ANZUP Annual Report 2022

The Directors of ANZUP Cancer Trials Group Limited (“ANZUP”) are pleased to submit the Annual Report for 2022

ANZUP Cancer Trials Group Limited Registered office Level 6, Lifehouse Building 119-143 Missenden Road Camperdown NSW 2050 Australia T: +61 2 9054 3600 F: +61 2 9054 3650 www.anzup.org.au @ANZUPtrials ANZUPtrials ANZUP

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 in Sydney,

anzuptrials

Australia. We also acknowledge Māori

ANZUP Cancer Trials Group

as tangata whenua of Aotearoa New

ACN 133 634 956 ABN 32 133 634 956

Zealand and as Treaty partners with the Crown as agreed in Te Tiriti o Waitangi.

ANZUP ANNUAL REPORT 2022

Contents

PAGE

ANZUP 2021/22 Highlights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Chairman’s Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5 Chief Executive Officer’s Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8 Organisational Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Governance Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Governance Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Thanks to Corporate and In-kind Supporters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 2022 ANZUP Membership . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 ANZUP’s History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-15 Mission, Objectives, Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16-21 Research Highlights – Committee Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22-32 Grants and Awards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33-34 Below the Belt Research Fund . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35-36 Below the Belt #YourWay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37-40 2021 ANZUP ASM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41-45 Fundraising, Partnerships and Engagement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46-47 Participating Centres . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48-49 Publications, Posters and Presentations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50-51 Financial Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52-73 Further Information and Contact Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

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ANZUP ANNUAL REPORT 2022

AT A GLANCE

ANZUP 2021/22 Highlights MEMBERSHIP*

1,989

100.5% since 2016

members

2016

2017

2018

2019

2020

2021

2022

22

ANZUP & CO-BADGED TRIALS**

2018/19

2019/20

2020/21

2021/22

2021 VIRTUAL ASM

ANZUP TRIAL PARTICIPANTS

7,050+

DELEGATES

FROM OVER 675 SITES

CDW

WORKSHOPS

CONCEPTS

ATTENDEES

*As at 31 March, 2022

2018/19

2019/20

32 115

5

2020/21

2021/22

31

24

25

229

115

261

6

4

7

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

AT A GLANCE

ANZUP ANNUAL REPORT 2022

ANZUP 2021/22 Highlights CORPORATE SUPPORTERS

IN-KIND SUPPORTERS

WEB PAGE VIEWS

114, 328

87,013

PAGE VIEWS

2021/22

2021/22

UNIQUE PAGE VIEWS

2,953 ASM PROGRAM PAGE VIEWS

2,915

ANZUP TWITTER FOLLOWERS

2022

2,722

Y UR WAY

2021

2,472 2020

146

2,139 2019

CHALLENGERS

1.051M+ 2021

ASM TWITTER IMPRESSIONS

$75,000

2021 BELOW THE BELT RESEARCH FUND GRANTS FELLOWSHIPS, SCHOLARSHIPS AND AWARDS

(INCLUDING DELEGATE FELLOWSHIP, STUDY CO-ORDINATOR, AND BEST OF THE BEST)

*As at 31 March, 2022

49

2019

43

2020

44

2021

RAISED

31 TEAMS

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ANZUP ANNUAL REPORT 2022

AT A GLANCE

At a glance

Chairman’s Report disciplines relevant to our work, and its composition ensures that all voices can be heard. Its subcommittees (Prostate; Bladder Urothelial Penile; Renal; Germ Cell) allow in-depth thinking about the specific diseases within our remit, and our non-disease-specific subcommittees (Quality of Life and Supportive Care; Translational Research) ensure that other key questions are considered and included in research design.

The SAC was expanded this year to include nuclear medicine representation, and is in the process of establishing an imaging working group.

I am honoured once again to provide this report on behalf of the ANZUP Board, and to share with you the progress made

by ANZUP over the last year.

ANZUP was established in 2008 to bring together clinicians and researchers of all disciplines involved in clinical care and research for all types of genitourinary cancers; together with community representatives affected by these cancers, or caring for those affected by them. Our vision is simple in concept: we want to minimise the effects of these cancers on the community and to improve the survival and the quality of life for the people these cancers impact. This vision is straightforward to state, but it is aspirational and complex to achieve. We will do so through ANZUP’s mission: to conduct and promote cooperative clinical trials and psychosocial research in these cancers.

Our work requires a deep understanding of these cancers and the effects they and their treatments have; constant learning and surveillance, to understand the science and new treatments and technologies becoming available; performing clinical trials that are carefully and rationally designed to be impactful and to influence health care practice and policy; and to engage various professional disciplines as we do so.

We also need to build systems and processes to support our work; ensure that the importance of research continues to be emphasised in the minds of clinicians and those for whom they care; grow opportunities for research, involving new institutions, regions, populations, and researchers; ensure that our trials provide maximum value, but designing translational, psychosocial, and other research questions linked to them; and train those who will continue ANZUP’s work into the future.

ANZUP is designed to ensure it is representative, and to maximise opportunities. The Scientific Advisory Committee (SAC) is comprised of representatives from clinical and scientific

The ANZUP Consumer Advisory Panel is involved at all levels of the organisation. CAP members have all been affected by genitourinary cancers in some ways, and freely and cheerfully donate their wealth of experience and personal expertise to ANZUP. CAP members attend committee meetings, workshops, our scientific meetings, and provide input and guidance to the SAC and to the Board. CAP members are frequently investigators on grant applications, and key members of trial management committees. The CAP is also integrally involved in decision-making regarding funding allocations for the Below the Belt Research Fund; the importance of their input in these processes is reflected in the fact that their opinion weights the scores given by other reviewers, rather than being one vote amongst several. This ensures that our research priorities align with the input from our community representatives.

ANZUP is overseen by a Board comprising directors elected from the ANZUP membership, and appointed directors who bring specific areas of expertise to enable the company to run effectively. The Board is served by a Governance subcommittee, a Finance and Audit subcommittee, and a Fundraising and Partnerships subcommittee.

The Board undertook an external review during 2021, which identified that overall the Board was performing very well but there were some points where our documentation and processes could be improved. The Board devoted several meetings to review these findings and to set up systems to implement the recommendations. The Board has also recognised that it is timely to review and refresh the ANZUP Constitution for this year’s Annual General Meeting.

I am deeply grateful to my fellow Board directors, all of whom are extraordinarily generous with the time and expertise that they donate to ANZUP. We are very fortunate to have such a capable and well-functioning Board. I would particularly like to express my gratitude to two former directors. Linda Martin was appointed to the Board in late 2010 and stepped down

AT A GLANCE

at the end of 2021. We are very grateful to Linda for her many outstanding contributions over so many years. The Board is currently reviewing its needs with a view to identifying a new appointed director during 2022. Professor Pam Russell AM was one of ANZUP’s inaugural directors and was instrumental in making ANZUP what it is today. Pam stepped down as Board director in early 2010 but remained a staunch supporter of ANZUP and an active member of the Scientific Advisory Committee. Pam died in early 2022 and the debt of gratitude owed to her by ANZUP and by the community of prostate cancer researchers can never be paid. We miss her wit and wisdom, and we are deeply thankful that we were able to have her in our lives.

The Board has refreshed the ANZUP Strategic Plan, with the aid of an external facilitator and in consultation with key stakeholders including the Consumer Advisory Panel, others in ANZUP leadership positions, and with input from early career researchers and international advisors. Our strategy now revolves around the following strategic goals: 1. C onduct high quality, multidisciplinary, practice-changing clinical trials in urogenital cancers. This will require an ongoing pipeline of ideas, best practice trial design and trial management systems, active engagement of various disciplines, and outcomes designed to influence clinical practice.

2. M aintain a portfolio of trials relevant to and accessible by all people with urogenital trials in Australia and New Zealand.

This implies that we will aim to have trials for all of the diseases within our remit; actively engage and find new ways to support New Zealand participation; and ensure that our systems maximise the opportunities for all communities to be involved, particularly under-resourced and under-served populations.

3. S trengthen ANZUP’s capacity for practice-changing clinical trials. This goal will be challenging, as it will involve building capability and capacity amongst our membership to design and lead trials; and to build internal capacity and productive external collaborations to allow us to perform the trials.

The goal of research that positively influences outcomes and clinical practice will be paramount as we consider and prioritise research questions.

4. F orward plan to maintain a vibrant and active urogenital cancer trials community. This goal encompasses training, mentorship, provision of resources, engagement of new sites, and facilitation of community input, with effective communication to all stakeholders. It will also require long term planning to cover the necessary financial and other resource requirements.

5. P rovide leadership in collaborative cancer clinical trials. This reflects ANZUP’s growing national and international influence in the genitourinary clinical research community; and continuing to develop and grow productive links with other groups performing complementary work.

ANZUP ANNUAL REPORT 2022

ANZUP is now a teenager but already shows maturity and accomplishments far beyond its years. Our robust governance, management, and financial systems have enabled us to survive and thrive despite the challenges of the COVID-19 pandemic.

We have grown our trial portfolio across disease types. We have continued our fundraising efforts to support ANZUP’s Below the Belt Research Fund, and I am pleased and proud to report that the Board has continued its commitment to reinvest all funds raised into research initiatives. In addition, the Board has provided additional substantial discretionary funding to several projects, allowing trials to begin that otherwise would not have been able to proceed. The Board has been able to make these commitments due to its careful financial management and investment strategy, including ethical investments through Perpetual.

This year has also seen several other highlights. Our TheraP trial was featured as an oral presentation at the ASCO Genitourinary Cancers symposium in February 2022, and was nominated for the Australian Clinical Trials Alliance Trial of the Year and other awards. The ENZAMET study reached its planned 470 event milestone and a further analysis will be presented at ASCO in June with an oral presentation. The RAMPART study finally opened in Australia after more than 10 years of planning, and immediately began recruiting well. Our virtual Annual Scientific Meeting was very well attended and led to a favourable financial result, which will enable still more initiatives. Planning for the 2022 Annual Scientific Meeting in Adelaide is well advanced. Concept Development Workshops were planned for the first part of 2022 for all subcommittees.

We are fortunate and grateful that our sponsors and corporate supporters have for the most part continued or even grown their support for ANZUP. ANZUP continues to be served brilliantly by our CEO Margaret McJannett and her team. They have continued to work hard and very effectively even during these challenging times, and provide seamless support for the very many activities that ANZUP undertakes. I cannot adequately express my thanks and gratitude to Marg and to all the ANZUP staff. Similarly, ANZUP can only do what it does because its members continue to donate their time and expertise. Our success is a testament to the selflessness and extraordinary generosity of so many people. I can only say thank you, which seems nowhere near enough.

Once again ANZUP completes its financial year having thrived, grown, and meeting more of its goals. Every day we come closer to achieving our vision although we know that there will always be more work to do. We have come a long way as we enter our teenage years; we know the best is yet to come.

I commend to you this 2021-2022 Annual Report of ANZUP Cancer Trials Group.

Ian Davis Director and Chair of the ANZUP Board

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ANZUP ANNUAL REPORT 2022

AT A GLANCE

Chief Executive Officer’s Report While ANZUP’s portfolio of high-quality cutting edge clinical trials continued to grow across the cancers we focus, most importantly we have several new trials at various stages of development with a number of concepts in pipeline that will progress throughout 2022/2023.

ANZUP exists to improve outcomes for people affected by below the belt cancers (bladder, kidney, testicular, penile and prostate). We do this by performing clinical trials to generate the evidence which can make a difference to people whose lives are affected by these cancers.

Over the last 12 months, despite the ongoing challenges and implications of COVID across all sectors, including clinical trials, ANZUP through the extraordinary efforts of many, has managed to achieve some significant milestones.

In terms of our clinical trials research, some highlights included: we reached recruitment targets for our UNISoN and PCRMIB trials with planning well underway for translational sub-studies; we opened at Nottingham University Hospital in the United Kingdom to help bolster recruitment for our BCG MM trial – recently reaching 80% of its recruitment target; we signed off on a large translational program of work for our ENZAMET trial bringing together expert project teams from across the world; we opened CLIMATE, our new testicular cancer biomarker study and as at 31 March it has already recruited seven out of the target 200 patients; we held the first investigator meeting for our soon to open EVOLUTION trial; and we continued to build on our international collaborations with the Canadian Cancer Trials Group, Cancer Trials Ireland, and our newly established partner, the Prostate Cancer Clinical Trial Consortium at Memorial Sloan Kettering in the United States to open our DASL-HiCaP trial.

It’s worth highlighting that we opened the trial in March 2020 and incredibly have reached over 40% of the recruitment target of 1,100 patients (as at 31 March 2022) – an amazing achievement.

In line with our strategic plan ANZUP supports the coming together of our multidisciplinary membership, including our consumer advisory panel, to bring new trial ideas forward for development. These annual Concept Development Workshop’s (CDW’s) provide a mechanism for us to continue to examine the evidence – current and future treatment and management- identify gaps, ensuring we remain patient centred while addressing critical clinical questions. These CDW’s are extraordinarily valuable to our experienced researchers however are a wonderful opportunity for our upand-coming future leaders. As a consequence, ANZUP also supports our fellows/trainees/junior researchers to attend these workshops. The CDW’s are currently underway across all subcommittees.

We were successful with our Cancer Australia grant application for infrastructure funding for 2022-2024. This funding is extremely valuable however every time our members come up with a new trial idea we need to find the funds to conduct the trial. Cancer Australia’s priorities for this period are to identify and develop cancer clinical trial protocols that address the healthcare system’s most important cancer clinical questions and reduce disparities in cancer outcomes, including Aboriginal and Torres Straight Islander and Culturally and linguistically diverse people.

ANZUP’s membership continued to grow and at the time of writing this report we are coming close to reaching 2000 members crossing all disciplines and craft groups.

Our #ANZUP21 Annual Scientific Meeting had to once again be flipped to a virtual event! However that didn’t diminish the enthusiasm of our members. We welcomed ~400 delegates to the meeting to hear the latest cutting edge management of GU research. There were many great sessions over the course of the 2 days with one of the highlights being a panel discussion addressing “Disparities in Cancer Care” with a focus on Aboriginal and Torres Strait Islander people. This gave a marvellous insight into how Indigenous people in Australia experience cancer care. This generated much discussion about potential causes of these differences and how ANZUP can work towards addressing these gaps.

AT A GLANCE Due to COVID-19 we had to again cancel both our Melbourne and Sydney Pedalthon events for 2021, and we held our second virtual Below the Belt #YourWay Challenge during the month of May. We saw 146 challengers and 31 teams run, walk, cycle and swim 18,976 kms and 638 hours across Australia, New Zealand, UK and beyond. This event raised $75,000 for ANZUP’s clinical trial research via the Below the Belt Research Fund, to support the important work of ANZUP’s clinicians and researchers. Our work would not be possible without wonderful people in the community supporting us.

