYPAD study continues to recruit. So far KEYPAD has recruited a total of 42 patients out of a total of 70 patients.

We would like to thank all the KEYPAD investigators and trial teams for their continued efforts throughout an arduous and unpredictable 2020. The concept of inhibiting tumour associated macrophages with denosumab is increasingly relevant with many other studies testing this idea internationally. We are also looking at commencing translational research on the study, with several concepts being proposed to commence in 2021/2022.

The UNICAB study is open across 11 sites in Australia and has recruited 21 of 48 patients to date.

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

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 later in 2021.

RESEARCH HIGHLIGHTS

ANZUP ANNUAL REPORT 2021

We’ve proposed a novel platform trying to test new ideas to run clinical trials in the CELEBRITY project. Funding applications were submitted during the year, 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.

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.

The aim is to capture data for outcomes of most 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.

ANZUP held the first of two RCC Horizon Scanning Meetings in February 2021, where we hope to examine the current data, the gaps and the opportunities for ANZUP to lead to future developments.

We would 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.

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.

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 improving outcomes for kidney cancer in partnership with our patients.

Prostate Cancer Subcommittee: Lisa Horvath and Jarad Martin

CHAIR, LISA HORVATH

DEPUTY CHAIR, JARAD MARTIN

After several years of sterling service chairing the ANZUP prostate subcommittee, in 2020 Scott Williams moved on to take on the Deputy Chair position on the SAC. Scott has steered the prostate group from a handful of studies to the triumph of the ENZAMET publication in the New England Journal of Medicine.

In November 2020, the first subcommittee was held under the new leadership of Lisa Horvath and Jarad Martin.

Following is an update of trial activities and achievements during the course of the year.

DASL-HiCaP DASL HiCaP opened in Australia during the COVID-19 pandemic and to date an impressive 146 men have been randomised. We are looking at opening the study in the UK, Ireland, Canada and the US in the coming year. This is an ANZUP-led randomised phase 3 trial of adding darolutamide to androgen deprivation therapy in conjunction with definitive or salvage radiation in high risk, clinically localised prostate cancer. Study Co-Chairs Associate Professor Tamim Niazi and Professor Christopher Sweeney are excited by the potential of this trial to improve treatment options for patients.

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ANZUP ANNUAL REPORT 2021

RESEARCH HIGHLIGHTS

Lu-PSMA Studies The TheraP study is the first randomised trial of Lutetium 177 Lu-PSMA-617 (Lu-PSMA) to read out. This landmark trial demonstrated that Lutetium-PSMA treatment compared with cabazitaxel chemotherapy in men with metastatic castrationresistant prostate cancer led to a higher PSA response and less side effects. Lutetium-PSMA is a new effective class of therapy and a potential alternative to cabazitaxel.

The TheraP study was accepted as an oral presentation by Study Chair Professor Michael Hofman at the virtual ASCO meeting held in May 2020. The trial report was published in the Lancet in February 2021.

There are now 2 new studies looking at Lutetium-PSMA in combination with hormone treatment. ENZA-p is now open randomising men with metastatic castration-resistant prostate cancer to enzalutamide +/- Lutetium-PSMA, with 29 men already recruited. The ANZUP co-badged study #UpFront PSMA is available for castrate sensitive men with high volume metastatic disease at diagnosis, with 26 randomised to testosterone suppression +/- Lutetium-PSMA.

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 multiparametric MRI in the original diagnosis of prostate cancer with the aim of decreasing the need for diagnostic biopsy.

GUIDE (ANZUP 1903) Study PI Kate Mahon

In the post-operative salvage setting, two concepts are taking shape. DIPPER is looking at a mixture of treatment deintensification for the low risk patient group, and integration of PSMA PET into treatment planning for other men.

EVOLUTION is a Phase II study of Lu-PSMA vs Lu-PSMA with ipilimumab and nivolumab in mCRPC. Primary endpoint is PSA-PFS. Novartis will supply Lu-PSMA, and BMS will supply ipilimumab and nivolumab. The draft protocol has been circulated for comment, including addition of quality of life/ health economic measures. A feasibility survey for sites is also being developed.

GUIDE will investigate a epigenetic ctDNA biomarker as a predictor of response to docetaxel and prognosis in mCRPC. This study will assess biomarker-driven chemotherapy vs standard of care. The study will open at 6 sites initially.

Translational Substudies The ENZAMET trial is proving to be a gold mine for translational research, with planned studies in genomics, cytokines and lipidomics planned for 2021. An engaged translational group is meeting regularly, and welcomes broader engagement. Other completed trials such as TheraP are also a great reservoir of potential translational sub-studies, and any interested investigators are encouraged to contact the relevant study principle investigator to discuss.

Changing practice for the benefit of our patients is the guiding principle for ANZUP. We had an update that based on the findings of ProPSMA, there has been significant progress towards potential MBS funding of this disruptive technology in 2021. We look forward to continuing this tradition of success, and strengthening ANZUP’s reputation as the world’s premier collaborative trials group for genitourinary cancers.

ENZAMET Translational Research: Serum Biomarker Project (ANZUP 1304-TR 01) Study PI Lisa Horvath

EVOLUTION (ANZUP 2001) Study PI Shahneen Sandhu

RESEARCH HIGHLIGHTS

ANZUP ANNUAL REPORT 2021

Germ Cell Cancer Subcommittee: Ben Tran and Fritha Hanning Other activity, including studies in the pipeline:

CHAIR, BEN TRAN

DEPUTY CHAIR, FRITHA HANNING

Despite all the ongoing challenges we faced during the year, the Germ Cell Subcommittee had a very productive year.

Below is an overview of our activity:

Study activity during the year included: • TIGER is open at 4 sites in Australia, with recruitment at 11 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, multi-centre 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.

• iTestis continues 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.

• P3BEP continued to recruit well despite the challenging year. 158 patients have been recruited across ANZ, UK and COG sites. Blood and tissue from consenting P3BEP participants will be collected for translational research studies.

• T he ANZUP surveillance guidelines for both stage 1 and advanced disease (following curative chemotherapy) featured on the ANZUP website and are pending eviQ review.

• L iz 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 Mini 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.

• 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.

• 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 virtual workshop was held on 13 November and resulted in a lot of productive discussion.

We are hoping that we are not faced with as many challenges in the year ahead and are able to progress some of the studies that are in the pipeline as well as some of the concepts above.

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Quality of Life and Supportive Care Subcommittee: Haryana Dhillon and Catherine Paterson

CHAIR, HARYANA DHILLON

DEPUTY CHAIR, CATHERINE PATERSON

And that was 2020 – it literally zoomed by.

In a time of global upheaval it is quite staggering to realise it was business almost as usual for ANZUP. Given we were already avid users of tele- and video-conferencing, it was a relatively smooth transition to Zoom for concept development workshops which meant work could continue. It was wonderful that the ANZUP mini-ASM was able to proceed in November 2020, with some hubs enabling small groups to be together for the meeting.

Concept Development Workshops Early input and engagement from those of us with a supportive care, psychosocial, and quality of life focus is critical in maximising the outcomes of ANZUP clinical trials. In addition to quality of life outcomes, we have introduced assessment of fear of cancer recurrence or progression or anxiety and depression in some of ANZUP’s newer clinical trials.

We are seeing an increase in discussion of patient experience during CDWs, at times data can best be collected as part of routine follow-up in the trial, while at others it requires inclusion of qualitative sub studies to inform our thinking about the problem and the experience. This means we will be better placed in the future to assess for these concerns, develop and evaluate interventions, and even investigate implementation of evidencebased approaches within ANZUP’s clinical trials.

In October, we held a virtual concept development workshop, and it was inspiring to have five new concepts presented to the group, many in very early stages of development which allowed the authors to gain maximum input from the collective wisdom of the group.

We were excited to hear about Catherine Paterson’s proposed mixed methods study of the unmet needs and quality of life of men diagnosed with penile cancer. This is a rare cancer, with major impacts on many, many aspects of men’s lives. The study has the potential to provide critical insights into how we can better support men affected by this cancer. It will be a world first, and help ANZUP establish networks with the clinicians treating penile cancers at the moment.

Felicia Roncolato presented her concept proposing a phase II trial of oxybutynin for troublesome hot flushes in men on ADT for prostate cancer. Since then Felicia has joined forces with Claire Beecroft, Medical Oncologist in Perth, who worked up a pilot study protocol at the ACORD Workshop in 2020. We are currently working on a proposal to access the data from existing, completed trial to explore the symptom clusters associated with hot flushes. This will be a big step forward in understanding how we might effectively intervene to reduce these symptoms in men.

Lorna Pembroke discussed her PhD study, PROCOG, investigating the cognitive impact of prostate cancer and treatments. Lorna’s study had previously been considered by the prostate cancer subcommittee and has subsequently been granted endorsement by ANZUP. I know Lorna is seeking people who are willing to refer men to the study for a one-off assessment which can be done via phone or videoconference.

Jasmine Yee sought input on a proposal investigating the feasibility and usefulness of body composition measurement with a bioimpedence device. One of the things needing exploration in this context is whether the reports provided can be used to facilitate engagement with lifestyle interventions such as exercise programs.

Subcommittee Meetings During the year we have held regular subcommittee meetings via Zoom and the subcommittee is seeing increased input into ANZUP trials more generally. This input is increasing the range of psychosocial and supportive care questions being addressed within the trials, aiming to better understand how we can support patients throughout their treatments and beyond.

Noel Castan QOL Fellowship Kath Schubach (Nurse Practitioner) was awarded the Noel Castan Fellowship during 2019. Kath decided to focus her work on the quality of life amongst people with bladder cancer, and received agreement from the BCG + Mitomycin C trial management committee to use the HQOL data from stage 1 of the trial to describe the quality of life of patients over time.

RESEARCH HIGHLIGHTS

This will be the first step in understanding how the disease, treatments, follow-up, and recovery impact the quality of patients’ lives. Kath is well supported in her Fellowship by our Deputy Chair, Prof. Catherine Paterson.

Online exercise for people with metastatic prostate cancer

ANZUP ANNUAL REPORT 2021

ASM 2020 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.

