UPdate newsletter - Autumn 2014

The Newsletter of ANZUP Cancer Trials Group Limited

MAY 2014

www.anzup.org.au

Large trials assess new hormone treatment for Prostate cancer An excerpt from our recent media release: Sydney 8 April, 2014: The Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group will be the international lead for two of the largest clinical trials for sufferers of the world’s most commonly diagnosed form of cancer, prostate cancer.

The international trials, which have the potential to radically change the way prostate cancer is treated, will together involve over 1,900 patients across Australia, New Zealand, Ireland, United Kingdom, and Canada. The trials involve a new hormone treatment, Enzalutamide. Enzalutamide is not currently approved in Australia for use in prostate cancer but has been shown to be effective in treating late stages of the disease.

The ENZAMET study will involve about 1,100 men with prostate cancer that has spread but has not yet been treated with hormones. The ENZARAD study will include about 800 men with prostate cancer that has not spread and that is planned for treatment with radiotherapy. Men with prostate cancer who are in either of these situations are encouraged to discuss these trials with their doctor or refer to the ANZUP website (www.anzup.org.au) for the trials, which commenced across Australia in March.

28 hospital sites in Australia and 2 in New Zealand will include over 350 patients for the ENZAMET study, and 25 hospital sites in Australia and 2 in New Zealand will include more than 250 patients for the ENZARAD trial.

Overall 1,900 patients will participate in these trials worldwide.

IN THE NEWS

Professor Ian Davis, Chair of ANZUP said the trials might be opportunities to change the lives of prostate cancer sufferers around the world.

“Clinical trials are imperative. All the medical research in the world means nothing if we can’t improve outcomes for our patients. Clinical trials are how we find out whether something works, how best to use it, and how it stacks up against what we are already doing” he said.

“These two trials aim to answer basic questions that patients and their doctors face every day in the clinic: what is the best way of treating men with prostate cancer? They will be two of the largest trials in prostate cancer and people around the world are already intensely interested in them and what their outcomes might be. These trials demonstrate once again that Australia punches above its weight in medical research,” he added.

“We have to do trials in Australia. Our health systems are not the same as the US or Europe.

We need to know how a treatment could or should be used in the Australian setting. A clinical trial is also often a good way of getting access to new treatments for our patients.

Australian research is recognised around the world as being of the highest quality. Even if you look at it in the most basic economic level we know that every dollar invested in Australia in medical research returns about $6 to the economy and in terms of savings in health care costs” he said.

ANZUP UPdate | 1

A LITTLE

Hello and welcome to ‘UPdate’

Message from the Chair

THE BELT

As you read through this edition of UPdate I think you will agree it’s been an amazing first quarter.

Welcome to the May 2014 edition of the newsletter of the Australian & New Zealand Urogenital and Prostate Cancer Trials Group Ltd (ANZUP).

COMMUNITY ENGAGEMENT FORUM

BELOW HILTON ON THE PARK MELBOURNE SUNDAY 13 JULY 2014 n 1PM – 4PM

This forum will provide information & the opportunity to discuss the importance of clinical trials & the impact that a diagnosis of prostate, bladder, kidney or testicular cancer can have on a person & their family.

Inside you’ll hear about: • O ur 2014 ANZUP ASM to be held in Melbourne July 13-15 • The launch of clinical trial UPdates • T he webcast of our recent ENZAMET and ENZARAD Investigator Meeting • A NZUP and PoCoG inaugural ACORD Fellowship • A ttending the Australian Clinical Trials Alliance Conference • T he inaugural ‘Below the Belt Pedalthon’, Tuesday 16 September • Updates from SAC & Subcommittee Chairs • ...And much more

FREE ENT RY

We hope you enjoy this edition of UPdate and all the wonderful news we have to share with you. Please let us know if you have any feedback on this issue or if you have something to contribute to the next one.

I have just spent some time preparing various sections of the Annual Report, to be presented to the members for our Annual General Meeting on 14 July 2014. I looked back at the 2013 report and saw language celebrating the wonderful progress we had made in the preceding year. None of us could have predicted just how much further we would come in the next 12 months. What an amazing adventure it has been! We have already met or exceeded most if not all of the goals outlined in our Strategic Plan 2013-2015, although we are not complacent and will not cease striving for even better outcomes. Here are some of the areas of success that we celebrate:

1. Clinical trials.

We have completed the EVERSUN trial, the first trial to come entirely from our group, and reported it at the 2014 ASCO Genitourinary Cancers Symposium where the results had been hotly awaited. The trial did not provide us with evidence to support our hypothesis that alternating therapy might prevent or delay progression of renal cell carcinoma, but it has provided additional evidence to support the current approach of maximising benefit from one agent before switching to another.

By the time you read this we will have initiated recruitment into two of our most ambitious projects to date: the ENZAMET and ENZARAD trials in metastatic and locally advance prostate cancer respectively. These two trials will include close to 2000 patients and will involve sites in Australia, New Zealand, Canada, the United States, Ireland and the United Kingdom. The time frame to bring these

BOOKINGS ESSENTIAL www.anzup.org.au

2 | ANZUP UPdate

ANZUP UPdate | 3

MORE ASM INFORMATION ON PAGE 19 AND BACK COVER

PLEASE TELL OTHERS ABOUT OUR EVERYDAY HERO PAGE!

projects to fruition was almost impossibly short and yet we have done so successfully, with amazing contributions from many ANZUP members and great support from our collaborators at the University of Sydney NHMRC Clinical Trials Centre, the All Ireland Cooperative Clinical Research Group (ICORG), and the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). Our team has enabled us to secure funding from Astellas; develop the protocols and other supporting documentation, including iterative review and input from local and international collaborators; submit the applications and obtain ethics approval; hold an investigator’s meeting; and initiate both trials; all within only a few months. What an extraordinary accomplishment simply to arrive at this point.

ANZUP IS GROWING WATCH THIS SPACE!

3. Annual Scientific Meeting.

Our plans are well underway for our ASM to be held at Melbourne Hilton on the Park on 13-15 July 2014. Make sure you register now if you have not already done so, and put the dates in your diary. Many thanks to our wonderful convening committee for pulling together an exciting program for the main ASM, as well as our Masterclass (previously the Trainees’ Day but now renamed to reflect reality more closely), the Consumer Advisory Panel education session, the Community Forum, and a great social program. If you have not already registered take a moment now to do so, and encourage your colleagues and trainees to attend. Abstract submissions closed in early April but various travel grants and fellowships might still be available, see: http://www. anzup.org.au/content.aspx?page=asm-support.

In collaboration with:

4. Fundraising and promotion.

ANZUP has also initiated new trials in the form of the phase 3 accelerated BEP trial (Principal Investigator: Peter Grimison) and the mitomycin/BCG non-muscle-invasive trial (Dickon Hayne), both supported by competitive grant funding. We have also submitted further grant applications for the 2014 round to support other clinical trials in prostate and urothelial cancers.

2. Membership.

(http://www.everydayhero.com.au/charity/view?charity=2503).

We had just over 600 members at the time of our last newsletter at the end of 2013; now we are well over 700. Rapid growth in numbers is certainly also worth celebrating, but more importantly our new members continue reflect our existing multidisciplinary mix of professions and geography. We warmly WELCOME welcome you all.

NEW MEMBERS!

