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Research Highlights – Committee Reports

Research Highlights Research Highlights

Scientific Advisory Committee: Ian Davis and Scott Williams

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

The SAC has evolved its agenda over time to allow it to spend more time on strategic matters and less on operational or trial-specific issues . This has allowed ideas to flow more freely and be taken up in our structures and processes . An example this year was a decision to recommend appointment of a new SAC member representing nuclear medicine, and we are grateful that Prof Andrew Scott has accepted the Board’s nomination into this role . ANZUP also welcomes Prof Lisa Butler as the scientific representative replacing Prof Pam Russell, who retired from the SAC early in 2020 . Prof Martin Stockler stood down from his role as deputy chair of the SAC, with thanks for his contributions; Martin’s SAC membership continues as clinical epidemiology representative, and we welcome Prof Scott Williams as the new deputy chair . The membership of the SAC is reviewed by the Board annually .

Meetings of the SAC were held virtually during 2020 . The planned face-to-face open meeting, usually held at the Annual Scientific Meeting, was unable to proceed . SAC functions effectively with the virtual format but face to face interactions are of great value, and we look forward to resuming these in 2021 when it is possible and safe to do so .

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

CHAIR, IAN DAVIS DEPUTY CHAIR, SCOTT WILLIAMS

Bladder, Urothelial and Penile Cancer (BUP) Subcommittee: Dickon Hayne and Shomik Sengupta

CHAIR, DICKON HAYNE DEPUTY CHAIR, SHOMIK SENGUPTA

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

Currently recruiting ANZUP trials

BCG+MM

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

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

PCR-MIB

There are 25 of a planned 30 patients enrolled on this study .

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

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

Below The Belt funded projects

Circulating immune cell changes in patients treated with Pembrolizumab and chemoradiation for bladder cancer (Weickhardt, 2016)

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

Translational work on blood biomarkers will commence upon completion of accrual of samples . ACCEPT ANZUP Co-operative multi-centre cystectomy database (Hayne, 2017)

An abstract on 100 consecutive patients was presented at the ANZUP Mini ASM in November 2020 .

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

The Exercyst Trial: Exercise Medicine Prior to Open Radical Cystectomy: Feasibility and Preliminary Efficacy (Taaffe, 2017)

We are delighted to report that all of the planned 20 patients have now been recruited .

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

Concepts

WACUP

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

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

SUBDUE-1

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

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

So far 7 patients have been recruited to this study .

During the year a protocol paper was submitted to BJUI .

ZipUp

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

Concept Development Workshops

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

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

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

Renal Cell Cancer Subcommittee: David Pook and Craig Gedye

CHAIR, CRAIG GEDYE DEPUTY CHAIR, DAVID POOK

We would like to thank everyone, including the investigators and trial teams for their continued efforts throughout a difficult and turbulent 2020 . Below is an update of renal cell trials and other ongoing activity and developments throughout the year .

The UNISoN study has the last few participants on treatment . An abstract was accepted for ASCO GU 2021 for the preliminary results of Part 1 . Part 2 of the study will be presented at ASCO 2021 with the final survival analysis being presented at ASCO GU 2022 . A translational research plan is being drafted that will be presented to the Translational Research Committee for review . Thank you to all the patients, their families, clinical trial coordinators and investigators involved in this trial and the BaCT team for coordination and data analysis . An analysis of the tumour response by RECIST in UNISoN was presented at the ANZUP mini ASM by Deepti Pandey, showing the challenges involved, and winning the best Coordinator talk at the meeting .

The KEYPAD study continues to recruit . So far KEYPAD has recruited a total of 42 patients out of a total of 70 patients . We would like to thank all the KEYPAD investigators and trial teams for their continued efforts throughout an arduous and unpredictable 2020 . The concept of inhibiting tumour associated macrophages with denosumab is increasingly relevant with many other studies testing this idea internationally . We are also looking at commencing translational research on the study, with several concepts being proposed to commence in 2021/2022 .

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

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

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

We’ve proposed a novel platform trying to test new ideas to run clinical trials in the CELEBRITY project . Funding applications were submitted during the year, but this remains in early stages of development . The idea is to make a clinical trial platform embedded in routine clinical practice using pre-existing resources . A number of emerging solutions will be tested, to see if these methods and technologies will enable us to share clinical trials to more Australians with kidney cancer .