During the year Holly Evans, Camille Short and their team have launched their online exercise study for individuals with metastatic prostate cancer. The 8-week program involves an individually tailored exercise program, devised using the online algorithm. It also includes complementary education and telehealth support for participants. As we saw the rapid expansion of telehealth services during the year – there is still much to learn about how to do this safely and effectively, and this initiative was very timely.

As we move 2020 into the past, it is important to acknowledge the challenges faced by many of our members, but particularly our patients and their families. Cancer in the time of COVID generated many uncertainties. As we head into 2021, hopeful that the pandemic will be controlled with global cooperation, we are hugely heartened to see progress in our area toward new intervention ideas to reduce the burden of a GU cancer diagnosis.

Translational Subcommittee: Arun Azad and Anthony Joshua The past year has been a very busy period for the Translational Research Subcommittee (TRS) and our first meeting as a group was held in May 2020.

ANZUP aims to make translational research a key focus and strength of the organisation moving forward, and the TRS will facilitate the overall translational research activity for ANZUPled trials.

Translational research plans are in place for ANZUP’s prostate cancer studies, and we are looking at forming a translational research plan for non-prostate cancer trials ongoing. 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 won’t be the direct responsibility of the TRS. For ENZAMET a comprehensive program of TR has been developed (tissue-based genomics, circulating tumour DNA markers, metabolomics, lipidomics, cytokines, imaging studies, etc), and we are awaiting funding approval to proceed. We anticipate commencing this work in the next financial year.

Results from the TheraP trial have established 177Lu-PSMA as a new standard of care option in metastatic castrationresistant prostate cancer (mCRPC). Funded by PCFA, TheraP demonstrated that Lu-PSMA had superior PSA response rates (PSA RR) and PSA-progression-free survival (PSA-PFS) compared to cabazitaxel.

CHAIR, ARUN AZAD

DEPUTY CHAIR, ANTHONY JOSHUA

Despite these practice-shaping results, outcomes from Lu-PSMA are variable and identifying molecular predictors is a priority.

We will shortly commence planning for correlative samples collected for TheraP. By testing circulating biomarkers in pretreatment blood samples collected on TheraP, we hope to better understand why some men respond and others do not benefit from Lu-PSMA therapy. This will help us to better use this new agent and result in improved outcomes for men with advanced prostate cancer. Results from this world-first study were presented at ASCO GU 2021.

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 samples from our ANZUP trials. Bio-specimen collection continues as part of existing trials, including ENZA-p, DASL-HiCaP, BCG+MM, P3BEP, KEYPAD, UNISoN and PCR-MIB. We look forward to a productive year ahead for the Translational Subcommittee and continued translational research activity for ANZUP.

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Consumer Advisory Panel: Belinda Jago and Ray Allen Highlights of the year in review

CHAIR, BELINDA JAGO

DEPUTY, CHAIR RAY ALLEN

The ANZUP Consumer Advisory Panel (CAP) are a group of dedicated volunteers who have had a cancer diagnosis themselves or have cared for a family member/loved one with cancer. The CAP plays a vital role in the provision of advice and feedback from a community perspective on ANZUP’s research strategy and priorities, and on community engagement and support. We also provide advice on trial design and conduct, recruitment, and twoway communication strategies to support dissemination of research findings back to the community. We are committed to clinical trials research as a key strategy for improving the outcomes of those affected by genitourinary cancers. CAP members are drawn from a broad range of backgrounds and have a wide perspective of the needs of cancer sufferers.

This past 12 months has been a very anxious time for patients, carers and their families who have had a cancer diagnosis to deal with as well as the added stress of dealing with the impact of the pandemic. However the patients were certainly in good hands with health professionals and the health services providing their care. They were able to adapt delivery of care ensuring that patient safety and clinical care was not compromised. We are extremely grateful to our dedicated health providers for their extraordinary efforts during this difficult time.

The CAP were able to continue to participate in ANZUP activities using virtual meeting platform. In some respects it gave us a greater opportunity to attend as travel costs and personal time were greatly reduced.

On a global scale, being in Australia/New Zealand has been the best place to be and we are very much looking forward to the future where vaccination programs will allow us to travel again and see the return of face-to-face ANZUP meetings that we all love so much.

It’s with pleasure that we provide you the ANZUP CAP 2021 Annual Report update.

- From the CAP’s perspective our regular subcommittee meetings that had been done by teleconference were now attended on Zoom. This was a welcome change to connect in a much more personal way for meetings that were not face to face anyway and will continue this way going forward.

- CAP members Melissa Le Mesurier and Michael Twycross were able to assist with publicising the lack of supply for BCG/Mitomycin which gained media attention.

- The CAP all made great contributions in some way (fundraising, promoting, participating and donating) to ANZUP’s new and innovative fundraising campaign “#YourWay” to raise funds and awareness for “below the belt cancers”. We are now in the process of signing up for the 2021 “Move #YourWay” campaign.

- We greatly missed our annual face to face education session and Annual Scientific Meeting, but we had the opportunity to attend 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 CAP member Melissa Le Mesurier who co-chaired the ANZUP Symposium. We also want to offer our gratitude to Scott Williams and Dickon Hayne for their public acknowledgment of the commitment and work that we so willingly do to support ANZUP’s research activities from a consumer perspective. We are now very much looking forward to the face to face Adelaide ASM in October 2021.

- The CAP was also represented in the recent Renal Cell Carcinoma (RCC) Horizon Scanning Meetings. They are a series of structured activities and discussions to identify and explore the top research priorities for RCC research in Australia and New Zealand.

From a consumer perspective we are very pleased to see this important activity being initiated for kidney cancer patients as their outcomes will benefit in the future from pursuing the identified priorities.

- The CAP was also involved as a team in reviewing the research applications received for the Below the Belt Research funding grants. This new team approach for the review was put in place following feedback from CAP member Colin O’Brien to ANZUP. The team approach gave the CAP confidence that our ranking of 19 applications was the voice of the community rather than that of an individual.

ACHIEVEMENTS

Other key activities in 2020/21 include: The CAP had the opportunity to review Participant Information and Consent Forms for: - ZipUp - UNICAB Teletrial - GUIDE

UNICAB Teletrial PICF The CAP reviewed the original UNICAB PICF back in 2018 (not 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. Positively, the CAP noted that from a community point of view, despite the terrible affects of COVID-19, it has certainly sped up the process for developing the teletrial models. This has ultimately meant much better access for trials, especially for those living in regional and rural areas.

ANZUP ANNUAL REPORT 2021

ACTA Trial of the Year Awards – Consumer Involvement Award This was certainly a highlight for 2020 and I was delighted and priviledged to be able to accept the ACTA Trial of the Year Consumer Involvement Award on behalf of ANZUP and the CAP. The award acknowledged the role we played from a community perspective as the trial developed from an idea into a trial recruiting patients in a global collaboration. The ENZAMET trial was one of the first PICF’s the CAP reviewed back in 2013 and looking back and now forwards it cements our belief that this is why we wanted to be involved with ANZUP and the importance of clinical trial research.

The CAP could not do what we do without the support and commitment from ANZUP Chair Ian Davis and ANZUP CEO Marg McJannett who have been ever present since our inception in 2012.

We offer our heartfelt thanks to you both as well as to the ANZUP Board, the Executive team and the membership for supporting and engaging with us. We are very much looking forward to working with you all for another productive year ahead.

CAP MEETING JUNE 2020 & BT

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RESEARCH HIGHLIGHTS

2020 ANZUP ASM: Henry Woo As a consequence of COVID-19 ANZUP made the difficult decision to postpone the face-to-face ANZUP ASM in Adelaide, and move it back a year to July 2021. We held numerous discussions with members and sponsors and decided to hold a virtual Mini ASM.

We also held the first of our two ‘ANZUP in Conversation’ panel discussions hosted by Joseph Ischia and Renu Eapen. The first of our stellar international line up on the panel were Silke Gillessen and Tom Powles - and this was truly a highlight.

The Monday morning saw the next ‘ANZUP in 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.

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.

The Mini ASM provided a platform to discuss and present the latest updates in GU cancer treatment, research and supportive care and to learn more about existing and planned ANZUP trials.

On behalf of the ‘mini’ organising committee for the 2020 ANZUP Mini ASM I’d like to thank everyone who presented, attended and help 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.

The program kicked off with a Nurses and Allied Health Session: In the face of a pandemic: Navigating a clinical trial where a panel explored the challenges of treating patients and the lessons learnt during a pandemic. This was a great session with some insightful conversations which are being collated into a research paper.

We also saw the return of the ever popular MDT Master Games. The afternoon was convened by Craig Gedye, Carole Harris and Nicky Lawrence. The panels were broken up by disease type. Each then endeavoured to educate the audience with real-life clinical challenges and audience polling.

On the Sunday evening we hosted a ‘virtual’ welcome drink session and held the first two highly anticipated ANZUPx talks – featuring Andrew Weickhardt and Catriona McNeil. Since its inception 3 years ago, ANZUPx has never failed to disappoint and this year, even virtually, was no different.

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

I’d like to take this opportunity to thank our members and our sponsors for their attendance, either virtually or at a local hub, and ongoing support of ANZUP. This meeting was only made possible by the dedication of each and every member of our ANZUP community. The convening committee of Ian Davis and Lisa Horvath displayed an extraordinary commitment to developing another world-class educational, inspirational and captivating program. I am grateful to the ANZUP subcommittee chairs for their review of the submitted abstracts and concepts. My thanks also to the ANZUP management team and in particular, Marg McJannett.

ANZUP continues to go from strength to strength. People continue to be diagnosed with genitourinary cancers, so even though we are making good progress there is more work to be done. With your help, ANZUP has the opportunity to place Australia and New Zealand at the forefront of the world of GU Oncology.

We look forward to the 2021 ANZUP ASM in Adelaide from Sunday 19 October to Tuesday 21 October 2021.