4 | ANZUP UPdate

Until recently we have had many grand plans but not the resources to see them to fruition. ANZUP is now in a position where we can start to implement some of these initiatives, including facilitating face-to-face meetings of the various subcommittees and a range of other activities.

You will start to see promotional material for ANZUP appearing here and there very soon. This is aimed at improving community participation in and support of our research, and also is part of our fundraising strategy.

The Board has clear plans for how funds can be raised and used to meet our strategic and visionary objectives and it is exciting to see these unfold. One very successful example has been fundraising through the EveryDay Hero initiative As I have mentioned previously, this has resulted in very valuable revenue that goes directly to support our research activities. It is wonderful to read the comments that many donors leave on the web site with their donations and to read about individual stories of people rising above hardship and grief to do something practical to support research into improving treatment for these cancers. We all need to continue to raise awareness of these issues, amongst our colleagues and also in the broader community.

We are now also able to accept donations directly through our web site. If you have any suggestions or ideas, or if you know someone who might be interested in supporting us, please call (02) 9562 5033 or email us at margaret@anzup.org.au.

2014 Corporate Supporters

We have also been able to grow our administrative support team, increasing the time available for our Marketing and Communication manager Liz Thorp, and developing a new part time project officer position. This will continue to improve our capacity and ability to communicate with you and the community more effectively.

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.

I am very grateful to all of you who contribute to ANZUP and in particular to my fellow Directors, members of the Board subcommittees, the Scientific Advisory Committee, the SAC subcommittees and the Consumer Advisory Panel led by Belinda Jago. The CAP continues to make fantastic contributions to our protocol development processes, communications, fundraising, and grant submissions. Thank you to everyone involved.

In 2012 we established our Corporate Supporter program and are delighted that this program has grown this year and we welcome our two additional industry partners in 2014. Through this program we have made significant inroads to supporting and facilitating better engagement with our members.

We welcome and acknowledge our Corporate Supporters for 2014.

I must as always acknowledge our never-resting Executive Officer Marg McJannett, our project officer Yi Feng, and our Marketing and Communication manager Liz Thorp. There is a great deal going on behind the scenes to keep our organisation moving smoothly along and it is sometimes easy to forget this, since so little of it is formally supported by infrastructure or project funding and therefore can sometimes be below the radar for funding bodies and other organisations. Finally, and once again, many thanks to all of you for your enthusiasm, support and contributions to ANZUP and its work. The sum of our parts is very impressive, and we continually show that we are far greater than that sum.

I can only begin to imagine how I will open the first newsletter of 2015.

Please enjoy this edition of UPdate.

IAN DAVIS Chair, ANZUP

ANZUP UPdate | 5

UPDATES FROM SAC & SUBCOMMITTEE CHAIRS

Bladder Cancer The bladder cancer sub-committee continues to grow in number and activity. Many thanks to Shomik Sengupta for taking on the role of Deputy Chair of the sub-committee and for his enthusiastic promotion of ANZUP and the bladder sub-committee, particularly amongst urologists.

Scientific Advisory Committee (SAC)

The SAC includes a broad representation from the relevant disciplines and its membership is reviewed annually by the Board. The SAC consists of members representing the major disciplines relevant to ANZUP, plus the Chairs of our Bladder, Kidney, Prostate and Testicular cancer subcommittees. The former group of people is intended to be nominated and appointed by recommendation of their craft group, ensuring that we continue to have broad multidisciplinary representation.

Some of our longest standing and in some cases founding SAC members are retiring from the SAC in 2014, including Colleen Nelson (scientist; Correlative and Translational Research chair), Manish Patel (urologist; Bladder chair), John Pedersen (Pathologist), Hema Samaratunga (Pathologist) and John Stubbs (Consumer Advisory Panel). I wish to thank them all profoundly for their wonderful contributions and we look forward to their future contributions to ANZUP in different ways.

We also welcome several new SAC members in 2014: Paul De Souza (medical oncologist; Correlative and Translational Research chair), Dickon Hayne (urologist and USANZ nominee; Bladder chair), Paul Waring (pathologist and RCPA nominee). Many thanks to them for taking on this role, and thanks to all our SAC members, past and present, for your commitment and the quality of your contributions.

Any ANZUP member may join any ANZUP subcommittee, with the exception of the Consumer Advisory Panel whose members are appointed by the Board. You might have indicated your wishes for subcommittee membership when you joined ANZUP but these can be changed as you wish at any time – simply let us know. Please continue to think about ways in which you might want to participate in ANZUP’s scientific activities. You can contribute as much or as little as you wish, but I hope that no-one ever feels that they are unable to be heard or unable to contribute. In particular those members who are in their early careers: involvement in ANZUP is a fantastic opportunity to see how outstanding research is done, to learn about research leadership and the complexities of running a clinical trial, and eventually to take your place as the clinical and research leaders of the future. One day you might be looking after me: we had better train you well!

Thank you for your participation and your creativity.

Please feel free to contribute any ideas or suggestions you might have for trials or related research projects.

IAN DAVIS Chair, Scientific Advisory Committee

Raising the profile One of the broader strategic goals of ANZUP is to raise our profile. This first quarter has seen significant inroads into achieving this goal.

The BCG + MMC trial - now open and recruiting!

It has opened at Fremantle Hospital, Royal Melbourne and the Northern Cancer Institute, with 9 further centres close to opening.

A trial update was presented at both the National Bladder and Kidney Cancer Symposium in Melbourne and at the USANZ Annual Meeting in Brisbane leading to further centres declaring an interest in joining the study. Ideally we need 15 centres so there is still the facility for new sites to get involved.

Our greatest challenge, as a cooperative trials group is cutting through the might of the larger foundations that have significant advertising and promotion budgets.

Two grant applications were submitted in this funding round. The first study investigates patients advanced urothelial cancer and renal impairment requiring first line chemotherapy. Fractionated cisplatin plus gemcitabine is compared to nab-paclitaxel plus carboplatin, or gemcitabine plus carboplatin. The second grant application was the OPTIMUM trial. This study seeks to answer two big questions: choice of (MVAC vs. Gem-Cis) and timing of (neo-adjuvant or adjuvant) peri-operative chemotherapy around cystectomy. Fingers crossed for those two!

To date, we have been well supported by individuals and organisations that have or are in the process of providing ANZUP with assistance in achieving this goal.

They have heard our story and been motivated to provide their services either for no cost or below minimum cost.

DICKON HAYNE Chair, Bladder Cancer subcommittee

Consumer Newsletter We are delighted to introduce the consumer newsletter.

This newsletter is our link, in lay terms, to the community who engage with us as patients, carers or supporters. Our goal is to publish the newsletter quarterly in hard copy and online.

What is a clinical trial?

ANZUP heroes tell their stories How to get involved in a CLINICAL TRIAL

6 | ANZUP UPdate

The RAIDER-B trial was successful in securing a Cancer Australia grant – congratulations to Farshad Faroudi and his co-workers. The study, which is an international collaboration with the UK, aims to recruit 60 Australian patients over 3 years looking at different adaptive radiotherapy techniques in muscle invasive bladder cancer.

AN ANZUP CANCER TRIALS GROUP PUBLICATION

ISSUE 1 • MAR 2014

Please contact the ANZUP office if you would be interested in having copies in your waiting rooms. You can view the electronic copy on our website: http://www.anzup.org.au/content.aspx?page=newsletter

MARKETING UPDATE

MARKETING UPDATE

The SAC continues to meet by teleconference quarterly and face-to-face at the Annual Scientific Meeting.