Thank you.

Strategic & Business Planning: In 2021 ANZUP undertook a review of the Strategic Plan and identified five Strategic Goals for implementation over the next 3 years.

• C onduct high-quality, multidisciplinary, practice-changing clinical trials in urogenital cancers • M aintain a portfolio of trials relevant to and accessible by all people with urogenital cancers in Australia and New Zealand • S trengthen ANZUP’s capacity for practice-changing clinical trials • F orward plan to maintain a vibrant and active urogenital cancer trials community • P rovide leadership in collaborative cancer clinical trials With ongoing support from our membership, a body of key stakeholders and our wider ANZUP community, we continue to fiercely pursue these goals, in order to achieve our mission: To improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers through practicechanging multidisciplinary collaborative clinical trials.

Meetings continued to be scheduled regularly across the year with the Finance & Audit Committee, Fundraising and Promotion Subcommittee, Operations Executive, Scientific Advisory Committee (SAC), SAC subcommittees, Consumer Advisory Panel (CAP) and Trial Management Committees (TMC).

These meetings help to ensure our ANZUP activities are aligned with our overarching Mission and Strategic Plan.

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 ANNUAL REPORT 2022

We also thank our corporate supporters, sponsors and donors, for their ongoing support and generosity. With their help, ANZUP will find better treatments and outcomes for GU/ below the belt cancer patients.

ANZUP was in a strong financial position leading into 2021 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 52 -73.

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).

Staffing: We acknowledge our committed and hardworking management team who work tirelessly to support our members, key stakeholders and the broader community.

We have continued to examine our current capacity in order to ensure support and capability in the key areas of clinical trials management, database coordination and support, internal and external communications, event production and promotion, fundraising and corporate partnerships and administrative support.

We are also extremely fortunate to continue to have our wonderful volunteers Lesley Tinkler and Jo Stubbs, supporting ANZUP. We also acknowledge our hardworking ANZUP Fellows, Felicia Roncolato, Ciara Conduit, Shalini Subramaniam, Blossom Mak and Danka Zebic, as well as our colleagues at NHMRC CTC at the University of Sydney, Walter and Eliza Hall Research Institute, and the Centre of Biostatistics and Clinical Trials, thank you for your support and your invaluable contribution.

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ANZUP ANNUAL REPORT 2022

AT A GLANCE

Education and mentoring:

Collaborations:

ANZUP seeks opportunities to expand the education and mentoring of our membership on an ongoing basis. We host a variety of educational events to further their education and continue to sow the seeds for new clinical trial concepts.

As always, the next generation of scientists and clinical researchers continue to be important to ANZUP, as they will be the leaders in the new clinical trials that will be carried out in the coming years and decades.

ANZUP is very proud of the collaborations we have forged with both national and international research groups in our efforts to improve treatment and outcomes for patients.

During 2021 we continued with our Concept Development Workshops (CDW). Although they were all held virtually we were delighted to welcome over 260 attendees with 25 concepts presented to our multidisciplinary members. As previously mentioned this is where many of the “seeds” for ANZUP clinical trials are first sown, and they are important to grow and foster a pipeline of innovative ideas to be considered for support from ANZUP to progress.

Earlier this year we were delighted to hold our first face to face Prostate Cancer CDW. It was a hybrid meeting however it was wonderful to finally be able to come together face-to-face, to enjoy that engagement you just don’t have with a zoom meeting. We look forward to more face-to-face meetings, including our inaugural ANZUP Prostate Cancer Rapid Fire Program to be held later in 2022. This is a multidisciplinary educational program developed to facilitate further understanding of contemporary oncology management through advances in clinical trials and will cover landmark clinical trials in prostate cancer, whilst providing mentorship from experts in the field to junior consultants and trainees.

https://anzup.org.au/about-anzup/our-collaborators/

We are grateful to all the investigators and trial staff at the 220 hospitals across over 10 countries that we collaborate with, as well as our colleagues at the NHMRC CTC, the Centre of Biostatistics and Clinical Trials (BaCT) and The George Institute for Global Health.

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.t of both the personal and professional adversity we all faced during the year.

As we reflect on the year that was, and the challenges we face as we move forward and adjust to the “new normal”, I would like to thank and acknowledge our incredibly hard working ANZUP Board of Directors, led by our Chair Prof Ian Davis, who continue to give their expertise, time and support so generously, guiding the organisation’s strategic direction. To our dedicated and highly skilled ANZUP Scientific Advisory Committee (SAC), Subcommittee Chairs and Deputies, CAP, Staff, Members, Site Investigators, Trial Staff and our ~ 2000 members. Thank you all. 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 the lives of people affected by bladder, kidney, testicular, penile and prostate cancers through practice-changing multidisciplinary collaborative clinical trials.

I commend to you ANZUP’s 2021/2022 Annual Report.

Margaret McJannett Chief Executive Officer, ANZUP

ANZUP is proud of the national and international partnerships we have forged in our efforts to improve treatment and outcomes for patients

AT A GLANCE

ANZUP ANNUAL REPORT 2022

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)

Prostate

mi

Independent Data Safety Monitoring Committee (IDSMC)

tte

Trial Management Committees

om

Scientific Advisory Committee (SAC)

Quality of Life and Supportive Care

ANZUP CEO & Management Team

SAC

Germ Cell

b su

Bladder, Urothelial and Penile

c

Renal Cell

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ANZUP ANNUAL REPORT 2022

AT A GLANCE

Governance Structure ANZUP Cancer Trials Group Ltd is the peak urogenital and prostate cancer cooperative trials group in the region. 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 and corporate governance of the Company. Its roles are to set the strategic direction, to appoint its CEO and to provide guidance and oversight to the management of the Company and its governance. The Board consists of five elected Directors and four Appointed Directors.

The Board meets approximately every two months and where possible one face-to-face meeting annually.

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 quarterly and where possible face-to-face at least once per year.

Scientific Advisory Committee (SAC) The Scientific Advisory Committee (‘SAC’) is advised by disease specific subcommittees (Prostate, Renal, Germ Cell and Bladder urothelial and penile) and non-disease-specific subcommittees (Quality of Life & Supportive Care, Translational Research and Consumer Advisory Panel). The SAC and the SAC subcommittees are responsible for oversight of clinical trial research to improve the treatment of bladder, kidney, testicular, penile and prostate cancers.

The Governance Committee is appointed by the Board to assist it to fulfill its responsibilities and 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.

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 members are appointed by the Board. The SAC meets quarterly and where possible one annual face-to-face meeting during the ASM.

Finance and Audit Committee

SAC Subcommittees

The Finance and Audit Committee (‘FAC’) assists the Board in fulfilling its responsibilities, such that:

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

Governance Committee

(a) it oversees the financial reporting process to ensure full disclosure of the Company’s financial information; (b) it ensures that the internal financial management of the Company has adequate accounting processes and systems, including assessing the performance of the external auditor; (c) it ensures that it receives from management reliable and timely financial reporting.

Fundraising and Partnerships Subcommittee

Operations Executive Committee

Board and Management

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 approximately once per month or most often if required.

The Board has delegated the day-to-day management of the Company to the CEO in accordance with the processes that the Board approves, namely:

Independent Data and Safety Monitoring Committee (IDSMC)

a) Operations;

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 ANZUP studies and co-opts others onto it when additional advice is required. The IDSMC advises the relevant Trial Management Committee (TMC) Chair(s), ANZUP Group Chair, CEO and Scientific Advisory Committee Chair.

The Fundraising and Partnerships Subcommittee reports to the FAC. Its main objectives is to identify and pursue opportunities to raise awareness and additional revenue to support ANZUP to achieve its mission.

b) financial and capital management and reporting;

c) information technology including cyber security protocols; and d) c ompliance with the limitations attached to government grants for research and aligned to the purpose and objectives of the company.

The Board has in place procedures to assess the performance of the CEO and to appoint and replace the CEO, if and when necessary.

Consumer Advisory Panel (CAP) The ANZUP CAP reports to the Board. It comprises consumer/ community representatives who contribute at all levels of

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 2022

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Governance Committee SCIENTIFIC ADVISORY COMMITTEE

FINANCE AND AUDIT COMMITTEE

Ian Davis – Chair

Joe Esposito – Chair

Scott Williams – Deputy Chair

Bernadette Crennan

Shomik Sengupta – Deputy Chair

Ian Davis

Arun Azad

Martin Dowling

Germ Cell:

Nicholas Buchan

Ex-officio

Lisa Butler Haryana Dhillon Joe Esposito Craig Gedye Fritha Hanning (until July 2021) Dickon Hayne Lisa Horvath George Hruby Belinda Jago Andrew Scott Nicky Lawrence Anthony Joshua James Kench Andrew Martin Kathryn Schubach

Margaret McJannett

FUNDRAISING AND PARTNERSHIPS SUBCOMMITTEE

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

Ben Tran – Chair Fritha Hanning – Deputy Chair (until end of 2021) Patti Bastick – Deputy Chair (from February 2022)

Bernadette Crennan

Catherine Paterson – Deputy Chair Renal Cell Cancer: Craig Gedye – Chair David Pook – Deputy Chair Translational Research:

Margaret McJannett

Arun Azad – Chair

Shomik Sengupta

Lucy Byers

Anthony Joshua – Deputy Chair

Martin Stockler

Juliana Trifunovic

Christopher Sweeney Bertrand Tombal Ben Tran

Ex-officio

CONSUMER ADVISORY PANEL

ANZUP & NHMRC CLINICAL TRIALS CENTRE (CTC)

Margaret McJannett

Ray Allen – Deputy

Thomas Cusick

Joe Esposito

Operations Executive Committee: Ian Davis – ANZUP Chair

Nisha Rana

Tuan Hoang

Dickon Hayne – Deputy Chair

Felicia Roncolato

Les Land

Shalini Subramaniam

Melissa Le Mesurier

Margaret McJannett – ANZUP CEO

Sonia Yip

Matt Leonard

Alison Zhang

Colin O’Brien

Belinda Jago – Chair

Michael Twycross Leonie Young Paul Zawa

Ex-officio Ian Davis Margaret McJannett

Dankar Zebic

ANZUP & CENTRE FOR BIOSTATISTICS & CLINICAL TRIALS (BaCT)

Craig Gedye – UNISoN

Haryana Dhillon – Chair

Ex-officio

Blossom Mak

Jarad Martin – Deputy Chair

Ray Allen

Melissa Le Mesurier

Alison Zhang

Lisa Horvath – Chair

Joe Esposito – Chair

Belinda Jago

Ciara Conduit

Operations Executive Committee: Ian Davis – Chair

Prostate Cancer:

Quality of Life & Supportive Care:

Ian Davis

ANZUP Fellows: Shalini Subramaniam

Thomas Cusick – Clinical Trials Project Manager Nisha Rana – Clinical Trials Operations Manager Antoinette Fontela Eugenie Lee CTC: Martin Stockler – CTC Clinical Lead Izabella Pokorski – Clinical Trials Operations

David Pook – UNICAB Andrew Weickhardt – PCR MIB Carole Harris Margaret McJannett Thomas Cusick Nisha Rana Alison Hall – Business Manager Komal Kanojia – Project Manager Deepti Pandey – Project Manager

12

ANZUP ANNUAL REPORT 2022

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 2021/ 2022 corporate supporters include:

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

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

AFI Branding, The Saturday Paper and FC Lawyers.

AT A GLANCE

ANZUP ANNUAL REPORT 2022

13

2022 ANZUP Membership Number of members

1,989

As at 31 March 2022 ANZUP had 1,989 members, a 100.5% increase since 2016.

100.5%

members

since 2016

Membership distribution AUSTRALIA/ NEW ZEALAND TOTAL

BY STATE/TERRITORY IN AUSTRALIA:

NT: 11

1,922

QLD: 279

WA: 116 SA: 116

NSW: 684 VIC: 551

NEW ZEALAND:

109

ACT: 33

TAS: 23

REST OF THE WORLD: USA: 20 Canada: 8 UK: 8 Ireland: 5 Singapore: 4 Malaysia: 3 Belgium: 2 India: 3 Indonesia: 2 China: 1 Denmark: 1 Hong Kong: 1 France: 1

Japan: Korea: Germany: Philippines: Spain: Switzerland: Turkey: Iran:

1 1 1 1 1 1 1 1

REST OF THE WORLD TOTAL

67

Building our multidisciplinary membership Medical Oncologist Clinical Trials Coordinator

Trainee

Registered Nurse

Scientist

Urologist Radiation Oncologist

Clinical Trials Coordinator

342

Pathologist

17

Medical Oncologist

316

Pharmacist

13

Trainee

299

Fellows

12

Registered Nurse

269

Consumer Advocacy

11

Urologist

215

Statistician

11

Radiation Oncologist

169

Epidemiologist

9

Scientist

128

Surgeon

8

Nuclear medicine

44

Endocrinologist

7

Students

37

Health economics

5

Allied Health

27

Medical Physics

3

Psychologist

24

Anaesthetist

1

Supportive Care & other

21

General Practitioner

1

14

ANZUP ANNUAL REPORT 2022

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

IA LS 2

IG

AT OR M

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

CEPTOR SH IP

20 1

5

-

U PRE PG ZU N A

AT A GLANCE

ANZUP ANNUAL REPORT 2022 2021

20

ANZUP

2018-2020

EB CEL

RAT

E

A 20

RIAL OF THE YEAR AT AW CT A

15

RD

S AR YE 0 S1

P RE S MET ZA EN

ENTATION

AT A

SC O

2020-2021

2021-2022

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

New ANZUP trials open – CLIMATE, GUIDE, RAMPART

First virtual ASM held

ANZUP co-badged study ProPSMA wins ACTA Trial of The Year

A NZUP celebrates 10th anniversary year I naugural Melbourne Pedalthon 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

2nd virtual ASM held 2nd virtual #YourWay held PCRMIB closed to recruitment and now in follow up

ANZUP reaches 1500 members (12 March) First tele-trials site opens

E NZAMET trial one of four ASCO Plenary Presentations I naugural 2019 Prostate Masterclass held in Boston T heraP, UNISoN & Pain-Free TRUS B trials recruit their final patients

-

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

#Y O

2

01 9

PR OS TAT EM

IN ASTERCLASS

O ST BO

N

UR WA Y

S

16

ANZUP ANNUAL REPORT 2022

ACHIEVEMENTS

Achievements

Mission, objectives, priorities Our mission: Our objectives:

To improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers through practicechanging multidisciplinary collaborative clinical trials.