Henry Woo Convenor, 2020 Mini ANZUP Annual Scientific Meeting

ANZUP ASM 2020 highlights

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Thanks to our 2020 ASM sponsors PLATINUM SPONSORS

GOLD SPONSORS

SILVER SPONSORS

BRONZE SPONSORS

INTERNATIONAL SPEAKER SPONSORS

RESEARCH HIGHLIGHTS

ANZUP ANNUAL REPORT 2021

Below the Belt #YourWay In line with ANZUP’s Strategic Plan to expand the Below the Belt Pedalthon, and to reformat the event during COVID-19, the Below the Belt #YourWay Challenge was held throughout the month of September 2020.

The Below the Belt #YourWay Challenge was open for the month of September and provided participants the option to ride, walk, run, and swim as many kilometres as they could, anywhere and at any time, whilst fundraising for ANZUP.

The Below the Belt #YourWay campaign idea originated from a song penned by ANZUP member Professor Dickon Hayne who recorded it with his two daughters, Zoe and Natasha.

The current www.belowthebelt.org.au website was updated so the branding represented the new activities. The website tracked participants, kilometres, fundraising via leader boards, and other virtual value adds e.g. gamification and badges. All participants required a way to track their kilometres.

This challenge was developed as a digital and virtual campaign to increase engagement and awareness of ANZUP and below the belt cancers, with both current and new supporters.

The main objective of the #YourWay Challenge was to raise $100,000 for ANZUP’s clinical trial research via the Below the Belt Research Fund. The funds raised then go on to support the important work of ANZUP clinicians and researchers allowing them to continue to improve treatments and outcomes for those with below the belt cancer during isolation and into the future.

Each participant was able to decide how they wanted to complete the challenge - at home, in their office, outdoors, as a team, with their family, with work colleagues, with a friend or by themselves. They could do it every day or just some days in September.

The #YourWay Challenge was a huge success with 237 individual participants and 43 teams involved, completing 72,783kms across Australia, New Zealand, the United Kingdom and beyond. And most impressively the fundraising target was surpassed and an extraordinary $173,000 was raised for the Below the Belt Research Fund.

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ACHIEVEMENTS

Some highlights from the event

Associate Professors Andrew Weickhardt and Dave Pook, also ANZUP members, completed their kilometres virtually by cycling in the Zwift cycling community.

Professor Dickon Hayne not only inspired the challenge with his song #YourWay, but he was the team captain for the Fiona Stanley Freemantle Hospital Group. They were the highest fundraisers raising an incredible $15,800 with several activities contributing to the challenge.

“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 Another ANZUP member, Professor Louise Emmett and her team ‘Sydney Opera House to Manly Beach’ walked all day and into the evening. They covered an incredible number of kilometres and were able to enjoy the scenic adventure.

Belinda Jago, Chair of ANZUP’s Consumer Advisory Panel, was the highest individual fundraiser raising $5,455. She also exceeded her walking goal of 150km and covered 347km.

ACHIEVEMENTS

ANZUP ANNUAL REPORT 2021

Thanks to our #YourWay sponsors and supporters GOLD SPONSORS

SILVER SPONSOR

BRONZE SPONSOR

SUPPORTERS

INTELLIGENT NEWS THESATURDAYPAPER.COM.AU

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Grants and Awards Infrastructure Grants Funds provided by Cancer Australia to support ANZUP infrastructure are managed by the University of Sydney NHMRC Clinical Trials Centre and therefore not reported in the financial accounts of ANZUP unless transferred in support of specific expenses incurred by ANZUP. Grants contributing to ANZUP infrastructure costs during the 2020-21 period are outlined below.

Funding Cancer Australia Infrastructure Grant: 1 July 2018 to 30 June 2021, AUD$1,500,000 awarded to ANZUP and our collaborator on the grant NHMRC CTC. During this reporting period AUD$270,750 was transferred to ANZUP and was reported in the Annual Accounts.

Research Grants Funds provided by Cancer Australia, the National Health and Medical Research Council, philanthropic funding bodies and pharmaceutical companies in support of ANZUP trial coordination are managed by the University of Sydney acting through NHRMC Clinical Trials Centre, and therefore not reported in ANZUP’s financial accounts. Funds to support ANZUP sponsored trials and site payments, insurance and other trial related costs are transferred to ANZUP and are reflected in these accounts.

ANZUP grant income and expenditure during this reporting period are included in the 2020/2021 financial accounts.

Grants awarded to ANZUP Cancer Trials Group during this reporting period are listed below: BCGMM: A randomised phase III trial adding mitomycin to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer. Funding by Cancer Australia AUD$457,143 (2013-2018). AUD$70,000 was transferred to ANZUP and reported in the annual accounts.

BL.12: A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen. Funding by NCIC Clinical Trials Group AUD$1,384,662, Specialised Therapeutics AUD$250,000 (2015-2018). During this reporting period no funds were transferred to ANZUP.

DASL-HiCaP: A randomised phase III double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in very high risk, clinically localised prostate cancer. Funding by Bayer USD$33,777,579. During this period USD$765,000 was transferred to ANZUP and reported in the annual accounts.

ENZAMET: A randomised phase III trial of Enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer. Funding by Astellas AUD$17,131,966 (2014-2020).

During this reporting period USD$15,400 was transferred to ANZUP and was reported in the annual accounts.

ENZA-p: A randomised phase II trial using PSMA as a therapeutic agent and prognostic indicator in men with metastatic castrationresistant prostate cancer treated with enzalutamide. Funding by Prostate Cancer Foundation of Australia AUD$4,000,000, Endocyte USD$320,000, St Vincent’s Clinic Foundation AUD$400,000, GenesisCare AUD$300,000, and Roy Morgan Research Ltd AUD$300,000 (2020-2024). During this reporting period AUD$2,333,942 was transferred to ANZUP and was reported in the annual accounts.

ENZARAD: A randomised phase III trial of Enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised prostate cancer. Funding by Astellas AUD$11,946,080 (2014-2020). During this reporting period no funds were transferred to ANZUP. KEYPAD: A phase II trial using denosumab and pembrolizumab in clear cell renal carcinoma. Funding by Merck Sharpe Dohme and Amgen AUD$2,454,925. During this reporting period no funds were transferred to ANZUP. Pain Free TRUS B: A placebo-controlled, randomised trial of methoxyflurane to reduce the discomfort of prostate biopsy. Funding by Cancer Australia AUD$354,764, Prostate Cancer Foundation of Australia AUD$242,331 (2015-2018).

During this reporting period no funds were transferred to ANZUP.

RESEARCH HIGHLIGHTS

PCR MIB: Pembrolizumab with ChemoRadiotherapy as treatment for Muscle Invasive Bladder Cancer.

Grant funding support from Merck Sharp & Dohme (Australia), AUD$455,800 to conduct the study, anticipated to take up to 5 years. During this reporting period, no funds were transferred to ANZUP. PET-MET: A retrospective, multi-centre study using scans and data obtained from patients enrolled onto the ENZAMET trial who underwent PSMA PET imaging within 3 months of enrolment. Funding Astellas AUD$550,000 (2020-2022).

During this reporting period, AUD$150,000 was received and reported in the annual accounts.

Phase III Accelerated BEP (Cancer Australia and Cancer Council Australia): A randomised trial of accelerated versus standard BEP chemotherapy for intermediate and poor risk advanced germ cell tumours. Funding by Cancer Australia AUD$363,583, Cancer Council Australia AUD$222,000 (2013-2018). During this reporting period AUD$30,000 was transferred to ANZUP and is reported in the annual accounts.

RAMPART: An international investigator-led Phase III multi-arm multi-stage multi-centre randomised controlled platform trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse.

Funding by University College London USD$2,080,000 (2020-2030). During this reporting period USD$295,200 was received and reported in the annual accounts.

RetroPSMA: A retrospective study to identify clinical predictors of early metastatic disease using PSMA PET imaging. Funding Astellas AUD$500,000 (2021-2023). During this reporting period AUD$250,000 was received and reported in the annual accounts.

ANZUP ANNUAL REPORT 2021

TheraP: An open label, randomised, stratified, 2-arm, multicentre phase 2 trial of Lu-PSMA617 theranostic versus cabazitaxel in progressive metastatic castration resistant prostate cancer. Funding received from PCFA and Endocyte AUD$2,525,000. During this reporting period AUD$100,000 was received and reported in the annual accounts.

TIGER: A randomised Phase 3 trial comparing conventionaldose chemotherapy using paclitaxel, ifosfamide, citplasin (TIP) with high-dose chemotherapy using mobilizing paclitaxel plus ifosfamide followed by high-dose carboplatin and etoposide (TI-CE) as first salvage treatment in relapsed or refractory germ cell tumours (TIGER). Funding Movember AUD$540,000. During this reporting period, no funds were transferred to ANZUP. UNICAB: A Phase II Trial Of Single Agent Cabozantinib In Patients With Locally Advanced Or Metastatic Non-Clear Cell Renal Cell Carcinoma Post Immunotherapy Or Who Are Unsuitable For Immunotherapy Funding from IPSEN AUD$1,173,201 (2018-2023). During this reporting period AUD$100,000 was received and reported in the annual accounts.

UNISoN: A phase II sequential cohort trial of single agent nivolumab, then combination ipilimumab + nivolumab in metastatic or unresectable non-clear cell renal cell carcinoma.

Funding from Bristol Myers Squibb AUD$1,681,822 (2017-2022). During this reporting period, no funds were received. #UpFrontPSMA: A co-badged randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer. Funding

by Peter McCallum AUD$115,579 (2019-2022). During this reporting period AUD$38,434 was received and reported in the annual accounts.

All funds received are utilised for the conduct of trial activity as performed by third party organisations under the direction of ANZUP.