Our members contribute to the scientific activities of ANZUP through their participation in our trials and our subcommittees. New concepts and trials are recommended to the SAC by each of the subcommittees for prioritisation according to our strategic plan. The SAC then advises the Board which concepts should move ahead, and we all begin to think about how to resource them.

ANZUP UPdate | 7

PROTOCOL SUMMARY - BCG + MMC trial

Background:

Trial Design:

Instillation of Bacillus of Calmette-Guerin (BCG) into the urinary bladder (intravesical administration) improves rates of disease recurrence and progression after transurethral resection (TUR) of high risk, non–muscle-invasive bladder cancer (NMIBC), but over 30% of people still recur despite optimal therapy with adjuvant intravesical BCG. Our meta-analysis, including a recent randomised phase 2 trial, suggests that outcomes might be improved further by using an adjuvant intravesical regimen that includes both Mitomycin C (MMC) and BCG. These promising findings require corroboration in a definitive, large scale, randomised phase 3 trial using standard techniques for intravesical administration.

Open label, randomised, stratified, 2-arm multicentre phase 3 clinical trial

Trial Aim: To determine the efficacy and safety of MMC in addition to BCG in patients with NMIBC Primary objective (endpoint) – To compare: 1) D isease free survival (evidence of transitional cell carcinoma [TCC] or death, DFS)

Study Population: The target population is adults with resected, high-risk NMIBC (high grade Ta or any grade T1) suitable for intravesical chemotherapy treatment. Key eligibility criteria include: prior transurethral resection of all visible tumour, adequate organ function, and ECOG performance status 0-2.

Study Treatments: Eligible participants are to receive either: • A rm A: Intravesical BCG Alone (standard): Induction (weekly x 6), followed by Maintenance (monthly x 10); or • A rm B: Intravesical BCG + MMC (experimental): Induction (weekly x 9), followed by Maintenance (monthly x 9).

Secondary objectives (endpoints) – To compare: 2) Activity (clear cystoscopy at 3 months)

Assessments

3) Time to recurrence (recurrence of TCC, TTR)

Assessments include cystoscopy (C), ratings of HRQL and resource use at baseline and months 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60. Clinical assessments including adverse events assessment are performed weekly before each induction chemotherapy instillation, then monthly before each maintenance chemotherapy instillation.

4) T ime to progression (recurrence of higher grade or stage, TTP) 5) S afety (adverse events graded according to CTC AE V4.03) 6) H ealth-related quality of life (HRQL) (QLQ-BLS24, QLQ-C30 & I-PSS) 7) Overall survival time (death from any cause) 8) Feasibility (compliance with intravesical therapy) 9) M arginal resource use (e.g. number of GP visits, number of outpatient and emergency department visits, number of inpatient admissions and the number of days admitted) Tertiary and correlative objectives (endpoints) 10) T o undertake exploratory biomarker studies as potential prognostic biomarkers or predictive biomarkers of treatment (association of biomarkers with clinical outcomes) 8 | ANZUP UPdate

Statistical Considerations: A sample size of 500 (followed until 213 events are observed) provides 85% power to detect a 10% improvement in DFS rate at 2 years from 70% on BCG alone to 80% on BCG and MMC (hazard ratio 0.63) at a significance level of 0.05, allowing for 10% noncompliance.

Germ Cell

The germ cell subcommittee continues to be very active in 2014.

Phase III RCT of accelerated BEP (plus translational sub study) - open and recruiting 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. Five of 22 ANZ sites have been activated, and Prof Martin Stockler recruited the first patient at Concord Hospital in early April.

Please see the protocol summary on page 11. Our UK colleagues are very interested in joining the trial, and have submitted an application for funding to coordinate the trial in the UK. We have also applied for funding to support the translational substudy.

I am pleased to advise Annie Yeung has been appointed as the new trial coordinator for accelerated BEP and BEP. If you have any questions in relation to these studies please use the p3bep@ctc.usyd.edu.au email address.

I would also like to acknowledge our ANZUP research fellows Anne Long and Felicia Roncolato, and the CTC operations staff led by Associate Oncology Program Manager Nicole Wong, for their tireless efforts in getting this study up and running.

e-shed survivorship interventional study This pilot study is developing an internet-based intervention to address psychosocial distress for survivors of testicular cancer. The study is being conducted by the Psycho-Oncology Co-operative Research Group (PoCoG) in collaboration with ANZUP and Swinburne University of Technology, and supported

by Cancer Council Australia and Sydney Catalyst.

The website for the pilot has been finalised, and the study will open in 5 pilot sites in the 2nd quarter of 2014. Special thanks to expert Research Coordinator Dr Louise Heiniger from PoCoG, and especially our fabulous consumer representatives who have done an incredible job in providing video interviews for the website and expert advice on content to “keep it real”.

Updates from studies in follow-up 1. “Chemotherapy and Cognition”.

Follow-up has been completed for this study of 150 patients led by Prof Ian Olver, which is prospectively monitoring cognitive function in patients managed with and without chemotherapy for testicular cancer.

Results of final statistical analysis are expected later this year. A manuscript led by Brent O’Carrigan reporting on the prevalence of hypogonadism amongst study participants, and its correlation with quality of life has been submitted for publication.

2. “Phase II study of accelerated BEP for advanced germ cell tumours”.

Follow-up is ongoing for this study, whose manuscript was published in Annals of Oncology (25: 143–148, 2014).

Movember Movember is expected to announce in the near future a global action plan for testicular cancer. This will fund a specified global collaborative project addressing key challenges for men diagnosed with and being treated for testicular cancer. ANZUP is delighted that Movember is supporting testicular cancer research, and hope to participate in the funded project.

New concepts 1. Patient portal for stage 1 testicular cancer Fritha Hanning (Medical oncologist, Auckland Hospital NZ) continues to develop an exciting concept for patients with stage I testicular cancer that is designed to assist patient decision making about surveillance vs. adjuvant therapy, promote patient compliance, address psycho-social distress, and minimise patient exposure to ionising radiation. A successful concept development meeting was conducted on 29 November 2013 in Sydney, and Fritha is conducting pilot work in Auckland.

2. Germ cell registry Cancer Australia is developing a data dictionary to support a germ cell registry for patients with testicular cancer, with a number of sites shortlisted for pilot work.

We hope that this can integrate with Ben Tran’s (Medical oncologist, Royal Melbourne Hospital) proposal for a ANZUP UPdate | 9

national germ cell registry that would collate clinical data and identify tissue for clinical and translational studies.

3. TIGER study This proposed international randomised trial of highdose chemotherapy with TI-CE versus conventional-dose chemotherapy with TIP for refractory and relapsed germ cell tumours is awaiting confirmation of sponsors and funding. ANZUP remain enthusiastic to participate.

Call for new members The Germ Cell Sub-committee always welcome new 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.

PROTOCOL SUMMARY - A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for participants with intermediate and poor-risk advanced germ cell tumours

Trial Aim:

Study treatment:

To determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poorrisk advanced GCTs.

