UPdate Summer 2019

The Newsletter of ANZUP Cancer Trials Group Limited

SUMMER 2019

CHRISTMAS MESSAGE FROM THE CEO

MARGARET MCJANNETT CEO, ANZUP

As we draw a close to this decade and look ahead to the 20’s, it is a great time to reflect on ANZUP’s achievements over the past 12 months.

In terms of our trials there is little doubt 2019 has seen some significant milestones for ANZUP. In particular, in June we celebrated a major achievement with our ENZAMET trial featuring at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. It certainly propelled us onto the international stage! Special thanks to the Study Co-chairs, Ian Davis and Christopher Sweeney for their commitment and leadership and to our local and international investigators from across the 85 sites, our collaborators at the NHMRC CTC, Cancer Trials Ireland, Dana-Farber Cancer Institute and the Canadian Cancer Trials Group, and to all the patients who participated on the trial. We were also featured in a Channel 9 news story on the importance of Translational Research in Clinical Trials. Men who participated in ANZUP’s ENZAMET and ENZARAD trials were asked to consent to the collection of blood and tissue samples for the purpose of translational research. Over 100,000 samples have been collected around the world, and are in the process of being transported to our central biobank at Chris O’Brien Lifehouse in Sydney. This will be one of the largest (if not the largest) collections of its type in Australia.

But it’s not just all about the ENZA studies! ANZUP’s clinical trials portfolio continues to grow across the major cancers we represent.

Currently we have 7 ANZUP-led active

and recruiting trials, 3 co-badged trials, 6 protocols in development, 25 concepts presented across 5 concept development workshops; and 6 Below the Belt Research Grants awarded in July. We are in discussions around ANZUP collaborating with international trials to answer important questions in these rare cancers.

We were delighted to announce that three of our trials reached their recruitment targets in the last couple of months; TheraP, UNISoN and PainFree TrusB. In September the last patient was randomised to our TheraP trial, five months ahead of schedule. Study Chair Michael Hofman, led this important prostate cancer study and we look forward to sharing the results with you in the New Year.

Shortly after the UNISoN trial reached its target of 85 patients, nine months ahead of the planned recruitment. We are grateful to Study Chair Craig Gedye, for his extraordinary efforts in leading this study, all the investigators and dedicated trial staff across Australia who did an amazing job on this important Non-Clear Cell Kidney Cancer trial.

Finally, last month we congratulated Nick Buchan and the Pain Free TRUS B team for recruiting the final patient & reaching the target of 420 patients – yet another significant milestone!

THE ENZAMET TEAM AT ASCO

There are also a number of exciting new studies due to open in early 2020 – including DASLHiCaP, ENZA-p and UpFrontPSMA. You can read more about these trials throughout this edition of UpDate.

Our 2019 ASM was another major achievement this year attracting ~400 delegates to Brisbane across the three days.

The theme ‘Making Connections’ explored how we can improve patient /carer/ clinician access to the right information, including supportive care and clinical trials, while encouraging links between the various disciplines, researchers and cross border collaborations. We are extremely grateful to the dedicated and hardworking convening committee led by the ever-thoughtful David Pryor developing a program that provided us with the most up to date scientific presentations from an impressive national and international faculty.

Our extraordinary international faculty Kelly Parsons, Phuoc Tran, Alison Birtle, Catherine Paterson and Betsy Plimack shared with us their insights, expertise and “talent” to ensure another high quality and innovative program that had something for everyone!

This year also marked the 6th year of our Below the Belt Pedalthon in Sydney and our second Pedalthon in Melbourne. Since its inception in 2014, we have raised over $1.65 million, which is in itself incredibly humbling, and has helped provide much needed seed funding to support our members to progress their new trial ideas to the point of becoming full scale studies. We thank every supporter; participant and donor for helping us reach this amazing goal. Whether you are an avid cyclist, new to the sport or just looking for a fun day, we invite you to join us in either Sydney or Melbourne and help us to continue to support the Below the Belt Research Fund. And if you can’t be there in person, you can always support, donate or promote the event through your networks.

For more details visit www.belowthebelt.org.au.

As we stop and reflect on the year that was, I think it’s important we acknowledge and thank all the truly amazing and dedicated people who continue to take time out of their very busy schedules to support and contribute to ANZUP. I would particularly like to thank our extremely hard working Board, led by Ian Davis and Guy Toner, the SAC, subcommittee chairs, deputy chairs, our CAP, Study Chairs, Site Investigators and the hundreds of Trial Staff and members; ANZUP would not exist without you and we certainly wouldn’t have achieved what we have without your tireless efforts.

To our wonderful volunteers Lesley Tinkler and Jo Stubbs, thank you for continuing to turn up each week (except when you are on holidays) and support ANZUP in anything and everything we ask of you. To our colleagues at NHMRC CTC and BaCT, our corporate supporters, sponsors and donors, thank you for your support and your invaluable contribution. I count myself extremely fortunate to work with such dedicated and hardworking team who continue to strive to support all our members and me. Thank you for your loyalty and support.

On behalf of the Board and management team, I wish you and your families our very best wishes for the festive season and a safe, happy and very successful 2020.

MARGARET MCJANNETT CEO, ANZUP 2 | ANZUP UPdate Summer 2019

HELLO, WELCOME TO ‘UPDATE’ Contents: CHRISTMAS MESSAGE FROM CEO . . . . . . . . . . . . . . . . . . . . Cover

MESSAGE FROM THE CHAIR . . . . . . . . . 3

ANZUP 2019 – YEAR IN NUMBERS . . . . 4

ANZUP CLINICAL TRIAL UPDATES . . . . . 7

TELETRIALS . . . . . . . . . . . . . . . . . . . . . . . 10

CREST/ACCORD WORKSHOP . . . . . . . 11

DISCRETE CHOICE EXPERIMENT WORKSHOP . . . . . . . . . . . . . . . . . . . . . . . 12

NEWS IN BRIEF . . . . . . . . . . . . . . . . . . . . 13

ANZUP SYDNEY PEDALTHON 2019 . . . 18

UPDATES FROM SAC AND SUBCOMMITTEES . . . . . . . . . . . . . . . . . 23

OTHER NEWS . . . . . . . . . . . . . . . . . . . . . 32

UPCOMING EVENTS . . . . . . . . . . . . . . . 35

MESSAGE FROM THE CHAIR

Welcome to this edition of UPdate, the newsletter of the Australian & New Zealand Urogenital and Prostate Cancer Trials Group Ltd (ANZUP)!

The chaos and excitement of ASCO, with our plenary presentation and our simultaneous NEJM paper, are now well behind us.

Don’t be fooled though into thinking that things have quietened down for ANZUP: it might appear that way, but everything is relative!

1. ENZAMET: the action there is by no means finished.

Martin Stockler presented some of the hot-off-thepress quality of life data at ESMO in September. This work showed that there were some early impairments in specific aspects of quality of life for me receiving enzalutamide on the trial, but overall we found improvement in deterioration-free survival (defined as the earliest of death, clinical progression, cessation of study treatment, or clinically important worsening from baseline scores in pertinent quality of life subscales). The early impairments due to side effects were insufficient to outweigh the benefits in terms of delay in clinical progression or improved survival. This is important: we need to understand the effects on our patients of introducing treatments earlier (and possibly for much longer) in their treatment course. This work gives us confidence that we are having positive impact in areas important to patient well-being and beyond the main trial endpoints of survival or progression.

We are here to improve things for our patients and their families: that’s in our mission, and here is level 1 evidence that we are doing it.

There has been widespread uptake of the information out of ENZAMET. People were obviously interested in the main findings, but I think many were surprised that we did not find an overall survival benefit by adding docetaxel to the mix. That’s not to say there isn’t one: we just didn’t detect it at this interim analysis, and there is a benefit in

secondary endpoints such as PSA or clinical progression, so the possibility exists that we might see something in the future. However, one important message from ENZAMET did get out and we think this will alter practice: clinicians in places like the USA that have access to multiple agents should not assume that if A is good, and B is good, then A+B = even better. “It seemed like a good idea” is not good enough for our patients when we have evidence of this quality to suggest otherwise.

Hot off the press - this week the US FDA approved the use of enzalutamide for men with metastatic hormonesensitive prostate cancer (mHSPC). And although this is not yet approved in Australia, it’s a great step forward and another option for men in the US with mHSPC. There is far more to come for ENZAMET. We plan to report longer term outcomes, especially for that group of patients who did well on both arms and so were not included in the interim analysis. We want to look further at the effects of the combination with docetaxel. We are planning detailed translational studies, and health economic studies, and no doubt many more riches will fall into our hands from this work.

2. Other current studies: Look around you at the ANZUP portfolio: it is booming! Since the last UPdate we have completed recruitment to UNISoN, TheraP and Pain Free TrusB. Three very important trials that may well change practice in the future. I won’t go into them all (you will read more inside this newsletter), but here’s a taste of what else is on offer: • U NICAB: an opportunity to use cabozantinib for non-clear-cell renal cell carcinoma patients who have received prior immunotherapy (mostly patients previously on UNISoN) – now open.