We do this by: • b ringing together clinicians, scientists and consumers to identify critical areas of unmet need that can be addressed through research in Australia and New Zealand • p roviding a collaborative forum to generate research ideas and concepts that address critical clinical questions • p roviding services and resources to support and fund research of the highest quality • p romoting access to clinical trials for all people affected by urogenital cancers in Australia and New Zealand • m entoring and building the skills of future research leaders • s ecuring government, industry and philanthropic funding to facilitate our independent research agenda • p romoting our research goals and progress to improve clinical practice and change lives.

ANZUP strategic priorities: our goals 2021- 2024: Goal one: Conduct high-quality, multidisciplinary, practice-changing clinical trials in urogenital* cancers Goal two: Maintain a portfolio of trials relevant to and accessible by all people with urogenital cancers in Australia and New Zealand Goal three: Strengthen ANZUP’s capacity for practice-changing clinical trials Goal four: Forward plan to maintain a vibrant and active urogenital cancer trials community Goal five:

Provide leadership in collaborative cancer clinical trials *Kidney, bladder, prostate, testis and penis

ACHIEVEMENTS

ANZUP ANNUAL REPORT 2022

Conduct high-quality, multidisciplinary, practice-changing clinical trials in urogenital cancers

Goal

The Monthly Trial UPdate is distributed to all members to promote improved patient recruitment to ANZUP trials, and hopefully instigate cross-referrals. The UPdate also informs members about trial recruitment, events and workshops and key trial highlights over the month.

ANZUP is comprised of a multidisciplinary group of members who are either involved in the treatment and research of genitourinary cancers, or have been diagnosed with, or have personal experience of, these cancers.

ANZUP’s diverse membership base ensures we develop robust, high quality clinical trials. Our trials are varied and extend across each of the tumour types ANZUP represents (prostate, kidney, bladder, testis and penis), and employ many types of treatments including radionuclear medicine, immunotherapy, online psychotherapy and other supportive care resources.

ANZUP regularly provides updates about trial recruitment status, including sessions held at the Annual Scientific Meeting (ASM), trial specific e-newsletters, social media and websites updates as well as the Trials Management Committee (TMC) meetings.

ANZUP and the international partners involved in ANZUP’s ENZAMET and ENZARAD trials undertake a twiceyearly International Trials Steering Committee meeting. This meeting is facilitated by ANZUP and allows ABOVE: EXAMPLE OF OUR ANZUP MONTHLY TRIAL UPDATE EMAILS relationships to be built or maintained with the international clinical trial community and also provides a platform to analyse the GU clinical trials landscape, discover gaps in research and ANZUP also strives to make certain junior researchers across consider new concepts. all disciplines attend and contribute at our events and ANZUP’s Scientific Advisory Committee (SAC) is at the workshops. Junior researchers are encouraged to contribute centre of the organisation and provides strategic scientific by inviting them to attend our Best of GU meetings, MDT direction, advice on prioritisation of projects, input from all Masterclasses, and our Concept Development Workshops. disciplines, and assistance for development of concepts and Each subcommittee undertakes regular analysis and reports proposals. on concepts submitted, trials in development, current trials, BELOW: ANZUP WEBSITE HOME PAGE and the pipeline, at quarterly meetings – via both face-toface where possible, and via Zoom.

The Principal Investigators (PIs) across ANZUP trials specialise in a range of areas including urology, surgery, radiation oncology, medical oncology, nursing and psychology. ANZUP continues to ensure the trial lead investigators are multidisciplinary, in efforts to have all-inclusive input into the research undertaken.

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, consider and review new concepts.

Concept development

2017

2018/19

2019/20

2020/21

2021/22

Total workshops

4

5

5

5

7

Total attendees

98

115

229

131

261

Total concepts presented

22

32

43

27

25

17

18

ANZUP ANNUAL REPORT 2022

ACHIEVEMENTS

Maintain a portfolio of trials relevant to and accessible by all people with urogenital cancers in Australia and New Zealand

Goal

ANZUP continues to raise awareness, participation and access to ANZUP trials through many different avenues.

Our subcommittee membership has continued to expand across all cancer types and areas of interest.

Subcommittee

Total Members Mar 2020

Mar 2021

Mar 2022

Prostate

531

579

668

BUP

367

395

423

Germ Cell

230

246

264

Renal

331

349

378

Translational

178

191

222

Quality of Life

202

219

247

We encourage attendance at the subcommittee meetings by both our regular attendees, and also new members, colleagues and trainees.

The Consumer Advisory Panel (CAP) is engaged across all ANZUP research projects including the Scientific Advisory Committee, subcommittee meetings, Concept Development Workshops and the Annual Scientific Meeting.

The membership of the CAP is across disease types and we ensure an optimal mix of individuals.

In the past, community links have been reinforced when consumers are invited to attend the Community Engagement Forum (CEF). 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 connect with the wider community about ANZUP activities, events and clinical trials. ANZUP has a Twitter account, Facebook account, Instagram account and a LinkedIn and YouTube account.

We promote the highlights and benefits of being an ANZUP member through participation at external meetings such as ANZUNS, the USANZ New Zealand Section Meeting, COSA and the Asia Pacific Advanced Prostate Cancer Symposium, to name a few.

ANZUP Twitter followers @ANZUPtrials

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 contribute content for the clinical newsletter UPdate and consumer magazine, ‘A little below the belt’. This publication is distributed to more than 400 clinical practices, and of these 28 are rural/regional sites.

1,666

2,139

2,472

2,722

2,915

2017/18

2018/19

2019/20

2020/21

2021/22

ANZUP is progressing innovative clinical trial delivery and breaking down participation barriers for prostate cancer patients in Victoria through a collaboration with an Australianfirst pilot model called TrialHub.

1,927 1,979 2,234 2,150 2,150

TrialHub is based at The Alfred Hospital in Melbourne.

It is a federally funded program that has been tasked to increase the availability and participation in cancer clinical trials in regional and remote Victoria and outer metropolitan Melbourne.

ANZUP Facebook followers @ANZUPtrials

2017/18

2018/19

2019/20

2020/21

2021/22

ANZUP Instagram followers @ANZUPtrials

192

510

450

464

457

2017/18

2018/19

2019/20

2020/21

2021/22

ACHIEVEMENTS

Goal

ANZUP ANNUAL REPORT 2022

Strengthen ANZUP’s capacity for practice-changing clinical trials

ANZUP continues to review, modify and improve its systems, procedures and governance principles to maintain 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 review of organisational policy. This makes certain we develop a sound quality management system to deliver our strategic plan.

ANZUP’s Concept Development Workshops have been simplified with the use of templates. Our subcommittees and broader membership are consulted often to determine if new or revised tools might further facilitate collaboration to broaden our scope as well as our capabilities.

As the number of ANZUP studies continues to increase and the membership steadily grows, we recognise the importance of clearly defined decision making processes and allocation of duties. The quality and integrity of ANZUP operations are supported by documented processes and policies.

Delivery of our strategic plan is made possible by continued fundraising, and our fundraising plan helps to broaden cost effective, sustainable, and regular revenue streams through a variety of fundraising activities.

Our Below the Belt Research Fund ensures all the money raised through the Below the Belt #YourWay Challenge and Below the Belt events, (and outside of COVID-19 the Sydney and Melbourne Pedalthons), is used to support future ANZUP trials.

The Below the Belt Research Fund has to date raised over $1.95 million. The ASM also supports the financial sustainability of ANZUP. ANZUP continues to expand the ASM by creating and presenting a high quality scientific program. In 2021 we again had to revise the format of the ASM due to the impact of COVID-19, and produced a fully virtual event showcasing ANZUP’s research activities and attracting over 400 delegates.

ASM Highlights 2016

2017

2018

2019

2020

2021

297

335

390

392

320

404

International speakers

4

6

7

5

9

8

Submitted abstracts

57

78

53

73

49

54

Fellowships, scholarships and awards

40

47

42

39

55

64

Delegates

19

20

ANZUP ANNUAL REPORT 2022

Goal

ACHIEVEMENTS

Forward plan to maintain a vibrant and active urogenital cancer trials community

Engaging, collaborating and widening ANZUP stakeholder relationships is undertaken various ways. 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 a significant focus for ANZUP and especially the Partnerships and Engagement role. ANZUP continues to develop, manage and retain these important relationships.

Collaborative links have allowed ANZUP to operate 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 amongst the groups’ Consumer Advisory Panels (CAPs) and EON reinforces links between groups by the sharing of concepts and resources.

In 2021/22 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 guarantee vigorous processes on trial development and operations.

ANZUP’s Key Relationships include:

ANZ 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 • 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) • Prostate Cancer Foundation New Zealand (PCFNZ) • TROG (Trans Tasman Radiation Oncology Group) Cancer Research • Urological Society of Australia & New Zealand (USANZ) • Walter and Eliza Hall Institute of Medical Research (WEHI)

International Partnerships and Collaborations • A dvanced Prostate Cancer Consensus Conference (APCCC): Asia-Pacific (APAC) Satellite Symposium • 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 • European Organisation for Research and Treatment of Cancer (EORTC) • Medical Research Council (MRC) UK • Prostate Cancer Clinical Trials Consortium (PCCTC) • University College London • US National Cancer Institute ANZUP’s multidisciplinary membership remains the most valuable stakeholder relationship. For members, ANZUP delivers an annual calendar of education and networking opportunities. In 2021/22 this included the Concept Development Workshops and the ASM, educational workshops and events, grant opportunities, scholarships, fellowships and awards. These allow ANZUP to support fellows, trainees and junior researchers on an ongoing basis. Such events and opportunities encourage the future generation of researchers to connect with experts in their field, hone their skills, enhance their knowledge, further scrutinise 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 strengthened another crucial relationship.

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

ACHIEVEMENTS

Goal

Provide leadership in collaborative cancer clinical trials This publication is received by key stakeholders, members, donors and supporters. The Below the Belt events, now also held virtually, and the pedalthons in both Sydney and Melbourne (unfortunately postponed this year due to COVID-19), also increase community awareness of clinical trials, urogenital cancers and the Below the Belt Research Fund.

ANZUP’s membership continues to expand and diversify. This has meant ANZUP often reviews ways we can optimally support and provide opportunities for our multidisciplinary membership. Crucially, 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 various channels including print, email, and social media updates.

Members are further supported, and provided leadership, 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 offer educational and mentoring opportunities for members across each of the four tumour streams, as well as quality of life and supportive care and translational research. But most importantly, these workshops encourage the progression of emerging clinical trial concepts so they can then be transformed into fully fledged clinical trials.

ANZUP has a presence and is active across multiple social media platforms, with profiles on Twitter, Facebook, Instagram, LinkedIn and YouTube. ANZUP’s Twitter account continues to have a constant stream of activity and a extremely connected clinical following.

The twice-yearly publication of our consumer magazine, ‘A little below the belt’ is an additional external communication strategy which is distributed both via print and digitally to cancer centres.

ANZUP ANNUAL REPORT 2022

ANZUP’s Twitter account continues to have a constant stream of activity and an extremely connected clinical following.

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

ANZUP has ongoing relationships with philanthropic and charitable groups and individuals including, Perpetual IMPACT Philanthropy Program, Alison McKendrick and family, Ian Garrow, The Paul Ramsay Foundation, The Nordia Foundation, Roy Morgan Research Ltd, The Lin Huddleston Charitable Foundation, the Macquarie Group Foundation, Prostate Cancer Foundation Australia (PCFA), Prostate Cancer New Zealand (PCNZ), Movember, Melbourne Racing Club Foundation, Hillcrest Foundation, Ken & Asle Chilton Trust and Origin Energy Foundation.

Regular communication about fundraising prospects, activities and Below the Belt events is made possible by utilising a corporate and community database. By building links with respected medical journalists and broadcasters, media coverage around ANZUP clinical trials has been raised.

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ANZUP ANNUAL REPORT 2022

RESEARCH HIGHLIGHTS

Research Highlights

Research Highlights Scientific Advisory Committee: Ian Davis and Scott Williams The ANZUP Scientific Advisory Committee (SAC) provides guidance for the scientific direction of the group. It provides the Board with strategic advice regarding scientific directions, prioritises initiatives as required, and is an essential checkpoint for projects as they develop into ANZUP trials.

The SAC is constituted to ensure input and communication from a diverse group of key disciplines that are stakeholders in our work. Its members are available to committee and to the Board to provide expert advice, and conduits to the professional bodies that they individually represent. 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 monitors progress of specific projects but also ensures that each meeting devotes the bulk of its time to discussion of strategic matters. Operational matters are overseen by trial management committees and trial executive committees, and at the level of the SAC subcommittees.

Larger scale strategic initiatives are discussed at the full SAC, which then provides advice for the Board and the ANZUP secretariat to act upon.

CHAIR, IAN DAVIS

DEPUTY CHAIR, SCOTT WILLIAMS

This year we farewelled from the SAC our New Zealand representative Dr Fritha Hanning, who also stood down as deputy chair of the Germ Cell Subcommittee, in order for her to devote time to other commitments in New Zealand.

Fritha has been a stalwart supporter of ANZUP for many years and we are very grateful for all of her contributions. The SAC nominated Dr Nicola Lawrence as the replacement New Zealand SAC representative, and Nicky was invited by the Board to take up this position which she did in early 2022.

The membership of the SAC is reviewed by the Board annually.

Meetings of the SAC continued to be held virtually during 2021. The SAC usually plans an open face-to-face meeting at the Annual Scientific Meeting but the COVID-19 pandemic meant that this once again was unable to proceed. We are planning to return to a face-to-face meeting for the 2022 Annual Scientific Meeting if possible.

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 2022

Bladder, Urothelial and Penile Cancer (BUP) Subcommittee: Dickon Hayne and Shomik Sengupta Concepts WAter or Chemotherapy to prevent Urothelial carcinoma a pre-imPlantation (WACUP) and Feasibility of Water Irrigation post TURBT for NMIBC CHAIR, DICKON HAYNE

DEPUTY CHAIR, SHOMIK SENGUPTA

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

Recruitment has been completed for the pilot study, and it has provided evidence of clinical tolerability and the laboratory analysis for the rationale. A publication will be developed on the pilot study. Funding is now being sought for a randomised study to investigate water irrigation vs chemotherapy.

SUBDUE-1: SUB-urothelial Durvalumab InjEction-1

As of 31 March 2022, recruitment is at 412 patients of a planned 500 and is recruiting well in Australia and the UK. The study randomised the 400th participant (reaching 80% recruitment) at Nottingham University Hospital.

This phase 1 trial looks at tolerability, safety and immunological efficacy of a sub-urothelial injection of durvalumab as a potential new primary treatment for non-muscle invasive bladder cancer.