Participants will be randomised to either “standard BEP” or “accelerated BEP” arm as follows:

ANZUP ASM

Taking our videos live The videos featuring Ian Davis talking about ANZUP have been well received in the community. They have also provided gravitas when we are talking with corporations from whom we are seeking sponsorship. We would like to thank Harley Oliver and Michael Newling for making these possible.They generously donated their expertise, time and effort to provide us with this fantastic resource. We are extremely grateful to them both Harley and Michael. If you haven’t taken the opportunity to view the videos please do so they are excellent.

David Pook (Convenor) and Andrew Weickhardt (convenor of Masterclass, previously known as Trainee Day) are working hard with the ANZUP ASM committee to develop an exciting program at the upcoming ANZUP ASM in July. This will include a strong germ cell program.

Please register now and encourage your trainees and colleagues to join us in Melbourne.

INVITATION TO CONTRIBUTE TO “G3” GLOBAL GERM CELL COOPERATIVE GROUP STUDY Dr Silke Gillessen from St. Gallen (Switzerland) is leading a retrospective study for patients with stage I seminoma who relapse after adjuvant treatment with carboplatin.

This is an excellent opportunity for Australasian sites to contribute to a global study, which requires submission of a simple paper-based case report form.

https://www.youtube.com/watch?v=iXHesaZKSBU

Standard BEP arm Primary objective - To compare PFS amongst participants randomised to standard BEP or accelerated BEP. Secondary objectives - To compare Overall survival , Response rates, Adverse events, Health-related quality of life, Preferences, and Delivered dose-intensity of chemotherapy Translational objectives - To determine associations between biomarkers and their correlations with clinical outcomes

Study Population: Male participants aged between 16 years and 45 years with advanced germ cell tumours (NSGCT or seminoma) of intermediate or poor prognostic category by modified IGCCCG criteria with adequate bone marrow, hepatic and renal function.

Trial Design:

MARKETING UPDATE

If you are interested, please contact:

Open-label, randomised, 2-arm, multicentre, phase 3 clinical trial.

Dr Gillessen from Switzerland via silke.gillessen@kssg.ch

Recruitment Target:

Dr Carmel Pezaro from Eastern Health in Melbourne via carmel.pezaro@monash.edu. Carmel will be submitting an ethics application at her local site, and would be happy to share her low risk ethics application with any other interested sites.

Part I of the trial aims to recruit 90 patients from about 25 sites in Australia and New Zealand, and an additional 60 patients from international sites in the United Kingdom and USA. Part 2 of the trial would recruit an additional 350 patients and is dependent on involvement of international trial groups.

If you participate, please also notify the ANZUP office at anzup@anzup.org.au so we can track our contribution to this global effort.

10 | ANZUP UPdate

PETER GRIMISON Chair, Germ Cell subcommittee

Participants will receive 4 cycles of Standard BEP as follows: Bleomycin 30,000 international units IV weekly (eg. days 1, 8 and 15 or days 2, 9 and 16) Etoposide

100 mg/m2 IV on days 1, 2, 3, 4, 5

Cisplatin

20 mg/m2 IV on days 1, 2, 3, 4, 5

Pegylated G-CSF 6mg SCI on day 6 Treatment is repeated every 3 weeks (21 days). The planned total duration of treatment is 12 weeks.

Accelerated BEP Arm Participants will receive 4 cycles of Accelerated BEP as follows: Bleomycin 30,000 international units IV weekly (eg. days 1 and 8 or days 2 and 9) Etoposide

100 mg/m2 IV on days 1, 2, 3, 4, 5

Cisplatin

20 mg/m2 IV on days 1, 2, 3, 4, 5

Pegylated G-CSF 6mg SCI on day 6 Treatment is repeated every 2 weeks (14 days).

Following the above regimen, an additional 4 weekly doses of bleomycin 30,000 international units will be given. The planned total duration of treatment is 12 weeks.

ANZUP UPdate | 11

Prostate Cancer The Investigator Meeting for the ENZA Trials

The Prostate Cancer subcommittee continues to be very productive in building on an impressive portfolio of clinical trials.

Powerpoint Presentations: To access the Powerpoint Presentations please visit http://www.anzup.org.au/ content.aspx?page=enzamet-enzarad-im and log in with your ANZUP username and password.

ENZAMET & ENZARAD open and recruiting

We will be collaborating with All Ireland Cooperative Oncology Research Group (ICORG) as well as the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). We will also be working with TROG on the Quality Assurance aspects of the ENZARAD trial. I presented the study to TROG members at the recent TROG ASM.

ENZAMET: Randomised phase III trial of testosterone suppression with or without enzalutamide as first line therapy for metastatic prostate cancer.

ENZARAD: Randomised phase III trial of radiation plus androgen deprivation therapy with or without enzalutamide as first line therapy for high risk, clinically localised prostate cancer.

Since my last report work has continued at a furious pace. We held the Investigator Meeting for both studies on 19 March. This was a very productive meeting with over 100 investigators and trial coordinators participating including representatives from our international collaborators. The sessions were recorded for future reference and for new sites starting up over the coming months. They are now available on the secure section of the ANZUP website.

Webcast: ANZUP members who are participating in the ENZAMET and ENZARAD trials are registered to access the webcast. Please visit http://www.webcasts.com.au/ ANZUP190314/, click on the session link and enter your email address on the following page. When viewing the webcast you can skip through the presentations by clicking on the ‘Chapter Selection’ button located on the bottom right corner of the video player page.

At the time of my report recruitment status: ENZAMET: 3 patients & ENZARAD: 1 patient with others expected to follow shortly.

I am very grateful to everyone involved, particularly our members at the local institutional level, in bringing these studies to this point. I am confident that we will now move quickly and efficiently to the next stages of bringing in more ANZ sites and opening internationally through our ANZ members and our collaborators at ICORG and NCIC CTG, and then of course successful completion of the trial.

Co-badged studies Our growing clinical trial portfolio of cobadged in the prostate cancer subcommittee are performing well.

The ProCare phase I/II randomised controlled trial of follow up of men with prostate cancer in primary care, led by PC4, is in follow-up phase now having accrued quickly.

RAVES Trial - open and recruiting The RAVES study, a phase III multi-centre randomised trial comparing adjuvant radiotherapy (within 4 months of surgery) with early salvage RT continues to accrue slowly.

I ask ANZUP members to keep this study fresh in their minds. Several substudies - germline DNA collected for a genetic epidemiology register, tissue banking of the primary specimen and a randomised decision aid study – are also open now.

The Randomised Controlled Trial of a Mindfulness Intervention for Men with Advanced Prostate Cancer (“Living Well with Prostate Cancer”) is now open in many centres and progressing well.

Prostate Cancer and in Gay and Bisexual Men and Their Partners Study, led by UWS: Recruitment has been broadened to include a comparison group of heterosexual men. The research focus and approved protocol won’t change. What it will do is deepen the understanding of the experiences of sexual wellbeing following prostate cancer in non-heterosexual men by application of a heterosexual comparison sample. We have disseminated the project flyers to cancer centres. Please encourage and promote possible participants to the study website (www.uws.edu.au/PCAS).

We have re-submitted a grant application through NHMRC for support of a prostate cancer study. We are hopeful that we will be successful this year. There are several concepts being worked up within the group also at present, while ANZUP also continues to be involved in several Movember-funded initiatives which we will notify you of as soon as details come to hand.

Call for new members The Prostate Cancer Sub-committee always welcomes new members including trainees who will contribute to research activity. Please encourage your interested colleagues and trainees to join the subcommittee.