• P hase 3 BEP: an international study that has just ticked over 100 patients recruited.

ANZUP UPdate Summer 2019 | 3

MESSAGE FROM THE CHAIR • B CGMM: this has reached half of its planned 500 patient recruitment.

• K EYPAD: this week reached 50% recruitment milestone of the planned 70 patients.

• P CR-MIB: a great option for patients considering bladder-conserving therapy.

• A nd many more! Check the ANZUP web site, or look at the ANZUP ClinTrials Refer app, for more information.

4. Lots Of Other Cool Stuff™. The team works tirelessly throughout the year on a range of other activities. We are planning our 2020 calendar but we have recently held our 2019 Best of GU symposium and our GU preceptorship, a day specifically for concept development for the joint ANZUP/PCFA prostate cancer clinical trials initiative, and held some fundraising activities. 2020 will see the return of the Concept Development Workshops, the Below the Belt Pedalthons, and lots more including some ideas early in development that we hope will come to fruition. The subcommittees and the Scientific Advisory Committee, our engine room of ideas, keep chugging along and generating new ideas and opportunities. If you are not part of that and you wish to be, just let us know: we want to provide opportunities for people to get involved.

Did you know:

And that is only some of the currently-active trials. We are brewing ideas across all of our disease types, and some of these will be kicking off in the near future.

3. 2020 Annual Scientific Meeting, 19-21 July 2020 in Adelaide. Our convenor Nick Brook and his team are doing a great job pulling the program and the faculty together for what is shaping up to be another fantastic meeting. The ASM theme is “Clear Vision,” which raises all sorts of interpretations: vision for the field, for our patients, and for ourselves; looking forward and looking back; uncovering and facing difficult truths; recognising, challenging, and shedding dogmas; understanding the personal and societal impact of cancer on our patients and ourselves; being able to focus beyond the tips of our own noses and see other people; being self-aware; and many more that you might be able to, well, envision. There will be the usual plethora of other activities including symposia, MDT Masterclass, and many others. You can keep track of progress here https://www.anzup.org.au/content.aspx?page=asmpreview2020.

Make sure you block out the time in your diaries now.

<waiting> OK, you’re back, thanks. See you there!

4 | ANZUP UPdate Summer 2019

• S ince 2008 we have run 26 trials involving over 4500 participants internationally • S ince the Concept Development Workshops were instituted in 2016 we have reviewed 126 concepts, many of which have gone on to development as trials • W e have provided over 280 ANZUP fellowships, scholarships, and awards, totalling over $600k There is a lot happening!

Special thanks as always to our CEO Marg McJannett, and to our wonderful staff and team of supporters. Some people wind down as the Christmas/ New Year period approaches; it seems to us that our activity only increases. This is a great problem to have. It is fantastic to be able to celebrate what we have achieved. It’s even better to be able to look ahead and see future opportunities to help the people we are here to serve.

We cannot do it without you, and we are very grateful to all of you for your support, your advice, and your involvement. We have achieved much; there is still much to do.

Please enjoy this edition of UPdate.

IAN DAVIS ANZUP Chair

ANZUP 2019 â&#x20AC;&#x201C; YEAR IN NUMBERS MEMBERSHIP

>68%

1,670+ members

2016

2017

2018

since 2016 (992)

2019

TRIALS

10

7 2016

2017

14 14 2018

2019

ASM

NEW TRIAL PARTICIPANTS IN 2018/19

DELEGATES

921

335

390

392

2017

2018

2019

PRECEPTORSHIP ATTENDEES

WORKSHOPS

36

42

39

CDW CONCEPTS

2017

2018

2019 ATTENDEES

2017

2018

2019

4

4

5

22

27

25

98

106

120

ANZUP UPdate Summer 2019 | 5

ANZUP 2019 â&#x20AC;&#x201C; YEAR IN NUMBERS ANZUP CLINTRIAL APP SCREEN VIEWS

CORPORATE SUPPORTERS IN-KIND SUPPORTERS

6

3

2019 1,446 1,604 1,724 2017

2018

WEB PAGE VIEWS

2017

140,912

2018

174,063

2019

197,390

FELLOWSHIPS, SCHOLARSHIPS AND AWARDS 47 INC TRAVEL FELLOWSHIP, STUDY CO-ORD, YOUNG INVESTIGATOR AND BEST OF THE BEST

33 51

TWITTER FOLLOWERS

2019

2019

2017

2017

243

4,176 LAPS

315

5,400 LAPS

FUNDS

324

5,183 LAPS

FUNDS

RIDERS

$255K

FUNDS

2018

2019

2018

RIDERS

2019

RIDERS

$297K

$236K

2299 2019

ANZUP

1891 2018

1560 2017

6 | ANZUP UPdate Summer 2019

BELOW THE BELT RESEARCH FUND GRANTS

7

8

6

2017

2018

2019

ANZUP CLINICAL TRIAL UPDATES TheraP and UNISoN reach recruitment and UNICAB enrols its first patient!

ANZUP has seen a couple of significant trials reach recruitment recently – TheraP, a new treatment for advanced prostate cancer using Lutetium-177 PSMA radionuclide therapy (Lu-PSMA). Also UNISoN, which will test whether new immune treatments can help people with rare kidney cancer (‘non-clear cell’ cancer).

On Tuesday 10 September the last patient (number 200) was randomised to ANZUP’s TheraP trial, five months earlier than expected.

Our Study Chair Prof. Michael Hofman, led this important prostate cancer study. ANZUP are proud to be at the cutting edge of research and we look forward to sharing the results.

TheraP is a truly collaborative effort – being a partnership between ANZUP and the Prostate Cancer Foundation of Australia (PCFA) with funding and support from the Australian Nuclear Science and Technology Organisation (ANSTO), Endocyte, It’s a Bloke Thing, Movember and CAN4CANCER. The study is an investigator initiated collaborative group study led by ANZUP in collaboration with the NHMRC CTC. A week later, on Thursday 19 September, the final patient was recruited to our UNISoN trial, nine months ahead of the planned recruitment timeline.

A/Prof Craig Gedye, our Study Chair, and all the investigators and dedicated trial staff across Australia have done an amazing job to get the trial to this point.

The study is in two parts, testing the effectiveness of combination immunotherapy in patients failed by PD1 immunotherapy alone.

ANZUP looks forward to sharing further updates on this important kidney cancer study, and are very proud of everyone who helped us get to this point, including our supporters BMS, and the team at the Centre for Biostatistics and Clinical Trials (BaCT).

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

In September we also saw our UNICAB trial recruit its first patient. The study is currently open at 10 of the 11 sites across Victoria, NSW, QLD and SA. Thank you to the teams from the open sites who continue to actively screen patients, and to Border Medical Oncology for registering the first UNICAB patient on 23 September 2019.

UNICAB is a Phase II Trial Of Single Agent Cabozantinib In Patients With Locally Advanced Or Metastatic NonClear Cell Renal Cell Carcinoma Post Immunotherapy Or Who Are Unsuitable For Immunotherapy.

Congratulations to Study Chair Dr David Pook and all the investigators and trial coordinators for helping to get the study to this point, and we look forward to sharing further important milestones.

You can read more about ANZUP’s trials here https://www.anzup.org.au/content.aspx?page=clinicaltrials.

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

SHAUN JENKINSON (ANSTO), A/PROF ANTHONY LOWE, PROF MICHAEL HOFMAN (STUDY CHAIR) AND MARG MCJANNETT (ANZUP) AT THE OPAL REACTOR

ANZUP UPdate Summer 2019 | 7

ANZUP CLINICAL TRIAL UPDATES

BCG MM (ANZUP 1301)

TIGER (ANZUP 1604)

Study sites: 13 sites open to recruitment

Study sites: 4 sites open

Recruitment: 254 patients randomised

Recruitment: 5 patients randomised

Target: 500 patients

KEYPAD (ANZUP 1601) Study sites: 14 sites open to recruitment in Australia with 2 more expected in 2019

Target: 420 patients internationally and 60 ANZ

UNISoN (ANZUP 1602)

Study Sites: 19 sites open

Recruitment: 35 patients randomised

Recruitment: 85 patients randomised in Part 1 & 41 patients randomised in Part 2

Target: 70 patients

Target: 85 patients Part 1 and 48 patients Part 2

P3BEP (ANZUP 1302)

UNICAB (ANZUP 1802)

Study sites: 42 sites open and recruiting 19 (ANZ), 10 (UK) and 13 (US)

Study sites: 11sites open

Recruitment: 108 patients randomised Target: 500 patients

PCR MIB (ANZUP 1502)

Study sites: 6 sites open to recruitment in Australia.

