UPdate Spring 2016

The Newsletter of ANZUP Cancer Trials Group Limited

SPRING 2016

EXPANDING OUR HORIZONS EXPANDING OUR HORIZONSEXPANDING O EXPANDING OUR HORIZONS EXPANDIN NG OUR HORIZONS EXPANDING OUR HOR EXPANDING OUR HORIZONS EXPANDING OUR HORIZONS EXPANDING OUR 2016 ANZUP ASM Convenor’s Report It was my pleasure and honour to act as the convenor for this year’s 2016 ANZUP ASM held at the Hilton Hotel in Brisbane.

The meeting with the theme “GU Oncology - Expanding our Horizons” achieved its aim, with cutting edge clinically relevant scientific presentations from national and international faculty, updates on ANZUP led trials and concepts, the best of supportive care and nursing and updates on the future of Urologic Oncology. We were privileged to welcome to Australia for the first time our international guest speakers Dean Bajorin and Piet Ost and welcome home ex-patriot John Oliffe. Unfortunately our final international guest, Freddie Hamdy was unable to attend due to a family emergency.

The ANZUP Community Engagement Forum “A little below the belt” was enthusiastically supported by a large number of patients, survivors, family, friends and general members of the community at large. This forum is an important conduit for information to the public and consumers regarding ANZUP and ANZUP led trials, why clinical trials are important and how we as Medical, Nursing and Allied Health professionals are trying to improve outcomes for our patients.

Sunday started for the first time with the extraordinarily popular Nurse’s Session sponsored by PCFA and Astellas.

It was standing room only to hear from leading academic Nurses from around Australia and New Zealand. A highlight was our international guest John Oliffe who gave an inspirational message of how our dedicated and talented Nurses can be involved in clinical trials and research.

The Sunday Night Evening Symposium was held in the regal surrounds of the Brisbane Tattersalls Club and was proudly sponsored by Astellas and Amgen. Outstanding presentations from Dean Bajorin and John Oliffe spoke to translating research into practice and getting the message out to the community respectively.

The MDT Masterclass was again voted as a highlight of the meeting by many and was “masterfully” co-ordinated

by Shomik Sengupta and Carmel Pezaro. A big thank you to all the various panel chairs and experts for making the Masterclass such a success.

Ian Davis reinforced the important new partnership between ANZUP and the PCFA. The relevance of this was further evident through the announcement of a new PCFA funded ANZUP badged trial investigating the potential role of Lu177-PSMA in metastatic prostate cancer. This trial will provide the very latest in potential therapies to our patients.

Monday kicked off a packed program with Piet Ost and Dean Bajorin providing world class presentations on the cutting edge topics of the potential role of Radiation as a vaccine in kidney and urothelial carcinoma and the rapidly evolving world of genomics in bladder cancer.

FULL ASM REPORT CONTINUED P5

Hello and welcome to ‘UPdate’ Inside you will hear about: ASM Convenor’s Report . . . . . . . . . . 1 Message from the Chair . . . . . . . . . . 2 ANZUP ASM Convenor’s Report continued . . . . . . . . . . . . . . . . . . . . . . 5 ANZUP ASM Speaker Interviews . . . 6 ANZUP ASM in Pictures . . . . . . . . . . 8 ANZUP ASM Awards and Achievements . . . . . . . . . . . . . . . . . 10 2016 Below the Belt Pedalthon . . . 14 Other News . . . . . . . . . . . . . . . . . . . 25 New ANZUP Website . . . . . . . . . . . 25 2016 Preceptorship in Prostate Cancer . . . . . . . . . . . . . 28 Events Calendar . . . . . . . . . . . . . . . . 30

Message from the Chair Welcome to this latest edition of UPdate, the newsletter of the Australian & New Zealand Urogenital and Prostate Cancer Trials Group Ltd (ANZUP).

The dust is only just settling after yet another fantastic ANZUP Annual Scientific Meeting, held in Brisbane on 1012 July. Every year this meeting seems to go from strength to strength and it has now firmly established itself as the premier multidisciplinary genitourinary cancer conference in Australia, if not the southern hemisphere – and fair warning to the northerners, we’re coming after you! The ASM grows in numbers of delegates and sponsors and is of course a key part of the ANZUP calendar, but it is far more important than simply its size and the revenue it generates for ANZUP. Every year I am struck yet again by the amazing sense of engagement and collegiality of our members.

Everyone at the ASM is there because they know they will hear great science, make or renew great connections, and will contribute to something that is really making a difference for our patients and their families.

The ASM program caters for everyone’s needs. We specifically cover all of our tumour types and ensure that we engage as many of our represented disciplines as possible. There is something of value for the most junior student or trainee as well as the crustiest of senior people.

We have a formal education program for our Consumer Advisory Panel as well as a well-attended Community Engagement Forum, aimed at demystifying clinical trials and promoting awareness of these cancers and the need to do better in them. Our packed program also included the MDT Masterclass; the Sunday evening symposium on “Getting the message out;” the annual open meeting of the Scientific Advisory Committee; and investigator meetings for various ANZUP trials. Congratulations to our 2016 convenor Ian Vela and his tireless convening committee for bringing a fantastic meeting together.

We are very grateful for the support of our sponsors and corporate supporters and it is gratifying that the feedback we consistently receive is that the meeting and their links to ANZUP are of great value to them. We always survey

2 | ANZUP UPdate

Message from the Chair continued our delegates, not only for the warm glow that the positive comments always bring, but to make sure that we are meeting our delegates’ needs and hearing their thoughts on how the meeting could be improved.

This year’s ASM also incorporated the Prostate Cancer Foundation of Australia’s annual Prostate Cancer Specialist Nursing Service conference. This was part of the recent agreement signed between ANZUP and PCFA whereby both organisations would participate in fundraising to support ANZUP prostate cancer clinical trials. It was great to have a part of the program dedicated to prostate specialist nurses and of course to have their involvement in the wider ASM as well. The 2017 ASM will be held in Melbourne and we are very fortunate to have Carmel Pezaro as our convenor. More news will follow soon but you can already pencil in the dates: 16-18 July 2017.

The ANZUP company Annual General Meeting was held on 11 July 2016 and it was a great pleasure to show how ANZUP is ploughing more and more of its resources back into clinical trials and development opportunities. The Board has worked very hard on refreshing our Strategic Plan, now available on our website. Behind the high level strategic plan is a detailed operational plan listing specific goals, actions, timelines and deliverables. The Board, our CEO Marg McJannett and our hardworking secretariat now all have the task of making these goals a reality. Some of them are quite aspirational but we have learned from our experience with ANZUP that what seemed unlikely a few years ago quite quickly becomes reality.

Clincal Trials ANZUP’s clinical trials program continues to accelerate in both depth and breadth. We have clinical trials active across all of our disease types and involving the various disciplines we represent. Not all of our clinical trials are the conventional “test a drug” ones; we also have studies involving surgery, radiotherapy, nursing and allied health input, psycho-oncology, supportive care, health economics and research translational questions. You can read more about all of this on our website and of course the ANZUP ClinTrials Refer app is available for anyone to download and use to find out details of each trial. We are excited to be expanding our presence yet further, with involvement of the European Organisation for Research and Treatment of Cancer (EORTC) and some additional US sites for our ENZARAD trial, and linking with the US

National Cancer Institute and the Alliance group for the forthcoming TIGER testicular cancer trial. Not only will these new strategic links help us in our current trials, but importantly they represent the advent of a new global cooperative intergroup structure that will be a unique vehicle for performing large scale international trials in the future.