ANZUP ASM PICTURED LEFT: Podraig Moran and Jennifer Connolly (Astellas), Scott Williams, Paul Nguyen, Ian Davis, Chris Sweeney, Anne Long, Martin Stockler

The convening committee have done a fantastic job in developing this year’s ANZUP ASM program. There is a superb line up of international faculty. Please encourage your colleagues to join us in Melbourne.

Advertising and ANZUP Through the generous support of Adshel, Principals and XXVI, The Saturday Paper and Become we have been able to produce a series of advertisements that will appear on outdoor banners in Melbourne in the lead up to the Community Engagement Forum in July. We hope these ads will create a conversation in the homes of people with testicular, prostate, kidney and bladder cancer that will encourage them to attend the Community Engagement Forum. Principals and XXVI have created stark billboard ads for our Melbourne campaign and we wish to thank them, Adshel and The Saturday Paper for their generosity and support.

MARKETING UPDATE

SCOTT WILLIAMS Chair, Prostate Cancer Subcommittee 12 | ANZUP UPdate

ANZUP UPdate | 13

Consumer Advisory Panel (CAP)

Renal Cell Cancer The RCC subcommittee continued to meet quarterly by teleconference over the last twelve months. Two trials are ongoing although neither is currently recruiting participants: 1. SORCE. The placebo-controlled SORCE trial evaluates the benefit and safety of adjuvant sorafenib given either for one or three years in the setting of resected RCC at intermediate or high risk of recurrence. SORCE is led by the Medical Research Council UK and closed to accrual in April 2013. Some of our original trial participants have now completed three years of planned therapy and are in the follow up phase; other participants continue to receive blinded study drug. The trial still has a considerable time to run and it now becomes even more important to keep trial participants on study and ensure timely collection and submission of data. ANZUP contributed very well to this trial and we are now well placed to participate in future similar trials.

Substudies of SORCE include the TRANSORCE tissue substudy and the patient preferences “PAS in SORCE” substudy. TRANSORCE samples are planned to be used in future laboratory research. PAS in SORCE was developed by ANZUP researchers Prunella Blinman and Martin Stockler, aiming to determine patient preferences and expectations in relation to the treatment and its toxicity. The PAS in SORCE substudy was also open at several UK sites and interesting results have already been obtained from only the baseline data, prior to any participants receiving blinded study drug. A forthcoming analysis will examine data from the 3-month time point, at which time 75% of participants will have received active sorafenib. Later time points will provide further interesting outcomes from the PAS in SORCE substudy.

2. EVERSUN. EVERSUN was based on the hypothesis that alternating treatments for renal cell carcinoma aimed at different biological mechanisms of action (sunitinib and everolimus) would be safe and would prevent or delay the development of resistance to treatment. EVERSUN was developed entirely by ANZUP and was supported with funding and study drug from Novartis. The trial attracted considerable international attention and the

14 | ANZUP UPdate

final results were presented at the ASCO Genitourinary Cancers Symposium early in 2014. The primary endpoint was not reached and the conclusions of the study were that, although this treatment is safe and well tolerated, the trial did not provide data that supported departure from the current linear treatment paradigm of treatment with a single agent until failure and then swapping to an alternative treatment. This negative result is still a significant contribution to the body of knowledge about how to use these drugs. The trial manuscript is now being prepared for submission for publication.

EVERSUN included the translational substudy (EVERSUN-T), led by Sonia Yip and was also presented at the ASCO Genitourinary Cancers Symposium in 2014.

EVERSUN-T involved measurement of circulating tumour cells (with the support of Colleen Nelson’s laboratory) as well as measurement of key serum markers (work by Nick Pavlakis’ group). EVERSUN-T demonstrated that this work was feasible but did not identify evidence of associations between clinical outcomes and changes from baseline in the markers included in the study.

Several other concepts are at various levels of development by the Renal Cell subcommittee, with active input from several members. A survey of national radiotherapy practice has been developed and should soon be rolled out.

Many thanks to all the RCC subcommittee members for your great contributions. We are also grateful to the Correlative and Translational Research subcommittee, the Quality of Life and Supportive Care subcommittee, and the Consumer Advisory Panel, for very helpful and timely advice whenever it is requested.

IAN DAVIS Chair, RCC subcommittee

I am delighted to report the ANZUP CAP now has representation across all cancer types and as a consequence we have at least one CAP member available to participate in the Bladder, Kidney, Testicular and Prostate Cancer subcommittees.

Trials and Research Study Participation Matt Carr continues to support the e-tc study which is being established to pilot-test an internet based intervention for men who have completed treatment for testicular cancer, and are experiencing difficulties adjusting back to normal life. Matt recently spoke and reported to the CAP that the study was progressing well and was showing great promise as a useful tool for testicular cancer patients. This study is another great example of CCTG’s working collaboratively together.

Matt is also involved in the Phase III BEP trial.

In the recent grant applications Colin O’Brien was involved with the resubmission of the Penthrox Pain Free Trus B trial and he commented at the last CAP teleconference, that from a consumer perspective, the application was very strong. Fingers crossed, this time round the submission will be successful!

Our newest CAP member Peter Stanford has hit the ground running, participating in his first Bladder cancer sub-committee meeting. Peter was also involved in the recent grant funding submissions for two bladder cancer trials. Thank you to Peter and Colin for their input and support of ANZUP activities.

CAP Education Session at July 2014 ASM Over the next few weeks the CAP Education Program for this year’s ASM will be finalised. All CAP members are once again looking forward to this opportunity to meet face to face, to learn and discuss ways that we, as consumers, can best support ANZUP while helping to educate the community on the importance of clinical trial research. We strongly encourage everyone to use their social media networks to spread the good news about ANZUP and the world class research that they are involved in.

We are also pleased to advise that Leonie Young, chair of the ANZBCTG CAP, will once again participate in our CAP Education session prior to the ASM. Leonie’s

experience, knowledge and mentoring skills are greatly appreciated by the entire CAP. Thank you Leonie!

CTCN – Clinical Trial Consumer Network As the Chair of the ANZUP CAP I am afforded the opportunity to attend meetings along with CAP Chairs from the other 13 Cancer Cooperative Trials Groups (CCTG). The last meeting was held face to face in Adelaide as part of the COSA 2013 ASM pre meetings.

This group comes together to discuss our differences and similarities, share information and explore what efficiencies we might be able to achieve, to help build stronger links between the CCTGs. Leonie Young and I shared a presentation highlighting the benefits of our joint CAP education program in July 2013. This presentation certainly created some positive discussion for the future.

I feel privileged to be part of a team of committed consumers who enjoy the opportunity to support ANZUP’s growing portfolio of research activities and thank all CAP members for volunteering their valuable time. Your contribution to ANZUP in many and various ways is greatly appreciated. I am looking forward to the rest of 2014.

BELINDA JAGO Chair, Consumer Advisory Panel

Sky Sport Network Sky Sport is providing ANZUP with both television advertising space and on air radio space pro-bono.

This will enable ANZUP to reach directly into our male demographic. Sky Sport will provide us with 30 second television commercial space in the lead up to the Community Engagement Forum that will run for approximately two weeks across their sport and racing networks. They are also going to begin a campaign of on-air discussions about ANZUP and our clinical trials. The aim of these on-air ads is to build awareness around who ANZUP is and the significant role we play in improving outcomes for patients with urogenital and prostate cancers

MARKETING UPDATE ANZUP UPdate

| 15

Correlative and Translational Research

Quality of Life and Supportive Care Living Well with Prostate Cancer - active and recruiting!