The aim is to capture data for outcomes of most interest (e .g . survival), provide a platform for smaller sites to take part in ANZUP trials, and ultimately reduce workload for sites and improve patient outcomes . Further grant applications are being prepared and we hope to be able to develop and launch this project soon .

We would like to recognise and congratulate again Assoc Prof Andrew Weickhardt for the Below the Belt Research Fund grant: 68Ga-PSMA PET as a potential imaging biomarker post tyrosine kinase inhibition of metastatic clear cell Renal Cell Cancer (PIRC) – a pilot study . Many targeted therapies affect cancer blood vessel development, and this project seeks to understand whether a PSMA PET scan is useful in visualising patients’ tumours after they have been treated with these therapies .

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

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

We have learned this year that we as a global community can work together to solve challenging health problems . We look forward to continuing to work to the goals of preventing, treating and improving outcomes for kidney cancer in partnership with our patients .

Prostate Cancer Subcommittee: Lisa Horvath and Jarad Martin

CHAIR, LISA HORVATH DEPUTY CHAIR, JARAD MARTIN

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

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

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

DASL-HiCaP

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

Lu-PSMA Studies

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

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

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

New Concepts

The lifeblood of ANZUP is the pipeline of new trial concepts which are originally presented at a concept development workshop, and then progressed through individual working parties with updates to the prostate subcommittee .

Several evolving concepts were discussed including Primary 2 looking at the integration of PSMA PET and multiparametric MRI in the original diagnosis of prostate cancer with the aim of decreasing the need for diagnostic biopsy . In the post-operative salvage setting, two concepts are taking shape . DIPPER is looking at a mixture of treatment deintensification for the low risk patient group, and integration of PSMA PET into treatment planning for other men .

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

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

Translational Substudies

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

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

GUIDE (ANZUP 1903) Study PI Kate Mahon ENZAMET Translational Research: Serum Biomarker Project (ANZUP 1304-TR 01) Study PI Lisa Horvath EVOLUTION (ANZUP 2001) Study PI Shahneen Sandhu

Germ Cell Cancer Subcommittee: Ben Tran and Fritha Hanning

CHAIR, BEN TRAN DEPUTY CHAIR, FRITHA HANNING

Despite all the ongoing challenges we faced during the year, the Germ Cell Subcommittee had a very productive year . Below is an overview of our activity:

Study activity during the year included:

• TIGER is open at 4 sites in Australia, with recruitment at 11 patients . This study aims to demonstrate how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumours that have returned after a period of improvement or did not respond to treatment . The open-label, randomised, stratified, 2-arm, multi-centre phase 3 trial, led by

Dr Darren Feldman from MSKCC, aims to recruit 420 patients internationally, with 60 patients to be recruited from Australia and New Zealand .

• iTestis continues to expand, opening at multiple sites across the country, with data for over 300 patients on the database . This is a testicular cancer registry, supported by

ANZUP, that hopes to engage as many sites and clinicians as possible .

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

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

• Liz Connolly recently presented “A Review of the

Australian Experience of High Dose Chemotherapy and

Stem Cell Transplants for Germ Cell Tumour” at MOGA and again at the ANZUP Mini ASM . This is fantastic local data demonstrating the excellent survival in Australian germ cell tumour patients who have received high dose chemotherapy for refractory disease .

Other activity, including studies in the pipeline:

• Micro RNA analyses appear to be a promising biomarker for testicular cancer, both seminoma and non-seminoma .

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

• The use of primary RPLND in stage 2A/B seminoma and marker negative non-seminoma is gaining momentum . The

PRESTIGE protocol examining the changes in HRQoL in patients undergoing primary RPLND is being circulated and we aim to open this study in 2021 as well .

• The Germ Cell Concept Development virtual workshop was held on 13 November and resulted in a lot of productive discussion .

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

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

CHAIR, HARYANA DHILLON DEPUTY CHAIR, CATHERINE PATERSON

And that was 2020 – it literally zoomed by .

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

Concept Development Workshops

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

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

In October, we held a virtual concept development workshop, and it was inspiring to have five new concepts presented to the group, many in very early stages of development which allowed the authors to gain maximum input from the collective wisdom of the group . We were excited to hear about Catherine Paterson’s proposed mixed methods study of the unmet needs and quality of life of men diagnosed with penile cancer . This is a rare cancer, with major impacts on many, many aspects of men’s lives . The study has the potential to provide critical insights into how we can better support men affected by this cancer . It will be a world first, and help ANZUP establish networks with the clinicians treating penile cancers at the moment .