ASM CONCEPT DEVELOPMENT SESSION

Concept Development Workshops There has been a considerable amount of ANZUP activity outside the direct trials arena as well. We have already held two Concept Development Workshops in May (germ cell and prostate) and another workshop at the ASM. The bladder and renal CDWs will be held in August. A key outcome of the prostate CDW was to refine and shortlist proposals for funding through the joint ANZUP/PCFA mechanism mentioned above. A SAC subcommittee met in June to review and rank the proposals. We are delighted to announce that the first trial supported through this initiative will be insert details led by Dr Michael Hoffman. We are now deep into the process of developing the full trial documentation and setting up all the systems necessary to open this trial as soon as possible. Watch this space! We look forward to more concepts coming through this and other mechanisms for funding support, but it is particularly gratifying to see that ANZUP is now in the position to help support this research directly instead of depending on the unreliable prospects of competitive grant funding. Our aim is to continue to improve this capability and capacity into the future.

ANZUP UPdate | 3

Message from the Chair continued ANZUP hosted its second GU Preceptorship in Prostate Cancer in August 2016. The 2015 Preceptorship was extremely successful and we are looking forward to hosting it again this year. Many thanks to Eva Segelov for her amazing Symposium and drive in making this happen. ANZUP will also be hosting the Best of GU evening later in the year, reviewing the highlights of the ANZUP and USANZ annual meetings.

Below the Belt Pedalthon Of course you will all already be aware that Tuesday 20 September 2016 will see the third annual ANZUP Below the Belt Pedalthon fundraising event at Eastern Creek in NSW. This is a great day for everyone involved and importantly all the revenue from the event goes to the Below the Belt Research Fund. This is another example of how ANZUP continues to grow its resources and at the same time re-invest them to support the work we need to do. Sadly Liz Thorp “left” ANZUP some time ago but, as the inverted commas imply, in reality she has donated an enormous amount of time since then in helping lock in the arrangements for the Pedalthon. Liz’s oversized clown shoes are now being filled by our new Marketing and Communications Manager, Lucy Byers. Lucy brings great expertise and experience and I encourage you to say hello to her when you meet her at an ANZUP function soon.

The Pedalthon is perhaps our major external fundraising event at the moment but there is a real need to continue to grow our fundraising capability. We have been fortunate to obtain a one-year extension on our Cancer 4 | ANZUP UPdate

Australia Support for Clinical Trials grant, but our vision continues to exceed our reach and we know that we will need more resources to do the work we and our patients need us to do. ANZUP also provides a range of other fundraising or donation opportunities as you will see on our web site. We also have the EverydayHero option allowing you to link to ANZUP as a beneficiary to fun runs or other activities. A large number of people are quietly making a substantial difference this way or through direct donations and we are extremely grateful. Thank you to all of you who support us in this way.

As always, I cannot end this without acknowledging the people behind the scenes who work so hard to make possible what we do. Thanks to my fellow Board directors; our ANZUP staff (Anne, AJ and Lucy); our indefatigable CEO Marg McJannett; our committee chairs and deputy chairs and members; the SAC; the CAP, our volunteers Lesley Tinkler and Jo Stubbs; our colleagues and collaborators at NHMRC Clinical Trials Centre, the Centre of Centre for Biostatistics and Clinical Trials (BaCT) and elsewhere; our corporate supporters, sponsors and donors; our “real life” employers who understand the importance of this work we do; and our families who patiently wait for us and support us.

ANZUP and what it does is only possible because there are so many people who are driven by their generosity and good will to donate their time and resources. Just imagine if we had to buy what it is that you all bring so cheerfully; I’m not even sure that’s possible. “Thanks” just seems far too small a word to express what we feel.

Please enjoy this edition of UPdate.

IAN DAVIS CHAIR.

DELEGATES AT THE 2016 ANZUP ASM

BRISBANE 2016

CONVENOR REPORT CONTINUED Spirited discussion was enjoyed during the ANZUP Concept Development Session, which was followed up with updates from the Community Advisory Panel and subcommittee chairs. The Best of the Best Oral presentations demonstrated the quality and breadth of research being undertaken by ANZUP members, as too did the record number of poster presentations. A busy Monday was very enjoyably rounded out with the conference dinner in the Hilton Ballroom, which included some of our local and international faculty demonstrating that their skills in the clinic are equally matched on the dance floor.

Tuesday started early with breakfast and the opportunity to “meet the Professor” Dr Dean Bajorin. Dean gave an inspiring message of mentorship, why he is an academic oncologist and how and why he has led the fellowship program at MSKCC. It was inspiring for trainees and challenging for those of us given the honour and privilege of training the next generation of leaders.

The rest of Tuesday included state of the art presentations on less common tumours such as penile and testis cancer and Dr Bajorin presented the latest data on immune therapy in bladder cancer. A session was devoted to the important topics of the younger GU oncology patient and rehabilitation. We were extremely fortunate to have Freddie Hamdy involved in the meeting and “present” through the wonders of technology, a fantastic talk on surgical research and clinical trials. Outstanding presentations from local faculty on the latest in translational research in GU oncology and how we can include such approaches in clinical trial design gave food for thought.

The meeting closed with awards for the best presentations in various categories and the 2016 Tolmar ANZUP Clinical Research Fellowship was awarded to Dr Arun Azad, medical oncologist and translational researcher from Monash Health in Melbourne.

My job as convenor was very easy due to the fantastic support and work of the extra-ordinary convening committee (with special thanks to the local team of David Pryor, Tanya Holt, Shona Mackenzie and Aneta Suder), the ANZUP secretariat and the YRD team. This dedicated group ensured this year’s ASM was the most successful and largest to date and demonstrates how ANZUP is going from strength to strength.

No matter how much hard work is put in from the organizing committee, the meeting itself would not be possible without the generous support of our sponsors: Platinum sponsors Janssen and PCFA; Gold Sponsors Sanofi, Amgen, Astellas, Bristol-Myers Squibb, ImmunoOncology and Novartis Oncology; Silver sponsors Ipsen, Ferring, Tolmar Australia and Bayer; and Bronze sponsor Pfizer Oncology.

Planning is already well underway for next year and we look forward to welcoming you to Melbourne, for an even bigger and more successful ANZUP ASM. IAN VELA 2016 Convenor

DELEGATES AT THE 2016 ANZUP ASM

Piet Ost gave a fascinating talk on the role of ablation of oligometastatic prostate cancer and then backed up to be involved in possibly one of the greatest debates ever seen anywhere, anytime – “Cytoreductive RRP (or EBRT to the prostate) is a good idea in men present with synchronous mets”. Our local dream team of Peter Heathcote and Joe Bucci put a well-constructed and spirited argument together for the negative however were pipped at the post by the affirmative team of Piet “Iolaus” Ost and Venu “Hercules” Chalasani. I am sure no-one present will ever look at a Mentos in quite the same way.

ANZUP UPdate | 5

ANZUP ASM Speaker Interviews John Oliffe

Professor Piet Ost

We were delighted to have Associate Professor Piet Ost, Radiation Oncologist from Ghent University Hospital in Belgium, as one on our international guests at this year’s ANZUP ASM. Midway through the conference I was given the opportunity to interview him on different aspects of his research. Piet and I discussed the role of hypofractionated radiation and its role in acting as an immune primer when given in combination with systemic therapy agents.

We also discussed the challenges of managing oligometastatic prostate cancer. Piet and his research team have recently completed accrual to the STOMP study a randomised trial assessing stereotactic radiation in this setting. He shared with us a summary of the STOMP trial and his team’s current and future research plans for oligometastatic patients. If you were unlucky enough miss the ASM this year, this interview provides a summary of what he presented at the meeting and would be of interest to medical oncologists, radiation oncologists and urologists alike. You can watch our full interview here.

I sat down with Prof. John Oliffe about the work he is doing with the Men’s Health Research Group out of the University of British Columbia. John has such an interesting perspective on men and health, the way we generally talk about men’s deficits as part of health, and the ways we can change the conversation to connect more effectively with men around their health. He has done some wonderful work with military veterans to develop a recover from post-traumatic stress disorder that build on men’s strengths; this approach has also shown promise when used in groups of men with prostate cancer. I so enjoyed our conversation and could have kept talking for hours! You can watch our full interview here.