The NHMRC-funded ‘Living Well with Prostate Cancer’ has continued to recruit well, with now over 125 men enrolled and recruitment on track to complete in mid-2014. This project is trialling the effectiveness of a mindfulness-based cognitive therapy (MBCT) group intervention over the telephone for men with advanced prostate cancer. Five mindfulness groups have now been completed with another three underway and men who participated in them have continued to report back to the project team that they found the techniques they learnt to be helpful.

Cancer Council Queensland and Griffith University would like to thank all the ANZUP members involved with the project across our 29 recruiting sites for all of your hard work referring patients and we look forward to having more of your patients involved this year.

If you would like any more information about the project, please contact the Project Manager, Rob McDowall, on (07) 3634 5314 or email robmcdowall@cancerqld.org.au.

Correlative and Translational Subcommittee

Sexual Wellbeing and Quality of Life after Prostate Cancer for Gay and Bisexual Men and their Partners

The Correlative and Translational subcommittee members contribute substantially from an early stage in all new concepts. As an example several Australian sites have contributed to the translational substudy of SORCE called TRANS-SORCE being led by the MRC in the UK.

‘Sexual Wellbeing and Quality of Life after Prostate Cancer for Gay and Bisexual Men and their Partners’ has been recruiting successfully, with 74 men and 21 partners recruited for the first phase of assessments and 39 men and 7 partners who have completed the second phase of interviews. Recruitment is ongoing to reach the project targets of 90 men and 70 partners for the first phase and 30 men and 20 partners for the second phase. As the target has been met for men in the second phase of the project, these interviews are now only continuing on a selective basis to ensure a broad variety of experiences.

An Honours student at University of Western Sydney has now become involved with the project to collect data on a sample of heterosexual men, which will allow comparative analysis between these two groups.

For the phase 3 BEP trial, prospective collection of biospecimens is being implemented for future translational studies assessing candidate biomarkers as possible prognostic or predictive biomarkers.

An international translational committee is being set up for the ENZAMET and ENZARAD trials with representatives from Ireland, Canada, USA and Australia. Proposed translational projects include metabolic studies and analyses of tissue DNA and circulating free DNA as prognostic and/or predictive of response to treatment, safety and resistance to study treatment. The logistics of setting up bio specimen collection for these 2 large multi-national studies has involved considerable effort by Lisa Horvath’s group at the Garvan Institute and the Chris O’Brien Lifehouse.

The project team would like to thank all ANZUP members who have been involved with the project.

Recruitment will be ongoing throughout this year until targets are reached and ANZUP members who would like to assist with recruitment are encouraged to contact the research team on 1800 19 20 02 or cancerandsexuality@uws.edu.au.

Results of the translational study EVERSUN-T measuring circulating tumour cells (conducted at Colleen Nelson’s laboratory, Brisbane) and key serum biomarkers (conducted

by Nick Pavlakis’s laboratory at the Kolling Institute) were presented as posters at ASCO GU and the Asian Oncology Summit in 2014. I would like to acknowledge Sonia Yip, Senior Translational Research Fellow and Manager, for her summary of these activities.

Everyday Hero

GoFundraise

If you are planning to participate in a major event such as City2Surf (Sydney) and City2Sea (Melbourne), or host your own event, and would like to fundraise for ANZUP please visit our Everyday Hero page:

GoFundraise helps individuals, charities and not-forprofit organisations fundraise through existing events, or you can create your own events. To view the events available on Gofundraise please visit our Charity Cause Page: http://www.gofundraise.com.au/beneficiary/anzup.

http://www.everydayhero.com.au/charity/view?charity=2503.

MARKETING UPDATE

SUZANNE CHAMBERS Chair, Quality of Life and Supportive Care Committee

The ASM convening committee have done a great job in developing this year’s ANZUP ASM program. There is the open SAC meeting on the Sunday as well as plenty of opportunity for you to contribute in the Concept Development Session Tuesday 15 July. I strongly encourage you to recommend the ANZUP ASM to your interested colleagues and trainees to join us in Melbourne.

Please encourage your basic science or clinician-scientist colleagues to join ANZUP and our subcommittee.

PAUL DE SOUZA Chair, Correlative and Translational Research Committee

Below the Belt Pedalthon Riding for Urogenital Cancers In 2013 Simon Clark, a young testicular cancer survivor, together with a group of friends who had been touched by urogenital cancers, approached ANZUP to discuss the possibility of holding an event to promote awareness and create a fundraising initiative towards supporting Urogenital Cancer research and prevention. As a consequence of those discussions “Below the Belt Pedalthon, Riding for Urogenital Cancers” has emerged.

“The good news is that we have recovered thanks to the medical treatment and advice we received from ANZUP members” said Simon.

“Now we want to give back”. “While the core event is a competitive test for both individuals and teams, so is the battle to find improved treatments and outcomes for these cancers”.

Whether you’re new to cycling, an avid cyclist or just looking for a challenge - the Below the Belt Pedalthon is the race for you. Pedalthon’s vision is to make a difference through raising awareness and attracting charitable dollars to improve treatments for these more common, but less glamorous “below the belt” cancers.

Our flagship event is the ultimate corporate challenge - a 4 hour team-based cycling pedalthon where strategy, teamwork and skill are all traits of success. 95% of funds raised will go directly to clinical trial research.

As the name suggests, this team based challenge is to ride as many laps as possible in four (4) hours. Within this time frame three (3) distinct “Power Play” time trial scenarios will exist where the fastest single lap achieved in this period will be awarded bonus laps to add to the teams total.

Teams comprise up to 8 members, however at least 3 are required on the track at any one point. Riders may interchange via the pit lanes according to team strategy. Event categories will apply throughout the event.

We would love to hear from all those cycling enthusiasts so we can put a couple of ANZUP teams joining us for the event on Tuesday 16 September, 2014 at Eastern Creek.

A sample of upcoming events is The Great Ocean Road Marathon 17-18 May 2014, VIC http://thegreatoceanroadmarathon.gofundraise.com.au/

16 | ANZUP UPdate

FLYER

ANZUP UPdate | 17

MARKETING UPDATE

Message from the Executive Office 2014 ASM We are very excited about plans for this year’s ANZUP Annual Scientific Meeting to be held in Melbourne July 13-15. The theme “From ideas to outcomes: patient focused research” will once again showcase the most up-to-date cancer treatment and education for clinicians, researchers and consumers by our outstanding international and national faculty. Our ASM will provide you with the opportunity to come together to hear about latest treatments and research and to discuss and explore new ideas to achieve our mission. It also provides a unique opportunity to meet in a friendly but focussed environment. The meeting sessions will be interwoven with generous networking opportunities during the refreshment breaks and other social activities allowing time to renew friendships and establish new professional connections.

We are very grateful to our extraordinarily hard working convening committee led by convener David Pook, along with Emma Beardsley, Ian Davis, Jeremy Grummet, Amy Hayden, Belinda Jago, Carmel Pezaro, Kathryn Schubach, Shomik Sengupta, Shankar Siva, Ben Tran, Andrew Weickhardt and Henry Woo for their tireless efforts in developing an exceptional scientific program. Thank you also to our subcommittee Chairs for providing invaluable advice and support. Our thanks to our MDT Masterclass convener Andrew Weickhardt for putting together a high quality ANZUP MDT Masterclass program: “Challenging cases in Uro-oncology”.