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

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

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

Subcommittee Meetings

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

Noel Castan QOL Fellowship

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

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

Online exercise for people with metastatic prostate cancer ASM 2020

We were delighted to have Cristiane Decat Bergerot join us for the mini-ASM as part of one of the ANZUP in Conversation sessions . Her insights regarding the patient experience, decision-making, and coping with GU cancers and their treatments were refreshing and provided a lot to think about .

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

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

Translational Subcommittee: Arun Azad and Anthony Joshua

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

CHAIR, ARUN AZAD DEPUTY CHAIR, ANTHONY JOSHUA

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

Translational research plans are in place for ANZUP’s prostate cancer studies, and we are looking at forming a translational research plan for non-prostate cancer trials ongoing . In addition, international trials e .g . ENZAMET and ENZARAD, have established a Translational Research Trial Executive Committee (TEC), which includes representation from the regions, and won’t be the direct responsibility of the TRS .

For ENZAMET a comprehensive program of TR has been developed (tissue-based genomics, circulating tumour DNA markers, metabolomics, lipidomics, cytokines, imaging studies, etc), and we are awaiting funding approval to proceed . We anticipate commencing this work in the next financial year .

Results from the TheraP trial have established 177Lu-PSMA as a new standard of care option in metastatic castrationresistant prostate cancer (mCRPC) . Funded by PCFA, TheraP demonstrated that Lu-PSMA had superior PSA response rates (PSA RR) and PSA-progression-free survival (PSA-PFS) compared to cabazitaxel . Despite these practice-shaping results, outcomes from Lu-PSMA are variable and identifying molecular predictors is a priority .

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

As always, we are grateful for the patients and families who enrol on our trials and donate bio-specimens that support our translational research . We could not conduct our activities without these high-quality samples . We would also like to acknowledge the participating sites thoroughness in obtaining correlative samples from our ANZUP trials . Bio-specimen collection continues as part of existing trials, including ENZA-p, DASL-HiCaP, BCG+MM, P3BEP, KEYPAD, UNISoN and PCR-MIB .

We look forward to a productive year ahead for the Translational Subcommittee and continued translational research activity for ANZUP .

Consumer Advisory Panel: Belinda Jago and Ray Allen

CHAIR, BELINDA JAGO DEPUTY, CHAIR RAY ALLEN

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

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

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

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

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

Highlights of the year in review

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

- CAP members Melissa Le Mesurier and Michael Twycross were able to assist with publicising the lack of supply for

BCG/Mitomycin which gained media attention .

- The CAP all made great contributions in some way (fundraising, promoting, participating and donating) to ANZUP’s new and innovative fundraising campaign

“#YourWay” to raise funds and awareness for “below the belt cancers” . We are now in the process of signing up for the 2021 “Move #YourWay” campaign .

- We greatly missed our annual face to face education session and Annual Scientific Meeting, but we had the opportunity to attend the virtual Mini ASM #ANZUP2020 .

This was a fabulous way to finish off the year COVID-style and included many excellent presentations . Well done to CAP member Melissa Le Mesurier who co-chaired the

ANZUP Symposium . We also want to offer our gratitude to Scott Williams and Dickon Hayne for their public acknowledgment of the commitment and work that we so willingly do to support ANZUP’s research activities from a consumer perspective . We are now very much looking forward to the face to face Adelaide ASM in October 2021 .

- The CAP was also represented in the recent Renal Cell

Carcinoma (RCC) Horizon Scanning Meetings . They are a series of structured activities and discussions to identify and explore the top research priorities for RCC research in

Australia and New Zealand .

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

- The CAP was also involved as a team in reviewing the research applications received for the Below the Belt

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

Other key activities in 2020/21 include:

The CAP had the opportunity to review Participant Information and Consent Forms for: - ZipUp - UNICAB Teletrial - GUIDE

UNICAB Teletrial PICF

The CAP reviewed the original UNICAB PICF back in 2018 (not recruiting as a teletrial) . This PICF had been adapted for use in a teletrial model that has been developed rapidly to deal with COVID-19 . Positively, the CAP noted that from a community point of view, despite the terrible affects of COVID-19, it has certainly sped up the process for developing the teletrial models . This has ultimately meant much better access for trials, especially for those living in regional and rural areas . ACTA Trial of the Year Awards – Consumer Involvement Award

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

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

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

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