HARYANA DHILLON Research Fellow, CeMPED School of Psychology, University of Sydney

TANYA HOLT Senior Radiataion Oncologist, Mater Radiation Oncology Centre

I really enjoyed listening to Piet [Ost] talk about the issues around radiation and some of the cutting edge research that’s happening in the area is fantastic – the innovation, the challenge, the discussion amongst everyone in the conference room.

LINDA MARTIN, ANZUP BOARD

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DELEGATES AT THE 2016 ANZUP ASM

ANZUP ASM Speaker Interviews Dean Bajorin At this year’s ANZUP ASM we were privileged to have in attendance Dr. Dean Bajorin, an internationally renowned expert in urothelial cancer and medical oncologist at Memorial Sloane Kettering Cancer Centre. In the following interview, Dr. Bajorin speaks about a number of key clinical and research issues in urothelial cancer including optimising utilisation of neoadjuvant chemotherapy, harnessing cancer genomics to improve use of systemic therapy, the immune-oncology “revolution” and selecting patients most likely to benefit from immune checkpoint inhibitors. You can watch our full interview here.

ARUN AZAD Medical Oncologist, Monash Health

DELEGATES AT THE 2016 ANZUP ASM

Craig Gedye

I discussed with Dr Craig Gedye, a medical oncologist at the Calvary Mater Newcastle, scientist at the Hunter Medical Research Institute and ANZUP RCC Chair, how significant steps have been made in treatment of metastatic renal cell carcinoma. He highlighted recent studies such as METEOR, a study of a VEGFR/MET inhibitor Cabozanitnib which showed superior efficacy over current treatments as well as highlighting the impressive increase in survival of over 6 months with Nivolumab, a checkpoint inhibitor compared to Everolimus. However despite the recent headline grabbing inroads with immune therapies, sadly the vast majority of patients with metastatic disease remain incurable. Challenges remain in understanding the heterogeneity of renal cell cancer and thus finding effective treatment.

Dr Gedye personifies the vision of ANZUP in bringing together clinicians and scientists. He and collaborators are developing several concepts in RCC including use of biomarkers to predict outcomes, use of immunotherapy combinations and developing trials in areas of need such as non-clear cell kidney cancer. You can watch our full interview here.

ANETA SUDER Medical Oncologist, Royal Brisbane Hospital

“I really enjoy coming to the ANZUP meetings because it’s a very welcoming environment and there’s a lot of interesting discussions.”

NATASHA ROBERTS, CLINICAL TRIAL COORDINATOR

ANZUP UPdate | 7

ANZUP ASM Expanding our Horizons MEET THE PROFESSORS BREAKFAST ANZUP IN ACTION

1.22

MILLION

TWITTER IMPRESSIONS

“It’s great to get all the different disciplines together and all the teams from around the country and including international speakers. It’s a great way to facilitate research, promote the growth of ideas putting them through their paces and into full concepts and trials.”

DAVID PRYOR, RADIATION ONCOLOGIST

57

ABSTRACTS

POSTER WALKABOUT

INTERNATIONAL GUEST SPEAKER PIET OST

NURSES’ BREAKFAST

8 | ANZUP UPdate

ANZUP ASM Expanding our Horizons CONFERENCE DINNER

INTERNATIONAL GUEST SPEAKER, DEAN BAJORIN

COMMUNITY ENGAGEMENT FORUM

ANZUP DEBATE

POSTER WALKABOUT

“The ASM is a time, not only to listen to presentations and be involved in more formal meetings, but there’s a huge amount of corridor conversation, sideline chat and that’s actually incredibly important.”

LISA HORVATH, MEDICAL ONCOLOGIST

297 ASM DELEGATES

COMMUNITY ENGAGEMENT FORUM

ANZUP UPdate | 9

ANZUP ASM Awards TOLMAR ANZUP URO-ONCOLOGY CLINICAL RESEARCH FELLOWSHIP Congratulations to our 2016 Fellow, Arun Azard.

Dr Arun Azad is a medical oncologist at Monash Health and senior research fellow at Monash University. The Fellowship will support his research into the delivery of personalised medicine for patients with advanced prostate cancer, using circulating tumour DNA (ctDNA).

The Tolmar ANZUP CRF supports an early/midcareer clinician or researcher of any health care discipline. This year’s call was for fellowships relating to prostate cancer and provides $60,000 for one year to the winner’s institution. ANZUP thanks Tolmar for their ongoing and generous support of the Clinical Research Fellowship.

“We are delighted to be awarding the 2016 Fellowship to Dr Azad, an outstanding medical oncologist and researcher, to help support his work in the field of personalised medicine in prostate cancer.”

IAN DAVIS

ASTELLAS YOUNG INVESTIGATOR OF THE YEAR AWARD Congratulations Carmel Pezaro, our inaugural winner.

Carmel Pezaro is a medical oncologist and clinical researcher with a substantial record in translational research. She has achieved many distinctions including various fellowships and a reward for a best publication through Monash University.

She has been a fantastic contributor to ANZUP including the Convenor of the MDT Masterclass at the 2016 ASM and will be the Convenor of the ASM to be held in 2017. She contributes many other ways to ANZUP including on committees, in concept development workshops and clinical trials.

The Astellas Young Investigator of the Year Award recognise an outstanding early career researcher in prostate cancer clinical trials research with up to $10,000 will to support his/her attendance to an international GU meeting and ANZUP ASM. ANZUP thanks Astellas for this new exciting partnership and their support of the Award.

“I would like to thank Astellas, for the generous donation to ANZUP, which has made this award possible. With the award, I will be able to extend my knowledge and research network. I also plan to disseminate the cutting-edge research findings from ASCO through participation in national oncology meetings in 2017.”

DR CARMEL PEZARO

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TOLMAR HEAD OF

ANZUP ASM Awards ANZUP ASM AWARDS AND ACHIEVEMENTS 2016 ANZUP/ Bayer Travel Fellowships

TOLMAR ANZUP 2016 Fellowship Arun Azad

Arun Azard

Rachel Delahunty

Inaugural Astellas Young Investigator of the Year Award

Anis Hamid

Carmel Pezaro

Sanjeev Bandi Philip Bredin Megan Crumbaker

Annette Haworth Mahesh Iddawela Andre Joshi Nishi Karunasinghe

ANZUP Trial Coordinator Scholarships

Rahul Ladwa

Irina Arzhintar

Kate Mahon

Charmayne Chorlton

Blossom Mak

Duncan Colyer

Todd Manning

Jenny Edmunds

Andrew Mant

Laura Galletta

Lauren Mitchell

Cynthia Hawks

Sayeda Naher

Sarah Mann

Brian Ngo

Manny Marquex

Wee Loon Ong

Lauren Mitchell

John Park

Lesley Oliver

Lana Pepdjonovic

Natasha Roberts

Marlon Perera

Janani Sivasuthan

ANZUP 2016 TRIAL COORDINATOR SCHOLARSHIP RECIPIENTS

2016 ANZUP ASM CONVENING COMMITTEE

2016 ANZUP/BAYER TRAVEL FELLOWSHIPS RECIPIENTS

SAVE THE DATE!

Handoo Rhee Matthew Roberts

Please save the date for our next ANZUP ASM. We look forward to seeing you in

Lewis Ronan Benjamin Shum

IAN VELA, ASTELLAS YOUNG INVESTIGATOR OF THE YEAR AWARD RECIPIENT CARMEL PEZARO, SHOMIK SENGUPTA

F MARKETING

MELBOURNE 16-18 JULY 2017 TOLMAR HEAD OF MARKETING CAROLINE PILOT AND TOLMAR ANZUP 2016 FELLOWSHIP RECIPIENT ARUN AZARD

#ANZUP17 ANZUP UPdate | 11

ANZUP ASM continued COMMUNITY ENGAGEMENT FORUM Each year our Community Engagement Forum offers a unique part of our Annual Scientific Meeting: where diverse experts can share their knowledge and take questions from the public. It’s a chance to discuss the importance of clinical trials in improving treatment for people diagnosed with prostate and urogenital cancers.