Please register now and encourage your friends, colleagues and trainees to come along. If they aren’t members of ANZUP (quite unimaginable!) please encourage them to join and take advantage of the discounted registration.

Tuesday 16 September 2014 Sydney at Motorsport Park, Eastern Creek For details email: bikerace@anzup.org.au

We thank and acknowledge this year’s major sponsors who provide invaluable support to ANZUP and our ASM. Without their sponsorship, we could not host such a high-quality meeting MORE spanning the three days.

ON BACK COVER

18 | ANZUP UPdate

Our sincere thanks go to this year’s ASM sponsors: PLATINUM:

GOLD:

SILVER:

BRONZE:

EVENING SYMPOSIUM:

TRAVEL FELLOWSHIPS:

MASTERCLASS:

BEST OF THE BEST:

MOBILE APP:

AV SPONSOR:

EXHIBITOR:

ANZUP UPdate | 19

13-15 JULY HILTON ON THE PARK MELBOURNE

OTHER NEWS & EVENTS

“FROM IDEAS TO OUTCOMES: PATIENT FOCUSED RESEARCH”

Clinical trial updates In March we launched our new Trial UPdates which we hope will provide our members with a regular overview of all current ANZUP Trials that are open and encourage recruitment.

Webcast We also held the ENZAMET and ENZARAD Investigator Meeting last month. There was a series of high quality presentations from the lead investigators providing: 1) background and rationale of each trial; 2) overview of the management of each protocol including treatment schedules, study visits, safety reporting and timelines; and 3) detailed training to site staff on data collection requirements and the electronic data capture system (INFORM). The meeting was recorded and we hope proves to be a useful resource to both investigators and trial coordinators as their sites are activated for these studies. Please don’t hesitate to contact us if you haven’t received your login details.

ANZUP and PoCoG inaugural ACORD Fellowship In February we announced a new joint initiative to support our members in developing new trial protocols.

The ACORD workshop provides a unique opportunity once every two years to:

Australian Clinical Trials Alliance National Summit Ian Davis and I recently attended Australian Clinical Trials Alliance (ACTA’s) inaugural national summit.

ACTA’s mission is to promote effective and cost-effective healthcare in Australia – best done by investigator led clinical trials that generate evidence to support decision making by health practitioners, policy-makers, and consumers. Australian researchers have led and conducted many high impact clinical trials but it’s also likely that the number and impact of clinical trials could be substantially enhanced by changes to the landscape in which trials are conducted, and their results implemented.

Presentations, panel discussions and a workshop-style business meeting formed the 1.5 day conference. A formal report on the proceedings and outcomes of the Summit will be published in the coming weeks. One of ACTA’s first projects will be to undertake a national survey to develop a comprehensive profile of Australia’s clinical trials networks, their activities and achievements.

You can read more about ACTA via their website at www. clinicaltrialsalliance.org.au.

Pedalthon

• L earn advanced clinical trials principles;

On Tuesday 16 September ANZUP will host an inaugural ‘Below the Belt Pedalthon’. The race is a 4 hour corporate cycling challenge where individual riders raise funds for ANUZP. This race is the initiative of testicular cancer survivor Simon Clarke. Simon is determined to raise the profile of urogenital and prostate cancers while also raising funds for trials. We thank Peter Grimison for referring Simon to us and encourage anyone who likes to cycle to build a team or join us on the day.

• A rrive with a protocol outline and leave with a complete protocol ready for Ethics approval.

Margaret McJannett Executive Officer, ANZUP

• M eet and network with a selected group of cancer researchers from the Asia Pacific Region; • L earn to design effective clinical trials with world leaders;

This initiative has proved to be very popular and we are currently awaiting the outcome of the reviews. We will announce the successful applicants in the next newsletter.

20 | ANZUP UPdate

Staff Changes at ANZUP’s Clinical Trial Operations Team We are delighted to welcome Nicole Wong as our new Associate Oncology Program Manager (AOPM) to the ANZUP team. Nicole has a Bachelor of Nursing & Bachelor of Science Honours (Anatomy & Histology). She joined the Clinical Trial Centre in 2006 as a trial coordinator and in 2009 was promoted to AOPM responsible for oversight of approximately 14 projects with local and international collaborators through the AGITG clinical trial network. Nicole is an experienced AOPM and will be responsible for the Operational Management of ANZUP Trials. She is looking forward to learning more about ANZUP and urogenital cancers.

Incorporating economic evaluation into your research and practice

package, TreeAge, participants gained experience in developing Decision Trees and Markov models at the workshop held over 6-7 March 2014.

Workshop participants represented diverse research and clinical backgrounds including oncologists, surgeons, nursing, psycho-oncology and allied health professionals.

ANZUP members welcomed the opportunity to build on their knowledge from the introductory CREST workshop with highlights including a greater understanding of the components of economic models, the introduction to the modelling software and the opportunity to network with other researchers and the CREST staff.

NHMRC Early Career Fellow at Epworth Prostate Centre, Adam Dowrick, came away from the workshop keen to translate his new knowledge into research stating, “The focus of my research since my PhD has been in investigating patient-reported outcomes. Working in prostate cancer where comparable treatments may have little difference in mortality, I plan to integrate health economics outcomes into all my studies to supplement the patient-reported outcome data to help define best practice”.

Other ANZUP members also intend to incorporate their new skills into a range of areas such as socioeconomic status and prostate cancer treatment and integrating economic evaluation into psycho-oncology and oncology dietetic research. The ANZUP participants would highly recommend this workshop to other researchers and wish to thank both the CREST staff and ANZUP for their support in this invaluable learning experience.

MERRAN FINDLAY

If you’ve ever wondered how to incorporate economic evaluation into your research, four ANZUP members were among twenty fortunate participants from clinical trials groups across Australia who recently took part in a 2-day intensive workshop to find out how.

Led by Richard De Abreu Lourenco, the enthusiastic and knowledgeable Cancer Research Economics Support Team (CREST) at the Centre for Health Economics Research and Evaluation (CHERE), University of Technology, Sydney facilitated an interesting and challenging mix of lectures and practical hands-on sessions. Utilising the economic modelling software

L to R: ANZUP Members Merran Findlay; Michelle Peate; Adam Dowrick, Stephen Goodall (CREST), Nathan Papa

ANZUP UPdate | 21

USANZ 2014 ASM at Brisbane Convention & Exhibition Centre 16 to 19 March This year’s USANZ (Urological Society of Australia and New Zealand) annual scientific meeting, convened by Greg Malone, with Eric Chung as scientific convenor, featured a packed program showcasing a stellar line-up of international guests too numerous to list. After a variety of hands-on workshops during Sunday, at the conference opening ceremony, the audience was privileged to hear the Harry Harris oration from Prof Ian Fraser, outlining the captivating story behind HPV vaccination and cervical cancer prevention.

The plenary session on Monday included a debate on prostate cancer prevention between Gerald Andriole (yes) and Shahrokh Shariat (no) – the audience response suggested that the case against prevailed. Subsequent breakout sessions addressed aspects of prostate cancer from screening and early detection, through new diagnostic pathways including biomarkers and transperineal biopsy, to management of the wide spectrum from low-risk localized disease to progressive castration-resistant disease.

