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

AN ANZUP CANCER TRIALS GROUP PUBLICATION

ISSUE 3, JULY 2015

DISCOVER THE LATEST IN CUTTING EDGE CLINICAL TRIALS LIVE COMMENTARY BY WORLD-RENOWNED UROGENITAL & PROSTATE CANCER EXPERTS

THE COMMUNITY ENGAGEMENT FORUM DIRECT FROM THE SOFITEL HOTEL

SUNDAY 12 JULY 2 A LITTLE BELOW THE BELT

BOOK YOUR FREE PLACE A N Z U P. O R G . A U

Welcome Welcome to the third issue of the ANZUP Cancer Trials Group consumer magazine A Little Below the Belt. In this issue, exceptional patients share their experience as we explore opportunities available for regional and remote patients to participate in a clinical trial. At the same time we examine some of the unique issues those patients face compared with their city counterparts.

We also meet Dr Craig Underhill, a medical oncologist from AlburyWodonga. Craig is a champion of rural and remote patients, driving their agenda and special needs at a local, state and national level.

We continue to follow the journey taken by our patients and their families as they navigate the health system after a cancer diagnosis.

We also look at a new ANZUP trial that has just received first round funding: The Pain Free TRUS B trial, created by Dr Jeremy Grummet, aims to reduce the pain and anxiety felt by men undergoing a prostate biopsy. Jeremy also outlines his own journey in taking an emerging idea through to a fully developed concept, as well as the challenges he faced when his initial request for funding was declined.

Colin O’Brien is a prostate cancer survivor and a member of the ANZUP Consumer Advisory Panel. He has worked closely with Jeremy in developing the concept from the perspective of the patient. Colin explains how he plays devil’s advocate on the potential trial by putting himself in the patient’s shoes.

In July each year, ANZUP hosts an Annual Scientific Conference for its members and members of the public. A free public forum will be held on Sunday, 11 July at the Wentworth Sofitel Sydney from 1pm4pm. World leading specialists in urogenital and prostate cancers will discuss the latest treatments and clinical trials. All are welcome to attend, and we encourage you to share this information with your family and friends. More information can be found on the ANZUP website, http://www.anzup.org.au We also look forward to introducing you to Anne Wallington. Anne has been a long-time supporter of ANZUP and runs annually in the City2Sea and other community events in memory of ANZUP CAP Chair Belinda Jago’s daughter, Bec. Testicular cancer is rarely funny. That said, we meet Melbourne actor and comedian Daniel Tobias who has managed to put a comedic spin on something that affects too many young Australian men in their prime. Daniel was diagnosed with testicular cancer just about the time that girls started to take an interest in him. A harrowing regimen of chemo and a subsequent orchiectomy provided the foundation for a hugely successful stage show of which he is both writer and producer. The Orchid and the Crow is an hilarious and poignant musical and theatrical exploration of his journey into and out of testicular cancer. It sounds an unlikely subject, but Daniel’s show is so successful he is about to do a 26-show season at the Edinburgh Fringe Festival.

ANZUP members and supporters work tirelessly to identify new and better treatments for patients affected by testicular, prostate, kidney and bladder cancer. However, we know cancer is cruel and, despite our very best efforts, takes those we love. In the past six months, ANZUP has said goodbye to two towers of our Consumer Advisory Panel: Matthew Carr and Ian Roos OAM. We wish to acknowledge their enormous contribution as patient advocates and salute their bravery. Rest in peace with our thanks for your courage and support.

Without the generosity of our patients, their families, friends, and carers, ANZUP would not be able to develop improved treatments.

We need to hear your stories to help others understand the importance of clinical trial research in making real and substantial changes to patient outcomes. Please let us know if you know someone whose story should be told. The contact details for ANZUP are just to the left of this story.

We wish to thank all our contributors to this issue. Their time and commitment is very much appreciated.

We hope you enjoy this issue of A Little Below the Belt. Don’t forget to look out for us online, and take a moment to read through the ANZUP website for all the latest news and trial information.

What’s inside 03 Welcome 04 Message from the Chair 06 Obituary 07 Message from the CAP Chair 08 Rural health & overview - Dr Craig Underhill 09 Brian Cooper ENZARAD trial patient 10 Steven Trigwell BCG MMC trial patient 11 From an idea to a trial 12 Daniel Tobias - testicular cancer 15 Telehealth - a revolution in healthcare 18 Fundraising champions 19 Searching for credible health information 20 Current ANZUP trials 26 Current ANZUP innovatons 27 Ask the doctor 28 Below the Belt Pedalthon

ANZUP Cancer Trials Group Level 6, Lifehouse Building 119-143 Missenden Road CAMPERDOWN NSW 2050 Locked Bag 77 CAMPERDOWN NSW 1450

Phone +61 2 9562 5033

Email anzup@anzup.org.au

Twitter @ANZUPtrials

Graphic design: georgiegirldesigns@icloud.com A LITTLE BELOW THE BELT 3

ANZUP Who we are & what we do

Professor Ian Davis presenting at the Concept Development Workshop held in November 2014 with funds provided by the Pedalthon and Mrs Ann Waterford.