There continues to be a worldwide shortage of BCG, which although during the year didn’t impact our recruitment, ANZUP members have been asked to remind centres that the best way to conserve BCG stocks in Australia is to put patients on the study.

There were promising results presented at ASCO GU 2022.

No immune-related toxicities were reported and the approach showed evidence of a desirable effect on the immune system.

Additional work on cytokines in urine and blood samples, and PDL-1 status before and after injection is underway. Funding is being sought from AstraZeneca for a phase 2 (SUBDUE-2) study as below.

PCR-MIB This study closed to recruitment and discussions are underway for a translational component of this study.

Below The Belt funded projects ACCEPT ANZUP Co-operative multi-centre cystectomy database (Hayne, 2017) To date 4 sites have begun contributing patient data, with 190 patients entered onto the database.

Members have been asked to contact ANZUP to obtain assistance with opening the study at non-Western Australian sites. The next step is to make the separate upper tract database available to sites that want to contribute this data.

The Exercyst Trial: Exercise Medicine Prior to Open Radical Cystectomy: Feasibility and Preliminary Efficacy (Taaffe, 2017) Recruitment and follow up has been completed. Data analysis and the manuscript is now being developed.

SUBDUE-2: A Phase I/II Trial of SUB-urothelial DUrvalumab InjEction in patients with BCGunresponsive high-risk, non-muscle-invasive bladder cancer This is a single-arm study of 30 patients (fully resected; BCGunresponsive/refusal), durvalumab injected at cystoscopy, with further injections over 12 months (tumour recurrence to be resected). Six local sites would be needed for recruitment (5-6 patients over 12 months). The budget is being submitted to AstraZeneca to fund this study.

ZipUp This study investigates the role of zirconium girentuximab PET scans in the imaging of urothelial cancer. It has now recruited 5/20 patients. COVID related difficulties affecting delivery of the zirconium girentuximab are slowing recruitment progress.

23

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ANZUP ANNUAL REPORT 2022

RESEARCH HIGHLIGHTS

Underlying Mechanisms of Chemoimmunotherapy Synergism in NonMuscle Invasive Bladder Cancer (NMIBC) A BTB grant is supporting this work and a research fellow fully funded by the WA Cancer and Palliative Care Network (WACPCN) is working on this project for the next 12 months. Twenty relapsed patients have been matched with twenty nonrelapsed patients. Biomarkers to be investigated are currently being finalised. Pre-treatment samples are to be tested first.

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.

The second fully Zoom Concept Development Workshop was held on Wednesday 28 April 2021 and had 4 concepts presented and over 35 people attend.

We look forward to the progression of BUP concepts and trials and, another productive year, and the possibility of face-to-face meetings and events. We thank all those who have attended or contributed to the BUP subcommittee meetings.

Renal Cell Cancer Subcommittee: David Pook and Craig Gedye the KEYPAD investigators and trial teams for their continued efforts throughout 2021.

The UNICAB study is open across 11 sites in Australia and has recruited 25 of 48 patients to date. Recruitment has been steady for this trial.

CHAIR, CRAIG GEDYE

DEPUTY CHAIR, DAVID POOK

We would like to thank everyone, including the investigators and trial teams for their continued efforts throughout another difficult year. Below is an update of renal cell trials and other ongoing activity and developments throughout 2021-2022.

Trial Updates The RAMPART study is now open and recruiting in Australia with the first participant from the Calvary Mater Hospital in Newcastle. This study will investigate if people with large/ higher risk primary kidney cancers may be eligible to take immunotherapy monotherapy or combination versus observation.

The UNISoN study has now moved to follow-up. A final abstract has been submitted for the ASCO Annual Scientific Meeting 2022. Work is being undertaken on translational studies.

The Trial Management Committee met and made the decision to set an end date to recruitment for the KEYPAD trial. The last date of recruitment will be 30th June 2022 and currently 55 patients are enrolled. We would like to thank all

Horizons Scanning Meeting In 2021, ANZUP facilitated a series of structured activities and discussions with clinical and scientific experts and consumers from across Australia to identify unmet needs in RCC that can be addressed through clinical trials research in Australia and New Zealand. The process sought to identify and align areas of unmet need in Australia and New Zealand with available skills and expertise.

The first workshop was held in February 2021 and identified a series of unmet needs in RCC that could be addressed through clinical trials research. A second workshop was held on 23 April 2021 and provided the opportunity to discuss ideas in the five areas rated as having the greatest potential in terms of priority and feasibility. The 3-hour facilitated virtual workshop was attended by 28 ANZUP members and staff, as well as representatives from the meeting sponsors.

The next step will be for the RCC subcommittee to review the ideas, determine how to assist the membership in identifying funding and logistical resources to address these ideas, and begin developing proposals and projects with the greatest potential in terms of priority, interest, and feasibility.

RESEARCH HIGHLIGHTS

Area of interest from Horizons Scanning Meeting Functional imaging in RCC/Theranostics in RCC

• Focus of research: o Determine the optimal radiotracer for different RCC subtypes (sensitivity and specificity) o Determine the clinical utility of functional imaging • Update: o Royal Brisbane Hospital has proceeded with the retrospective PSMA PET study in metastatic RCC. Collaboration with other ANZUP sites will be pursued in future.

De-escalation of systemic therapy • Focus of research: o De-escalation of systemic therapy used in 1st and 2nd-line treatment of metastatic RCC (e.g. ipilimumab / nivolumab maintenance nivolumab) o C onsider link to functional imaging: are there targets that indicate a response to treatment (e.g. VEGF signalling)?

Management of small renal mass • Focus of research: o Understanding of current management approaches o D evelopment of consensus guidelines for active surveillance Management of low-volume metastatic RCC • Focus of research: o Range of possible research questions Supportive care questions in RCC • Focus of research: o Addressing unmet supportive care needs in RCC

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Concept Development Workshop A concept development workshop (CDW) was held via Zoom on Friday 30 July 2021. The CDWs are designed to facilitate and support members who actively contribute in our meetings and across our research activities and have an idea/concept they would like to put forward for discussion and, if supported, to further develop into a future grant application.

Three concepts were presented and discussed: Concept #1: Single arm phase 1 combination study of 177LuDOTA-girentuximab with axitinib in patients with pretreated kidney cancer Concept #2: Single arm study of 177Lu-DOTA-girentuximab given prior to cytoreductive nephrectomy in patients with metastatic clear cell kidney cancer Concept #3: Pembrolizumab after metastectomy for oligometastatic renal cell carcinoma: a randomised trial We look forward to the growth of renal cell cancer trials and have high expectations for a productive year for the Renal Cell Cancer Subcommittee.

Thanks again to all the RCC subcommittee members, our clinical sites, our collaborators, and especially our trial participants. We look forward to continuing to work to the goals of preventing, treating, and improving outcomes for renal cell carcinoma patients.

o I mproving informed decision-making across a range of clinical decisions

Prostate Cancer Subcommittee: Lisa Horvath and Jarad Martin Following is an update of prostate cancer trial activities and achievements during the past year.

ANZUP Prostate Cancer Trials GUIDE GUIDE will investigate an 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 opened in November 2021.

CHAIR, LISA HORVATH

DEPUTY CHAIR, JARAD MARTIN

DASL-HiCaP DASL HiCaP is now open at all Australian and New Zealand sites. There are now 53 sites including the UK and USA. This trial opened at Dana-Farber Cancer Institute in Boston, USA in February 2022 and in March 2022 the 440th participant was recruited, reaching 40% recruitment.

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ENZA-p ENZA-p has now recruited 128/160 patients (as of 1 March 2022). This study is randomising men with metastatic castration-resistant prostate cancer to enzalutamide ± Lutetium-PSMA, and is open at 16 participating centres.

#UpFront PSMA The ANZUP co-badged study #UpFrontPSMA is available for castrate sensitive men with high volume metastatic disease at diagnosis, with 26 randomised to testosterone suppression ± lutetium-177 PSMA. Over 50% of the recruitment target has been reached. ANZUP members have been asked to encourage recruitment to the study.

Concept Development Workshop A pipeline of ideas and new trial concepts comes from the concept development workshop (CDW). The concepts might then be progressed through individual working parties with updates to the prostate subcommittee.

The CDW was held on Friday 18 March 2022 as a hybrid meeting. There were 31 attendees and 5 concepts presented and discussed. These included: Chris Sweeney: BSPOKE-CaP Trial Biology-Specific, PatientOriented Knowledge Evolution for Prostate Cancer Craig Gedye: ADAPT - Adaptive DegArelix for metastatic hormone sensitive ProsTate carcinoma

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

TheraP officially finished follow-up on 31 December 2021 and commenced close-out procedures in 2022 and the TheraP biomarker abstract was accepted as an oral presentation at ASCO GU 2022.

EVOLUTION 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. This study has now opened with a site initiation planned for the Peter MacCallum Cancer Centre.

Natasha Roberts: Cross-sectional survey investigating unmet needs for men diagnosed with prostate cancer Teesha Downton: Bipolar Androgen Therapy to extend response to Darolutamide in nonmetastatic castrate resistant prostate cancer Tahlia Scheinberg: Randomised phase 2 study of sphingosine kinase inhibitor in men with AR signalling inhibitor resistant mCRPC There were also a couple of presentations generating discussion within the group from: Scott Williams on M0 advanced prostate cancer, and Steve McCombie on Pain-Free TP: A phase 3 double-blind placebocontrolled randomised trial of methoxyflurane to reduce the discomfort of local anaesthetic transperineal prostate biopsies.

Clinical Research Projects DIPPER In the post-operative salvage setting DIPPER is looking at a mixture of treatment de-intensification for the low-risk patient group, and integration of PSMA PET into treatment planning for other men. The protocol is now being finalised and discretionary funding from ANZUP has been obtained to support the study. The Consumer Advisory Panel is now to provide feedback.

PRIMARY 2 PRIMARY 2 will look 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. Site initiation visits have taken place at Peter MacCallum Cancer Centre (2 patients are ready to be randomised) and St. Vincent’s Hospital (HREC approval obtained). The database is now being finalised.

RESEARCH HIGHLIGHTS

Translational Substudies ENZAMET TR By the end of February 2022, 90% of biospecimens were in Australia. Remaining samples from UK/Ireland are to arrive in the following 4-6 weeks. The Astellas agreement regarding the translational substudies was signed.

Results of the 470-event analysis for ENZAMET is pending and will trigger the health economic analysis that will take place in the next 12 months. The survival outcomes data will be presented at ASCO 2022.

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TheraP TR TheraP is providing a great pool of potential translational sub-studies. The study will be submitted for the Australian Clinical Trials Alliance - Trials of the Year Awards this year. The clinical imaging biomarker data was presented at ASCO GU in February 2022.

We extend our thanks to the prostate cancer subcommittee for the dedication to improving treatments and outcomes in prostate cancer, and we look forward to another busy and successful year ahead.

Germ Cell Cancer Subcommittee: Ben Tran and Patti Bastick

CHAIR, BEN TRAN

DEPUTY CHAIR, PATTI BASTICK

Despite the ongoing challenges 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: CLIMATE - our new testicular cancer biomarkers trial opened and recruited their 1st patient. This trial is a collaboration between ANZUP and the Walter and Eliza Hall Institute of medical research (WEHI). This testicular cancer trial is called: Assessing the Clinical utility of miR-371a-3p as a marker of residual disease in Clinical Stage 1 Testicular Germ Cell Tumour, following orchidectomy. ometimes, patients are given treatment when there is a high S suspicion of recurrence of testicular cancer, but not all of these patients actually have a recurrence. Current blood tests and scans can only be so good at confirming recurrence of testicular cancer. A new blood test is in development that looks very promising at being an extremely sensitive and specific blood test for testicular cancer. CLIMATE is an ANZUP study aimed at determining whether this blood test, miR-371, is sufficiently accurate in order to be used to guide treatment or nontreatment, thereby improving QOL in testicular cancer survivors.

CLIMATE is a parallel study to SWOG and COG studies.

CLIMATE has opened at Newcastle and Epworth Freemasons Hospitals. Three patients are suitable for enrolment at the Peter MacCallum Cancer Centre.

IGER is open at 4 sites in Australia, with recruitment at 11 T patients in Australia. There are 378/420 patients recruited globally. Recruitment is to be completed later in 2022. There has been a recruitment pause in Australia whilst awaiting HREC approval of protocol amendment. All ANZUP members have been encouraged to refer relapsed patients to TIGER where possible. This study aims to demonstrate how well standarddose 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. i Testis continues to expand, opening at multiple sites across the country, with data approaching close to 900 patients on the database. This is a testicular cancer registry, supported by ANZUP, that hopes to engage as many sites and clinicians as possible. ANZUP members have been asked to encourage interested sites to join the database.

P3BEP ccontinued to recruit well despite the challenging year. 197 patients have been recruited across ANZ, UK and COG sites. This study is comparing the standard dosing and 3 weekly scheduling of BEP chemotherapy (Bleomycin, Etoposide and Cisplatin), with the same doses given every 2 weeks, also referred to as “accelerated BEP”. Blood and tissue from consenting P3BEP participants will be collected for translational

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research studies. Interim analysis of response rate will be undertaken at the end of March 2022 and an interim analysis of progression free survival will be done later in 2022.

undergoing primary RPLND received ANZUP endorsement from the SAC. It is now awaiting final ethics approval, with the study to open in the next few months.

The ANZUP surveillance recommendations for both stage 1 and advanced disease (following curative chemotherapy) are on the ANZUP website and are pending eviQ review. The ANZUP surveillance protocols have been downloaded 32K times from the ANZUP website.

PREPARE: Pseudoephedrine in patients with retrograde ejaculation (Ciara Conduit) Patients who had undergone RPLND will be asked to complete a health-related quality of life (HRQoL) survey (Stage 1). Stage 1 will open at Peter Mac (PMCC) soon with 50 men to be recruited.

Men who report retrograde ejaculation will be recruited to the treatment study with pseudoephedrine (30 men). This study has been funded through the Below the Belt Research Fund. It will be submitted to the SAC for review and endorsement.

Post-chemotherapy surveillance protocol/Survivorship recommendations for Testicular Cancer Drafts of the protocol and survivorship guidelines have been developed and are being reviewed by the Consumer Advisory Panel. The stage I surveillance calculator is also being updated.

Other activity, including studies in the pipeline:

The Germ Cell Concept Development virtual workshop was held on 4 March 2022 and provided a platform for a lot of productive discussion about current studies and ideas for future studies.

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

As we move into 2022, we hope the challenges faced over the past two years will dissipate so we can focus on current studies and also progress both concepts and studies in the pipeline.