Ian Davis was joined by panelists to discuss the issues around cancer, trials and care before taking questions from the floor. Bryan Gibson gave his patient’s perspective on his participation in the ENZARAD prostate cancer trial. David Pryor and Suzanne Chambers discussed the processes of decision making and participating in a trial. Haryana Dhillon discussed the issues around sourcing credible information and Dickon Hayne gave up update on ANZUP’s research highlights. Richard De Abreu Lourenço talked about the costs of cancer care and why it’s important to assist groups like ANZUP. Thanks to our members, marketing team and the Cancer Council Queensland, we had a full house of local community members.

Thanks to the Courier Mail and ABC Radio Brisbane for their support in running patient stories to support the event.

IAN DAVIS, HARYANA DHILLON, BELINDA JAGO, RICHARDDE ABREU LOURENÇO, DAVID PRYOR, LES LAND AND LEONIE STUBBS

IAN DAVIS AND LES LAND ON ABC RADIO BRISBANE DISCUSSING THE FORUM

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Thanks to our 2016 ASM Sponsors PLATINUM:

GOLD:

SILVER:

BRONZE:

EVENING SYMPOSIUM SPONSORS:

NURSES’ SESSIONS SPONSORS:

TRAVEL FELLOWSHIPS:

BEST OF THE BEST SPONSOR:

EXHIBITORS:

MEET THE PROFESSOR BREAKFAST SPONSOR:

MDT MASTERCLASS:

MDT MASTERCLASS TRANSPONDER SPONSORS:

COFFEE CART SPONSOR:

ANZUP UPdate | 13

REGISTER TO RIDE RIDING

FOR

U R O G E N I TA L

CANCERS

FROM SIMON CLARKE

Support our riders and defeat 4 cancers At the age of 24 I was diagnosed with Stage 1 seminoma testicular cancer and was lucky enough to be treated by ANZUP member, Dr. Peter Grimison. Through early detection and amazing support I came through the treatment process and was determined to give back.

Unfortunately my remission journey lasted three years and earlier this year my cancer re-emerged and I was forced to undertake radiation. While this was a setback, the good news is that I’m back on the path of remission and have an even bigger desire to try make a difference.

Pedalthon’s founding ambitions were to try and change how we all view, act, respond and treat these urogenital cancers. As you know, these are so often diagnosed yet so rarely talked about.

SUPPORT HERE DIRECT TO ANZUP

OUR ANZUP RIDERS

I think it would only be fitting for ANZUP to also lead from the front by way of fundraising efforts and, as such, I am asking that each of you would be kind enough to donate and/or send your support to these ANZUP team members through Everyday Hero.

I truly admire the work that you do and am inspired to give you the best opportunity to develop your groundbreaking ideas into clinical trials.

SIMON CLARKE, PEDALTHON FOUNDER

SIMON CLARKE AND PETER GRIMISON AT PEDALTHON 2015

Australian & New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group 14 | ANZUP UPdate

www.belowthebelt.org.au

ANZUP in Below the Belt action

Will you join us this year?

The ANZUP Below the Belt Pedalthon is a race for riders of all levels and from all walks of life.

This great race welcomes all, from pharma, large corporates, small business, hardworking police, firies and Olympic cyclists all lined up in lycra on the starting line All there to help beat urogenital cancers, with all funds raised going to Below the Belt Research Fund. Of course it’s incredibly important we have ANZUP members as part of the race, and there’s nothing better than seeing familiar faces joining us on the track. Last year, we were delighted to see synergised group of ANZUP members from different areas join us on the day and race around the track.

“It is a great personal fitness challenge.

Whether you are a serious cyclist or just enjoy a relaxed pedal on the weekend the event will motivate you to get out on your bike and train. It’s also a chance to ide on a beautiful, smooth, wide road without traffic. That’s something most Sydney cyclists don’t get to do often…the free massage at the end was also a highlight!”

KAREN BRACKEN ANZUP member and rider

“To think that everyone cared so much to come together to help people suffering from below the belt cancers… It’s a great opportunity to fundraise for a very important cause, but also to challenge yourself, have fun, and make new friends.”

PETER GRIMISON ANZUP member and rider

SUPPORT ANZUP! NO REGISTRATION FEE! As part of team ANZUP, we waive the registration cost of your ride.

Instead we ask you just do your best to fundraise through your networks. If you have any questions contact lucy.byers@anzup.org.au.

It’s time to get ready to race!

Register Now [https:// belowthebeltpedalthon2016. everydayhero.com/au/sign-up]

ANZUP UPdate | 15

UPDATES FROM SAC & SUBCOMMITTEE CHAIRS Scientific Advisory Committee (SAC) The ANZUP Scientific Advisory Committee comprises a broadbased membership ensuring that we have appropriate representation of disciplines in our decisionmaking and strategic processes.

The SAC reviews trial concepts and prioritises them according to ANZUP’s strategic direction.

It was very valuable in November 2015 to have a faceto-face meeting of the SAC to think about strategic planning and how the SAC can work most effectively in the future. This has resulted in a change to the meeting agenda to ensure we dedicate time each meeting for these purposes.

The SAC has met twice by teleconference during 2016 and also had its annual face-to-face meeting at the ASM on 10 July 2016, open to all ANZUP members. This is a great opportunity for all of us to see how the SAC is thinking and working. We are very grateful to all our SAC members for their contributions to ANZUP’s work. Since

the last UPdate newsletter the chair of the Correlative and Translational Research Subcommittee, Paul De Souza, stepped down from his role. The subcommittee members were asked to nominate people for the chair and deputy chair roles. As a result Arun Azad has now been appointed as chair and takes a place on the SAC; Anthony Joshua is the new deputy chair. Thank you to both of them for taking on this new role. I stepped down as chair of the Renal Cell Subcommittee and Craig Gedye has now been elected chair, with David Pook continuing as deputy. Thanks to both of them also.

The SAC recently undertook a formal process of reviewing and ranking the applications for the joint ANZUP/PCFA funding scheme for prostate cancer trials.

It is important to have a broad base of expertise in this process as well as fairness and transparency, and I thank the SAC members who participated.

IAN DAVIS Chair, Scientific Advisory Committee

INTELLIGENT NEWS THESATURDAYPAPER.COM.AU 16 | ANZUP UPdate

Bladder Cancer The ANZUP bladder cancer subcommittee continues to make steady progress with its core businesses of conceiving, developing, supporting and performing clinical trials in bladder cancer. Catching up face to face with colleagues at the ASM always reinvigorates the group and provided a great opportunity to recruit new support to current and future planned trials. The upcoming concept development workshop should further consolidate new ideas discussed at the meeting as well as developing existing concepts already in the subcommittee pipeline.

Trial Updates Recruiting Trials BCGMM: Addition of mitomycin to BCG in high risk non muscle-invasive bladder cancer.

10 sites open: Recruitment 76 A face to face trial management committee meeting at the ASM in Brisbane provided a perfect opportunity to iron out issues relating to recruitment at open sites and troubleshoot problems affecting planned sites which have yet to open.

With the BCG shortage issues now behind us, a period of accelerated recruitment is anticipated. The efforts of the group to have continued to successfully recruit this trial despite, the previous problems with BCG supply not to mention funding shortfalls, is a testament to the dedication of its members.

A further funding application for the stage 2 of the study will be submitted in the next funding round. Now is the time for members with translational concepts which might run alongside the second stage of trial, to bring those important ideas forward.

BL-12: NAB Paclitaxel vs Paclitaxel in patients with advanced urothelial cancer progressing on or after a platinum containing regimen

18 Australian sites open: Australian recruitment 23 This multicentre randomised phase II Collaboration with Canadian cancer Trials Group continues to recruit well in Canada and Australia. Overall, 145 of the target of 199 patients for Australia and Canada had been recruited.

The trial was likely to be open for another year and more sites are still required.

RAIDER-B: Examining adaptive external beam radiotherapy techniques in the treatment of muscleinvasive bladder cancer.