Tuesday’s plenary included comprehensive updates on bladder cancer technologies (Prokar Dasgupta) and upper tract urothelial cancer (Shahrokh Shariat) as well as a debate on the role of biopsy for small renal masses between Brad Leibovich and Michael Jewett – with both speakers finally agreeing on selective application.

Further aspects of bladder and kidney cancer featuring in the day’s breakout sessions included the role of lymphadenectomy and chemotherapy for the former, nephron-sparing surgery for small renal masses and tumour thrombectomy for venous extension of renal cancer.

Wednesday morning featured the inaugural AUA (American Urological Association)-USANZ joint panels, including one addressing prostate cancer – when to treat.

This featured Alan Partin, James Eastham, Shahrokh Shahriat and Gerald Andriole from the AUA and Mark Frydenberg, Henry Woo and Dickon Hayne from USANZ, and debated the interventional options for both low-risk and high-risk localized disease. Other sessions provided updates on germ-cell tumour management (including surveillance for Stage I disease, contemporary imaging 22 | ANZUP UPdate

options & chemotherapy guidelines and new systemic treatments on the horizon), a summary of current national trials and a multi-disciplinary forum on difficult cases.

A joint session co-badged with ANZUP featured two of the international guests, Matthew Rettig speaking about multidisciplinary collaboration in urooncology trial design and Brad Leibovich speaking on how clinical trials impact on urologic practice. In addition, Dickon Hayne provided an update on ANZUP’s current, completed and developing trials and Jeremy Grummet described the process whereby the ANZUP conceptdevelopment pathway helped him progress the pain-free TRUS biopsy trial.

The Saturday Paper Recently launched in Australia, The Saturday Paper has been providing ANZUP with advertising space.

We thank The Saturday Paper for their support.

MARKETING

WALKING TOWARDS LIFE

Don’t be in the dark about clinical trials.

ANZUP is the leading light in better treatments for testicular, prostate, kidney and bladder cancer.

To find out more about ANZUP’s clinical trials visit www.anzup.org.au

In addition to the highlights outlined above, the meeting featured a large number of high-quality free papers, presented in both poster and podium sessions – predominantly from Australia and New Zealand, but also including a growing number of international authors.

USANZ trainees made up a substantial proportion of contributors, and the best of their papers vied on Tuesday for the Keith Kirkland prize in clinical research (won by Helen Nicholson: Timing of intra-operative NSAID and pain outcomes after ureteroscopy) and the Villis Marshall prize in laboratory research (won by Kenny Rao: Zinc preconditioning protects the rat kidney from ischaemic injury).

Overall, the 2014 USANZ ASM was clearly a great success, providing attendees the ideal mix of interesting scientific content and fun-filled social events at a sun-drenched venue on Brisbane’s Southbank. Planning is already underway for a cobadged session at the 2015 USANZ ASM in Adelaide.

We continue to explore other opportunities for collaboration with USANZ. SHOMIK SENGUPTA

Asian Oncology Summit 2014

Survey of patterns of practice re bone health

Kuala Lumpur hosted the 6th Asian Oncology Summit earlier this month, convened by Lancet Oncology. It was held in conjunction with the 10th Annual Conference of the Organisation for Oncology and Translational Research (OOTR). Over 3 days we heard presentations including latest treatments in genitourinary and other cancers, new findings from laboratory studies, developments relating to cancer stem cells and clinical trials networks in Asia-Pacific. It was an excellent opportunity to network with our counterparts in SE Asia and to catch up with a few familiar faces from the Australian oncology research community.

We have distributed a 22-item study specific survey to 156 members of the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) to examine current practice, knowledge and opinions on the provision of bone health management for prostate cancer patients treated with curative intent and preferences for who should be responsible for bone health management and barriers that affect implementation of bone management strategies.

Surveys were open for one month via SurveyMonkey with a reminder email sent at two weeks.

Two ANZUP studies were presented. One poster was about the EVERSUN trial in renal cell carcinoma, testing 2 targeted therapies given in an alternating sequence (sadly our Clinical Research Fellow, Dr Anne Long, was unexpectedly unable to attend to present this one). The second poster was about its translational substudy on circulating biomarkers, EVERSUN-T. I had the honour of presenting the outputs of the hard work of the EVERSUN trials team, participating sites in ANZ and their patients and our laboratory research collaborators, using an innovative electronic SONIA YIP

Twitter Did you know ANZUP is tweeting? If you aren’t already following us you can find us at @anzuptrials.

We hope all ANZUP members with twitter accounts will start following us. Key dates, trials updates, news and good news stories are regularly being tweeted.

MARKETING UPDATE

Twenty three cancer care providers responded to the survey. Majority were male, medical oncologists and practicing in tertiary hospital setting. Calcium supplementation, Vitamin D supplementation and weight bearing exercise were the top lifestyle factors discussed for the prevention of osteoporosis. The main barriers to care identified included lack of time and lack of training. A third of respondents identified medical oncologists as most appropriate to manage bone health. Other potential providers included endocrinologists and GPs. When asked for further comments or suggestions, two major themes emerged regarding management guidelines and responsibility. This included making bone health assessment part of routine care when commencing hormone therapy and the need to clarify who is ‘in charge’ of bone health management.

We are very grateful to all members who had provided their feedback and hope that we may gain feedback from others on this topic through further discussions.

If you have a comment on this area, please contact the project lead Prof Bogda Koczwara on bogda.koczwara@flinders.edu.au.

BOGDA KOCZWARA

Facebook ANZUP is also on Facebook. Do you use Facebook as a way of staying in touch? Please let us know what information you would like to read about through Facebook so we can tailor the site to meet the needs of our members. Don’t be afraid to send photos through of ANZUP members doing what they do best.

ANZUP UPdate | 23

13-15 JULY HILTON ON THE PARK

• MELBOURNE •

2014 ASM

ANNUAL SCIENTIFIC MEETING The Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group is pleased to announce our 2014 Annual Scientific Meeting (ASM) will be held at Hilton On The Park Melbourne from 13-15 July, 2014.

“From ideas to outcomes: Patient focused research”

Our ASM provides a unique opportunity to bring together all disciplines of health professionals involved in researching and treating cancers of the genitourinary system.

We will soon be updating the program with those selected for oral presentation, so please check the ANZUP website.

Program highlights will include: • State of the art presentations from leading international and Australian experts; • Up-to-date management and research for prostate and other genitourinary cancers; • Opportunities for researchers to present their research; • Clinical trial Concept Development Workshop; • Overviews of current and planned ANZUP trials; • ANZUP MDT Masterclass where delegates have the opportunity to have questions answered by expert panels; • Community Engagement Forum: A little below the belt.

We have an outstanding international faculty including: Robert Bristow - Clinician-Scientist and Professor within the Departments of Radiation Oncology and Medical Biophysics at the University of Toronto.

Eric Klein - Chair of the Glickman Urological and Kidney Institute and Professor of Surgery in the Lerner College of Medicine of the Cleveland Clinic.

Christian Kollmannsberger - Medical Oncologist, British Columbia Cancer Agency (BCCA) Vancouver Cancer Centre.

Theresa Wiseman - Lead for Health Service Research, The Royal Marsden NHS Foundation Trust London.