Recruitment: 20 patients randomised Target: 30

8 | ANZUP UPdate Summer 2019

Recruitment: 6 Target: 48 patients

ANZUP CLINICAL TRIAL UPDATES ANZUP studies soon to open ENZA-p (ANZUP 1903)

ANZUP Co-badged studies FASTRACK II (TROG 15.03)

Study sites: 12 anticipated to participate

Study sites: 8 sites open and recruiting

Recruitment: 0

Recruitment: 62 patients randomised

Target: 160 patients

Target: 70 patients

#UpFrontPSMA (ANZUP 1904) Study sites: TBD Recruitment: 0 Target: 140 patients

DASL-HiCaP (ANZUP 1801) Study sites: close to 100 anticipated

Recruitment: 0 Target: 1,100 patients across Australia, New Zealand, US, Canada, UK and Ireland

NINJA (TROG 18.01)

Study sites: 10 sites are anticipated to participate across Australia. Currently 3 sites are open Recruitment: 28 patients so far

NMIBC-SI Evaluation Study sites: 17 sites open

Recruitment: Patients enrolled field test 1: 220 (closed - completed) Patients enrolled field test 2: 198

ANZUP UPdate Summer 2019 | 9

TELETRIALS ANZUP to pilot Teletrials Model in 2020 In 2019, ANZUP has made crucial headway with implementing a teletrials model, with the UNICAB trial set to pilot the model in 2020.

The ANZUP teletrial model is being developed, with guidance and advice provided by the Clinical Oncology Society of Australia (COSA), who have released supervisory plans as well as national guide for implementation. ANZUP has also consulted with the Victorian Comprehensive Cancer Centre (VCCC) to discuss the various logistical processes involved in setting up a clinical trial within different types of models.

UNICAB is a single agent trial looking at evaluating the study drug cabozantinib in patients with locally advanced or metastatic non-clear renal cell carcinoma. Due to the simple study design of the trial, coupled with the fact that the study drug is an oral drug with no complicated nor involved shipping and storage conditions, the UNICAB trial was picked as the first ANZUP trial able to pilot the ANZUP teletrial model. Currently, a feasibility assessment has been sent to the particular hospital identified as a potential good fit to run the teletrial model servicing a catchment area of approximately 380,000 people across the border of two States. This hospital will act as a Primary hospital, taking on the responsibility of the satellite hospital/s within the regional trials network it belongs. It will aim to deliver treatment and oversight to these hospitals expanding access to the UNICAB trial in communities that would not likely have had any other opportunity to participate, and whereby would need to have travelled long distances to larger hospitals to gain access.

Access to specialist cancer care services is a significant issue faced by residents of rural, remote, Indigenous and some regional communities in countries with large rural and outer metropolitan populations.

The lack of access to specialist services may be due to a lack of specialist oncologists locally, limited scope of practice of other rural health professionals and/or overall rural workforce shortages. Poor access to such specialised health care services could be one of the contributors to the disparity in survival and disease related outcomes 10 | ANZUP UPdate Summer 2019

that exist between metropolitan and non-metropolitan patients, although the authors acknowledge this issue is complex and may also relate to other factors such as behavioural or cultural factors.

Clinical trials offered to people diagnosed with cancer may include new and experimental drug therapies or imaging technologies, minimally invasive diagnostic or surgical techniques, or supportive care interventions.

However, as with access to specialist care, patients living outside of major metropolitan centres face many barriers in accessing clinical trials. Barriers to participation include the limited availability of trial sites closer to home and the increased cost and inconvenience of travel to major centres where the trials are taking place.

The core principles of the teletrial model are: 1. To increase accessibility to trials thereby reducing the need for people with cancer to travel to larger centres to attend study related visits and undertake study related procedures. Using tele-oncology models, there is an opportunity for patients from rural or regional sites to be recruited, consented, treated and attend follow-up visits â&#x20AC;&#x201C;a hub-and-spoke approach between a primary trial site and a satellite site.

2. To develop collaboration and networking between regional/rural and metropolitan centres, and between tertiary centres even within the same metropolitan setting, with the aim of delivering greater engagement in research activity, improving adherence to evidence based practice, improving the rate of recruitment of patients into clinical trials, reducing the disparity in cancer outcomes for geographically dispersed populations, building clinical trial capacity, and providing trial-related training.

The implications of telemedicine and teletrials, and the consideration of how to engage and support rural and remote communities in research in genitourinary cancers, is of crucial importance to ANZUP as we work towards our mission of improving both treatments and outcomes for those with a GU cancer diagnosis over a vast demographic and geographic representation across Australia.

Information derived from: https://www.cosa.org.au/groups/regional-rural-oncology/activities/

CREST/ACCORD WORKSHOP

On the 31st of August 2019, I was excited to be heading up to Chris Oâ&#x20AC;&#x2122;Brien Lifehouse in Sydney to attend the Asia Pacific Clinical Oncology Research Development (ACORD) one day Concept Development Workshop.

On the day, Prof Martin Stockler and key faculty members gave a series of didactic presentations interspersed with small-group sessions. Although the material and research principles delivered were at times weighty, the faculty held the rapt attention of participants with their charismatic teaching styles.

One of the things I valued most from this workshop was the opportunity to obtain tailored feedback about my concept from a panel of faculty members and other workshop participants. This laudable workshop format transformed an already excellent learning day into an incredible, personalised experience. Prof Stockler, as well as other faculty members with a wide spectrum of expertise, provided excellent input which enabled us to refine our concepts. These small-group sessions were run as a dynamic series of short presentations by each participant in turn, followed by intensive targeted feedback. All presentations were timed, thus ensuring that each participant had equal opportunity to deliver a succinct concept, ask goal-orientated advice from the panel, and glean immediate feedback.

I went away from this workshop feeling inspired and better placed to write up new concepts in a persuasive and effective style. I am truly grateful for the constructive comments and advice I received from Prof Stockler and his powerhouse team, and look forward to progressing my concept further.

The week-long Protocol Development Workshop scheduled for September 2020 will undoubtedly be an invaluable chance to learn more. I do hope to be given the opportunity to attend!

LIZ LIOW ANZUP FELLOW

This laudable workshop format transformed an already excellent learning day into an incredible, personalised experience.

ANZUP UPdate Summer 2019 | 11

DISCRETE CHOICE EXPERIMENT WORKSHOP I was grateful to be invited to attend the discrete choice experiment (DCE) workshop organized by the Cancer Research Economics Support Team (CREST) in Sydney on the 11th of November 2019. This workshop was chaired by the eminent A/Prof Richard De Abreu Lourenรงo. Other faculty included prominent experts in the field, Prof Stephen Goodall and Prof Debbie Street.

DCEs are a systematic survey method that can be used as a powerful tool to evaluate health care interventions and their outcomes. DCEs utilize a unique design where each survey question is presented as a scenario with 2 varying sets of features or attributes. By pitching one hypothetical scenario against another, respondents are asked to indicate their preference and acceptability of competing alternatives.

The lucky participants of this workshop were exposed to a jam-packed day of learning that incorporated both didactic teaching as well as interactive sessions. The workshop program was split into 5 sessions: introduction to DCEs, attribute selection and vignette development, designing experiments and survey construction, data analysis, and last but not least, the practicalities of DCEs. A particularly useful activity was the opportunity to read and dissect a DCE publication. We were then invited to debate, discuss, and answer questions relating to our DCE journal article in small groups.

The sheer amount and complexity of data presented in the papers provided me with important insights on the robust research methods involved with designing, analysing, and reporting DCEs. I have to admit that the statistical aspects of analyses which included models such as mixed logit, multinomial logit, and random effects logit, were somewhat daunting! Thankfully, all the presenters were patient teachers who did not mind the many questions put forth by the group of enthusiastic participants.

12 | ANZUP UPdate Summer 2019

I thoroughly enjoyed being introduced to this impactful research instrument on this day. I relished spending a productive day learning about the key aspects of designing a discrete choice experiment (DCE), meeting participants of different backgrounds, and familiarising myself with viewing healthcare from a health economics perspective. As ANZUP fellow, I am keen to be able to make positive contributions to all ANZUP research endeavours. Armed with my newfound knowledge, I look forward to potential collaborative opportunities with the CREST team on future ANZUP projects that may benefit from the incorporation of stated preference data.

Liz Liow ANZUP Fellow

NEWS IN BRIEF The Advanced Prostate Cancer Consensus Conference (APCCC19) The APCCC took place on 29 â&#x20AC;&#x201C; 31 August 2019 in Basel, Switzerland.

The Advanced Prostate Cancer Consensus Conference (APCCC) was initiated to provide a forum to discuss and debate current questions on the clinical management of men with advanced prostate cancer, with a special focus on these unclear situations. Two days of the conference are dedicated to high-level presentations, discussions, and debates to summarize and conceptualize the available literature and evidence.