3 of 12 planned ANZ sites open: First Australasian patient recruited in New Zealand The international multi-centre collaborative study continues recruiting well through the MRC in the UK and has commenced accrual in ANZ. PCR-MIB: Pembrolizumab with ChemoRadiotherapy as treatment for Muscle Invasive Bladder Cancer.

This novel phase 1 non-randomised study of 30 patients over 2 years funded by Merck will examine the feasibility and tolerability of the addition of this PD-1 inhibitor to chemo-radiation. 5 sites across NSW, VIC, and WA are anticipated to open in the next couple of months.

Patient Reported Symptom Index in Non Muscle-Invasive Bladder Cancer This study co-badged with ANZUP will develop a new QoL tool for NMIBC. Ethical and site approvals are underway and work towards developing the symptom index (SI) has begun. Testing the SI will be in two phases: qualitative interviews to pretest the draft SI, and large scale field testing (multi-centre).

Concepts ACCEPT: Advancing Cystectomy Care – an Enhanced Recovery Pathway Trial (ACCEPT) ACCEPT aims to develop and introduce an evidence and consensus based Enhanced Recovery Pathway (ERP) for cystectomy care across multiple ‘high volume’ cystectomy sites in ANZ. An ANZUP survey informed ANZUP UPdate | 17

Bladder Cancer the content of the ERP and initially a collaborative multi-centre audit is planned. The data set has been defined and the data collection tools developed. Ethical approvals are currently being sought. Once the ERP and data collection is established a prospective trial with randomized interventions in peri-operative cystectomy care may be possible.

Targeting the AR in Bladder Cancer This novel target continues to generate interest within the sub-committee whilst the practicalities of feasibility of a clinical trial design possibly in collaboration with an industry sponsor are being determined.

DICKON HAYNE Chair, Bladder Cancer Subcommittee

Germ Cell Phase III RCT of Accelerated BEP (plus translational sub study) - open at 28 sites and 26 patients recruited.

This randomised trial of chemotherapy with accelerated BEP versus standard BEP for patients with intermediate or poor-risk advanced germ cell tumours is supported by Cancer Council Australia and Cancer Australia, and is currently open at 28 ANZ sites. 26 patients have been recruited. We continue to work with collaborators to open the study in the UK and USA with collaborators from Cambridge Clinical Trials Unit and Children’s Oncology Group. Version 3.0 of the protocol, which allows recruitment of paediatric patients aged 11 years and over, and female patients, has been approved at 10 sites. We are liaising with the Australia New Zealand Gynaecological Oncology Group and the Australian and New Zealand Children’s Haematology/ Oncology Group to promote recruitment of paediatric patients and patients with FIGO stage IV ovarian germ cell tumours. If you have any questions in relation to this study, then please email mailto:p3bep@ctc.usyd.edu.au.

ANZUP Stage I Testicular Cancer Followup Recommendations Important evidence-based recommendations for the follow-up of stage I testicular cancer have been approved by the ANZUP Scientific Advisory Committee and Consumer Advisory Panel, and are now available for use. A clinician guideline, patient handout, and excel calculator which generates a personalised schedule have been developed by Andrew Weickhardt, Nicola Lawrence, Annie Yeung and Fritha Hanning; with the assistance of the ANZUP Germ Cell Subcommittee and Consumer Advisory Panel. It is hoped that the recommendations will reduce unnecessary variance and radiation exposure in this group of patients.

Current concepts in development Concepts in development include: - e -TC 2.0: a prospective study of an eHealth intervention for TC survivors led by Drs Ben Smith and Louise Heniger in collaboration with PoCoG, building on the successful e-TC study - a surgical study for stage II seminoma, led by Drs Shomik Sengupta and Manish Patel - a n immunotherapy study for chemotherapy-refractory germ cell tumours

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Germ Cell G3 Meeting, Chicago, June 2016 A number of germ cell subcommittee members attended the Global Germ-Cell Cancer Group (G3) seventh annual meeting during the American Society of Clinical Oncology Annual Meeting in June 2016. A number of projects were discussed, including: - t he IGCCCG update initiative (to which ANZUP is contributing data, led by A/Prof Guy Toner and Dr Nicola Lawrence) - D r Ben Tran’s venous thromboembolism validation study - a registry for palliative treatment in germ cell tumours - r egistries for unusual clinical scenarios in seminoma including relapse after adjuvant carboplatin, very high BHCG tumour marker titres, and post-chemotherapy PET-positivity Please contact me if you would like contacts to contribute to these studies.

Malignant Germ Cell International Consortium (MaGIC) Meeting, Cambridge, June 2016 Peter Grimison attended the MaGIC meeting in Cambridge UK, which was convened by members of the Children’s Oncology Group (USA) and Children’s Cancer and Leukaemia Group (UK), and chaired by Dr Lindsay Frazier from Dana-Farber Cancer Institute, Boston USA. Members are active in both clinical and translational studies, and enthusiastic to increase collaborations with ANZUP and other adult cooperative groups on protocols.

The GCT explorer was presented. This clinical and translational database was developed at Southwestern University Texas USA; and is suited to large scale collaborative translational studies. MaGIC also plan a larger conference focussing on germ cell tumours.

Movember – TIGER and GAP5 Translational Research Project Movember is generously supporting ANZUP’s participation in the TIGER study. This very important international randomised trial for refractory and relapsed germ cell tumours, of high-dose chemotherapy with TI-CE versus conventional dose chemotherapy with TIP, is led

by Alliance. ANZUP continues to work with the CTC and Alliance to open the study at 6 ANZ sites later in 2016.

ANZUP also continues to work with Movember on their GAP5 Translational Research Project, which is a translational project that aims to identifying the biological drivers of relapse in this cohort of men. It is hoped that the final research plan will give ANZUP and its Australian collaborators the opportunity to participate in this important research.

Updates from studies in follow-up Chemotherapy and Cognition: Prof Ian Olver presented an abstract on behalf of the study team at the 2016 American Society of Clinical Oncology Annual Meeting, Chicago, June 2016, for this study which prospectively monitored cognitive function in patients managed with and without chemotherapy for testicular cancer.

Conference delegates were reassured that the study found no significant adverse cognitive effects of chemotherapy at 12 months following treatment, however were cautioned to interpret results with caution given the limited sample size. A manuscript is in preparation.

Phase II study of accelerated BEP for advanced germ cell tumours: An updated analysis was conducted by Drs Andrew Martin and Nicola Lawrence at a median follow-up of 6 years found no further relapses, but 2 further deaths – one related to known disease progression, and one unrelated to disease or treatment.

These encouraging results are being presented as an oral abstract at the ANZUP Annual Scientific Meeting, Brisbane, July 2016 and Medical Oncology Society of Australia Annual Scientific Meeting, Gold Cost, August 2016. A manuscript has been submitted.

Call for new members The Germ Cell Sub-committee always welcome new MAGIC MEETING, CAMBRIDGE UK

ANZUP UPdate | 19

Germ Cell members including trainees who will contribute to research activity. Please encourage your interested colleagues and trainees to join the sub-committee.

We are a multi-disciplinary group, and we encourage participation of members not only from medical oncology, but also from surgery, radiation oncology,

nursing, psycho-oncology, and basic science. Again I thank the efforts of investigators, staff from ANZUP and the CTC, and patients for these achievements.

PETER GRIMISON Chair, Germ Cell Subcommitte

Prostate The prostate subcommittee continues to be buoyed by exciting funding developments and our ongoing study progress.

The recent announcement of the ANZUP-PCFA Partnership Grant initiative has stimulated a lot of trial concept activity for the group. This initiative has secured up to $1.5M over 3 years to support what we often find so frustrating in the clinical research arena – that of finding the seed funding to develop concepts into early phase clinical trials which are then competitive going forwards.

