Chief Executive Officer’s Report

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 . 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 .

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 .

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 .

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

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

Zealand

• Strengthen ANZUP’s capacity for practice-changing clinical trials

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

• Provide 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 . 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 .

Education and mentoring:

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 .

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.

Collaborations:

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 .

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