A number of ANZUP members including ANZUP Chair Ian Davis, Bertrand Tombal, Chris Sweeney, Michael Hofman, Declan Murphy and Mark Frydenberg were involved in the scientific program and join the discussion with fellow prostate cancer experts from around the world.

You can learn more about the program online: https://www.apccc.org/apccc2019.html.

The conference concludes with voting by an interdisciplinary expert panel on pre-defined consensus questions targeting areas of clinical relevance. Following the conference, a manuscript with these expert recommendations is published in a peer-reviewed journal.

APCCC focusses on idealised situations, but in the end provides useful expert consensus recommendations particularly for areas where no clear evidence exists to guide practice.

Ian Davis ANZUP Chair

ANZUP & PCFA Partnership Grant With the renewal of our Memorandum of Understanding for our PCFA ANZUP Partnership Grant for a further three years, ANZUP called to our membership for prostate cancer concepts.

An array of ideas and concepts were submitted and in order to reach the shortlist we received feedback from a multidisciplinary panel with the end goal aim of becoming an ANZUP sponsored Protocol.

The shortlisted applicants presented their concepts on Tuesday 26 November 2019 in Melbourne, and it was great to see so many enthusiastic members and creative and interesting concepts.

Congratulations to the shortlist: David Wetherell, Kate Mahon, Anthony Joshua, Shahneen Sandhu, Craig Gedye, and Louise Emmett with Matthew Roberts.

ANZUP UPdate Summer 2019 | 13

NEWS IN BRIEF USANZ NZ Section Meeting In October, ANZUP CEO Marg McJannett and Shomik Sengupta attended the USANZ New Zealand Section Meeting in Christchurch to provide an update on ANZUP’s trials, activities and performance for the year.

The Genito Urinary Meeting, which was chaired by ANZUP Board member Nick Buchan, took place on the first day of the conference, and along with Shomik presentation on behalf of ANZUP, Nicky Lawrence also presented on the ANZUP Trials ENZAMET results.

2020 Concept Development Workshops Face to face Concept Development Workshops (CDW) for each of the cancers ANZUP focuses on will be held in the second quarter of 2020.

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

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

2020 CDW dates: • Quality of Life – 1 April • Renal Cell – 2 April • Germ Cell – 7 April • BUP – 30 April • Prostate – 1 May

14 | ANZUP UPdate Summer 2019

The ANZUP concept development process:

IDEA

CDW

SAC

WORKING GROUP

• New idea or concept • Complete concept outline

• Reviewed by MDT • Written feedback

• S AC endorsement based on subcommittee recommendations

• W orking group for development, mentoring and support

NEWS IN BRIEF

Best of GU Oncology Evening Symposium 2019 â&#x20AC;&#x201C; Adelaide Food for thought was on the menu at the Best of GU Evening Symposium, held in Adelaide on Wednesday 6 November. Adelaideâ&#x20AC;&#x2122;s GU oncology community dined out on the latest in uro-oncology, radiation oncology, medical oncology and nuclear medicine from experts in the field.

The evening commenced with a great presentation from A/Prof Catherine Paterson on the un-met needs of men with uro-genital cancer from. Technology was on our side and we were fortunate enough to then Zoom in Dr Alison Birtle from the UK, talking about connecting trial networks to study uncommon malignancies, and lessons learnt from the POUT trial.

A/Prof Louise Emmett gave a comprehensive update on theranostics in prostate cancer, and the evening concluded with A/Prof Nick Brook talking about the #ANZUP2020 ASM being held in Adelaide from 19-21 July 2020.

Thank you to the presenters, attendees and a special thanks also to our sponsors Astellas, AstraZeneca, Ipsen and MSD. The videos from the event are also available to watch online here.

Prof Henry Woo, who also chaired the Symposium, presented highlights from the numerous talks that Prof Kelly Parsons gave at #ANZUP19.

ANZUP UPdate Summer 2019 | 15

NEWS IN BRIEF ANZUP Preceptorship 2019 On 29 and 30 November, 39 trainees came together for a day and a half of intense learning under the guidance of 8 ANZUP Preceptors and Convenor Professor Eva Segelov.

Consistently rated ‘above and beyond’ expectations, the 2019 Prostate Cancer Preceptorship didn’t disappoint.

With most attendees citing career development as their motivation for taking part, the pathways small group discussions, seminal papers, quiz the expert sessions and interactive multidisciplinary nature of the course provided excellent take home value.

Participants prepared papers in advance with awards for the best presentations during the Preceptorship given to James Churchill, Sarah Latham, Olivia Perelini, Alice Minhinnick & Alistair Wickham.

Thank you to Convenor Eva Segelov and Assistant Convenor Cameron McLaren for helping put together this expert, interactive program. Also many thanks to the Preceptors Venu Chalasani, Louise Emmett, Amy Hayden, Jarad Martin, Shahneen Sandhu, Jeremy Shapiro and Henry Woo who gave up their time to ensure another fantastic workshop.

Thanks also to our 2019 sponsors Astellas, AstraZeneca, BMS, Ipsen, and Janssen – we could not run this important program without their support.

To stay up to date with future learning and development opportunities, visit www.anzup.org.au and follow us on Twitter @ANZUPtrials.

Valuable experience being able to meet with different specialties, gain appreciation of how they contribute to GU cancers and how we got to where we are. The preceptors were inspirational and simply brilliant. Extremely impressed with their professionalism, knowledge and adaptability to discussions. Thank you for a great opportunity.

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Well done on putting this together to encourage and foster the next generation of prostate docs.

NEWS IN BRIEF

ENZAMET - Health Related Quality of Life (HRQoL) Health-related quality of life (HRQoL) in a randomised phase 3 trial of enzalutamide with standard first line therapy for metastatic, hormonesensitive prostate cancer (mHSPC).

Health-related quality of life was a key secondary outcome in the ANZUP-led ENZAMET trial.

HRQoL of participants in the ENZAMET trial was evaluated using three measures developed by the European Organisation for Research and Treatment of Cancer (EORTC) and the EuroQol Group to determine the different treatment effects of the two participating patient groups.

The following questionnaires were used to comprehensively assess HRQoL: • The EORTC Core Quality of Life questionnaire (QLQ-C30) a general measure of HRQoL used across cancer populations, includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), and a global health and qualityof-life scale. Symptoms commonly reported by patients (dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), are assessed along with the financial impact of the disease and treatment.

• The EORTC Prostate Cancer Module (QLQ-PR25) asks 25 questions to assess HRQoL specific to men with prostate cancer. It includes rating scales assessing urinary and bowel symptoms, hormone treatment symptoms, sexual function, and use of incontinence aids.

• The EQ-5D-5L questionnaire is a standardised, selfrated measure of health status designed to provide a score for use in evaluation of the economic costs of the treatment. It provides a descriptive classification based on self-assessment of 5 categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 5 level rating scale.

ENZAMET STUDY CO-CHAIR PROFESSOR CHRISTOPHER SWEENEY WITH THE HRQOL POSTER AT ESMO

Conclusions The addition of enzalutamide (versus non-steroidal anti-androgen therapy (NSAA: bicalutamide, nilutamide, or flutamide)) to testosterone suppression saw: • Global health and quality of life was maintained; • Improved deterioration-free survival (defined as the time from when the patient was randomised to their first significant worsening of physiological signs and symptoms, or death); o The early impairments in specific aspects of HRQoL did not outweigh the subsequent benefits of delayed clinical progression; • Deterioration-free survival benefits at 3 years were smaller with treatment with early docetaxel than without it, however these difference were not beyond the play of chance.

Enzalutamide added to testosterone suppression alone: • Is an appropriate option for men with metastatic hormone-sensitive prostate cancer starting testosterone suppression alone.

For men who are candidates for docetaxel treatment when starting testosterone suppression: • Longer follow-up is needed to determine if the delays in disease progression and in the time to clinical deterioration with enzalutamide and concurrent early docetaxel treatment also results in improved overall survival beyond 3 years.

The results of this study were presented as a Poster Discussion by Martin Stockler and exhibited for the duration of the Congress at the European Society for Medical Oncology (ESMO) Congress in Barcelona on Sunday 29 September 2019.

ANZUP UPdate Summer 2019 | 17

ANZUP SYDNEY PEDALTHON 2019

Another fantastic day was had by all with 174 riders from 35 teams taking to the track at Eastern Creek, and raising more than $160,000 so far to support your research endeavours via ANZUP’s Below the Belt Research Fund.

The energy, enthusiasm and generosity shown by our “Pedalthoners”, our sponsors and their supporters ensured our 6th year of racing was one of the biggest and best years yet.

The NSW Police won the 2019 Below the Belt Champions with a combined team total of 164 laps – a great team effort.

Our very own ANZUP All Stars Team rose to the occasion, as the 1st highest fundraisers. Special mention also goes to Morton, Quarry Mining, Macquarie Crankers and the ANZUP Dream Team who reached the top 5 fundraisers.