ANZUP held a full-day Concept Development Workshop in May, working through 10 concepts ranging from initial diagnosis through to advanced disease, including imaging and translational ideas. Ultimately, after robust discussions on the day and further assessment by as scientific panel, it was decided to move forward with a new therapeutic approach based on the concept “A prospective phase II randomised controlled of Lutetium-177 PSMA radionuclide therapy”. Extensive follow-up discussions have already been undertaken around this, with the first face to face protocol development working group meeting being held later this month. While resources have been committed to this study, we are very keen to see the other ideas prosper with ongoing support from the committee members.

We anticipate that many will progress through the subcommittee in the near future.

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Our open studies continue to be very dynamic. ENZAMET remains the stellar performer, with 734 patients enrolled (of 1100). A few concepts are trickling in around what to do with the extensive bank of translational samples that will be available from this study. I encourage everyone to think through and submit ideas they may have in this respect.

The big question for ENZAMET now is what to do next!

ENZARAD has also recently seen our biggest accruing months. 270 men (of 800) are enrolled now, and this should be boosted by the recent final ratification of the protocol

by EORTC. Several large European sites should open soon, along with a number of UK sites, which all bodes well.

The Pain-Free TRUS-B study is now activated across six centres and 15 men have been randomised. The purpose of this trial is to determine whether the addition of inhaled methoxyflurane to local anaesthesia improves the pain, discomfort and experience of TRUS biopsy. The recruitment aim is 420 patients.

Several concepts continue to be developed in the committee, and we encourage the proposal of new concepts. A number of studies have also been reviewed for consideration of co-badging with the members providing useful feedback on these as they come through. As always, I remind everyone to prod any colleagues with a prostate cancer interest to join and contribute.

SCOTT WILLIAMS Chair, Prostate Cancer Subcommittee

Renal Cell The RCC subcommittee teleconference on 6 May 2016 was my first as chair, and was well attended with robust discussion. Thanks to all who called in and a very big vote of thanks to Ian Davis who has been chairing the RCC subcommittee since ANZUP’s inception; big shoes to fill.

Previous RCC trials that ANZUP has run including SORCE and EVERSUN were discussed. One patient remains on EVERSUN, and a number of patients remain on observation in SORCE. There has been a lot of activity in the RCC subcommittee over the last few months, with four clinical trial protocols shaping up.

KEYPAD is a single-arm, phase II trial of pembrolizumab and denosumab in pre-treated advanced clear cell renal cell carcinoma, in the second-line following progression through VEGFR TKI. 70 patients will be recruited to examine the effect of adding RANK inhibition to immunotherapy. RANKL is expressed by tumour associated macrophages and by ccRCC tumour cells themselves, suggesting that it is an additional mechanism of immunoevasion in these patients. A suite of biomarker studies are planned in conjunction with the study, so a baseline tumour specimen and on-treatment blood tests are an essential part of the protocol. This protocol has been provisionally approved by both MSD and Amgen and we are working hard with the NHMRC CTC to complete logistics. We hope to have the trial open before the end of 2016.

UNISoN is a sequential cohort trial of nivolumab alone, followed (if needed) by ipilimumab + nivolumab in patients with advanced non-clear cell RCC. Clear cell RCC and urothelial cancer are excluded, but patients with any other histology may be eligible. Two-weekly nivolumab will be offered to all patients; if this is unhelpful i.e. their cancer progresses, and they remain well they may reconsent for treatment with ipilimumab + nivolumab, followed by nivolumab maintenance.

The trial is powered to observe a response rate in this second cohort of patients, and so up to 95 patients in

all may be recruited. Again, a suite of biomarker studies are planned in conjunction with the study, including a mandatory on-treatment tumour biopsy at nivolumabalone progression, to compare to a baseline tumour specimen. While it is challenging to re-biopsy patients in a clinical trial, this second sample before eligible patients start the second cohort of treatment (ipi/nivo) will help predict future patients who will be resistant to nivolumab or ipi/nivo, sparing them futile treatment.

This protocol is in late stages of development and about to be formally submitted to BMS for funding.

RAMPART is the long awaited sequel to SORCE. Ian Davis and Martin Stockler have been involved in the development of this study for some years, and with the protocol firming up, the Renal Adjuvant Multiple Arm Randomised Trial is ready for public discussion. This is a multi-stage multi-centre randomised controlled platform trial international phase III trial of adjuvant therapy in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse. The MRC UK is leading the study, but given ANZUP’s substantial contribution to SORCE, we have been invited to participate from the outset. The trial will have three arms: – Arm A: active monitoring for 1 year – Arm B: durvalumab (anti-PD-L1) for 1 year – Arm C: durvalumab for 1 year + tremelimumab (antiCTLA4) x 2 doses Co-primary endpoints are DFS and OS. The trial is well powered to show the proposed benefit of checkpoint immunotherapy in this disease with 1750 patients expected to be enrolled. ANZUP is represented on the Trial Development Group but also on the TRANSRAMPART translational group examining substudies.

Finally, FASTRACK II is a trial of Focal Ablative Stereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial Scientific. This multicentre phase II clinical trial of stereotactic ablative body radiotherapy for primary kidney cancer is being led by Shankar Siva and is a TROG led study, but intergroup co-operative agreements have been drafted to cobadge this as an ANZUP trial. A pilot phase (20 patients) is about to start at the Alfred, Austin, Calvary ANZUP UPdate | 21

Renal Cell Mater Newcastle, RAH, Peter Mac, Princess Alexandra, and Royal North Shore pilot sites. Study start-up planned July 2016. An NHMRC funding application for full study funding has been submitted.

While this represents a lot of activity, we are keen to develop further proposals and ideas for patients with kidney cancer, and we welcome you to attend the RCC Concept Development Workshop, on Wednesday 17 August 2016, at Level 5 Boardroom, Lifehouse Building, 119 – 143 Missenden Road, Camperdown NSW. The CDW is designed to facilitate and support members who actively contribute on a regular basis both in our teleconferences and across our research activities who have an idea or concept they would like to put forward for discussion and, if supported, to further develop into a future grant

application. Funding is available to support successful applicants’ attendance should this be required. As noted above we hope to have trials in second-line for clear cell RCC, and first-line for non-clear cell, so put on your thinking caps for a first and third line trial for metastatic clear cell RCC in particular. Please don’t hesitate to contact me should you have any questions or queries.

Thanks once again for your interest and support for kidney cancer patients in Australasia – we have a number of options for patients’ treatment, but we are excited about examining new opportunities to improve their lives.

CRAIG GEDYE Chair, Renal Cell Cancer Subcommittee

Correlative and Translational Research The Correlative and Translational Research (C & TR) Subcommittee is undergoing significant changes. I am the new Chair and will be ably supported by A/Prof. Anthony Joshua, our new Deputy Chair.

I am a medical oncologist and translational researcher based at Monash Health and Monash University. I recently returned from a prostate cancer fellowship in Vancouver with Prof. Kim Chi and am very excited to be taking on this leadership role with the C & TR Subcommittee.

My goals as Chair are to: 1. Ensure that the C & TR Subcommittee is centrally involved at an early stage in the design of translational studies for all ANZUPled clinical trials; 2. Promote and support clinical trials with translational outcomes as the primary endpoint; and 3. Engage with similar translational committees

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attached to our international partners and cooperative groups. To achieve these goals, we will be assembling a multi-disciplinary working group comprising the best uro-oncology translational researchers in Australia. Of course, all of our activities including subcommittee teleconferences will remain open to all ANZUP members.

Our planned new activities of course complement ongoing biospecimen collection for exisiting ANZUP trials including P3BEP, BL-12, ENZAMET and ENZARAD. I look forward to bringing you more updates on the C & TR Subcommittee and reporting on all the new and exciting activities that we have planned. We also plan to hold a translational meeting at the 2017 ANZUP ASM. More details to follow.

ARUN AZAD Chair, Correlative and Translational Research Subcommittee

Quality of Life and Supportive Care Exciting times in the QOL subcommittee, during our Strategic Planning meeting in April this year we identified a number of messages about our subcommittee that we wanted to share, along with concepts to work on.