Quality of Life and Supportive Care Subcommittee: Haryana Dhillon and Catherine Paterson This concept aims to identify the factors underpinning preference-sensitive treatment decisions for men, their caregivers and clinicians following a diagnosis of metastatic prostate cancer.

CHAIR, HARYANA DHILLON

DEPUTY CHAIR, CATHERINE PATERSON

Concept Development Workshops In early March 2022, we held a hybrid concept development workshop, and it was encouraging to have five new concepts presented to the group. Discussion at the workshop allowed the authors to obtain full input from the group’s knowledge and wisdom.

Colin O’Brien presented ‘Making difficult decisions: understanding the factors that impact treatment decisions in men with small volume metastatic prostate cancer’. This concept highlights that new imaging approaches have added more decision points for men and clinicians, some of these decisions are not well informed by clinical data to guide them. Men and their treating clinicians are faced with making decisions regarding continued surveillance or commencement of treatment, these decisions have been exacerbated by the availability and use of new imaging approaches (e.g. PSMA-PET) which provide additional information about disease but where evidence for optimal treatment approaches are unclear.

Richard de Abreu Lourenço presented his concept, ‘What influences decisions to have a testicular prosthesis’. This concept will address variables impacting choice to have testicular prosthesis post-orchidectomy. It will address the impact on patients following decision; are they happy, are they not?

Cynthia Hawks presented ‘Biopsy notification of cancer diagnostic results by a Clinical Nurse – where to from here?’

Cynthia presented a summary of results from her PhD, including outcomes at her site and avenues for the future.

Camille Short presented, ‘Evaluation of ASGuide: A webbased health promotion program for Active Surveillance in Prostate Cancer.’ Active Surveillance (AS) is a recommended treatment option for individuals diagnosed with low-risk prostate cancer. AS aims to reduce overtreatment and the associated side-effects. It involves monitoring biological markers of the disease progression so that curative treatment can be delayed or avoided entirely unless clinically necessary. While uptake of AS is generally increasing globally, approximately 10% of individuals will cease AS without signs of clinical progression. The research and others suggest this is due to unmet informational needs, “a desire to act”, anxiety, fear of progression and family pressure. Whilst there are many potential supportive care intervention options that could be

RESEARCH HIGHLIGHTS

used to support AS patients, web-based interventions are one of the most promising. This study aims to adapt an AS webbased intervention developed by UK colleagues for use in an Australian setting and evaluate it in a RCT.

Subcommittee Meetings During the year regular subcommittee meetings were held via Zoom and the subcommittee is continuing to see increased input into ANZUP trials more generally. This input is broadening the range of psychosocial and supportive care questions being addressed within the trials. In turn this should lead to better understanding about how we can support patients throughout their treatment journey.

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 HRQoL data from stage 1 of the trial to describe the quality of life of patients over time.

Project Title: The unmet informational and supportive care needs among patients diagnosed and living with non-muscle invasive bladder cancer (NMIBC).

Grant Purpose: Conducting a series of sub-studies and secondary analyses provides us with an opportunity to build ANZUP’s capacity to strategically conduct research to understand which ‘quality of life’ instruments best capture the impact of below the belt cancers and their treatment on the lives of patients and their families and to research how to improve supportive care.

Update: Kath has commenced her first year of her PhD at the University of Canberra. Her primary Supervisor is Dr Catherine Paterson. Throughout this year she has managed to complete two compulsory subjects: ‘The Practice of Research’, completed in semester one and currently the ‘Principles of Research’ to be completed in semester two. She has also attended intensive workshops gaining knowledge and skills to be utilised throughout her doctorate.

Kath is planning to complete her PhD by publications and submitted her manuscript for publication towards the end of Semester Two, 2021. She is looking to submit this in the Journal of Cancer Survivorship. This will provide the first paper of her doctorate. The title of the paper is; ‘What are the experiences of sexual wellbeing interventions in males affected by genitourinary cancers and their partners: A systematic integrative review population.’

Online exercise for people with metastatic prostate cancer Camille Short and team published their Exercise Guide trial results after building and testing a website for men with advanced prostate cancer, providing computer-tailored

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exercise prescription and behaviour change help. The paper is titled, ‘Acceptability and Preliminary Efficacy of a Weband Telephone-Based Personalised Exercise Intervention for Individuals with Metastatic Prostate Cancer: The ExerciseGuide Pilot Randomised Controlled Trial.’

In summary: Previous research supports the participation in supervised exercise among individuals with metastatic prostate cancer to help lessen the physical and psychological disease burden. However, many individuals experience considerable barriers to attending face-to-face exercise services. To overcome some of these limitations, digital interventions that can be delivered remotely have been proposed. This pilot study investigated the acceptability, safety and preliminary efficacy of an 8-week computer-tailored web-based exercise intervention.

They demonstrated that a web-based exercise program with telehealth support was acceptable and could be implemented safely. Participants in the intervention group increased their participation in moderate to vigorous physical activity compared to the control group. This study provides insight into the prospect of web-based exercise prescription for individuals with metastatic prostate cancer as an alternative for individuals who cannot access supervised exercise interventions.

Annual Scientific Meeting 2021 We were extremely fortunate to have a magnificent panel present at the ASM – Gail Garvey, Daniel Lindsay and Dorothy Keefe. They shared work they are doing to address ‘Disparities in Cancer Care’ with a focus on Aboriginal and Torres Strait Islander people.

Gail Garvey, presented “What do we know about survivorship needs of Indigenous people in Australia?” This gave a marvellous insight into how Indigenous people in Australia experience cancer care. Daniel Lindsay followed with an update on his research, “Out of pocket costs of Aboriginal & Torres Strait Islander people with prostate cancer,” generating much discussion about potential causes of these differences.

Finally, Dorothy Keefe shared with us “What Cancer Australia is doing to improve cancer outcomes in Aboriginal & Torres Strait Islander people” showcasing a range of resources now available to support cancer care health professionals working with Indigenous people. Dorothy encouraged the audience to consider what they could do to help address these disparities, suggesting starting by asking people if they are Indigenous in our daily practice. Only then can we link people to Indigenous health supports better able to meet their needs.

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Translational Subcommittee: Arun Azad and Anthony Joshua The past year has yet again been both busy and productive with several Translational Research Subcommittee (TRS) meetings held.

ANZUP continues to make translational research a key focus and strength of the organisation and the TRS is facilitating the overall translational research activity for ANZUP-led trials.

Bio-specimen collection continues as part of existing trials, including ENZA-p and DASL-HiCaP, BCGMM, P3BEP, KEYPAD, UNISoN and PCR-MIB as well as translational research plans for ANZUP’s prostate cancer studies, with ENZAMET, ENZARAD and TheraP. For ENZAMET a comprehensive program of TR has been developed (tissue-based genomics, circulating tumour DNA markers, metabolomics, lipidomics, cytokines, imaging studies, etc). To date, 90% of biospecimens reached Australia by the end of Feb 2022. Remaining samples from UK/ Ireland are to arrive in the following 4-6 weeks. The Astellas agreement regarding the translational substudies was signed.

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

By testing circulating biomarkers in pre-treatment 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. Plasma and blood samples for all but one participating site are now in the central laboratory. The TheraP clinical imaging biomarker data were presented at ASCO GU in Feb 2022 and demonstrated that in men with mCRPC, PSMA SUVmean ≥10 was predictive of a higher likelihood of favourable response to LuPSMA than cabazitaxel, whilst a high volume of disease on FDG PET was associated with a worse prognosis regardless of randomly assigned treatment.

CHAIR, ARUN AZAD

DEPUTY CHAIR, ANTHONY JOSHUA

BCGMM TR work is underway at the Fiona Stanley Hospital.

In addition, a Below the Belt Research Grant was secured

by Steve McCombie for the study, ‘Identifying tumour and immune stromal features that correlate with optimal benefit from BCG and Mitomycin: A translational sub-study of patients in the BCGMM trial’. The BCGMM Trial is a currently recruiting ANZUP trial aiming to determine if the combination of BCG and mitomycin is more effective than BCG alone in the treatment of patients with aggressive bladder cancer that has not yet invaded the muscle of the bladder wall. As part of this trial tumour and biopsy tissue samples are telescopically removed from patient’s bladders at several timepoints during their treatment. This sub-study plans to perform extensive analyses on these samples to try and determine if it can be predicted which patients may do better with BCG treatment alone, combined BCG and mitomycin treatment, or those that may not be likely to respond to either BCG or the combination.

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 meticulousness in attaining correlative samples from our ANZUP trials.

We look forward to another productive year ahead for the Translational Research Subcommittee and ongoing translational research activity for ANZUP.

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Consumer Advisory Panel: Belinda Jago and Ray Allen We have also been invited by members to speak or join other meetings. We enjoy the opportunity to attend these additional engagements as they provide an avenue to continue to promote ANZUP and raise community awareness of the importance of clinical trial participation.

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. We demonstrate a commitment to clinical trials research as a key strategy for improving the treatments and outcomes of those affected by genitourinary cancers, and provide the voice to consider ‘what is the value of this clinical trial to the community?’

The ANZUP CAP for the last 12 months has continued to provide their support to the many ANZUP committees and the membership from a community perspective.

Despite not being able to meet face to face we have been a very busy group once again. The important work ANZUP does to help improve treatments and outcomes for cancer patients through clinical trial research never stops, and in fact continues to grow.

As a group representing the community, quality of life remains a very important goal. Many of the treatments that cancer patients need to take to keep their cancer at bay, often for an extended period of time, can considerably affect the way they are able to lead their life.

So, as we review new research proposals, this continues to remain an important goal – treatments that can provide better outcmes, and at the same time provide a good quality of life, so the patient can continue doing what is important to them.

As part of our reviewing process, we now invite the Principal Investigators of the research to listen to our discussion and comments. This provides a greater understanding of how a patient may “feel” about the proposals being put forward.

It also allows the Principal Investigator to then provide feedback as to why things have to be done a certain way and answer some of the technical questions.

Highlights for the year in review • T he CAP were delighted to have CAP member Colin O’Brien present his idea “decision making preferences for men with a rising PSA post radical prostatectomy” at a Concept Development Workshop. This was a first for a CAP member based on his personal experience.

• G reat learning opportunity about Patient Information and concept forms where there are pre-screening PICF’s needed to make sure the main study will be suitable for the patient. Thank you to Kate Mahon PI who made time to discuss this with us following the feedback provided by the CAP. • A ttending Part 2 of the Renal Cell Carcinoma (RCC) Horizon Scanning Meeting which ensures there is a much needed pipeline of prioritised research ideas/ opportunities for kidney cancer.

• M any CAP members again supported the annual Move #YourWay Campaign in May 2021 through participation, fundraising, donating, and promotion using our personal experiences.

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As part of the Move #YourWay Campaign several stories were published: o Melissa LeMesurier, supported by ANZUP member Shomik Sengupta, had an excellent article published in Body and Soul.

Other key activities in 2021/22 included: • R ay Allen has also been involved in discussions for a new concept, (GenI-AIRSPACE), investigating active surveillance in prostate cancer.

• Review of the follow up recommendations for:

o Leonie Young and Belinda Jago also provided different experiences for other publications.

• T he CAP were given the opportunity to have their own strategic planning session facilitated by Alison Evans to contribute our thoughts and ideas around the strategic planning process for ANZUP. The session was greatly appreciated by the CAP and it also reinforced the importance of the CAP’s contribution to ANZUP.

o Stage 1 Testicular Cancer and o Metastatic Testicular Cancer Post-Chemotherapy The CAP had the opportunity to preview Patient Information and Consent Forms for: • DIPPER • EVOLUTION

• W e completed a Patient Brochure Review – Getting started on XTANDI - (enzalutamide) a drug we became familiar with when working on the ENZAMET study. It was really good to be able to offer feedback for an important brochure that patients need to read and review when starting a new treatment. It was gratifying to see our suggestions were taken on board for the final brochure patients are now given.

• C AP members attended the 2021 virtual ASM and had excellent feedback on the program. We also had 3 CAP members actively participate in various sessions. Like everyone, we are very much looking forward to a face to face meeting in Adelaide 2022.

• T he CAP participated on the Below the Belt Research Fund Grant reviews. The CAP considered that 6 of the 15 applications were worthy of BTB funding and 4 of these were selected for a grant. This reinforces that while as consumers we consider studies differently to the healthcare professionals and those working in research, our outcomes are very similar and well aligned.

• CLIMATE • PRESTIGE • WATER As you can see, the CAP has many opportunities to put their unwanted cancer experience to good use. To assist with our busy schedule, we warmly welcomed two new CAP members, Tuan Hoang and Paul Zawa, to their first meeting in February 2022. Both Paul and Tuan were recommended by ANZUP members and we thank them for their assistance.

We also advise that CAP member Matt Leonard, and our New Zealand representative, is taking an extended break due to family and work commitments. Matt has been an enthusiastic and committed CAP member and we will miss his valued contribution greatly. We wish Matt all the best and look forward to him being able to return in the future.

In closing, the CAP continue to be engaged and fully supported by ANZUP through our many activities.We thank ANZUP Chair Ian Davis and ANZUP CEO Marg McJannett for their excellent leadership supported by a small and hardworking management team. The fact half of the CAP have been volunteering with ANZUP since 2012 is testament to members wanting to be part of this organisation.

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Grants and Awards Infrastructure Grants Funds provided by Cancer Australia to support ANZUP’s infrastructure up until December 2021 were managed by the University of Sydney and not reported in the financial accounts of ANZUP unless transferred in support of specific expenses incurred by ANZUP. In January 2022 ANZUP was successful in our 2022-2024 Support for Cancer Clinical Trials grant application and ANZUP will administer this grant. Other Grants/ Funding during the 2021-22 period are outlined below.

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 $12,018.72 was transferred to ANZUP.

Infrastructure Funding

DASL-HiCaP: A randomised phase III double-blind, placebocontrolled 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$53,173,088. During this period USD$485,455 was transferred to ANZUP and reported in the annual accounts.

Cancer Australia Infrastructure Grant: 1 July 2018 to 30 December 2021, AUD$1,750,000 awarded to ANZUP and our collaborator, The University of Sydney. During this reporting period AUD$125,000 was transferred to ANZUP and is 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$19,962,490 (2014-2022).

During this reporting period USD$94,910 was transferred to ANZUP and was reported in the annual accounts.

ANZUP was also successful in applying for the 2022-2024 Cancer Australia Infrastructure Grant and was awarded $1,250,000 for the next 3 years. During this reporting period ANZUP received AUD$260,000 and is reported in the Annual Accounts.