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ANZUP ANNUAL REPORT 2021

RESEARCH HIGHLIGHTS

Participating Centres Throughout Australia and New Zealand ANZUP TRIALS IN EVERY STATE AND TERRITORY IN AUSTRALIA

1

IN TOTAL

12

TRIAL SITE

73

TRIAL SITES

TRIAL SITES NT

15

QLD WA

TRIALS

29

SA

2

TRIAL SITES

NSW

TRIAL SITES

ACT

3

VIC

TRIAL SITES

ANZUP TRIALS THROUGHOUT NEW ZEALAND

25

1

TRIAL SITE

TAS

1

TRIAL SITES

TRIAL SITE

IN TOTAL

9

TRIAL SITES

5

TRIALS

CURRENT ANZUP TRIALS (18) BLADDER

TESTICULAR

PROSTATE

KIDNEY

BCG+MM

P3 BEP

DASL-HICAP

NINJA

KEYPAD

PCR MIB

TIGER

ENZAMET*

PAIN FREE TRUS B*

UNICAB

ENZARAD*

THERA P

UNISON**

ENZA-p

UpFrontPSMA

FASTRACK II*

NMIBC

proPSMA*

* TRIALS IN FOLLOW UP

CO-BADGED STUDIES

RESEARCH HIGHLIGHTS

ANZUP ANNUAL REPORT 2021

Participating Centres Across the rest of the world IN TOTAL

5

89

TRIAL SITES

IRELAND

3

12

CANADA

TRIAL SITES

TRIALS

TRIALS

UK

5

23

3

TRIAL SITES

TRIALS

TRIALS

AUSTRIA

1

1

TRIAL SITE

TRIAL

SLOVENIA

1

TRIAL

BELGIUM SPAIN

1

TRIAL

1

TRIAL SITE

5

TRIALS

USA

1

25

TRIAL SITES

TRIAL

1

TRIAL SITE

3

TRIAL SITES

FOR A COMPLETE LIST OF ALL CURRENT ANZUP TRIALS AND ALL THE PARTICIPATING CENTRES THROUGHOUT AUSTRALIA, NEW ZEALAND AND WORLDWIDE, PLEASE REFER TO OUR WEBSITE WWW.ANZUP.ORG.AU

22

TRIAL SITES

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ANZUP ANNUAL REPORT 2021

RESEARCH HIGHLIGHTS

Publications and Presentations 2020/21 Presentations TheraP ASCO, 29 May - 2 June 2020 Oral presentation by Michael Hofman.

TheraP: A randomised phase 2 trial of Lu-PSMA-617 (LuPSMA) theranostic versus cabazitaxel in metastatic castration resistant prostate cancer (mCRPC) progressing after docetaxel - initial results (ANZUP protocol 1603).

BL.12 JAMA Oncology, 17 September 2020 Efficacy and Safety of nab-Paclitaxel vs Paclitaxel on Survival in Patients With Platinum-Refractory Metastatic Urothelial Cancer Srikala S. Sridhar, MD; Normand Blais, MD; Ben Tran, MD; M. Neil Reaume, MD; Scott A. North, MD; Martin R. Stockler, MD; Kim N. Chi, MD; Neil E. Fleshner, MD; Geoffrey Liu, MD; John W. Robinson, MD; Som D. Mukherjee, MD; Yasmin Rahim, MD; Eric Winquist, MD; Christopher M. Booth, MD; Nghia Trung Nguyen, MD; Emma K. Beardsley, MD; Nimira S. Alimohamed, MD; Gail T. McDonald, MSc; Keyue Ding, PhD; Wendy R. Parulekar, MD RAVES The Lancet, 28 September 2020 Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial Andrew Kneebone, Carol Fraser-Browne, Gillian M Duchesne, Richard Fisher, Mark Frydenberg, Alan Herschtal, Scott G Williams, Chris Brown, Warick Delprado, Annette Haworth, David J Joseph, Jarad M Martin, John H L Matthews, Jeremy L Millar, Mark Sidhom, Nigel Spry, Colin I Tang, Sandra Turner, Kirsty L Wiltshire, Henry H Woo, Ian D Davis, Tee S Lim, Maria Pearse.

Publications e-TC 2.0 Journal of Psychosocial Oncology Research and Practice, 31 August 2020 Online psychological self-management intervention for testicular cancer survivors: promising acceptability and preliminary efficacy, but limited feasibility Allan ‘Ben’ Smith, Orlando Rincones, Louise Heiniger, Peter Grimison, Ben Tran, Martin R. Stockler, Guy Toner, Beth Cohen, Ian Olver, Britt Klein, Margaret McJannett, Phyllis Butow

SORCE ASCO Journal of Clinical Oncology, 14 October 2020 Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial Tim Eisen, MB BChir, PhD; Eleni Frangou, MSc (Res); Bhavna Oza, MBBS2; Alastair W.S. Ritchie, MD; Benjamin Smith, BSc; Rick Kaplan, MD; Ian D. Davis, MBBS, PhD; Martin R. Stockler, MBBS, MSc; Laurence Albiges, MD, PhD; Bernard Escudier, MD; James Larkin, PhD; Axel Bex, MD, PhD; Steven Joniau, MD, PhD; Barry Hancock, MD; Gregers G. Hermann, MD, DMSc; Joaquim Bellmunt, MD, PhD; Elizabeth Hodgkinson, BPharm, MSc; Grant D. Stewart, MBChB; Jim Barber, DM; Janet Brown, MD; Rhona McMenemin, MSc; Paul Nathan, MBBS, MD; Lisa M. Pickering, PhD;Mahesh K.B. Parmar, DPhil; and Angela Meade, DPhil.

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

Posters ASCO GU 2021 – Virtual Meeting – 11-13 February 2021 Abstract TPS266: DASL-HiCaP (ANZUP 1801): Darolutamide augments standard therapy for localized very high-risk cancer of the prostate—A randomized phase III double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation.

First Author: Tamim Niazi, MD

TheraP The Lancet, 11 February 2021 [177Lu] Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial.

Michael S Hofman, Louise Emmett, Shahneen Sandhu, Amir Iravani, Anthony M Joshua, Jeffrey C Goh, David A Pattison, Thean Hsiang Tan, Ian D Kirkwood, Siobhan Ng, Roslyn J Francis, Craig Gedye, Natalie K Rutherford, Andrew Weickhardt, Andrew M Scott, Sze-Ting Lee, Edmond M Kwan, Arun A Azad, Shakher Ramdave, Andrew D Redfern, William Macdonald, Alex Guminski, Edward Hsiao, Wei Chua, Peter Lin, Alison Y Zhang, Margaret M McJannett, Martin R Stockler, John A Violet, Scott G Williams, Andrew J Martin, Ian D Davis for the Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group.

P3BEP ASCO Journal of Clinical Oncology, 17 March 2021 Survival and New Prognosticators in Metastatic Seminoma: Results From the IGCCCG-Update Consortium Jorg Beyer, MD; Laurence Collette, PhD; Nicolas Sauv´e, MSc; Gedske Daugaard, MD; Darren R. Feldman, MD; Torgrim Tandstad, MD; Alexey Tryakin, MD; Olof Stahl, MD; Enrique Gonzalez-Billalabeitia, MD; Ugo De Giorgi, MD; St´ephane Culine, MD; Ronald de Wit, MD; Aaron R. Hansen, MD; Marko Bebek, MD; Angelika Terbuch, MD; Costantine Albany, MD; Marcus Hentrich, MD; Jourik A. Gietema, MD; Helene Negaard, MD; Robert A. Huddart, MD; Anja Lorch, MD: Fay H. Cafferty, PhD; Daniel Y. C. Heng, MD; Christopher J. Sweeney, MD; Eric Winquist, MD; Michal Chovanec, MD; Christian Fankhauser, MD; Daniel Stark, MD; Peter Grimison, MD; Andrea Necchi, MD; Ben Tran, MD; Axel Heidenreich, MD; Jonathan Shamash, MD; Cora N. Sternberg, MD; David J. Vaughn, MD; Ignacio Duran, MD; Carsten Bokemeyer, MD; Anna Patrikidou, MD; Richard Cathomas, MD; Samson Assele, MSc; and Silke Gillessen, MD for the International Germ Cell Cancer Classification Update Consortium.

Abstract TPS367: KEYPAD (ANZUP 1601): Denosumab and pembrolizumab in clear cell renal carcinoma: A phase II trial.

First Author: Craig Gedye, PhD, FRACP

Abstract TPS390: P3BEP (ANZUP 1302): An international randomized phase III trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumors (GCTs).

First Author: Shalini Subramaniam, MBBS

Abstract TPS177: ENZA-p (ANZUP 1901): A randomized phase II trial using PSMA as a therapeutic agent and prognostic indicator in men with metastatic castration-resistant prostate cancer treated with enzalutamide.

First Author: Louise Emmett, FRACP, MBChB, MD

Abstract 325: UNISON (ANZUP 1602) - nivolumab then ipilimumab + nivolumab in advanced non-clear cell renal cell carcinoma: Part 1—Nivolumab monotherapy.

First Author: Craig Gedye, FRACP, MBChB, PhD

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FINANCIAL REPORT

Financial Report

Annual Financial Report 2021

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

ANZUP Cancer Trials Group Limited ABN: 32 133 634 956

Annual Financial Report – 31 March 2021 Directors’ report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Auditor’s independence declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Financial statements

Statement of profit or loss and other comprehensive income . . . . . . . . . . . 61

Statement of financial position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Statement of changes in equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Statement of cash flows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Notes to the financial statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65-72

Directors’ declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Independent auditor’s report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74-75

General information The financial statements cover ANZUP Cancer Trials Group Limited as an individual entity. The financial statements are presented in Australian dollars, which is ANZUP Cancer Trials Group Limited’s functional and presentation currency.

ANZUP Cancer Trials Group Limited is a not-for-profit unlisted public company limited by guarantee.

The financial statements were authorised for issue, in accordance with a resolution of directors, on 28 May 2021.

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FINANCIAL REPORT

ANZUP Cancer Trials Group Limited Directors’ report 31 March 2021

The directors of ANZUP Cancer Trials Group Limited (the company) submit their annual financial report for the year ended 31 March 2021.