We are very grateful to this year’s Platinum Sponsors Morton Real State and homely.com.au, Gold Sponsors GenesisCare and Silver Sponsors Pfizer Oncology and Northshore Mitsubishi as well as the numerous event supporters we have. Not to mention the great event support we continually receive from Entoure and last but not least, our Sydney Pedalthon Ambassador and Commonwealth Games champion, Kaarle McCulloch.

The only disappointment was that we had hoped Craig Gedye would ride in his chicken suit. A goal for 2020...

Join us again in 2020 for more great days on wheels in Melbourne on Sunday 15 March at Sandown Raceway and Sydney on Tuesday 15 September at Sydney Motorsport Park, Eastern Creek.

The Pedalthon website!

Visit www.belowthebelt.org.au now to stay up to date with all the latest Pedalthon news.

Features include a real time funds tracker and leader board, “Find a Team” – matching single riders to teams in need of some extra pedal-pushers and so much more.

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Visit now: www.belowthebelt.org.au

ANZUP SYDNEY PEDALTHON With thanks to our very generous event supporters Platinum Sponsors

Gold Sponsor

Silver Sponsors

INTELLIGENT NEWSANZUP UPdate Summer 2019 THESATURDAYPAPER.COM.AU

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ANZUP SYDNEY PEDALTHON

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ANZUP SYDNEY PEDALTHON

ANZUP UPdate Summer 2019 | 21

Like cycling, don’t like cancer?

REGISTER NOW! www.belowthebelt.org.au

Sunday 15 March 2020

Fight cancer below the belt by riding or supporting the Melbourne Pedalthon.

Sandown Racecourse, Springvale, Victoria

Individual registration: $180 Registration to open race (3 hour challenge), sprint challenge.

LIKE CYCLING? The Melbourne Pedalthon returns for its 3rd year and invites you to ride and help those living with below the belt, (kidney, bladder, testicular, penile and prostate) cancers . Whether you’re a keen cyclist, novice, are just looking for a challenge or want a fun day out with the family – then this is the ride for you!

DON’T LIKE CANCER? Every cent raised by the Pedalthon goes directly towards clinical trials research, which means straight into the hands of experts committed to improving treatments and outcomes for those living with kidney, bladder, testicular, penile and prostate cancer .

1,800 RIDERS

Registration to open race (3 hour challenge), sprint challenge.

Family challenge registration for 2 adults and 2 children (team of 4): $150 Registration to family challenge (1 hour challenge).

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

SINCE 2014 OVER

Open race challenge registration (team of 4): $600

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BELOW THE BELT RESEARCH FUND PROJECTS AWARDED

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22,749 LAPS RIDDEN

www.belowthebelt.org.au

With thanks to our venue partner:

#BTBPedalthon

#MELBPedal2020

UPDATES FROM SAC AND SUBCOMMITTEES

Scientific Advisory Committee (SAC) The ANZUP Scientific Advisory Committee (SAC) has not met formally since its meeting at the ASM in Brisbane in July, but continues to be active in advising and steering ANZUP’s strategic direction. The SAC executive has been set up to allow us to respond quickly when there is time pressure, for example when a funding opportunity arises. This has worked very well but is intended to be used judiciously: we rely on the broad multidisciplinary nature of the SAC to give us informed input into our decisions. The entire field of genitourinary cancers is advancing rapidly, which means we need to continue to look ahead and consider where are the evidence gaps, not only now, but also in coming years. We are positioned to be able to ask and answer questions that might not be asked and answered otherwise. We continue to consider novel models for

research and as an example we hope to be able to open recruitment soon to at least one trial using a “teletrial” model. The SAC members provide invaluable advice from the perspective of the organisations and disciplines they represent, and also provide mechanisms for us to communicate back what we are doing and the outcomes of our work.

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

All ANZUP members are reminded that you are welcome to participate in any of the subcommittees at whatever level you wish. If you are not currently on a subcommittee mailing list and you wish to be, please let me or the ANZUP secretariat know so that we can add you.

IAN DAVIS Chair, ANZUP Scientific Advisory Committee

Update your member details now!

Need to update your contact details or subscription preferences?

2020

Update your member details now at www.anzup.org.au/member/updateprofile.aspx to stay up to date on all the latest ANZUP news and events.

ANZUP UPdate Summer 2019 | 23

Bladder, Urothelial and Penile Cancer (BUP) A major change within the Bladder subcommittee occurred in 2019, with our renaming to BUP! – Bladder, DICKON HAYNE SHOMIK SENGUPTA Urothelial and Penile Cancer Subcommittee. Bladder cancer describes most of the workload included in the remit of the subcommittee. Upper tract transitional cell cancer and bladder transitional cell cancer are both ‘Urothelial cancer’ (diseases of the lining of the urinary tract) and concepts and trials related to upper tract TCC have already been adopted by the sub-committee. Other types of bladder cancer that are not ‘urothelial’ do exist.

Penile cancer is a rare but significant male cancer not previously specifically recognised by the ANZUP subcommittees and needing a home.

Other highlights during 2019 included: • T he BCG-mitomycin study, comparing sequential BCG & Mitomycin to standard BCG for high-risk non-muscle invasive bladder cancer (NMIBC), has recruited half of its recruitment target, with 250 of a planned 500 patients accrued. The management of these patients has been made difficult by restrictions in the supply of BCG, and this may also affect availability of study treatments. It is important to have discussions at each site between clinicians, pharmacy staff and suppliers to ensure BCG supplies for patients who need it. Enrolment in the BCGmitomycin trial requires fewer doses of BCG per patient certainly in Arm B of the study, and thus maybe helpful in preserving scarce supplies.

• T he PCR-MIB study is assessing the effects of adding Pembroluzimab to chemo-radiotherapy for muscleinvasive bladder cancer. Having overcome some initial barriers, the study has now recruited 20 of 30 participants. Blood samples are being collected for the Below-the-Belt (BtB) funded translational substudy.

A number of potential future studies are at various stages of development and/or discussion: • ACCEPT multicentre cystectomy database is collecting data from West Australian centers, with ethics and 24 | ANZUP UPdate Summer 2019

governance review underway to open at other sites interstate. It is hoped this database will not only provide much needed audit of cystectomy practices but also enable implementation and evaluation of interventions such as Enhanced Recovery pathways.

• W ater irrigation for low/intermediate risk NMIBC is a Below the Belt funded single centre pilot study, with plans for a subsequent ANZUP trial to compare it to post-resection chemotherapy.

The 2019 Below the Belt grants included funding for a Phase I study of sub-urothelial injection of Durvalumab and a pilot study of translational markers of NMIBC response to therapy. It is hoped these studies can lead onto subsequent ANZUP studies.

New concepts with novel PET agent for bladder cancer have also been proposed in 2019.

This year’s ANZUP ASM also included scientific presentations on the need for survivorship studies in penile cancer, and the consumer engagement forum brought forward a motivated and interested penile cancer survivor who has provided significant impetus to plan further work in this area.

ANZUP has also welcomed two new CAP members, Melissa Le Mesurier and Michael Twycross, both of whom have had a bladder cancer diagnosis. We are delighted to have both Melissa and Michael on board, already making a contribution to the recent review of the SUBDUE PICF. We encourage all members of the BUP Subcommittee to bring new concepts to the next Concept Development Workshop (CDW), to be held 30 April 2020. The CDW’s give members a unique opportunity to present new concepts, participate in robust discussion around gaps in research and plan for future grant applications.

Of the 15 most common Australian cancers, bladder cancer remains the ONLY malignancy where outcomes are deteriorating as demonstrated by survival data from the Australian Institute of Health and Welfare showing an overall reduction in 5-year survival (9% survival reduction in men and 16% reduction in women). This situation is unacceptable and it is the responsibility of organisations such as ANZUP to strive to promote research activities leading to better outcomes for bladder cancer patients.

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

Germ Cell In the pipeline, the following continue to be a focus for the Germ Cell Subcommittee for 2020.

BEN TRAN

FRITHA HANNING

Over the course of 2019, The Germ Cell Subcommittee continued to be very productive, welcoming new members, including trainees, who contributed to research activity. A focus for 2019 was to develop a surgical protocol, consider the merits of a randomised registrybased trial, and engage our endocrinology colleagues in exploring a protocol for hypogonadism or fertility.

Some highlights of the year in review for the Germ Cell Subcommittee include: 1. T IGER opened at multiple sites in Australia, recruiting 5 patients. This has been one of the most important studies in germ cell cancer for some time, comparing TIP versus TICE (high dose with stem cell rescue) as first salvage for platinum refractory disease.

2. i Testis continued to recruit patients, looking for additional sites. This is a testicular cancer registry, supported by ANZUP, that hopes to engage as many sites and clinicians as possible. Please contact Ben Tran if you are interested in participating. Data collection support can be provided.

3. P 3BEP continued to recruit well. 102 patients have been recruited across ANZ, UK and COG sites! Well done to Peter Grimison and team on successfully driving this study!