By the Chair of ANZUP, Professor Ian Davis ANZUP is the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. We are here to improve outcomes for people and their families affected by cancers of the urinary system (prostate, kidney, bladder and testicles). ANZUP is made up of a very diverse range of people involved in the care of these cancers and research into them. Collectively, our different backgrounds give us an all-around perspective so that we are able to hear and absorb people’s opinions and needs. This is very important because we want to ensure that we have a strong understanding of where the needs are, what the scientific questions are, how to ask and answer those questions, and what tools we have as clinicians and researchers to help us get to where we want to be: making a real difference for people affected by these cancers.

people who participate in our clinical trials. These people go into a trial knowing that there are no guarantees (even a proven treatment does not work on everyone), but also knowing they will receive the very best care possible and that they are making a difference for those who follow. This is altruism at its very best, and it is humbling for me to be part of it. Our profound thanks to all of you who take part in clinical trials. You are our Apollo astronauts, leading the way for us all.

ANZUP is active right across the spectrum of these cancer types, not just in the “conventional” trials of new treatments, but also to help support our basic understanding of the cancers, the needs of the patients, and emerging new technologies and treatments. The only way that all of this information can be pulled together meaningfully is through clinical research and clinical trials.

They are the best tools we have to generate the evidence we need to answer your questions and give the best possible advice and treatment. We want to make sure that all the activity in research, from test tubes, mice and machines, all the way through to that different way of doing things to improve treatment, ends up giving us useful information. But even that is not enough; we need to make sure that this information is known, understood and applied in clinical practice and healthcare policy.

ANZUP came into existence to conduct clinical trials that can’t or won’t be undertaken by pharmaceutical or other companies. As we have grown and matured as a group we have been able to take on a range of other functions, too. One of the areas of which we are most proud is our educational strategy to foster and mentor junior clinicians and researchers to help build them into the leaders of the future. These junior clinicians and researchers receive tangible assistance and well-organised education through our various grant systems and activities, such as our Annual Scientific Meeting. This is already paying off with many of these people now taking leadership roles in ANZUP and elsewhere. It has also contributed to a very strong culture of collaboration and cooperation between the various professional disciplines, something of a rarity in other parts of the world. We are blessed to have such commitment and support from so many individuals and organisations.

Now, thanks to various fundraising initiatives, we have the capacity to grow these functions even more, as evidenced by several Concept Development Workshops and other programs that started in 2014 and will continue to mature and bear fruit.

This is a complicated process and it can take a while to get there. We and other research groups around the world, including others in Australia and New Zealand, have already made a lot of progress along these lines, but there is always more to be done. We rely on the generosity of our members to donate their time to do this work. Very few people get rich from a career in research; they all have jobs in the Real World! We also rely on the generosity of the

ANZUP is proud of its strong connections to the broader community. We must never lose sight of why we are here.

To this end we are brilliantly served by our Consumer Advisory Panel which gives advice to ANZUP at all levels.

Panel members are involved in all our various committees and provide advice to our Scientific Advisory Committee and to the ANZUP Board. They ensure our continued relevance, they facilitate communication to and from the

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broader community, and many members have a practical role in supporting our research as members of research teams.

We are confident that we are on the right track strategically and that we can make our trials, and the results of our research, understandable and relevant.

This newsletter is one of the many ways in which we communicate with the broader community. Our website https://www.anzup.org.au is also packed with useful information. The ANZUP ClinTrials Refer app is generally available for mobile devices and is a great way to see what trials we are conducting. We hold a Community Engagement Forum every year at our Annual Scientific Meeting where we seek to provide more information about cancer in general and genitourinary cancers in particular, and try to demystify and clarify the issues around clinical trials. We are not complacent, however, and would love to hear suggestions about how we might improve. We would also love to hear your own stories, especially if you have been on an ANZUP trial.

Once again, this edition of the newsletter is packed with information. We will take you on a guided tour of our clinical trials, including many of our recent successes and upcoming opportunities. You will read the personal reflections of one of our Consumer Advisory Panel members and the value of ANZUP and its activities. You will meet some of the researchers and read about some of the challenges, particularly for people with cancer who live away from a major centre. You will hear about what is involved in taking part in a clinical trial and the sorts of things you might (or might not!) expect. You will encounter one of our patients who has an entertaining and unique story (as do they all).

There is information about our Annual Scientific Meeting to be held in Sydney on 12-14 July 2015 as well as an invitation to the Community Engagement Forum. You will also discover more about fundraising activities such as the Pedalthon that are so critical to support the work we do.