First up, the QOL subcommittee is interested in any research and/or interventions with potential to alleviate the impact of UG cancer and its treatments on people living with the disease. Our aim is to not just comment on inclusion of QOL and patient-reported outcomes in ANZUP treatment trials, but develop and run symptom management and supportive care trials.

Two priority areas identified for follow-up were adherence to treatment(s) and the role of physical activity. In talking about adherence want to know: What is the adherence to anti-cancer treatments in GU & Prostate cancer disease groups?

What is the adherence to supportive care recommendations in people on active treatment?

What is the adherence to lifestyle advice?

What are the factors impacting adherence?

the clinic and community, as well as the interventions that are feasible to delivery in practice and trials.

Living Well with Prostate Cancer The NHMRC-funded Living Well with Prostate Cancer Project successfully trialled a mindfulnessbased cognitive therapy group intervention over the telephone for men with advanced prostate cancer. A total of 190 men were recruited and 14 mindfulness groups were run over the course of the project, with each group containing an average of 6 men. Men were followed-up over the course of nine months and intervention outcomes have been analysed. A manuscript has recently been accepted for publication in the peer review journal, Quality of Life Research [1].

This manuscript examines the relationship between mindfulness skills and distress at baseline of the trial.

A manuscript publishing outcome data from the trial is currently under peer review. If you would like any more information about the project, please contact the Project Manager, Dr Melissa Legg, on (07) 3634 5191 or email melissalegg@cancerqld.org.au.

SUZANNE CHAMBERS Chair, Quality of Life and Supportive Care Subcommittee Chambers SK, Foley E, Clutton S, McDowall R, Occhipinti S, Berry M, Stockler MR, Lepore SJ, Frydenberg M, Gardiner RA, Davis ID, Smith DP. The role of mindfulness in distress and quality of life for men with advanced prostate cancer. Quality of Life Research 2016. Available at http://link.springer.com/ article/10.1007/s11136-016-1341-3

1.

Where are we best to intervene?

We are working up initial concepts in this area at the moment and are looking forward to sharing these for feedback over the next few months as the ideas crystalise.

Recently, physical activity as a potential moderator of fatigue was considered. The group is very committed to exploring opportunities to incorporate physical activity interventions into the group program and our ongoing trials. Right now what we are aiming to do is determine what programs could be implemented now and what the outstanding questions about exercise in our populations are. Doing this will help enhance the infrastructure available to support physical activity in

Twitter Did you know ANZUP is now tweeting to over 1000 followers?

Our community are sharing trial updates and news across Twitter. We’re always interested in retweeting your thoughts, stories and insights with the rest of our followers. At our ASM in July our #ANZUP15 thread made over 1.2 million impressions in 3 days. Follow @ANZUPtrials and start communicating with leading professionals today.

ANZUP UPdate | 23

Consumer Advisory Panel (CAP) The opportunity for the CAP to be part of ANZUP’s Annual Scientific Meeting is invaluable, because it means we are better placed to support ANZUP’s research activities from a consumer perspective. The Sunday saw a full day of activity for the CAP and while I was busy winging my way from Melbourne after a wedding on the Saturday night, Ray opened and welcomed everyone to the CAP Education Session. We were sorry that John Stubbs and Tony Sonneveld (both long standing CAP members) were not able to join us. In particular we send Tony our best wishes as he continues to undergo treatment for his advanced prostate cancer.

Ian Davis kicked off the program with an overview of ANZUP’s 2016-2018 strategic plan. Leonie Young then presented on consumer representation in clinical trial research; an excellent reminder for even the more experienced members of the scope of our role. We thank Leonie who continues to work with our CAP sharing her vast experience as a consumer advocate of many years in this space and in her current role as CAP Chair of the ANZBCGT. We continued with presentations on translational research and what it means, making sense of the dollars in cancer trials, and the Quality of Life office explaining their role and how they work with ANZUP. We welcomed Haryana Dhillon, Deputy Chair of ANZUP’s Quality of Life and Supportive Care subcommittee, who spoke to us about some research ideas focused on patient adherence to treatment and the role that exercise can play in improving patient outcomes. With the recent change of faces within the CAP team, we put aside last year’s idea for a CAP project so we could focus on building a team. With the new members on board the CAP considered how we can work more closely with the ANZUP membership to continue to educate the community on the benefits of clinical trials.

In the coming months we will scope out a project in line with ANZUP’s strategic plan of increasing its profile and engagement with the community. For our last,

24 | ANZUP UPdate

but certainly not least, session Ian Davis presented his Concept Outline and Patient Information and Consent Form on the Effectiveness of Topical Broccoli in Big Toe Cancer. It was a humorous but educational presentation covering an important reason for the CAP being involved with ANZUP. We came away knowing there is much that we can do in the months ahead as we have the opportunity to progress some of our thoughts and ideas.

CONSUMER ADVISORY PANEL, ANZUP ASM 2016

The Sunday was all about the Community Engagement Forum. I commend Marg, her team and ANZUP’s Brisbane members who drove this event. The presentations were greatly appreciated by the audience and we had some wonderful feedback. We thank all the presenters who freely give up their time and make the day successful and informative.

The Sunday finished with welcome drinks and the CAP dinner; an annual face to face catch up for shared experiences and ideas. As a group we respond enthusiastically and always meet the timelines. We strongly believe in what we do and are happy to support the ANZUP membership in any way we can.

We thank Ian Davis, the ANZUP Board, and especially Marg and her team for making us feel welcome and valued. The CAP is very much looking forward to another busy and successful year ahead.

BELINDA JAGO Chair, Consumer Advisory Panel

OTHER NEWS

New ANZUP website The ANZUP website is the hub for much of the organisation’s activity. In late 2015, the ANZUP team began looking at updating the website. Working with two agencies the updates include: - A new professional design, look and feel - Navigation options for members, patients, community and supporters - Mobile responsive and easy to navigate from smartphones.

- Greater access to resources for members, subcommittees and trial groups.

- Integrating our new content management software The ANZUP website has now been launched and can be seen live right now.

VISIT THE ANZUP WEBSITE

OTHER NEWS

Prostate Cancer Concept Development Workshop, May 2016 The ANZUP Prostate Cancer Concept Development Workshop held on the 5th May received 8 highly innovative research concepts ranging from new therapy combinations, the optimal use of new diagnostic tools, to translational research questions. Many of the concepts incorporated translational, quality of life and cost effectiveness evaluations, and the input and expertise of the attendees was highly valued. Feedback about the concepts was provided, and will be further discussed at the Prostate Subcommittee.

Generous support from the new ANZUP and PCFA collaboration of $1.5 million over the next 3 years will support an ANZUP led study in prostate cancer. Following the workshop and after significant deliberation, Michael Hofman’s ‘prospective phase II randomised controlled of Lutetium-177 PSMA radionuclide therapy + LHRHa/enzalutamide versus LHRHa/enzalutamide alone in castrate-resistant prostate cancer’ was selected as the successful applicant for further development.

ANNE WOOLLETT Clinical Trials Project Manager

Germ Cell Concept Development Workshop, May 2016 The ANZUP Germ Cell concept development workshop was held on the 4th May and was attended

by ANZUP members from across Australia. The two concepts that were presented and discussed were a surgical trial and an immunotherapy trial. The afternoon involved a brainstorming session for future research, and the discussion inspired a wide range of ideas including quality of life studies, patterns of care studies and interventional trials. The input from multiple disciplines was welcomed and the concepts and ideas developed during this workshop will be further discussed by the Germ Cell Subcommittee.

NICOLA LAWRENCE ANZUP Fellow

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OTHER NEWS

ASCO Annual Meeting June 3-7, 2016 Chicago This year’s ASCO theme “Coming together to share our collective wisdom” saw presentations on exciting advances in cancer immunotherapy and personalised care through genomic medicine and progress enabled by collection of big data. With ~39,000 delegates, including a number of Australians, delegates took advantage of the educational opportunities ranging from debates, tumour boards, abstract presentations, Meet the Professor sessions, case-based learning, poster discussion sessions, and a number of symposia providing attendees with expert insights and global perspectives on the latest treatments and communication strategies making for a very busy few days.