4. T he ANZUP surveillance guidelines for patients with advanced disease who have completed curative chemotherapy are now available on the ANZUP website.

1) M icro RNA analyses appear to be a promising biomarker for testicular cancer, both seminoma and non-seminoma. Ben Tran is leading an ANZUP effort, which will serve as a parallel study to both SWOG 1824 and AGCT1531, two international studies which have only recently started recruiting patients. The focus will be on patients with stage 1 testicular germ cell tumours.

2) P lanning is underway for a surgical study for testicular germ cell tumours. The use of RPLND in stage 2 Seminoma and Recurrent Node-only Non-Seminoma has been reported by several groups internationally.

We’re hoping to start an ANZUP study that will help address PROMs in this patient population.

3) H aving a survivorship plan is increasingly recognised as an important component of ongoing care for testicular germ cell tumour patients. Jeremy Lewin is leading an effort in generating a clinically useful survivorship plan that can be implemented across Australia.

4) H ypogonadism is a complex issue in testicular cancer survivors. It can be a result of both primary or secondary, with secondary causes often underappreciated and perhaps more common. Feasibility studies using iTestis are underway to determine the proportion of survivors with secondary hypogonadism.

And if the population is sufficient a small pilot study using novel agents to address this will be designed.

We continue to look forward to the Germ Cell Concept Development Workshop, being held 7 April 2020, where there will be a focus on developing an ANZUP protocol focused on hypogonadism and limiting its long term effects on testicular cancer survivors. We hope you can attend! We’re also keen to have concepts submitted in this area, to drive discussion. We’re also keen to receive surgical concepts and discuss potential surgical studies in germ cell tumours.

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

ANZUP UPdate Summer 2019 | 25

Renal Cell

CRAIG GEDYE

DAVID POOK

This year has proved as rewarding, productive and successful as the last for the Renal Cancer Subcommittee.

With ongoing brisk activity, new trials have opened and further developments in new protocols are forthcoming.

The UNISoN study has completed primary accrual, showing the extraordinary strength of network of sites across the country. We are once again very grateful to the teams around Australia working on this study together.

The KEYPAD study continues to recruit and will evaluate the effectiveness of this promising combination of PD-1 antagonist pembrolizumab with the RANKL inhibitor denosumab and test the hypothesis that addition of RANKL inhibition will block tumour immuno-suppression and increase effectiveness of anti-PD1 immunotherapy.

The translational sample collection has continued successfully; we will require input and advice to guide the next steps with these specimens. New sites have also joined – we welcome BMO and Townsville. SVSH will also be joining soon.

The UNICAB study has now opened across 11 sites in Australia and with a target of 48 participants. So far we have accrued three patients on this trial. UNICAB is an exciting phase II trial of cabozantinib in patients with metastatic or unresectable non clear-cell renal cell carcinoma who have progressed on, or are not candidates for immunotherapy. Congratulations also go to Dr David Pook and Dr Carol Harris who have been working with ANZUP and BaCT to develop the UNICAB study.

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The timelines for this study were very tight and our team did an incredible job in opening the first site (Ashford Cancer Centre) in April which was less than 15 months from when the trial idea was first presented to Ipsen (the company who has the license for cabozantinib in Australia and is funding the study). This study was also designed as a partner to the UNISoN study, as patients can be enrolled on UNICAB if they progress on UNISoN. The study also provides a treatment option for patients who have medical conditions that do not allow them to be treated with immunotherapy.

The RCC Subcommittee also held a successful face-toface Concept Development Workshop in May with close to 20 attendees and two promising concepts presented.

ANZUP’s Concept Development Workshops (CDW) continue to help us develop a path towards fullyfledged kidney cancer trials, highlighting space for new opportunities to brainstorm potential answers to the tough clinical questions in kidney cancer research, and we appreciate the attendance of those across the multidisciplinary ANZUP membership base. We encourage all RCC Subcommittee members to attend our next CDW in 2020 – date to be confirmed.

We extend our thanks to CTC and BaCT and ANZUP fellows Alison, Shalini and Liz, who have shown the RCC Subcommittee much support across 2019.

We look forward to the growth of renal cell trials, and have high expectations for another productive year for the Renal Cell Cancer Subcommittee.

CRAIG GEDYE & DAVID POOK Chair and Deputy Chair, RCC Committee

Quality of Life & Supportive Care

HARYANA DHILLON

CATHERINE PATERSON

Recent News So much activity and so little time. While we have not met again as a group, members of the committee are actively working away on their respective projects and we are moving closer to integrating more novel supportive care and psycho-social questions and substudies into the ANZUP treatment trials. We have provided comment and input into three studies submitted to the ANZUP/PCFA Clinical Trials initiative and some will have been reviewed by the time this update goes to print.

key findings is that patients felt they take part in trials but don’t get to hear more about their progress and outcomes. We think there are a number of innovative ways ANZUP can improve their experience and will be looking forward to working with ANZUP’s CAP to create some change in this area. Further interviews are required to reach data saturation and we will be aiming to recruit additional participants for interviews over the next 3-4 months. Great to see some initial outcomes from Natasha’s Janssen Allied Health Professional Fellowship.

You may remember Tam Bui’s presentation at the Nurses’ Symposium during the ASM and the survey many members completed. Tam presented the results of the survey as a poster (using the new better poster format) and a mini-oral presentation at COSA. Tam has already drafted a manuscript reporting the results of this survey which will be submitted for publication soon. She has also provided a brief summary of results for you to read.

Nicholas Ralph gave an excellent presentation on the 10-year quality of life outcomes in men with prostate cancer. Using the results from 106 men recruited pre-treatment, they identified three trajectories of HRQOL (physical, mental, and life satisfaction).

In brief, ADT, comorbidities, and lower socioeconomic status indicates risk for poorer long-term quality of life.

The question for us now, is how to support men at risk of poorer HRQOL to ensure they remain as well as possible for as long as possible.

Best of GU Our Deputy Chair, A/Prof Catherine Paterson travelled to Adelaide to be part of ANZUP’s Best of GU and to help launch the 2020 ASM. Catherine gave an excellent overview the work she has undertaken to identify the unmet needs of men with urogenital cancers. It is so important for us to be supporting a highquality long view of the developments required to improve our ability to address the unmet needs of these men. Catherine has been particularly proactive in taking up work in the area of penile cancer, a long neglected and challenging rare cancer, there is definitely plenty of work to be done.

Presentations from members at COSA The recent Clinical Oncology Society Meeting (COSA) in Adelaide featured poster presentations from a number of our members.

Notably, Natasha Roberts presented the preliminary results of her qualitative study exploring patient experiences of participating in clinical trials. One of the

ASM 2020 The content for the 2020 ASM is progressing beautifully with Amanda Hutchinson representing our subcommittee on the conference organising committee. We are delighted to have Cristiane Decat Bergerot joining us for the meeting as an invited international speaker. Cris is rapidly developing her international profile as a psychooncology researcher and is currently collaborating with members of ANZUP and the Psycho-Oncology Cooperative Group (POCOG) to adapt existing fear of cancer recurrence interventions to the renal cell cancer population. It will be terrific to have her at the meeting to talk further about the work she is doing, life as an early career researcher in the US, and how she is ANZUP UPdate Summer 2019 | 27

Quality of Life & Supportive Care grappling with the challenges of an academic career and parenthood. As always if you have suggestions and ideas for the program, speakers, and innovative topics please get in touch with Amanda.

Concept development workshops After holding our own CDW earlier in 2019, we have had excellent representation from the QOL and Supportive Care subcommittee in the tumour stream meetings. This is helping us to develop a more structured and strategic approach to providing input into trials. At this stage we are advocating strongly for the inclusion of assessment

Experiences of genitourinary cancer nurses with scanxiety and tumour marker-related anxiety in people with cancer: results of a survey Anxiety in people with cancer may be heightened when the progress of their cancer is assessed, such as around the time of a scan (scanxiety) or tumour marker (tumour-marker related anxiety). We invited genitourinary cancer nurses who attended the 2019 ANZUP Nurses’ Symposium to complete a hardcopy or online questionnaire to explore their experiences on scanxiety and tumour marker-related anxiety.

Thirty-four out of 70 cancer nurses completed the survey. The median age was 50 years (range, 29 to 66) and the median time worked in oncology was 6 years (range, 1 to 35). Most nurses worked with prostate cancer, and were often involved with patient education, booking scans and discussing investigation results.

Eight-five percent of nurses had seen scanxiety in people with cancer. Of these, most nurses believed it occurred ‘quite often’ (48%) or ‘very often’ (41%), and was at least of moderate severity. Most nurses perceived ‘waiting for the results of a scan’ (82%) and ‘pre-existing anxiety or depression’ (94%) as factors contributing ‘quite a lot’ or ‘a lot’ to scanxiety.