ENZAMET Translational Research Program: During this reporting period US$110,000 was transferred to ANZUP for TR Execution Milestone Direct Costs 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 trials managed by the University of Sydney, are 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: Adding mitomycin to BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: a 2-stage, randomised phase 3 trial. Funding by NHMRC AUD$ $1,587,163.80. (2019 – 2023). AUD$22,500 was transferred to ANZUP and 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 castration resistant prostate cancer treated with enzalutamide. Funding by Prostate Cancer Research Alliance: The Australian Government and Movember Foundation Collaboration 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$1,154,037 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$13,184,412 (2014-2022). During this reporting period no funds were transferred to ANZUP.

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ACHIEVEMENTS

Grants and Awards continued EVOLUTION: A randomised phase II trial of Radionuclide 177Lu-PSMA Therapy versus 177Lu-PSMA in Combination with Ipilimumab and Nivolumab for Men with Metastatic Castration Resistant Prostate Cancer (mCRPC). Funding by Prostate Cancer Foundation of Australia AUD$1,500,000; Bristol Myers Squibb USD$1,296,698, Novartis USD$320,000 (2021-2024). During this reporting period ANZUP received AUD$1,842,874 and is reported in the annual accounts.

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 ANZUP received AUD$7,000 for Translational Reasearch site payments and is reported in the annual accounts .

RAMPART: Renal Adjuvant MultiPle Arm Randomised Trial (RAMPART) An international investigator-led phase III multiarm 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.

During this reporting period ANZUP received AUD$670K AUD$7,000 for Translational Research site payments and is reported in the annual accounts

TIGER: A Randomised Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilising Paclitaxel plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumours (ANZUP 1604). Funding received from the Movember Foundation $454,803.74. No funds were received in this reporting period.

UNISoN: Phase II sequential cohort trial of Single Agent Nivolumab, then Combination Ipilimumab + Nivolumab in metastatic or unresectable non-clear cell renal cell carcinoma (ANZUP 1602) . Bristol Myers Squibb (BMS) provided funding USD$1,681,822 and product to support the UNISoN trial.

During this reporting period ANZUP received no funds from BMS. We successfully applied for philanthropic grants from the Hillcrest Foundation $68,000, and the Ken & Asle Chilton Trust $4,800, as reported in the annual accounts.

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 (ANZUP 1801). During this reporting period ANZUP received AUD$275,000 and this is reported in the annual accounts.

ACHIEVEMENTS

ANZUP ANNUAL REPORT 2022

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

DR CIARA CONDUIT, MEDICAL ONCOLOGIST, PETER MACCALLUM CANCER CENTRE

Ciara Conduit: Exploring the activity of pseudoephedrine in treating retrograde ejaculation following retroperitoneal lymph node dissection in survivors of testicular cancer (PREPARE) Testicular cancer (TC) is one of the most common cancers diagnosed in young men in Australia. While most men can expect a positive outcome, treatment can result in long-term side effects.

DR MEGAN CRUMBAKER, ST. VINCENT’S HOSPITAL SYDNEY

Megan Crumbaker: A Phase II study of high dose testosterone in combination with carboplatin in men with metastatic castrate-resistant prostate cancer Prostate cancer that has spread beyond the prostate and its nearby areas is usually incurable and targeted with treatment that lowers testosterone, called ADT. ADT is associated with several side effects,

Sometimes after retroperitoneal lymph node dissection (RPLND; surgery involving the lymph nodes at the back of the abdomen), important nerves controlling ejaculation can become disrupted. This results in retrograde ejaculation (RE), where sperm flows back into the bladder instead of through the penis after orgasm.

It is sometimes called a dry orgasm.

Although RE is not harmful or painful, it may affect sensation during orgasm and result in infertility (difficulty conceiving a pregnancy). While RE may resolve spontaneously in some men, it becomes a chronic problem for others and existing treatments are not standardised, nor always helpful or successful.

We plan to conduct a pilot study exploring the effectiveness of an oral medication, pseudoephedrine (an ingredient in ‘Cold and Flu’ tablets), to improve RE

including some that worsen over time on treatment. Though effective initially, prostate cancers generally become resistant to ADT eventually. This resistance allows the cancer to grow, causing symptoms, such as pain, and shortened lifespan.

Research shows that prostate cancer cells in the lab can adapt to ADT in ways that make them vulnerable to attack from high testosterone levels. Recent prostate cancer trials used pulses of testosterone in men with ADT-resistant cancer to try to shrink the cancer and improve men’s overall wellbeing. The research found that the treatment is safe, associated with improved quality of life and has anti-cancer effects.

Based on this research and other research into the effect of testosterone on resistant

following RPLND. As pseudoephedrine causes tightening of the bladder muscle, it prevents sperm flowing back into the bladder and thus helps sperm move through the penis. It is therefore a potentially effective treatment for RE. Whilst some studies in men with RE due to other causes have shown pseudoephedrine may be helpful, it is not known how effective this approach is for men with RE after RPLND. We are currently undertaking a study to help understand how common RE is after RPLND, and how it affects men’s health-related quality of life (HRQoL). To follow up, we would like to recruit men with RE following RPLND and explore the effectiveness of pseudoephedrine as a treatment and improve our understanding of the impacts that RE has on HRQoL for survivors of TC.

prostate cancer cells, we hypothesise that adding a particular chemotherapy drug, carboplatin, will enhance the effectiveness of testosterone treatment without compromising quality of life.

We have treated 9 men with the combination of testosterone and carboplatin. Many of the patients on this pilot study report feeling much better due to an increase in their testosterone levels.

The treatment has also stopped the growth of some men’s cancer. We would like to use funding from this grant to expand the study to other cancer centres to improve access to this novel treatment, assess the effectiveness of the treatment, and determine whether a larger trial comparing it against other prostate cancer treatments would be worthwhile.

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ACHIEVEMENTS

DR STEVE MCCOMBIE, UROLOGY SPECIALIST, FIONA STANLEY HOSPITAL, WA

immune system to help kill cancer cells.

Instillation of a chemotherapy agent called mitomycin into the bladder also has proven effective in the treatment of these tumours. Mitomycin works both by directly destroying cancer cells and

Steve McCombie: Identifying tumour and immune stromal features that correlate with optimal benefit from BCG and mitomycin: a translational sub-study of patients in the BCGMM Trial

may also cause release of cancer cell

Optimal treatment of aggressive bladder cancer that has not yet invaded the muscle of the bladder wall involves removing all visible tumour using a fibreoptic telescope, followed by regular instillation of a bacterial protein called Bacillus Calmette–Guérin (BCG) into the bladder. BCG activates the body’s

BCG alone in the treatment of patients

components that assist activation of the body’s immune system to help kill cancer cells.

The BCGMM Trial is a currently recruiting ANZUP trial aiming to determine if the combination of BCG and mitomycin is more effective than with aggressive bladder cancer that has not yet invaded the muscle of the bladder wall.

As part of this trial, tumour and biopsy tissue samples are telescopically removed from patient’s bladders at several timepoints during their treatment. We plan to perform extensive analyses on these samples to try and determine if it can be predicted which patients may do better with BCG treatment alone, combined BCG and mitomycin treatment, or those that may not be likely to respond to either BCG or the combination. These analyses include looking at how BCG sticks to cancer cells, studying ways in which cancer cells can defend themselves against mitomycin, testing whether the immune cells visible in the cancer tell us who will do best with which treatment, and identifying if different tumour sub-types do better with different treatments.

DR JOSHUA KEALEY, MASTER OF SURGERY CANDIDATE, MONASH UNIVERSITY, UROLOGY REGISTRAR

Joshua Kealey: ACCEPT-U – Australian Multicentre Prospective Registry to Evaluate Practice and Patient Outcomes in Upper Tract Urothelial Carcinoma Upper tract urothelial carcinoma (UTUC) is a rare cancer of the lining of the kidneys and ureter. Whilst UTUC is similar to bladder cancer it is often more advanced at diagnosis, more challenging to treat and more likely to cause death. Diagnosis requires a combination of laboratory tests, imaging and endoscopic procedures.

Treatments are based on cancer stage and presence of metastasis.

Treatment ranges from surgical removal of the kidney and ureter, for those in whom cure is attainable, to palliative treatments where cure is not possible.

Due to the small number of people diagnosed with UTUC it is challenging to study individual treatments and outcomes in large trials. Often patients diagnosed with UTUC have multiple medical comorbidities and are excluded from trials, which makes results difficult to extrapolate to these groups. Whilst some data is collected in generic government cancer registries it is too limited to be of specific clinical use.

There is also little known about the compliance with international guidelines to ensure that Australian patients are receiving the highest level of care regarding their UTUC. We propose an Australian UTUC registry

to assess the patterns of care in Australia.

We aim to enrol patients after their diagnosis of UTUC. The ways in which patients present, undergo investigation, treatment and follow-up will be recorded and analysed. By analysing the complete journey of patients diagnosed with UTUC we aim to identify areas of improvement and provide feedback to clinicians to ensure the best possible outcomes. A comparison of individual treatments and their outcomes will also aim to provide some clarity around treatment decisions.

We will combine this database with the previously created bladder cancer cystectomy database (ACCEPT) to ensure that all urothelial cancers are covered by this multicentre registry.

ANZUP ANNUAL REPORT 2022

Y UR WAY The 2021 Below the Belt Move #YourWay Challenge in May welcomed 146 challengers and 31 teams who ‘moved’ their way anytime, anywhere and with anyone collectively completing 18,976 kms and 638 hours.

Whether they were walking, running, doing yoga, cycling, or dancing, they were also raising awareness and funds for below the belt cancer research.

The challenge raised $75,000. We thank all those who completed the challenge, supported or donated.

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ANZUP ANNUAL REPORT 2022

See your suburb #YourWay See Your Suburb #YourWay invited family and friends to attempt the 5km, 10km and or 20km challenge while seeing parts of the Inner West never seen before. It could be undertaken as a selfguided walk or cycle and was suitable for all ages.

Thank you to Inner West Council for helping ANZUP raise funds for below the belt cancer research.

ANZUP ANNUAL REPORT 2022

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ANZUP ANNUAL REPORT 2022

Thanks to our #YourWay Sponsors and Supporters SPONSORS

SUPPORTERS

ANZUP ANNUAL REPORT 2022

2021 ANZUP ASM Due to the ongoing impact of COVID-19, ANZUP again made the decision to postpone the face-to-face ANZUP Annual Scientific Meeting (ASM) in Adelaide and move it to 17-18 October 2022. Following many discussions with members and sponsors a second virtual ASM was held.

On behalf of the organising committee for the 2021 ANZUP ASM we would like to thank everyone who presented, attended, and helped organise ANZUP’s second virtual ASM – be it through our virtual platform or in person at one of the hubs held across the country.

The 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.

The program kicked off with a Nurses and Allied Health Session where a panel explored the challenges faced when undertaking nursing research and how to establish a pathway to make the research process easier. This was a great session with some insightful advice and shared experience.

We also saw the return of the ever-popular Multidisciplinary (MDT) Masterclass.

The afternoon was convened by Carole Harris and the panels were broken up by disease type. Each then endeavoured to educate the audience with real-life clinical challenges and audience polling.

Our ANZUP Symposium hosted a panel of national speakers who explored ‘Disparities in Cancer Care.’ Gail Garvey, Daniel Lindsay, and Dorothy Keefe gave extremely interesting and thought-provoking presentations highlighting the need for ongoing research, support and improved outcomes in the Aboriginal and Torres Strait Islander community.

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, were again held.

“Congratulations on what was a fantastic ANZUP ASM yet again – thank you so much!”

The ASM was completed with an entertaining crossfire debate, ‘No time to lose: to improve survival we can’t wait for data on overall survival’, given by David Pryor and Dave Pook.

We would like to take this opportunity to thank all who attended, either virtually or at a local hub, and for the ongoing support of [ANZUP ASM 2021 survey ANZUP. This meeting is only made possible respondent] by the dedication of each and every member of the ANZUP community. The convening committee displayed an extraordinary commitment to On the Sunday afternoon we hosted a ‘virtual’ welcome developing another world-class educational, thoughtdrinks session and held the first of the fabulous international provoking, and captivating program. We are grateful to keynote faculty presentations with Bertrand Tombal chairing the ANZUP subcommittee chairs for their review of the the session, ‘Clearer Vision’, with Chris Parker, Heather Payne submitted abstracts and concepts. And finally, this meeting and Alison Birtle. is only possible thanks to the support of our sponsors including Cancer Australia, who provide key infrastructure We began Monday of the ASM with the second stellar line funding to ANZUP. up of international guests. Chris Sweeney chaired the session with three thought-provoking presentations from Eli Van We now look forward to finally hosting the face-to-face Allen, Matt Galsky and Sima Porten where they explored ANZUP ASM 2022 in Adelaide from Sunday 10 July to ‘Horizon scanning the future is better than 20/20 vision’.

Tuesday 12 July.

“Thanks for the hard work and perseverance in staging the event. Really well done. Sometimes what you lose in physical interaction you can gain through many KOL’s contributing from all over the world in a succinct manner!”

[ANZUP ASM 2021 survey respondent]

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ANZUP ANNUAL REPORT 2022

ANZUP ASM 2021 highlights

“The sessions were fantastic and we got a lot out of them” [ANZUP ASM 2021 survey respondent]

ANZUP ANNUAL REPORT 2022

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ANZUP ANNUAL REPORT 2022

Thanks to our 2021 ASM sponsors The Australian and New Zealand Urogenital and Prostate Cancer Trials Group gratefully acknowledge the generous support of our 2021 ASM sponsors.

PLATINUM SPONSOR

GOLD SPONSORS

SILVER SPONSORS

ANZUP ANNUAL REPORT 2022

MDT MASTERCLASS

INTERNATIONAL SPEAKER

DELEGATE SCHOLARSHIPS

CONFERENCE APP

BEST OF THE BEST AWARDS

ANZUP NURSES SYMPOSIUM

SATCHEL BAG

LIVE AND ON DEMAND VIDEO WEBCAST

SYMPOSIUM

MINI BRONZE SPONSORS

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ANZUP ANNUAL REPORT 2022

Fundraising, Partnerships and Engagement ANZUP has been fortunate to maintain a strong level of support, from new and existing donors and supporters, to help us achieve our mission: improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers through practice-changing multidisciplinary collaborative clinical trials.

Joe’s book, Finding Hope in Times of Uncertainty: A Guide to Thriving in the Challenging World of Today, shares practical ways to tackle uncertainty in your daily life and help you bounce back after a crisis. Joe generously donated $5 from each copy sold to support ANZUP clinical trials.

Although we have faced challenging times with the pandemic, we have developed and implemented new fundraising strategies, including virtual campaigns and communications to keep raising funds and awareness.