Directors

Associate Professor Guy Toner

The following persons were directors of the company during the whole of the year and up to the date of this report, unless otherwise stated: Ian Davis (Chair) Guy Toner (Deputy Chair – until 20 July 2020) Joe Esposito (Deputy Chair from 20 July 2020) Nicholas Buchan Martin Dowling Glenn Ferguson Linda Martin Henry Woo Shomik Sengupta Lisa Horvath (appointed 20 July 2020)

Information on directors Professor Ian Davis

Deputy Chair (until 20 July 2020) Associate Professor Guy Toner is a Consultant Medical Oncologist at Peter MacCallum Cancer Centre and Associate Professor of Medicine at the University of Melbourne. He is a graduate of the University of Melbourne and undertook sub-specialty training in medical oncology in Melbourne before spending 3 years at Memorial Sloan-Kettering Cancer Center, New York. His clinical and research interests include all urological cancers with a particular interest in testicular cancer, which was the subject of his MD thesis. He has been an active member of other cooperative trials groups including as a past member of the Scientific Advisory Boards of the ANZ Breast Cancer Trials Group and the Australian Sarcoma Study Group.

Professor Toner was Head of the Medical Oncology Unit at Peter MacCallum Cancer Centre from 1993-2007. He was Chair of the ANZ Germ Cell Trials Group from 1995 until it merged to form ANZUP and since then was the Deputy Chair of ANZUP until 20 July 2020.

Chair Professor Ian Davis is chair of the ANZUP Board and of its Scientific Advisory Committee. He is a medical oncologist and Professor of Medicine and Head of the Eastern Health Clinical School, Monash University and Eastern Health, in Melbourne, Australia. He holds honorary appointments with the Olivia Newton-John Cancer Research Institute and Austin Health. He is an adjunct Associate Professor of the University of Melbourne, and Associate of the University of Sydney. His primary clinical interests are in urologic cancers, and his primary research interests are in cancer immunology and the biology of urologic cancers.

Prof Davis is a member of the Medical & Scientific Committee and of the Standing Subcommittee on Research for the Cancer Council Victoria. He founded the Urologic Oncology Group of the Clinical Oncology Society of Australia (COSA), is a member of COSA Council, and was previously a COSA Board director.

Mr Joe Esposito Deputy Chair (from 20 July 2020) Mr Joe Esposito is a Melbourne based director who has recently established a business consultancy practice, Grumentum Capital Pty Ltd. For 8 years, until 2020, he owned and operated a BOQ (Bank of Queensland) branch in the inner city suburb of Collingwood. He has had over 20 year’s experience in corporate banking in Australia and New Zealand. Between 2003 and 2006 he was the CEO of ASX listed Jetset Travelworld Limited.

Mr Esposito has a close affinity with the objectives of ANZUP and the needs of cancer consumers. His qualifications include a Bachelor of Commerce, a Master of Applied Finance and a Diploma in Finance and Mortgage Management. He is a graduate member of the Australian Institute of Company Directors. Mr Esposito was appointed the Deputy Chair from 20 July 2020. .

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

ANZUP Cancer Trials Group Limited Directors’ report continued 31 March 2021

Dr Nick Buchan Dr Nick Buchan is a Urologist based in Christchurch, New Zealand and works in both public and private practice. Dr Buchan’s practice focuses on the diagnosis and management of urological cancers. He gained his experience in medical trials while on fellowship at the Vancouver Prostate Centre. The Vancouver Prostate Centre is one of the largest research and clinical centres in the world that focuses on translational research into prostatic diseases, prostate cancer in particular. Currently Dr Buchan is managing director of the Canterbury Urology Research Trust (CURT). CURT is a trust that conducts urological trials for contract research organisations (CROs) as well as its own investigator lead trials in urological conditions with the focus being urological oncology. Dr Buchan is also a previous director of a privately owned hospital in Christchurch, Forte Health and managing director of a large Urology specialist practice, Urology Associates.

Mr Martin Dowling Mr Martin Dowling has held executive and senior management level financial and commercial roles at some of the largest companies in the world. He has delivered in leadership roles against a broad portfolio of responsibilities across a range of industries including mining, mining services, manufacturing and engineering. He has a Bachelor of Commerce and MBA degree and is a Fellow of CPA Australia and a graduate member of the Australian Institute of Company Directors. He is committed to the pursuit of charitable and societal goals as a Director on not-for-profit boards and also actively in the local community.

Mr Glenn Ferguson AM Mr Glenn Ferguson AM is a Solicitor of the High Court of Australia and the Supreme Court of Queensland. He is a past President of the Law Council of Australia and past President of Lawasia the law association for Asia and the Pacific and a past President of the Queensland Law Society. He is also a Senior Counsellor with the Queensland Law Society and has previously chaired their professional standards committee. Mr Ferguson is a Founding Fellow of the Australian Academy of Law, a Fellow of the Australian Institute of Company Directors and a Fellow of the Australia and New Zealand College of Notaries. He was appointed the inaugural Adjunct Professor in Law at the University of the Sunshine Coast. He is currently Chair of Lexon Insurance and a Governor of the College of Law. He has

been appointed by both Federal and State Governments to various advisory boards and task forces in the legal, business and immigration sectors. In the 2015 Australia Day Honours, Mr Ferguson was made a Member of the Order of Australia “For significant service to the law and to the legal profession, both nationally and in the Asia Pacific region, and to the community”.

Ms Linda Martin Ms Linda Martin has recently retired after a broad career in Executive roles spanning public, private and not for profit organisations. She was previously CEO of not-for-profit Musculoskeletal Australia, a Senior Executive in the Victorian Public Service, working primarily in the health and community service sectors in large scale operational and project roles and a senior consultant in a strategic branding and marketing company. As Managing Director of a management consultancy firm she worked in diverse industries including banking, insurance, health, aged care, disability and transport sectors. Her work as an Executive coach and mentor continues. Ms Martin has also been a lecturer in Social Work at the University of Melbourne, an industry representative on the Monash University, School of Public Health and Preventive Medicine Postgraduate Courses Committee and a Board Director of QEC. Ms Martin’s focus has been on governance, strategic and business planning and reform and the development of strategic alliances. She is passionate about achieving consumer outcomes in health.

Professor Henry Woo Professor Henry Woo is a urological surgeon who subspecialises in prostate disease. He is the Director of UroOncology and Professor of Robotic Cancer Surgery at the Chris O’Brien Lifehouse. He is also Professor of Surgery at the Sydney Adventist Hospital Clinical School of the University of Sydney.

He has published widely in major urological journals. He is an Associate Editor of the journal Prostate Cancer Prostatic Diseases and serves on the journal editorial boards of European Urology, BJUI, Prostate International, Asian Journal of Urology and World Journal of Men’s Health. He also serves on the board of the charitable Australian Urological Foundation (AUF) and is a member of the Executive Committee of the Asian Pacific Prostate Society (APPS).

Professor Woo is passionate about clinical trials and procuring the best evidenced based options for his patients. He also has particular interests in surgical education and the role of social media in learning and health advocacy.

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ANZUP Cancer Trials Group Limited Directors’ report continued 31 March 2021

Professor Shomik Sengupta Professor Shomik Sengupta is Professor of Surgery and deputy Head of School at the Eastern Health Clinical School, Monash University and a consultant urologist and Uro-Oncology lead at the Department of Urology, Eastern Health. He has a practice with a urooncology subspecialty interest – including open, laparoscopic and robotic cancer surgery. Professor Sengupta also has a strong interest in urologic research, including involvement in clinical trials through the Australian and New Zealand Urogenital & Prostate (ANZUP) Cancer Trials Group, where he is a member of the Board and the Scientific Advisory Committee. Professor Sengupta Shomik has more than 100 original publications to date and has been an invited speaker, session chair and convenor at numerous scientific meetings.

Professor Lisa Horvath Professor Lisa Horvath is the Director of Research at Chris O’Brien Lifehouse.

She completed medical school at the University of Sydney and trained in medical oncology at Royal Prince Alfred Hospital, where she was appointed to the senior staff in 2003. She completed her PhD in translational research at the Garvan Institute of Medical Research in 2004. Professor Horvath’s research interest is predominantly in the field of prostate cancer in particular biomarkers, prostate cancer biology and clinical trials. She holds academic appointments at both the University of Sydney and the University of New South Wales and is the Head of Advanced Prostate Cancer research group at The Kinghorn Cancer Centre/Garvan Institute of Medical Research. Professor Horvath is the Conjoint Chair of Medical Oncology (Genitourinary Cancers) at Lifehouse. She has published more than 100 original research papers in peer-reviewed journals in the last 20 years.

She has presented extensively at national and international meetings both peer-reviewed and invited presentations.

Professor Horvath is an elected ANZUP Board Director, a member of the ANZUP Scientific Advisory Committee and is Chair of the ANZUP Prostate Cancer Subcommittee.

Company Secretary Ms Margaret McJannett was appointed secretary on 9 February 2011 and continues in office at the date of this report. Ms McJannett also serves as the company’s Chief Executive Officer.

Meetings of Directors During the year, five meetings of directors were held.

Attendances by each director were as follows:

Directors’ meetings

Number eligible to attend

Number attended

Ian Davis

5

5

Guy Toner

2

2

Nicholas Buchan

5

3

Martin Dowling

5

4

Joe Esposito

5

5

Glenn Ferguson AM

5

5

Linda Martin

5

4

Henry Woo

5

4

Shomik Sengupta

5

5

Lisa Horvath

3

3

Principal activity The mission of the Company is to conduct clinical trial research to improve treatment of Bladder, Kidney, Testicular, Penile and Prostate Cancers.

Objectives of the company The objectives of the Company are to develop, foster and promote prostate and urogenital cancer research by: • providing access to clinical trials for all appropriate Australian and New Zealand patients; • increasing involvement of and collaboration with various professional disciplines in clinical and preclinical research; • providing opportunities for clinical research; • building systems to simplify and streamline clinical research of the highest quality; • fostering a culture of research amongst all clinicians involved in the care of patients with urogenital cancers; • providing training opportunities for the next generation of clinical researchers; • providing for translational studies in prostate and other urogenital cancers, including tissue banking from clinical trials for further studies.

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

ANZUP Cancer Trials Group Limited Directors’ report continued 31 March 2021

The company intends to meet these objectives through performing industry sponsored and other clinical trials, ensuring these trials are widely accessible to patients, creating strong links with Cancer Australia and other peak bodies, engaging professional disciplines at all levels of protocol development and implementation, and securing funding to support clinical research training positions.

Court proceedings

Review of operations

The company was not a party to any such proceedings during the year.