Cancer nurses identified different strategies to reduce scanxiety, including reducing waiting times between 28 | ANZUP UPdate Summer 2019

of fear of cancer recurrence or progression within the clinical trials, this will help us to identify and direct resources to address these needs strategically. We have also, with Richard Lourenço De Abreu been working on the inclusion of preference assessments within a number of trials, this will, again, help to direct resource as needed to the psychosocial and supportive care needs patients identify as part of their treatment decision-making.

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

results and the scan; practical supports such as providing clear instructions about scan preparation; psychological supports; effective communication, and; education of patients and clinicians. This included explaining the rationale of doing a scan, setting expectations for the scan and describing the scan process itself. Nurses were ‘not at all comfortable’ conveying scan results by phone (42%), email (70%), or print-out (48%) prior to patients being reviewed by their oncologist, while 62% were ‘very comfortable’ discussing scan results after the oncologist consultation.

With regard to tumour markerrelated anxiety, cancer nurses believed this occurred in all people with cancer, with most perceiving this as severe.

In conclusion, cancer nurses commonly see people with cancer who experience scanxiety or tumour marker-related anxiety, and this can be severe. They are wellplaced to help manage scanxiety in these people, but optimal strategies to do so require more research.

We acknowledge the contribution of the cancer nurses who participated in this survey.

The results of this study are being presented as a poster abstract at the 2019 Clinical Oncology Society of Australia Annual Scientific Meeting.

Dr K Tam Bui

Prostate Cancer

SCOTT WILLIAMS

LISA HORVATH

This year proved to be yet another busy year, full of activity in all aspects of the prostate cancer subcommittee.

We reached the 5-year milestone since the activation of our duo of enzalutamide studies – ENZAMET and ENZARAD. Both are fully recruited and in follow-up, with ENZAMET reaching its first interim analysis.

On 2 June 2019, it was with much excitement that the ANZUP-led ENZAMET trial first interim analysis featured in the plenary session at the American Society of Clinical Oncology Annual Scientific Meeting in Chicago.

This was one of only four plenary sessions chosen from over 6,000 abstracts submitted. This study closed to enrolment in 2017, with patients recruited from Australia, New Zealand, USA, UK, Ireland and Canada.

The first interim analysis showed a survival benefit of 33% for those in the enzalutamide arm. These fantastic results were also concurrently published in the New England Journal of Medicine on 2 June.

Following the publishing of ENZAMET data, in early December 2019 the US FDA approved the use of enzalutamide for mHSPC. The team continues to accumulate a substantial biorepository around the ENZA studies, which will provide an enduring resource for future biomarker research. The international translational research committee welcome your ideas for study of these samples.

Our other actively recruiting ANZUP-led studies also continued to progress well. The Pain-Free TRUSB randomised trial closed in on the recruitment target of 420 on 5 November following ongoing contributions from our NZ study leaders. Similarly, the randomised trial of cabazitaxel chemotherapy against LutetiumPSMA in castrate-resistant disease (TheraP) achieved its accrual target of 200 participants on 10 September.

Of our co-badged studies, proPSMA (with ARTnet and TROG) rapidly completed accrual of 300 men randomised between conventional and PSMA-PET imaging. With a six month accuracy endpoint, this has the potential to produce practice-changing results within a year. The RAVES study (with TROG and USANZ) looking at adjuvant against early salvage radiotherapy after prostatectomy is in the final analysis phase and we should hear results at a major meeting very soon. Now more than a decade after inception, these results are eagerly awaited internationally. We have also added the NINJA study (TROG-led) to our portfolio – assessing two novel hypofractionated approaches to radiation therapy for early prostate cancer.

Several exciting concepts are continuing in development. A large global follow-up study to ENZARAD has largely completed protocol writing, with the delicate commercial and collaborative group agreements coming together well. We anticipate a rush of activity on this in the near future. Other exciting concepts around biomarker implementation and earlier use of Lutetium-PSMA use are also well developed now, while a number of concepts and Below-the-Belt funded studies are progressing well.

ENZA-p is an ANZUP-led randomised phase II trial using PSMA as a therapeutic agent (Lutetium -PSMA) and prognostic indicator (PSMA-PET) in men with metastatic castrate-resistant prostate cancer treated with enzalutamide (ANZUP 1901). This study is being led by A/Prof Louise Emmett from St Vincent’s Hospital in Sydney. The study aims to recruit 160 patients, across 12 sites – with the view to open the study in early 2020.

DASL-HiCaP is also an ANZUP-led randomised phase 3 trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation in high risk, clinically localized prostate cancer. Study Co-Chairs are Prof Chris Sweeney and A/Prof Tamim Niazi and the study aim to recruit 1,100 patients from close to 100 sites across Australia, New Zealand, US, Canada, UK and Ireland. We are planning to recruit the first patient to DASL-HiCaP by early 2020.

#UpFrontPSMA #UpFrontPSMA is an ANZUP-led Randomised Phase 2 Study of Sequential 177Lu-PSMA617 and docetaxel versus docetaxel in metastatic hormone-naïve prostate ANZUP UPdate Summer 2019 | 29

Prostate Cancer cancer. This study is being led by Prof. Michael Hofman and the study aims to recruit 140 patients across 11 sites.

Continuing on as an exciting ANZUP initiated activity is the concept development workshop, the most recent of which was held in May. Eleven study ideas were presented, with a view to developing a path forward to a fully-fledged prostate cancer clinical trial.

The multidisciplinary nature of the event means that a holistic analysis of trial concepts are conducted, from psycho-oncology and survivorship to molecular biology and biomarker studies. The workshop is a truly outstanding and educational event, with a vision to finding the answers to the tough clinical questions in prostate cancer research.

We would like to take the opportunity to encourage all to participate in the prostate cancer concept development workshop on 1 May 2020. No matter how small or simple you may think an idea to be, we are interested in hearing about them. Good clinical questions make good study ideas, so even if you don’t feel you have the skills to take an idea forward to a full study, we have a collegiate and experienced team of collaborators can help make it happen.

The prostate subcommittee continues to grow and has seen some exciting achievements over the past few months, as well as a number of new studies on the horizon, putting ANZUP very much on the map in prostate cancer clinical trial research.

SCOTT WILLIAMS & LISA HORVATH Chair and Deputy Chair, Prostate Cancer Subcommittee

NATASHA ROBERTS AT COSA

Consumer Advisory Panel (CAP) welcome addition to the ANZUP CAP, as we have not had a Bladder Cancer representative since early this year so they have had to hit the ground running. We are delighted to have both Melissa and Michael on board, already making a valuable contribution for the recent review of the SUBDUE PICF.

BELINDA JAGO

RAY ALLEN

CAP Connections 2019 has seen a number of changes to our CAP. First and foremost, we are delighted to welcome our newest CAP members Michael Twycross and Melissa Le Mesurier to the ANZUP CAP following a successful introduction at the recent ANZUP ASM 2019, with the theme “Making Connections”. Michael and Melissa’s brief bios are included here and for their complete details you can follow this link. They are an especially 30 | ANZUP UPdate Summer 2019

Making connections is a very important theme for the ANZUP CAP as it is the connection of us as patients and carers with our treating teams that leads to the introduction of new CAP members.

We still have a core group of CAP members who have been with ANZUP since the CAP’s inception in 2012.

Each one of us has been connected to ANZUP through an ANZUP member, and we have highlighted a few of these connections below. These relationships are an integral part of the process of creating a committed Consumer Advisory Panel.

Consumer Advisory Panel (CAP) I am constantly in awe of the skills My introduction to ANZUP came that are assembled within ANZUP through A/Prof Guy Toner, who was and the tireless commitment and our daughter Bec’s oncologist at dedication, freely given, towards the Peter Mac. As a family we had already making the lives of cancer sufferers done a great deal of fundraising to better and, one day, eradicating the help support the ONTrac Adolescent diseases altogether. and Young Adults service, and when she died in Oct 2011 I felt the need to NEW MEMBERS MELISSA LE MESURIER AND My connection with my disease MICHAEL TWYCROSS do more than just fundraise. I wanted and the progressive accumulation to try and use the knowledge that I of knowledge from my time with ANZUP have provided had gained through an unwanted cancer experience and me with tools to better understand the needs of those put it to good use. I spoke to Guy about this and he told men and women who, on their ‘Friday afternoon’, will me to come back in a few months, “I have an idea”, he receive a cancer diagnosis. My role on the CAP, as with said, “but take some more time out.” A few months later my colleagues, is to connect and make available our he talked to me about ANZUP and the CAP which was collective experience to the various ANZUP membership in its early stages, and it sounded very interesting. From streams and to the public we serve. there, the connection was made and now 8 years later I am still here. I truly enjoy the opportunity to be involved Each year that I’m involved with ANZUP, the CAP with a great group of individuals who, like me, want to sees a marked evolution in in both the quantum and give something back in a meaningful way. the complexity of the work being undertaken. We CAP Deputy Chair, Ray Allen, has also shared his experience with connecting to the ANZUP CAP. My personal cancer journey began eight and a half years ago with a Friday afternoon diagnosis of prostate cancer. That ruined my weekend good and proper, but it was also the day that I became connected – connected to my cancer. If we had to live together, just like any relationship, I had to learn about this new partner. That wasn’t easy. Good information was sparse and ranged from confusing to inaccurate.

are seeing trends toward individualised medicine, and extensive bio databases capable of predictive modelling to complement trial findings. We are also seeing, very importantly, a stronger emphasis on a patient’s quality of life.