Joe’s podcast Simplify Cancer invited ANZUP Ambassador, comedian, journalist, and testicular cancer survivor Michael Shafar, for episode ‘Finding the Comedy in Cancer’. Joe and Michael shared their testicular cancer experiences and how finding humor through life can help get us through difficult times. You can listen to this very entertaining podcast via

We have received support through participation in community activities, gifts in wills, corporate partnerships, trusts and foundations, appeals, and participation in our fundraising events.

Thank you to ANZUP’s valuable donors and supporters for their continued support of ANZUP’s practice-changing multidisciplinary collaborative clinical trials.

Highlights Sharing Life-Changing Research Stories In mid-2021, ANZUP developed its first integrated appeal.

The purpose of the appeal was to inform our donors and supporters about our award-winning international clinical trial, ENZAMET. Trial participant Owen Reid shared his experience of prostate cancer and how the ENZAMET clinical trial made a significant difference to his health. The appeal was a great success with not only raising funds but also raising awareness of the work ANZUP is undertaking.

Following on from the appeal, we shared another trial participant Rob Lewis’s prostate cancer story on the ENZA-p clinical trial in our ‘A little below the belt’ magazine and Below the Belt Bulletin.

Our thanks go to Owen and Rob for sharing their stories.

Community Support Testicular cancer survivor, author and podcaster Joe Bakhmoutski has been a wonderful supporter of ANZUP over the years.

https://simplifycancer.com/ep079/

Michael Shafar hosted ANZUP’s Comedy Night, Laugh Your Way in May 2021. The event launched the Below the Belt #YourWay Challenge, with 65 attendees, at Seed Spaces in Sydney, who generously supported ANZUP with the venue and onsite support.

Michael invited his comic pals (and some of Australia’s best comedians), Suren Jayemanne, Daniel Muggleton, and Sam T to support the event and cause, bringing many laughs with their hilarious one-liners and anecdotes.

Gabs Festival The Great Australasian Beer Spectapular (GABS) was held with Festivals in Sydney, Melbourne and Brisbane during May and June 2021, and they supported ANZUP as one of their official charity partners.

Globally recognised as one of the best beer festivals in the world, GABS is like Disneyland for craft beer enthusiasts of all ages. Not only was there amazing street food, and other beverages including non-alcoholic options, but the event stared Michael Shafar who performed his comedy show during the festival in support of ANZUP. We also sold (and sold out!) ANZUP and Below the Belt merchandise at the events and received 10% of all raffle sales for the biggest beer prize. Along with ongoing communications raising awareness about ANZUP and below the belt activities via their channels, the GABS Festival also provided a feel-good factor of giving back to cancer research.

The event raised over $6,000 for ANZUP. Our thanks go to the GABS Festival organisers for their support.

ANZUP ANNUAL REPORT 2022

Origin Energy Golf Day Origin Energy organised the Origin Energy Golf Day at Massey Park Golf Club in Concord Sydney in mid-May 2021.

After 18 holes the team was provided with a presentation about ANZUP, below the belt cancers, why clinical trials are so important and ANZUP’s latest research.

It was great to receive support once again from the team at Origin Energy. Since 2015, Origin Energy staff and the Foundation have donated over $70,000 to ANZUP through their matched giving program and participating in ANZUP’s Below the Belt events. We are extremely grateful for their continued support.

Trusts, Foundations and Philanthropy

overcoming limited health and digital literacy in the collection and use of electronic patient-reported outcome assessment of symptoms in people with genitourinary cancer.

The late Alastair McKendrick was a treasured member of ANZUP’s Consumer Advisory Panel. ANZUP is very grateful for the ongoing support of the McKendrick family.

Roy Morgan Research Roy Morgan Research has provided significant funding to the ENZA-p: A randomised phase II trial using PSMA as a therapeutic agent and prognostic indicator in men with metastatic castration-resistant prostate cancer treated with enzalutamide clinical trial. ANZUP is very grateful for their ongoing support.

The Hillcrest Foundation and Ken & Asle Chilton Trust

ANZUP would like to thank and acknowledge our incredible Supporters, Foundations, and Trusts for their ongoing commitment and support.

ANZUP is extremely grateful to the Hillcrest Foundation and to the Ken and Asle Chilton Trust for their support to fund important translational research as part of ANZUP’s kidney cancer UNISoN Trial.

Anita Castan and the Nordia Foundation

With their support, ANZUP will be able to look further into the tumour tissue samples and blood tests from the people who were on the UNISoN kidney cancer clinical trial.

The Noel Castan Fellowships were generously funded by Anita Castan through The Nordia Foundation. The Noel Castan Fellowship aims to build ANZUP’s research capacity and increase the translation of information collected from our trials, which will contribute to a better understanding of how to optimise patient care.

The Noel Castan Fellowship was awarded to ANZUP members, Dr. Hui-Ming Lin, Senior Research Officer at The Garvan Institute of Medical Research, and Kathryn Schubach, a nurse practitioner with clinical expertise working with urooncology patients.

Hui-Ming Lin’s ‘Bioinformatics’ project is an analysis of the lipidomic and cytokine profiles from ANZUP’s ENZAMET study, which may identify novel biomarkers from the enzalutamide response, and provide new therapeutic targets to overcome enzalutamide resistance to improve the outcome of prostate cancer patients.

Kathryn Schubach’s ‘Quality of Life’ project will develop new questions in trials, using existing data innovatively enhancing and facilitating collaboration and thereby drawing attention and meaning to ‘the patient experience’ and aligning with the mission of ANZUP’s clinical research to improve outcomes.

Alison McKendrick and Family Our thanks go to Alison McKendrick and family for their generous donation to fund Associate Professor Haryana Dhillon’s Quality of Life project. The project is focussing on

The outcome is to learn if we can predict which people are most likely to benefit from the single treatment or combined treatment, providing a more targeted approach to treatment for people with kidney cancer. This will enable a clearer treatment path, which we hope will reduce uncertainty and anxiety. This funding was enabled through The Hillcrest Foundation.

Friends of ANZUP Friends of ANZUP is a community connecting people whose lives have been affected by prostate, kidney, bladder, penile and testicular cancers. Friends of ANZUP aims to provide the community with information and the benefits of clinical trials and how to access them, ANZUP’s research portfolio, practical information, stories, and articles through e-news and ANZUP’s ‘A little below the belt’ magazine, invitations to ANZUP’s Community Engagement Forum, and regular updates from ANZUP’s clinical community.

Throughout 2021 the Friends of ANZUP community has grown to nearly 600 and we continue to expand the community, with individuals, families, and carers that we hope to educate and inform about clinical trials and assist ANZUP in raising awareness of the benefits of clinical trials research and ultimately help us continue to fight cancer below the belt.

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ANZUP ANNUAL REPORT 2022

RESEARCH HIGHLIGHTS

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

1

IN TOTAL

108

25

TRIAL SITE

TRIAL SITES

TRIAL SITES NT

20

QLD

WA

TRIALS

6

TRIAL SITES

37

SA

TRIAL SITES

NSW

6

ACT VIC

TRIAL SITES

ANZUP TRIALS THROUGHOUT NEW ZEALAND

31

1

TRIAL SITE

TAS

1

TRIAL SITES

TRIAL SITE

IN TOTAL

8

TRIAL SITES

5

TRIALS

CURRENT ANZUP TRIALS (20) BLADDER

TESTICULAR

PROSTATE

KIDNEY

BCGMM

P3 BEP

DASL-HICAP

NINJA

KEYPAD

PCR MIB*

TIGER

ENZAMET*

PAIN FREE TRUS B*

UNICAB

NMIBC*

CLIMATE

ENZARAD*

TheraP

UNISON*

ENZA-p

UpFrontPSMA

RAMPART

* TRIALS IN FOLLOW UP CO-BADGED STUDIES

proPSMA*

FASTRACK II*

RESEARCH HIGHLIGHTS

ANZUP ANNUAL REPORT 2022

Participating Centres Across the rest of the world IRELAND

4

13

TRIAL SITES

TRIALS

6

UK

CANADA

23

3

TRIAL SITES

TRIALS

TRIALS

AUSTRIA

1

1

TRIAL SITE

TRIAL

SLOVENIA

1

TRIAL

6

1

TRIALS

TRIAL SITE

BELGIUM SPAIN

1

TRIAL

3

TRIAL SITES

USA

1

30

TRIAL SITES

TRIAL

1

TRIAL SITE

IN TOTAL

102

TRIAL SITES

8

TRIALS

30

TRIAL SITES

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ANZUP ANNUAL REPORT 2022

RESEARCH HIGHLIGHTS

Publications, Posters & Presentations 2021/22 Publications ENZAMET Research Review, 1 May 2021 EDUCATIONAL SERIES – Enzalutamide in men with metastatic hormone-sensitive prostate cancer: focus on the ARCHES and ENZAMET trials.

Ian D. Davis SUBDUE-1 BJU International, 6 May 2021 A phase I open label dose-escalation study to evaluate the tolerability, safety and immunological efficacy of sub-urothelial durvalumab injection in adults with muscle-invasive or high-risk non-muscle-invasive bladder cancer (SUBDUE-1, SUB-urothelial DUrvalumab injection-1 study): clinical trial protocol Andrew Moe, Elizabeth Liow, Andrew Redfern, Nicole Swarbrick, Tom Ferguson, Ian D. Davis, Dickon Hayne ENZAMET European Urology, 22 May 2021 Overall Survival of Men with Metachronous Metastatic Hormone-sensitive Prostate Cancer Treated with Enzalutamide and Androgen Deprivation Therapy.

Christopher J Sweeney, Andrew J Martin, Martin R Stockler, Stephen Begbie, Kim N Chi, Simon Chowdhury, Xanthi Coskinas, Mark Frydenberg, Wendy E Hague, Lisa G Horvath, Anthony M Joshua, Nicola J Lawrence, Gavin M Marx, John McCaffrey, Ray McDermott, Margaret McJannett, Scott A North, Francis Parnis, Wendy Parulekar, David W Pook, M Neil Reaume, Shahneen K Sandhu, Alvin Tan, Thean Hsiang Tan, Alastair Thomson, Emily Tu, Francisco Vera-Badillo, Scott G Williams, Sonia Yip, Alison Y Zhang, Robert R Zielinski, Ian D Davis, ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) ENZA-p BJU International, 24 May 2021 ENZA-p trial protocol: A randomised phase II trial using PSMA as a therapeutic target and prognostic indicator in men with metastatic castration-resistant prostate cancer treated with enzalutamide (ANZUP 1901).

Louise Emmett, Shalini Subramaniam, Anthony Joshua, Megan Crumbaker, Andrew Martin, Alison Y. Zhang, Nisha

Rana, Ailsa Langford, Jenna Mitchell, Sonia Yip, Roslyn Francis, Michael S. Hofman, Shahneen Sandhu, Arun Azad, Craig Gedye, Margaret McJannett, Martin R. Stockler, and Ian D. Davis on behalf of the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and the ENZA-p investigators.

Pain Free TRUS-B BJU International, 17 July 2021 ‘Pain-free TRUS B’: a phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasonography-guided prostate biopsy (ANZUP 1501) Dickon Hayne, Jeremy Grummet, David Espinoza, Steve P. McCombie, Venu Chalasani, Kate S. Ford, Mark Frydenberg, Peter Gilling, Barbara Gordon, Cynthia Hawks, Alex Konstantatos, Andrew J. Martin, Anthony Nixon, Colin O’Brien, Manish I. Patel, Shomik Sengupta, Shekib Shahbaz, Shalini Subramaniam, Scott Williams, Henry H. Woo, Martin R. Stockler, Ian D. Davis, Nick Buchan, on behalf of the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) TheraP BMJ Journals, 9 August 2021 Advanced prostate cancer experimental radioactive treatment—clinical trial decision making: patient experiences Bianca Viljoen, Michael S Hofman, Suzanne K Chambers, Jeff Dunn, Haryana Dhillon, Ian D Davis and Nicholas Ralph

RESEARCH HIGHLIGHTS

RAMPART Contemporary Clinical Trials, 21 September 2021 RAMPART: A phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse Bhavna Oza, Eleni Frangou, Ben Smith, Hanna Bryant, Rick Kaplan, Babak Choodari-Oskooei, Tom Powles, Grant D. Stewart, Laurence Albiges, Axel Bex, Toni K. Choueiri, Ian D. Davis, Tim Eisen, Alison Fielding, David Harrison, Anita McWhirter, Salena Mulhere, Paul Nathan, Brian Rini, Alastair Ritchie, Sarah Scovell, Clare Shakeshaft, Martin R. Stockler, Nat Thorogood, Mahesh K. B. Parmar, James Larkin, Angela Meade

ANZUP ANNUAL REPORT 2022

Poster Presentations ASCO 2021: Virtual Meeting, 4 June 2021 – 8 June 2021 UNISoN (ANZUP 1602) Abstract #4565 Ipilimumab + nivolumab in people with rare variant renal cell carcinoma refractory to nivolumab alone: Part 2 of UNISON (ANZUP 1602) nivolumab then ipilimumab + nivolumab in advanced non-clear cell renal cell carcinoma

ENZAMET European Urology, 30 September 2021 Overall Survival of Men with Metachronous Metastatic Hormone-sensitive Prostate Cancer Treated with Enzalutamide and Androgen Deprivation Therapy Sweeney, C. J.; Martin, A. J.; Stockler, M. R.; Begbie, S.; Chi, K. N.; Chowdhury, S.; Coskinas, X.; Frydenberg, M.; Hague, W. E.; Horvath, L. G.; Joshua, A. M.; Lawrence, N. J.; Marx, G. M.; McCaffrey, J.; McDermott, R.; McJannett, M.; North, S. A.; Parnis, F.; Parulekar, W.; Pook, D. W.; Reaume, M. N.; Sandhu, S. K.; Tan, A.; Tan, T. H.; Thomson, A.; Tu, E.; Vera-Badillo, F.; Williams, S. G.; Yip, S.; Zhang, A. Y.; Zielinski, R. R.; Davis, I. D.; Investigators, Enzamet Trial; the, Australian; New Zealand, Urogenital; Prostate Cancer Trials, Group ExerciseGuide Cancer, 25 November 2021 Acceptability and Preliminary Efficacy of a Web- and Telephone-Based Personalised Exercise Intervention for Individuals with Metastatic Prostate Cancer: The ExerciseGuide Pilot Randomised Controlled Trial Holly E. L. Evans, Daniel A. Galvão, Cynthia C. Forbes, Danielle Girard, Corneel Vandelanotte, Robert U. Newton, Andrew D. Vincent, Gary Wittert, Ganessan Kichenadasse, Suzanne Chambers, Nicholas Brook and Camille E. Short ENZAMET Journal of Clinical Oncology, 20 December 2021 Health-Related Quality of Life in Metastatic, HormoneSensitive Prostate Cancer: ENZAMET (ANZUP 1304), an International, Randomized Phase III Trial Led by ANZUP Martin R. Stockler, Andrew J. Martin, Ian D. Davis, Haryana M. Dhillon, Stephen D. Begbie, Kim N. Chi, Simon Chowdhury, Xanthi Coskinas, Mark Frydenberg, Wendy E. Hague, Lisa G. Horvath, Anthony M. Joshua, Nicola J. Lawrence, Gavin M. Marx, John McCaffrey, Ray McDermott, Margaret McJannett, Scott A. North, Francis Parnis, Wendy R. Parulekar, David W. Pook, M. Neil Reaume, Shahneen Sandhu, Alvin Tan, Thean Hsiang Tan, Alastair Thomson, Francisco Vera-Badillo, Scott G. Williams, Diana G. Winter, Sonia Yip, Alison Y. Zhang, Robert R. Zielinski, and Christopher J. Sweeney

First Author: Craig Gedye ASCO GU 2022: Virtual Meeting, 17-19 February 2022 ENZA-p (ANZUP 1901) Abstract # TPS205 ENZA-p: 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 (ANZUP 1901) First Author: Louise Emmett DASL-HiCaP (ANZUP 1801) Abstract # 352254 DASL-HiCaP: Darolutamide Augments Standard Therapy for Localized Very High-Risk Cancer of the Prostate –a randomized phase 3 double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in very high risk, clinically localized prostate cancer (ANZUP 1801) First Author: S M McBride SUBDUE-1 Abstract #483 SUB-urothelial Durvalumab InjEction – 1 (SUBDUE-1) – Results from the first nine urothelial cancer patients using a doseescalation schedule First Author: Dickon Hayne TheraP (ANZUP 1603) Abstract # 356724 PSMA PET and FDG PET as predictors of response and prognosis in a randomized phase 2 trial of 177Lu-PSMA-617 (LuPSMA) versus cabazitaxel in metastatic, castration-resistant prostate cancer (mCRPC) progressing after docetaxel (TheraP ANZUP 1603).