The company’s net income for the year was $1,420,905 (2020: $1,183,147).

At 31 March 2021, the company had net assets of $6,803,703 (2020: $4,866,161).

Changes in state of affairs There were no significant changes in the state of affairs of the company during the year ended 31 March 2021.

Subsequent events No matters or circumstance have arisen since the end of the year that have significantly affected, or may significantly affect, the operations of the company, the results of these operations, or the state of affairs of the company in future years.

Future developments Likely developments in the operations of the company and the expected results of those operations in future years have not been included in this report as the inclusion of such information is likely to result in unreasonable prejudice to the company.

No person has applied for leave of Court to bring proceedings on behalf of the company or intervene in any proceedings to which the company is a party for the purpose of taking responsibility on behalf of the company for all or any part of those proceedings.

Environmental issues The company’s operations are not regulated by any significant environmental regulation under a law of the Commonwealth or of a State or Territory.

Indemnification of officers and auditors The company has paid premiums to insure each director against liabilities for costs and expenses incurred by them in defending any legal proceedings arising out of their conduct involving a wilful breach of duty in relation to the company.

The amount of the premium paid during the period was $2,408.

Auditors’ independence declaration A copy of the auditors’ independence declaration as required under section 307C of the Corporations Act 2001 is set out on the next page.

Signed in accordance with a resolution of Directors.

Ian Davis Chairman Sydney, 28 May 2021

HANDS UP FOR ANZUP

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FINANCIAL REPORT

Tel: +61 2 9251 4100 Fax: +61 2 9240 9821 www.bdo.com.au

Level 11, 1 Margaret St Sydney NSW 2000 Australia

DECLARATION OF INDEPENDENCE BY LEAH RUSSELL TO THE DIRECTORS OF ANZUP CANCER TRIALS GROUP LIMITED As lead auditor of ANZUP Cancer Trials Group Limited for the year ended 31 March 2021, I declare that, to the best of my knowledge and belief, there have been: 1. N o contraventions of the auditor independence requirements of section 60-40 of the Australian Charities and Not-for-profit Commission Act 2012 in relation to the audit; and 2. No contraventions of any applicable code of professional conduct in relation to the audit.

Leah Russell Director BDO Audit Pty Ltd Sydney 28 May 2021

BDO Audit Pty Ltd ABN 33 134 022 870 is a member of a national association of independent entities which are all members of BDO Australia Ltd ABN 77 050 110 275, an Australian company limited by guarantee. BDO Audit Pty Ltd and BDO Australia Ltd are members of BDO International Ltd, a UK company limited by guarantee, and form part of the international BDO network of independent member firms. Liability limited by a scheme approved under Professional Standards Legislation.

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

63

ANZUP Cancer Trials Group Limited Statement of Profit or Loss and Other Comprehensive Income For the year ended 31 March 2021

Notes

2021

2020

$

$

Revenue

3 (a)

4,768,493

4,992,543

Other Income

3 (b)

458,992

260,305

Employee benefits expenses

(1,142,571)

(985,986)

Trial and investigation support

4 (a)

(2,089,748)

(1,733,831)

Administration expenses

4 (b)

(574,261)

(1,349,884)

Net current year surplus 1,420,905 1,183,148

Other comprehensive income for the year Unrealised gains/(losses) on financial assets 516,015 (284,853)

Total comprehensive income

1,936,920

898,295

The above statement of profit or loss and other comprehensive income should be read in conjunction with the accompanying notes.

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ANZUP ANNUAL REPORT 2021

FINANCIAL REPORT

ANZUP Cancer Trials Group Limited Statement of Financial Position For the year ended 31 March 2021

Notes

2020

2019

$

$

Current assets

Cash and cash equivalents

5

1,947,853

2,324,857

Trade and other receivables

6

1,368,199

646,549

Total current assets

3,316,052

2,971,406

Non-current assets Office equipment 7 10,929 8,705 Right-of-use-assets

8 37,039

Other financial assets

9

8,567,706

5,445,059

Total non-current assets

8,615,674

5,514,448

60,684

Total assets

11,931,726

8,485,854

Current liabilities Trade and other payables

10

525,333

322,406

Deferred income

4,455,262

3,134,556

Employee benefits

59,957

63,287

Lease liabilities

23,210

22,208

5,063,762

3,542,457

11

Total current liabilities

Non-current liabilities Employee benefits

48,320

37,410

Lease liabilities

16,563

39,825

64,883

77,235

11

Total non-current liabilities

Total liabilities 5,128,645 3,619,693

Net assets

6,803,081

4,866,161

Equity

Retained earnings

6,571,919

5,151,014

Financial assets reserve

231,162

(284,853)

Total equity

6,803,081

The above statement of financial position should be read in conjunction with the accompanying notes.

4,866,161

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

65

ANZUP Cancer Trials Group Limited Statement of Changes in Equity For the year ended 31 March 2021

Financial Assets Reserve

Retained earnings

$

Total equity

$ $

Balance at 1 April 2019

-

3,967,866

4,029,990

Net income for the year Other comprehensive income for the year

-

1,183,148

1,183,148

(284,853)

-

(284,853)

Total comprehensive income for the year

(284,853)

1,183,148

898,295

Balance as at 31 March 2020

(284,853)

5,151,014

4,866,161

Balance at 1 April 2020

(284,853)

5,151,014

4,866,161

Net income for the year Other comprehensive income for the year

-

1,420,905

1,420,905

516,015

-

516,015

Total comprehensive income for the year 516,015 1,420,905 1,936,920

Balance as at 31 March 2021

231,162

6,571,919

The above statement of changes in equity should be read in conjunction with the accompanying notes.

6,803,081

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ANZUP Cancer Trials Group Limited Statement of Cash Flows For the year ended 31 March 2021

Notes

2021

2020

$

$

Cash flows from operating activities Receipts from grants (inclusive of GST)

4,043,086

4,670,776

Receipts from sundry income (inclusive of GST)

1,202,007

1,181,147

Receipts from donations (inclusive of GST)

364,588

386,588

Interest received

4,713

12,381

Interest paid

(2,791)

(3,748)

Dividend, interest and distribution received

168,867

172,534

Payments to suppliers and employees

(3,524,305)

(4,451,857)

Net cash inflow from operating activities

2,256,165

1,967,821

14

Cash flows from investing activities Payments for office equipment

7

(7,067)

(6,748)

Net withdrawals/(contributions) in FVTOCI financial assets

(2,606,633)

(1,282,025)

Net cash outflow from investing activities

(2,613,700)

(1,288,773)

Cash flows from financing activities Repayment of leases

(19,468)

(21,252)

Net cash outflow from financing activities

(19,468)

(21,252)

Net increase/(decrease) in cash and cash equivalents

(377,004)

Cash and cash equivalents at the beginning of the year

2,324,857

1,667,061

1,947,853

2,324,857

Cash and cash equivalents at the end of the year

5

The above statement of cash flows should be read in conjunction with the accompanying notes.

657,796

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

ANZUP Cancer Trials Group Limited Notes to the financial statements For the year ended 31 March 2021

Note 1.

Summary of significant accounting policies This financial report covers ANZUP Cancer Trials Group Limited (the company) as an individual entity for the year ended 31 March 2021. The company is limited by guarantee and is incorporated and domiciled in Australia. The financial statements are presented in Australian dollars, which is the company’s functional and presentation currency.

The company’s accounting policies adopted in the preparation of the financial statements are set out below.

New, revised or amending Accounting Standards and Interpretations adopted The company has adopted all of the new, revised or amending Accounting Standards and Interpretations issued by the Australian Accounting Standards Board (AASB) that are mandatory for the current reporting period. Any new, revised or amending Accounting Standards or Interpretations that are not yet mandatory have not been early adopted. The following Accounting Standards and Interpretations are most relevant to the Company:

Basis of preparation This financial report is a general purpose financial report which has been prepared in accordance with Australian Accounting Standards - Reduced Disclosure Requirements, including the Australian Accounting Interpretations and other authoritative pronouncements of the Australian Accounting Standards Board and the Australian Charities and Not-forprofits Commission Act 2012, as appropriate for not-for-profit oriented entities. These financial statements do not comply with International Financial Reporting Standards as issued by the International Accounting Standards Board (‘IASB’).

Historical cost convention The financial report has been prepared on an accrual basis and is based on historical costs. Cost is based on the fair values of the consideration given in exchange for assets.

(a) Income tax The company is exempt from the payment of income tax under section 50-5 of the Income Tax Assessment Act 1997.

The company is a deductible gift recipient.

(b) Revenue recognition Revenue from government and pharmaceutical grants received under enforceable agreements, where there are sufficiently specific performance obligations imposed, is deferred until the obligations are satisfied. If the performance obligations are not sufficiently specific, revenue will be recognised upon receipt.

Donations are recognised when received by the company.

Sponsorship revenue is recognised over the period to which the sponsorship relates.

Annual Scientific Meeting (ASM) conference revenue is recognised during the year in which the event takes place.

The company contracts a professional events co-ordinator to manage the staging of the ASM conference including the receipt of revenue and payment of expenses in relation to the event.

Interest revenue is recognised as interest accrues using the effective interest method.

Other revenue is recognised in the year to which it relates.

(c) Current and non-current classification ssets and liabilities are presented in the statement A of financial position based on current and non-current classification.

An asset is current when: it is expected to be realised or intended to be sold or consumed in normal operating cycle; it is held primarily for the purpose of trading; it is expected to be realised within twelve months after the reporting period; or the asset is cash or cash equivalent unless restricted from being exchanged or used to settle a liability for at least twelve months after the reporting period. All other assets are classified as non-current.

A liability is current when: it is expected to be settled in normal operating cycle; it is held primarily for the purpose of trading; it is due to be settled within twelve months after the reporting period; or there is no unconditional right to defer the settlement of the liability for at least twelve months after the reporting period. All other liabilities are classified as non-current.

(d) Cash and cash equivalents Cash and cash equivalents includes cash on hand, deposits held at call with financial institutions and other shortterm, highly liquid investments with original maturities of three months or less that are readily convertible to known amounts of cash which are subject to an insignificant risk of changes in value.