For me, my connection with ANZUP has been life changing.

The second edition of the Consumer Magazine is already out and highlights the importance of clinicians connecting interested patients and their families to ANZUP.

In the absence of good, widely available information, I connected with my clinical team, bombarding them with questions, which were always answered comprehensively. Of course, through all this my connection to my support group, my family, was an essential element in dealing with the darker moments.

In closing for 2019, on behalf of the CAP we wish everyone and happy and healthy festive season with your family and friends and look forward to what 2020 may send our way. It’s sure to be another successful and busy year as the well laid foundations ensure that ANZUP continues to grow.

At a routine follow up consultation with my Urologist, I was asked if I had any interest to be involved with research into prostate and other cancers. I left the consultation with an invitation to attend ANZUP’s Annual Scientific Meeting to see if I would consider joining the Consumer Advisory Panel, where my connection with clinical trials would begin.

BELINDA JAGO AND RAY ALLEN Chair and Deputy Chair, CAP

My time on the Consumer Advisory Panel has been an amazing personal engagement and I’m sure that all my colleagues on the CAP will endorse this view.

ANZUP UPdate Summer 2019 | 31

OTHER NEWS Hellos and Goodbyes Welcome Nisha Nisha Rana has an extensive background in Clinical Trials management and operations. Hailing from the UK, Nisha started her career in the clinical setting as a biomedical scientist and soon found herself working as a research scientist.

Passionate about delivering ground breaking research from the laboratory bench to the patient’s bedside quicker (translational research), Nisha was keen to hang up her lab coat and move into Clinical Trials management.

Although having worked in a research management capacity in a host of Therapeutic Areas (TA) including: Respiratory, Oncology, Mental Health, Emergency & Critical Care, Cardiovascular and Musculoskeletal medicine; Nisha still considers herself a scientist and first and foremost, a patient!

Still actively involved in developing research processes to streamline Clinical Trial set-up and running as well as managing the handling of research biological samples as part of the greater translational research efforts of ANZUP.

Welcome Evie Lucy Byers our Marketing and Communications Manager, welcomed baby Evie Rose Patricia Byers who came into the world on Father’s Day. Here’s a photo and Mum and baby Evie and we wish Lucy, Evie, Alex and Grace all the best for their first Christmas together.

Farewell Jaclyn In December we farewelled Jaclyn in the role of Clinical Trials Project Manager. We wish Jaclyn all the best as she takes some time to spend with her family.

Thank you Emily We would like to thanks Emily Tu from the CTC who has worked tirelessly on the ENZAMET trial and has now handed over to Shirley Yung. Thanks for all your work over the years Emily.

32 | ANZUP UPdate Summer 2019

Senior Research Fellow – Prostate Cancer Outcomes Registry Applications are now open for the position of Senior Research Fellow for the Prostate Cancer Outcomes Registry. Details for the role and applying can be found at the following link: http://careers.pageuppeople. com/513/cw/en/job/600957/senior-research-fellow-pcor.

2019 ANZUP Mundipharma Clinical Research Fellowship study Dr Arsha Anton was awarded the 2019 ANZUP Mundipharma Clinical Research Fellowship, and using the funds to further develop her REAL-Pro study. REAL-Pro is a Registry-based Study of Enzalutamide vs Abiraterone assessing cognitive function in ELderly patients with Metastatic Castration-Resistant Prostate Cancer. She is currently looking for additional sites to be involved in this study. For more information please click here.

Join us at #ANZUP2020 in Adelaide It’s a pleasure to invite you to the ANZUP ASM in 2020, 19-21 July 2020 at the Adelaide Convention Centre for the first time.

Our theme for #ANZUP2020 is ‘Clear Vision’.

What does Clear Vision mean for us as GU cancer professionals? It means we need to see clearly which data deserves attention, which treatments hold promise for the future, which drugs deserve to be tested in clinical trials, and most importantly it means we need to see clearly what the priorities are for our patients.

I look forward to welcoming you next year.

NICK BROOK, #ANZUP2020 Convenor

#ANZUP2020 Speaker Spotlight Prof Heather Payne We welcome Prof Heather Payne as one of our #ANZUP2020 International Faculty.

Heather Payne was appointed as a Consultant in Clinical Oncology at University College London Hospitals, London in 1997. She trained to be a doctor at London University in St Mary’s Hospital Medical School and after qualifying spent some working in general medicine and surgery, paediatrics and psychiatry.

She then travelled to work as a volunteer doctor in the Caribbean island of Haiti where conventional medicine was mixed with voodoo practices.

She returned to London to train as a Clinical Oncologist and during this time developed an interest in urological oncology. Heather now have a busy practice specialising only in the management of prostate cancer at University College London Hospitals. Her work involves the management of all stages of prostate cancer as part of a multidisciplinary team. She treats men with radiotherapy, chemotherapy, hormone therapy and is involved in clinical trials investigating novel agents.

She pioneered a programme of High Dose Rate Brachytherapy for prostate cancer at University College London Hospitals which has allowed the delivery of higher and potentially more effective doses of radiotherapy for men with high risk or locally advanced prostate cancer. The academic challenges of these new technologies are fascinating, but this is balanced with a very human side to the job and that is in caring for men and their families at a very difficult time.

Heather was appointed as a professor of prostate oncology at University College London which has led to many collaborations and research in the departments of physics, nuclear medicine, pharmacology and radiology. She is the Principle Investigator in a number of international multi-centre and local studies. Heather is the chair of the British Uro-oncology Group (BUG) which she started as a professional organisation to support oncologists with a specialised interest in urological tumours. She also serves on the Prostate Cancer Charter for Action the Department of Health Prostate Cancer Advisory Group for the United Kingdom and is the Oncology Clinical Lead for the National Prostate Cancer audit.

Heather’s main areas of research are prostate radiotherapy and brachytherapy and the treatment of castration resistant prostate cancer. She is also involved in a number of studies looking at quality of life form men with prostate cancer and have a special interest in erectile dysfunction for men with advanced disease.

‘I am really looking forward to the meeting as it is a great opportunity for learning and sharing best practice, meeting old friends and hopefully making some new ones! I look forward to the great Australian welcome and of course some sunshine.’

ANZUP UPdate Summer 2019 | 33

ABSTRACTS & CONCEPTS OPEN FEBRUARY

EARLYBIRD REGISTRATIONS OPEN FEBRUARY

ANNUAL SCIENTIFIC MEETING ADELAIDE CONVENTION CENTRE 19-21 JULY 2020

C L E A R

V I S I O N

#ANZUP2020 34 | ANZUP UPdate Summer 2019

UPCOMING EVENTS 2020 FEBRUARY

MARCH

FEBRUARY

13-15

28

ASCO GU

APAC APCCC

SAN FRANCISCO

SINGAPORE

MARCH

MARCH

7-10

16-19

USANZ ASM

TROG ASM

APRIL

APRIL

APRIL

15

1

2

7

MELBOURNE PEDALTHON

ANZUP QUALITY OF LIFE CONCEPT DEVELOPMENT WORKSHOP

ANZUP RENAL CELL CONCEPT DEVELOPMENT WORKSHOP

ANZUP GERM CELL CONCEPT DEVELOPMENT WORKSHOP

MAY

JULY

MAY/JUNE

1

29-2

19-21

ANZUP PROSTATE CONCEPT DEVELOPMENT WORKSHOP

CHICAGO

ADELAIDE CONVENTION CENTRE

2020 ASCO ANNUAL MEETING

SEPTEMBER

18-22

SYDNEY PEDALTHON

ESMO CONGRESS MADRID

12-14

ANZUP ANNUAL SCIENTIFIC MEETING

MOGA ASM

NOVEMBER

SEPTEMBER

15

AUGUST

NOVEMBER

11

11-13

ANZUP BEST OF GU EVENING SYMPOSIUM

COSA ASM

MELBOURNE

BRISBANE

NOVEMBER

27-28 ANZUP PRECEPTORSHIP

ANZUP UPdate Summer 2019 | 35

from all of us at ANZUP Cancer Trials Group

Gumtree - the scent of Australia. Artwork donated by James Daw Illustration. http://www.daw2art.com/

ANZUP Cancer Trials Group Level 6, Lifehouse Building, 119-143 Missenden Road, Camperdown NSW 2050 Tel: +61 2 9562 5042 Email: anzup@anzup.org.au www.anzup.org.au