While ASCO doesn’t necessarily provide the GU focus we all love it does provide us with an excellent opportunity to hold a number of key meetings with our international collaborators and stakeholders. One of the major highlights included hosting our second International Trial Steering Committee (ITSC) meeting for the Enzalutamide studies. It was a very productive meeting with Ian Davis (ANZUP Chair, Co-Chair ENZAMET), Scott Williams (Co-Chair ENZARAD), Margaret McJannett (ANZUP CEO), Martin Stockler (Clinical lead, Clinical Trials Centre, University of Sydney) and Nicky Lawrence (ANZUP Fellow) along with our international partners including Co-Chairs of

the ENZAMET and ENZARAD studies respectively Chris Sweeney and Paul Nguyen, Dana Farber Cancer Institute (DFCI); Cynthia Burkhardt and LeaEtta Hyer, Hoosier Cancer Research Network; Simon Chowdhury, Guys Hospital London; Ray McDermott, Eibhlín Mulroe and Olwyn Deignan, Cancer Trials Ireland; Bertrand Tombal, Chair Clinic Trials - European Organisation for Research and Treatment of Cancer (EORTC); Silke Gillessen St. Gallen, Switzerland and Chair EORTC GU Group ; Paul Kelly, Cork University, Ireland; Francisco (Paco) Badillo and Scott North, Canadian Cancer Trials Group (CCTG) contributing to the evening discussion. Chris Sweeney also presented a brief overview of the ICECaP initiative and related translational projects, to which ANZUP will be asked to contribute patients.

As a consequence of these ENZA ITSC meetings discussions have begun around potential ideas for future collaborative studies. We have also made significant inroads into establishing partnerships which we hope will become a global genitourinary cooperative trial consortium in the future. We plan to meet again at ASCO GU in Orlando in February 2017.

We also presented Trials in Progress posters for the ENZAMET and ENZARAD trials, as well as a poster presenting the results of the prospective longitudinal study of chemotherapy and cognition in testicular cancer.

ANZUP UPdate | 27

OTHER NEWS

PRECEPTORSHIP 2016 Following on from the success of last year’s event, the ANZUP Preceptorship in Prostate cancer was held again this year. More than 40 participants from Medical Oncology, Radiation Oncology and Urology backgrounds attended this interactive small group course.

Under the close guidance of consultant preceptors, participants learned about the evolution of prostate cancer treatment through critical appraisal of the seminal clinical trials, to understand why we practice as we do today. A/Prof Eva Segelov and A/Prof Jeremy Shapiro co-convened the event at the Intercontinental in Sydney August 26-27. We thank our sponsors - Astellas, Ipsen, Novartis, and Jansen. Without their support it would not have been possible.

MEGAN CRUMBAKER Assistant Convenor

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OTHER NEWS

SAVE THE DATE

Can you help us find the next great patient story?

Wednesday 25, October 2016

“Best of GU Oncology” Evening Symposium

A little below the belt Conducting clinical trial research to improve the treatment of bladder, kidney, testicular & prostate cancer

Venue GG Restaurant 150 Clarendon St, East Melbourne VIC Time 7.00pm - 10.30pm Symposium Chair: Carmel Pezaro For more information visit: https://www.anzup.org.au/

Welcome Lucy Byers In May, ANZUP welcomed Lucy Byers into the organisation as our new Marketing and Communications Manager.

Lucy has worked in strategic and operational marketing positions for over 13 years, managing marketing, events, communications, sponsorship, digital and branding activities in a variety of industries including healthcare, property, not for profit, education, design and events.

Lucy brings to ANZUP extensive experience in increasing awareness and engagement for organisations as we seek to grow a number of our fundraising and marketing programs.

We’re delighted to have her on board.

BOOK YOUR FREE PLACE AT OUR 2016 COMMUNITY FORUM - SUNDAY JULY 10 DETAILS PAGE 3

AN ANZUP CANCER TRIALS GROUP PUBLICATION

ISSUE 5, JULY 2016

Have you read our consumer magazine “A little below the belt”? The Magazine is produced twice a year; and provides consumers, cancer centres, families of patients, corporate supporters and philanthropists with a lay understanding of what ANZUP does, trials that are open and recruiting, definitions of cancer and treatment terms, stories from our patients currently on trials and our fundraising activities.

The last issue had a focus on our regional and remote patients. We were delighted to be asked to send replacement copies to a number of cancer centres.

Patients respond well to the educative nature of the magazine and also, in particular, the interviews conducted with our trial patients.

Do you have a patient on a trial with an interesting story or passionate belief in the benefit of being on a clinical trial? Please email lucy.byers@anzup.org.au.

We know patients take the magazine home and digest over a few weeks.

Please consider having the magazine available in your rooms or consider referring your patient to the ANZUP website to read the magazine online.

If you would like copies contact ANZUP.

Upcoming 2016 Events 14-16 SEP

AGITG ASM 2016 (http://www.ranzcr2016.com/)

20 SEP

ANZUP Below the Belt Pedalthon, Sydney (http://belowthebelt.org.au)

15-17 NOV

COSA ASM (http://cosa2016.org/)

13-16 OCT

RANZCR 2016 ASM (http://www.ranzcr2016.com/)

25 OCT

Best of GU 2016 (http://anzup.org.au)

22-23 NOV

Sydney Cancer Conference, Sydney (http://sydneycancerconference.com.au)

7-10 DEC

2016 ICBM, Melbourne (http://www.icbm2016.com/)

Free ClinTrial Refer ANZUP App The ClinTrial Refer ANZUP app provides a current list of clinical research trials conducted in cancer centres in Australia and New Zealand.

Designed for oncologists, general practitioners, research unit staff and patients, ClinTrial Refer ANZUP has searchable clinical research trial details, hospital locations and contacts, and inclusion and exclusion criteria.

Available for download from

ClinT

rial R Aust efer ra Urog lian & Ne wZ en Canc ital and P ealand ro er Tri als G state roup

Apple iTunes: https://itunes.apple.com/au/app/clintrial-refer-anzup/id894317413?mt=8 Google Play: https://play.google.com/store/apps/details?id=com.lps.anzup&hl=en

ANZUP Membership benefits include: • Access to a multidisciplinary network for Urogenital and Prostate cancer researchers, including clinicians, nurses, psychologists, scientists, allied health and consumer representatives • Opportunity to contribute to the scientific and strategic development of ANZUP through its SAC and subcommittees • Support for the development of investigator-initiated studies

30 | ANZUP UPdate

• Mentoring and support of young investigators across all our research activities • ANZUP newsletter UPdate and regular sector news updates • Discounted registration at ANZUP’s annual scientific meeting • Access to educational resources, workshops and seminars • Access to grant opportunities • Voting rights at ANZUP annual general meeting and other general meetings

• Other benefits that will be extended from time to time for members only Please join the group and take advantage of the many opportunities for training and mentorship. Maybe you’ll be a future leader of genitourinary cancer research, and maybe you’ll make the current leaders less crusty.

There is no membership fee and membership does not need to be renewed annually. Find out more http://anzup.org.au/members.aspx

OUR THANKS Thank you to our 2016 Corporate Partners and Supporters We are very grateful for the infrastructure support we receive from Cancer Australia however the funds are not sufficient to support ANZUP’s increasing research activities. In 2012 we established our Corporate Supporter program and are delighted that this program has continued to grow. Through this program we have made significant inroads to supporting and facilitating better engagement with our members. We thank our partners Air New Zealand, Adshel, Active Display Group, The Saturday Paper and Mumbrella and our fantastic corporate supporters:

ANZUP UPdate | 31

SAVE THE DATE

ANZUP ANNUAL SCIENTIFIC MEETING

16-18 JULY 2017 PULLMAN ALBERT PARK MELBOURNE

Please check our ANZUP website for updates www.anzup.org.au.

#ANZUP17