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FINANCIAL REPORT

ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2021

(e) Plant and equipment Plant and equipment is stated at historical cost less accumulated depreciation and impairment. Historical cost includes expenditure that is directly attributable to the acquisition of the items.

The depreciation rate used for each class of plant and equipment is as follows: Office equipment – reducing balance at 20%.

The residual values, useful lives and depreciation methods are reviewed, and adjusted if appropriate, at each reporting date.

An item of plant and equipment is derecognised upon disposal or when no further future economic benefit to the company. Gains and losses between the carrying amount and the disposal proceeds are taken to profit and loss.

(f) Trade and other receivables Trade receivables are initially recognised at fair value and subsequently measured at amortised cost using the effective interest method, less any provision for impairment. Trade receivables are generally due for settlement within 30 days.

Collectability of trade receivables is reviewed on an ongoing basis. Debts which are known to be uncollectable are written off by reducing the carrying amount directly.

A provision for impairment of trade receivables is raised when there is objective evidence that the company will not be able to collect all amounts due according to the original terms of the receivables.

(g) Right-of-use assets A right-of-use asset is recognised at the commencement date of a lease. The right-of-use asset is measured at cost, which comprises the initial amount of the lease liability, adjusted for, as applicable, any lease payments made at or before the commencement date net of any lease incentives received, any initial direct costs incurred, and, except where included in the cost of inventories, an estimate of costs expected to be incurred for dismantling and removing the underlying asset, and restoring the site or asset.

Right-of-use assets are amortised on a straight-line basis over the unexpired period of the lease or the estimated useful life of the asset, whichever is the shorter. Where the entity expects to obtain ownership of the leased asset at the end of the lease term, the depreciation is over its estimated useful life. Right-of use assets are subject to impairment or adjusted for any remeasurement of lease liabilities.

(h) Trade and other payables These amounts represent liabilities for goods and services provided to the company prior to the end of the financial year and which are unpaid. Due to their short-term nature they are measured at amortised cost and are not discounted. The amounts are unsecured and are usually paid within 30 days of recognition.

(i) Deferred income The liability for deferred income is the unutilised amount of grants received on the condition that specified services are delivered or conditions fulfilled. The services are usually provided or conditions usually fulfilled within 12 months of receipt of the grant.

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2021

(j) Lease liabilities A lease liability is recognised at the commencement date of a lease. The lease liability is initially recognised at the present value of the lease payments to be made over the term of the lease, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, the Company’s incremental borrowing rate.

Lease payments comprise of fixed payments less any lease incentives receivable, variable lease payments that depend on an index or a rate, amounts expected to be paid under residual value guarantees, exercise price of a purchase option when the exercise of the option is reasonably certain to occur, and any anticipated termination penalties.

The variable lease payments that do not depend on an index or a rate are expensed in the period in which they are incurred.

Lease liabilities are measured at amortised cost using the effective interest method. The carrying amounts are remeasured if there is a change in the following: future lease payments arising from a change in an index or a rate used; residual guarantee; lease term; certainty of a purchase option and termination penalties. When a lease liability is remeasured, an adjustment is made to the corresponding right-of use asset, or to profit or loss if the carrying amount of the right-of-use asset is fully written down.

(k) Employee benefits Short-term employee benefits Liabilities for wages and salaries, including non-monetary benefits, annual leave and long service leave expected to be settled within 12 months of the reporting date are recognised in current liabilities in respect of employees’ services up to the reporting date and are measured at the amounts expected to be paid when the liabilities are settled.

Other long-term employee benefits The liability for annual leave and long service leave not expected to be settled within 12 months of the reporting date are recognised in non-current liabilities, provided there is an unconditional right to defer settlement of the liability. The liability is measured as the present value of expected future payments to be made in respect of services provided by employees up to the reporting date using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures and periods of service.

Expected future payments are discounted using market yields at the reporting date on national government bonds with terms to maturity and currency that match, as closely as possible, the estimated future cash outflows.

(l) Goods and Services Tax (GST) Revenues, expenses and assets are recognised net of the amount of associated GST, unless the GST incurred is not recoverable from the taxation authority. In this case it is recognised as part of the cost of acquisition of the asset or as part of the expense.

Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the taxation authority is included with other receivables or payables in the statement of financial position.

Cash flows are presented on a gross basis. The GST components of cash flows arising from investing or financing activities which are recoverable from, or payable to the taxation authority, are presented as operating cash flow.

(m) Investments and other financial assets Other financial assets are initially measured at fair value through Other Comprehensive Income. Classification is determined based on the purpose of the instrument.

Financial assets are derecognised when the rights to receive cash flows have been transferred. Investment financial assets are classified as non-current assets when they are not expected to be sold within 12 months after the end of the reporting period. All other financial assets are classified as current assets.

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FINANCIAL REPORT

ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2021

Note 2. Critical accounting judgements, estimates and assumptions The preparation of the financial statements requires management to make judgements, estimates and assumptions that affect the reported amounts in the financial statements. Management continually evaluates its judgements and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgements, estimates and assumptions on historical experience and on other various factors, including expectations of future events, management believes to be reasonable under the circumstances. The resulting accounting judgements and estimates will seldom equal the related actual results. The judgements, estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities are discussed below.

Estimation of useful lives of assets The company determines the estimated useful lives and related depreciation charges for its plant and equipment.

The useful lives could change significantly as a result of technical innovations or some other event. The depreciation charge will increase where the useful lives are less than previously estimated lives, or technically obsolete or nonstrategic assets that have been abandoned or sold will be written off or written down.

Employee benefits provision As discussed in note 1, the liability for employee benefits expected to be settled more than 12 months from the reporting date is recognised and measured at the present value of the estimated future cash flows to be made in respect of all employees at the reporting date. In determining the present value of the liability, estimates of attrition rates and pay increases through promotion and inflation have been taken into account.

Determining whether a grant contains enforceable and sufficiently specific obligations The interaction between AASB 15 and AASB 1058 require management to assess whether the government grants and other funding received need to be accounted for under AASB 15 or AASB 1058. Key to this assessment is whether the government grants and other funding agreements contain: • a contract with a customer that creates ‘enforceable’ rights and obligations, and • the contract includes ‘sufficiently specific’ performance obligations.

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

71

ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2021

2021

2020

$ $

Note 3 (a). Revenue Grant income Donations Honorariums

3,634,331

3,297,088

364,588 386,588 28,147 31,136

Corporate Supporter Program

118,750

Sponsorship

387,225 381,151

Annual Scientific Meeting

235,452

140,000 756,580

4,768,493 4,992,543

Note 3 (b). Other Income Interest income

4,713

12,381

Investment income

168,867

172,535

Sundry income

320,500

11,010

Forex gain (loss) on bank revaluation

(35,088)

64,380

458,992 260,305

Note 4 (a). Trial and investigation support Grant funding Grant funding: Below The Belt Grants paid

1,929,748

1,473,159

160,000

260,672

2,089,748 1,733,831

Note 4 (b). Administration expenses Accounting and auditing fees

44,419

36,340

120,597

507,355

43,779

95,742

Information technology

34,707

31,291

Insurance

13,626 25,555

Workshops, Meetings & Annual Scientific Meeting expense Consulting fees

Registration Travel and accommodation

961 1,916

182,368

Catering and conference

4,836

245,915

Telephone and teleconferencing charges

6,460

18,672

25,079

24,718

Depreciation and amortisation Marketing expenses

127,630

41,704

Sundry expenses

138,016

57,865

12,151

82,359

Pedalthon expenses

574,261 1,349,884

Note 5. Current assets - cash and cash equivalents Cash at bank

1,947,853

2,324,857

1,304,530

236,376

Note 6. Current assets - trade and other receivables Trade receivables Prepayments Accrued income

41,617 175,603 22,052

234,570

1,368,199 646,549

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ANZUP ANNUAL REPORT 2021

FINANCIAL REPORT

ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2021

2021

2020

$ $

Note 7. Non-current assets- property, plant and equipment Office equipment - at cost Less accumulated depreciation

32,587

24,981

(21,658)

(16,276)

10,929 8,705

Movements in carrying amounts

Carrying amount at beginning of year

8,705

Additions

7,607 6,748

4,074

Depreciation expense

(5,383)

(2,117)

10,929 8,705

Note 8. Non-current assets- right-of-use-assets Land and buildings – right-of-use At cost 83,285 83,285 Less accumulated amortisation Total right-of-use-assets at end of year

(46,246)

(22,601)

37,039

60,684

Movements in carrying amounts of right-of-use-assets

Land and buildings – right-of-use Carrying amount at the beginning of the year Amortisation charge

60,684

83,285

(23,645)

(22,601)

Carrying amount at the end of the year 37,039 60,684

The Company leases the office premises under an agreement of a 3.75 year term, with no option to extend explicitly stated.

Note 9. Non-current assets – other financial assets Managed funds

8,567,706

5,445,059

8,567,706 5,445,059

Note 10. Current liabilities - trade and other payables Trade payables

14,013

12,906

Accruals

511,320 309,500

525,333 322,406

Note 11. Lease liabilities Current

23,210 22,208

Non-current

16,563 39,825

Total lease liabilities

39,774

62,033

The Company has discounted the future lease payments using the weighted average incremental borrowing rate of 4.5% as at the date of initial application, being 1 April 2019.

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

73

ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2021 2021

2020

$ $

Note 12. Remuneration of auditors

The following fees were paid or payable for services provided by the auditor: Audit of the financial report

4,650

4,650

Other services - assistance with preparation of the financial report

2,600

2,600

7,250 7,250

Note 13. Reconciliation of cash flows from operations with net income for the year Net income for the year

1,420,905

1,183,148

Depreciation and amortisation

27,040

24,718

Change in operating assets and liabilities: (Increase) / Decrease in trade and other receivables

(721,651)

(504,683)

Increase in trade and other payables

1,522,295

1,229,048

7,577

35,590

Increase in employee benefits

Net cash inflow from operating activities

2,256,165

1,967,821

Note 14. Related party transactions Key management personnel The aggregate compensation made to members of key management personnel of the company is set out below:

Key management personnel compensation

227,444

225,326

Transactions with related parties During the year, the company received honorariums of $28,147 (2020: $31,136). These honorariums were in relation to speaking engagements undertaken by Ian Davis.