First Author: James Patrick Buteau

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ANZUP ANNUAL REPORT 2022

FINANCIAL REPORT

Financial Report

Annual Financial Report

2022

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2022

ANZUP Cancer Trials Group Limited ABN: 32 133 634 956

Annual Financial Report – 31 March 2022

Contents Directors’ report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Auditor’s independence declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Financial statements Statement of profit or loss and other comprehensive income . . . . . . . . . . . 59 Statement of financial position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 Statement of changes in equity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Statement of cash flows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 Notes to the financial statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Directors’ declaration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Independent auditor’s report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

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 27 May 2022.

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ANZUP Cancer Trials Group Limited Directors’ report 31 March 2022

The directors of ANZUP Cancer Trials Group Limited (the company) submit their annual financial report for the year ended 31 March 2022.

Mr Joe Esposito Deputy Chair

Directors 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) Joe Esposito (Deputy Chair) Nicholas Buchan Martin Dowling Glenn Ferguson Linda Martin (until 13 Dec 2021) Henry Woo Shomik Sengupta Lisa Horvath

Information on directors Professor Ian Davis 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 is an 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 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 years’ 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.

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.

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ANZUP ANNUAL REPORT 2022

ANZUP Cancer Trials Group Limited Directors’ report continued 31 March 2022

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 as well as Managing Director of FC Lawyers. 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 (until 13 Dec 2021) 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 Urology in the College of Health and Medicine at the Australian National University. Additionally, he is the Head of the Department of Urology, the Director of the SAN Prostate Centre of Excellence and Deputy Chair of the Medical Advisory Committee at the Sydney Adventist Hospital. He has published widely in major urological journals. He is an Associate Editor of the Société Internationale d’Urologie Journal and serves on the journal editorial boards of World Journal of Urology, Prostate Cancer and Prostatic Diseases, Prostate International, Asian Journal of Urology and World Journal of Men’s Health.

He is a Fellowship elected Councillor (Board Director) of the Royal Australasian College of Surgeons and has recently been appointed as Chair of the Australian and New Zealand Association of Urological Surgeons and as a Board Director of the Urological Society of Australian and New Zealand. 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 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 UroOncology lead at the Department of Urology, Eastern Health. Shomik has a practice with a urooncology subspecialty interest – including open, laparoscopic and robotic cancer surgery. Shomik 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. Shomik has more than 130 original publications to date and has been an invited speaker, session chair and convenor at numerous scientific meetings.

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ANZUP Cancer Trials Group Limited Directors’ report continued 31 March 2022

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 140 original research papers in peerreviewed 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

Nicholas Buchan

5

5

Martin Dowling

5

5

Joe Esposito

5

5

Glenn Ferguson AM

5

5

Linda Martin

4

3

Henry Woo

5

5

Shomik Sengupta

5

5

Lisa Horvath

5

5

Principal activity The mission of the Company is to improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers through practice-changing multidisciplinary collaborative clinical trials.

Objectives of the company The objectives of the Company are to develop, foster and promote prostate and urogenital cancer research by: • bringing together clinicians, scientists and consumers to identify critical areas of unmet need that can be addressed • through research in Australia and New Zealand • providing a collaborative forum to generate research ideas and concepts that address critical clinical questions • providing services and resources to support and fund research of the highest quality • promoting access to clinical trials for all people affected by urogenital cancers in Australia and New Zealand • mentoring and building the skills of future research leaders • securing government, industry and philanthropic funding to facilitate our independent research agenda • promoting our research goals and progress to improve clinical practice and change lives.

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ANZUP ANNUAL REPORT 2022

ANZUP Cancer Trials Group Limited Directors’ report continued 31 March 2022 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 $536,908 (2021: $1,420,905). At 31 March 2022, the company had net assets of $7,379,412 (2021: $6,803,703).

Changes in state of affairs There were no significant changes in the state of affairs of the company during the year ended 31 March 2022.

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 $3,327.

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, 30 May 2022

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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 2022, 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. N o contraventions of any applicable code of professional conduct in relation to the audit.

Leah Russell Director

BDO Audit Pty Ltd Sydney 30 May 2022

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ANZUP Cancer Trials Group Limited Statement of Profit or Loss and Other Comprehensive Income For the year ended 31 March 2022

Notes

2022

2021

$

$

Revenue

3 (a)

4,884,099

4,768,493

Other Income

3 (b)

265,841

458,992

Employee benefits expenses

(1,245,157)

(1,142,571)

Trial and investigation support

4 (a)

(2,625,216)

(2,089,748)

Administration expenses

4 (b)

(742,659)

(574,261

536,908

1,420,905

Unrealised gains/(losses) on financial assets

39,423

516,015

Total comprehensive income

576,331

1,936,920

Net current year surplus

Other comprehensive income for the year

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 Cancer Trials Group Limited Statement of Financial Position As at 31 March 2022

Notes

2022

2021

$

$

Current assets Cash and cash equivalents

5

2,251,334

1,947,853

Trade and other receivables

6

1,972,783

1,368,199

Total current assets

4,224,117

3,316,052

Non-current assets Office equipment

7

15,075

10,929

Right-of-use-assets 37,039

8

52,124

Other financial assets

9

9,717,342

8,567,706

Total non-current assets

9,784,541

8,615,674

Total assets

14,008,658

11,931,726

Current liabilities Trade and other payables

10

238,976

525,333

Deferred income

6,237,839

4,455,262

Employee benefits

44,837

59,957

Lease liabilities

11

25,774

23,210

Total current liabilities

6,547,426

5,063,762

Non-current liabilities Employee benefits Lease liabilities

52,380

48,320

11

29,441

16,563

Total non-current liabilities

81,821

64,883

Total liabilities

6,629,246

5,128,645

Net assets

7,379,412

6,803,081

Equity Retained earnings 7,108,827 6,571,919 Financial assets reserve 270,585 231,162

Total equity

7,379,412

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

6,803,081

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ANZUP Cancer Trials Group Limited Statement of Changes in Equity For the year ended 31 March 2022

Financial Assets Reserve

Retained earnings

Total equity

$

$

$

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

6,803,081

Balance at 1 April 2021

231,162

6,571,919

6,803,081

Net income for the year Other comprehensive income for the year

-

536,908

536.,908

39,423

-

39,423

Total comprehensive income for the year

39,423

536,908

576,331

Balance as at 31 March 2022

270,585

7,108,827

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

7,379,412

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ANZUP Cancer Trials Group Limited Statement of Cash Flows For the year ended 31 March 2022

Notes

2022

2021

$

$

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

5,208,356

4,043,087

Receipts from sundry income (inclusive of GST)

859,985

1,202,007

Receipts from donations (inclusive of GST)

181,663

364,588

Interest received

-

4,713

Interest paid

(51,399)

(2,791)

Dividend, interest and distribution received

242,195

168,867

Payments to suppliers and employees

(4,987,826)

(3,524,305)

Net cash inflow from operating activities

1,452,974

2,256,166

13

Cash flows from investing activities 7

(12,125)

(7,067)

Net withdrawals/(contributions) in FVTOCI financial assets

Payments for office equipment

(1,109,248)

(2,606,633)

Net cash outflow from investing activities

(1,121,373)

(2,613,700)

Cash flows from financing activities Repayment of leases

(28,120)

(19,470)

Net cash outflow from financing activities

(28,120)

(19,470)

Net increase/(decrease) in cash and cash equivalents Cash and cash equivalents at the beginning of the year Cash and cash equivalents at the end of the year

5

303,481

(377,004)

1,947,853

2,324,857

2,251,334

1,947,853

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

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2022

ANZUP Cancer Trials Group Limited Notes to the financial statements For the year ended 31 March 2022

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 2022. 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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ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2022

(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.

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ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2022

(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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ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2022

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 • t he contract includes ‘sufficiently specific’ performance obligations.

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ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2022 2022

2021

$

$

Note 3 (a). Revenue Grant income Donations Honorariums

3,978,392

3,634,331

181,663

364,588

27,661

28,147

Corporate Supporter Program

104,545

118,750

Sponsorship

115,664

387,225

Annual Scientific Meeting

476,174

235,452

4,884,099

4,768,493

Note 3 (b). Other Income Interest income

(48,626)

4,713

Investment income

242,195

168,867

Sundry income

72,272

320,500

-

(35,088)

265,841

458,992

2,411,887

1,929,748

213,329

160,000

2,625,216

2,089,748

44,265

44,419

Workshops, Meetings & Annual Scientific Meeting expense

201,808

120,597

Consulting fees

Forex gain (loss) on bank revaluation

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

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

103,238

43,779

Information technology

18,714

34,789

Insurance

23,410

13,626

338

961

Registration Travel and accommodation Catering and conference

4,936

1,916

48,873

4,836

Telephone and teleconferencing charges

15,126

6,460

Depreciation and amortisation

36,828

25,079

Marketing expenses

112,914

127,630

Sundry expenses

132,209

138,016

-

12,151

742,659

574,261

Pedalthon expenses

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

2,251,334

1,947,853

1,856,139

1,304,530

114,129

41,617

2,515

22,052

1,972,783

1,368,199

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

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ANZUP ANNUAL REPORT 2022

FINANCIAL REPORT

ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2022

Note 7.

2022

2021

$

$

Non-current assets- property, plant and equipment

Office equipment - at cost Less accumulated depreciation

44,711

32,587

(29,636) 15,075

(21,658) 10,929

Movements in carrying amounts

Carrying amount at beginning of year

10,929

8,705

Additions

12,125

7,607

Depreciation expense

(7,979)

(5,383)

15,075 10,929

Note 8.

Non-current assets- right-of-use-assets

Land and buildings – right-of-use At cost

121,301

83,285

Less accumulated amortisation

(69,177)

(46,246)

52,124

37,039

Total right-of-use-assets at end of year

Movements in carrying amounts of right-of-use-assets Land and buildings – right-of-use Carrying amount at the beginning of the year

37,039

60,684

Additions

38,016

-

(22,931)

(23,645)

52,124

37,039

Amortisation charge Carrying amount at the end of the year

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

9,717,342

8,567,706

9,717,342

8,567,706

211

14,013

238,765

511,320

238,976

525,333

Current

25,774

23,211

Non-current

29,441

16,563

Total lease liabilities

55,215

39,774

Note 10.

Current liabilities - trade and other payables

Trade payables Accruals

Note 11.

Lease liabilities

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 2022

69

ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2022

Note 12.

2022

2021

$

$

Remuneration of auditors

The following fees were paid or payable for services provided by the auditor: Audit of the financial report Other services - assistance with preparation of the financial report

Note 13.

5,800

4,650

2,600

2,600

8,400

7,250

Reconciliation of cash flows from operations with net income for the year

Net income for the year Depreciation and amortisation

536,908

1,420,905

36,828

27,040

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

(604,584)

(721,651)

Increase in trade and other payables

1,494,882

1,522,295

(11,060)

7,577

Increase/ (Decrease) in employee benefits

Net cash inflow from operating activities Note 14.

1,452,974

2,256,164

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

225,326

227,444

Transactions with related parties During the year, the company received honorariums of $27,661 (2021: $28,147). 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 (2021: 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 (2021: nil).

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

4,694,261

2,653,049

One to five years

11,224,950

6,092,237

15,919,211

8,745,285

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ANZUP ANNUAL REPORT 2022

FINANCIAL REPORT

ANZUP Cancer Trials Group Limited Notes to the financial statements continued For the year ended 31 March 2022

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 2022, the number of members was $1,989 (2021: 1,819).

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

181,663

364,588

(100,587)

(139,782)

81,076

224,806

45%

62%

FINANCIAL REPORT

ANZUP ANNUAL REPORT 2022

ANZUP Cancer Trials Group Limited Director’s Declaration For the year ended 31 March 2022

The directors of the entity declare that: 1. The 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. c omply with Australian Accounting Standards – Reduced Disclosure Requirements and the Division 60 of the Australian Charities and Not-for-profits Commission Regulation 2013; and b. g ive a true and fair view of the entity’s financial position as at 31 March 2022 and of its performance for the year ended on that date.

2. The 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 2022.

3. In 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, 30 May 2022

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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 2022, 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 2022 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 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.

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.

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 2022

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, 30 May 2022

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ANZUP ANNUAL REPORT 2022

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

ANZUP Cancer Trials Group Limited Registered office Level 6, Lifehouse Building 119-143 Missenden Road Camperdown NSW 2050 Australia

T: +61 2 9054 3600 F: +61 2 9054 3650 www.anzup.org.au

ACN 133 634 956 ABN 32 133 634 956