Receivable from and payable to related parties There were no trade receivables, trade payables or loans to or from related parties as at year end (2020: nil).

Note 15. After balance date events No matters or circumstances have arisen since the end of the year which may significantly affect the operations of the company, the results of those operations, or the state of affairs of the company in subsequent years.

Note 16. Contingent liabilities and capital commitments The company has no contingent liabilities or capital commitments as at year end (2020: nil).

Commitments contracted for at the reporting date, but not recognised as liabilities are as follows: Research grants Within one year

2,653,049

1,514,645

One to five years

6,092,237

5,318,747

8,745,285 6,833,392

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ANZUP ANNUAL REPORT 2021

FINANCIAL REPORT

ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2021 Note 17. Members’ guarantee The company is limited by guarantee. If the company is wound up, each member of the company undertakes to contribute to the assets of the company an amount not exceeding $50 for payment of the debts and liabilities of the company including the costs of the winding up. This undertaking continues for one year after a member ceases to be a member of the company.

At 31 March 2021, the number of members was 1,819 (2020: 1,732).

Note 18. Information furnished under the Charitable Fundraising Act The following requirement in a requirement under the Charitable Funds Act: Revenue from fundraising activities Fundraising expenses Net surplus from fundraising appeals Surplus as a percentage of revenue The net surplus is applied towards achieving ANZUP’s charitable objectives.

Note 19. Company details The company’s registered office is: Level 6, Lifehouse Building 119-143 Missenden Road Camperdown NSW 2050 The principal place of business of the company is: Level 6, Lifehouse Building 119-143 Missenden Road Camperdown NSW 2050

364,588

386,588

(139,782)

(124,063)

224,806

262,525

62%

68%

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2021

ANZUP Cancer Trials Group Limited Director’s Declaration For the year ended 31 March 2021

The directors of the entity declare that: 1. T he financial statements, comprising the statement of profit or loss and other comprehensive income, statement of financial position, statement of cash flows, statement of changes in equity, and accompanying notes, are in accordance with the Australian Charities and Not-for-profits Commission Act 2012 (ACNC Act) and: a. comply with Australian Accounting Standards – Reduced Disclosure Requirements and the Division 60 of the Australian Charities and Not-for-profits Commission Regulation 2013; and b. give a true and fair view of the entity’s financial position as at 31 March 2021 and of its performance for the year ended on that date.

2. T he provision of the Charitable Fundraising Act 1991 and the regulations under the Act and the conditions attached to the authority have been complied with for the year ended 31 March 2021.

3. I n the directors’ opinion, there are reasonable grounds to believe that the entity will be able to pay its debts as and when they become due and payable.

This declaration is made in accordance with a resolution of the Board of Directors and is signed for and on behalf of the directors by:

Ian Davis Chairman Sydney, 28 May 2021

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FINANCIAL REPORT

Tel: +61 2 9251 4100 Fax: +61 2 9240 9821 www.bdo.com.au

Level 11, 1 Margaret St Sydney NSW 2000 Australia

INDEPENDENT AUDITOR’S REPORT To the members of ANZUP Cancer Trials Group Limited Report on the Audit of the Financial Report Qualified opinion We have audited the financial report of ANZUP Cancer Trials Group Limited (the registered entity), which comprises the statement of financial position as at 31 March 2021, the statement of profit or loss and other comprehensive income, the statement of changes in equity and the statement of cash flows for the year then ended, and notes to the financial report, including a summary of significant accounting policies, and the responsible entities’ declaration.

In our opinion, except for the effects of the matter described in the Basis for qualified opinion section of our report, the accompanying financial report of ANZUP Cancer Trials Group Limited, is in accordance with Division 60 of the Australian Charities and Not-for-profits Commission Act 2012, including: (i) G iving a true and fair view of the registered entity’s financial position as at 31 March 2021 and of its financial performance for the year then ended; and (ii) C omplying with Australian Accounting Standards – Reduced Disclosure Requirements and Division 60 of the Australian Charities and Not-for-profits Commission Regulation 2013.

Basis for qualified opinion Cash donations are a significant source of fundraising revenue for the registered entity. The registered entity has determined that it is impracticable to establish control over the collection of cash donations prior to entry into its financial records. Accordingly, as the evidence available to us regarding fundraising revenue from this source was limited, our audit procedures with respect to cash donations had to be restricted to the amounts recorded in the financial records. We therefore are unable to express an opinion whether cash donations the registered entity recorded are complete.

We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under those standards are further described in the Auditor’s responsibilities for the audit of the Financial Report section of our report. We are independent of the registered entity in accordance with the auditor independence requirements of the Australian Charities and Not-for-profits Commission Act 2012 (ACNC Act) and the ethical requirements of the Accounting Professional and Ethical Standards Board’s APES 110 Code of Ethics for Professional Accountants (including Independence Standards) (the Code) that are relevant to our audit of the financial report in Australia. We have also fulfilled our other ethical responsibilities in accordance with the Code.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.

Report on Other Legal and Regulatory Requirements We also report that: a) t he accompanying financial report shows a true and fair view of the financial result of fundraising appeals for the year ended 31 March 2021, as required by the Charitable Fundraising Act 1991; b) t he accounting and associated records of ANZUP Cancer Trials Group Limited have been kept in accordance with the Charitable Fundraising Act 1991 and the associated Regulations for the year ended 31 March 2021; c) m oney received as a result of fundraising appeals conducted during the year have been properly accounted for and applied in accordance with the Charitable Fundraising Act 1991 and the associated Regulations; and d) a s at the date of this report, there are reasonable grounds to believe that ANZUP Cancer Trials Group Limited will be able to pay its debts as and when they fall due.

BDO Audit Pty Ltd ABN 33 134 022 870 is a member of a national association of independent entities which are all members of BDO Australia Ltd ABN 77 050 110 275, an Australian company limited by guarantee. BDO Audit Pty Ltd and BDO Australia Ltd are members of BDO International Ltd, a UK company limited by guarantee, and form part of the international BDO network of independent member firms. Liability limited by a scheme approved under Professional Standards Legislation.

FINANCIAL REPORT

Tel: +61 2 9251 4100 Fax: +61 2 9240 9821 www.bdo.com.au

ANZUP ANNUAL REPORT 2021

Level 11, 1 Margaret St Sydney NSW 2000 Australia

Other information Those charged with governance are responsible for the other information. The other information obtained at the date of this auditor’s report is information included in the registered entity’s annual report, but does not include the financial report and our auditor’s report thereon.

Our opinion on the financial report does not cover the other information and accordingly we do not express any form of assurance conclusion thereon.

In connection with our audit of the financial report, our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial report or our knowledge obtained in the audit or otherwise appears to be materially misstated.

If, based on the work we have performed on the other information obtained prior to the date of this auditor’s report, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard.

Responsibilities of responsible entities for the Financial Report The responsible entities of the registered entity are responsible for the preparation and fair presentation of the financial report in accordance with Australian Accounting Standards – Reduced Disclosure Requirements and the ACNC Act, and for such internal control as the responsible entities determine is necessary to enable the preparation of the financial report that is free from material misstatement, whether due to fraud or error.

In preparing the financial report, responsible entities are responsible for assessing the registered entity’s ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the responsible entities either intends to liquidate the registered entity or to cease operations, or has no realistic alternative but to do so.

Those charged with governance are responsible for overseeing the registered entity’s financial reporting process.

Auditor’s responsibilities for the audit of the Financial Report Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with the Australian Auditing Standards will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of this financial report.

A further description of our responsibilities for the audit of the financial report is located at the Auditing and Assurance Standards Board website (http://www.auasb.gov.au/Home.aspx) at: http://www.auasb.gov.au/auditors_responsibilities/ar4.pdf This description forms part of our auditor’s report.

BDO Audit Pty Ltd

Leah Russell Director Sydney, 28 May 2021

BDO Audit Pty Ltd ABN 33 134 022 870 is a member of a national association of independent entities which are all members of BDO Australia Ltd ABN 77 050 110 275, an Australian company limited by guarantee. BDO Audit Pty Ltd and BDO Australia Ltd are members of BDO International Ltd, a UK company limited by guarantee, and form part of the international BDO network of independent member firms. Liability limited by a scheme approved under Professional Standards Legislation.

77

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ANZUP ANNUAL REPORT 2021

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

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

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

How you can help

$50k–$250k

Kick off a pilot study

Support a clinical trial

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

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

$1m–$5m

Give a grant or fund a scholarship

Be kind in-kind Investment and support comes in all shapes and sizes. In-kind donations can include secretariat support, meeting room use and auctionable goods for fundraising.

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

Find out more • Find out about our trials • Join Friends of ANZUP

Visit us at www.anzup.org.au

• Donate and help fund a trial • Get involved in below the belt fundraising events • Read our member newsletter, UPdate • Read our consumer magazine, A little below the belt

Follow us @ ANZUPtrials

ANZUPtrials

ANZUP

anzuptrials

ANZUP Cancer Trials Group

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organise your registration.

Email belowthebelt@anzup.org.au to Email belowthebelt@anzup.org.au to organise your registration. organise your registration.

Registration includes: jersey or t-shirt, breakfast, coffee, lunch, beverages, Registration includes: jersey or t-shirt, Registration includes: jersey or t-shirt, day insurance, awards, supporter page, breakfast, coffee, lunch, beverages, breakfast, coffee, lunch,supporter beverages, entertainment. day insurance, awards, page, day insurance, awards, supporter page, entertainment. entertainment.

Sideline Supporter Registration: Free Sideline Supporter Registration: Free If you're unable to ride,Registration: but would like to Sideline Supporter Free support Pedalthon fundraising.

If you're the unable to ride,through but would like to If you're the unable to ride,through but would like to support Pedalthon fundraising. support the Pedalthon through fundraising.

#BTBPedalthon #BTBPedalthon #BTBPedalthon

#SYDPedal21 #SYDPedal21 #SYDPedal21