ANZUP is a not-for-profit charity. We fundraise because we must: every trial we conduct must find its own financial support; our work is not fully covered by the government support we receive through Cancer Australia. Research of all types, and particularly clinical trials, is badly underfunded in Australia and New Zealand. We are committed to finding ways to do the trials that need to be done. You can help by contributing to our fundraising activities, and there is information about how in this newsletter and on the website.

You can also help by raising awareness of the need for better support for clinical trials and by advocacy for improved research funding. Letters and emails are good, but don’t underestimate the power of a personal visit to your local Member of Parliament. They understand that someone who

Once again, this edition of the newsletter is packed with information. We will take you on a guided tour of our clinical trials, including many of our recent successes and upcoming opportunities. You will read the personal reflections of one of our Consumer Advisory Panel members and the value of ANZUP and its activities.

Professor Ian Davis, ANZUP Chair

goes to the trouble of a personal visit is serious. They tend to pay attention to that!

Cancer has this horrible way of getting personal and taking from us those we love. Although we are making great progress, and ANZUP and other clinical trials make a real difference, there are times we don’t get the outcome we want. ANZUP and the broader community have lost two giant figures in recent months. Matthew Carr was a larger-than-life warrior in every sense of the term, and a fantastic supporter of ANZUP through his involvement on the Consumer Advisory Panel. Ian Roos was a powerful voice for those with cancer and was instrumental in helping us establish the success of ANZUP. We will miss them both. We are all better for having known them, even if it was for far too short a time.

Such loss may be all too familiar to you. You are probably reading this because you, or someone you love, have been touched by cancers such as these. You can add so many more names to list: sometimes the names of giants; sometimes simply the names you quietly hold in your hearts. We are here to honour them, and we are here to do something about it. I am very proud to be a part of it, and I am very grateful to all our members - and all of you who are reading this - for the efforts you make to ensure we achieve our goal.

Thanks for your interest in ANZUP.

In July each year, ANZUP hosts an Annual Scientific Conference for its members and members of the public. A free public forum will be held on Sunday, 12 July at the Wentworth Sofitel Sydney from 1pm-4pm. World leading specialists prostate and other urogenital cancers will discuss the latest treatments and clinical trials. All are welcome to attend, and we encourage you to share this information with your family and friends. More information can be found on the ANZUP website, https://www.anzup.org.au A LITTLE BELOW THE BELT 5

Obituary

Heartfelt salute to one of our own Matthew Carr Every member and friend of ANZUP plays a part in the campaign to eliminate and alleviate the devastating effects of below the belt cancers. We are all cognisant that outcomes are, at times, less than optimal. But each day, our individual and collective efforts put us one step closer to achieving our high objectives.

Just recently, one of our own, a member of ANZUP’s Consumer Advisory Panel, passed away as a result of testicular cancer - one of the diseases that is the reason for ANZUP's existence.

Matthew Carr, Army Major, husband and father of two, died on 31 January, 2015. He was just 38 years old. He packed much into those short years with tours in Iraq and Afghanistan as a professional soldier, a recently completed Master’s degree and much more. But perhaps the standout aspect of Matthew’s life was his commitment to “helping the next guy”.

From the time of diagnosis of his testicular cancer in his early 20s, Matthew became heavily involved in promoting awareness to ensure young men heard the message out

about his disease. In 2009, he published his biography, Battle Scars which focussed on how he dealt with his cancer.

He was an impressive and engaging communicator and continued to work tirelessly with ANZUP, despite a deteriorating prognosis.

There is possibly no better way of expressing his passing than to say that our dear colleague died on active service.

Ray Allen Deputy Chair, ANZUP Consumer Advisory Panel

Fond farewell to an ANZUP stalwart Ian Roos OAM Ian was an academic, an advocate, an ally and an asset. He was a stalwart supporter of ANZUP, the broader prostate cancer community and indeed the whole cooperative cancer clinical trials group structure in Australia. I vividly remember, after we were unsuccessful in our first application to Cancer Australia for funding to set up ANZUP, how Ian spent considerable time with me outlining where we could strengthen our application to the point where we were ultimately successful. That conversation, and many that followed, led to our governance structure and in particular our Consumer Advisory Panel, subsequently seen by many organisations as a shining example of how community and consumer involvement should work.

Ian was never short of an opinion and recognised that not everyone always agreed with him. He had a unique and effective style of communication. However, he was always willing to listen and take a balanced view, and I know that I, personally, always came away from our interactions with a new and broader perspective. Ian was awarded the Medal of the

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Order of Australia in 2009 “For service to the community through raising awareness of men's health issues.” The honour was richly deserved.

Ian was a cancer “survivor” for a long time and sadly we can no longer say it is so. The word “survivor” is such an imperfect one: passing through the experience of cancer is about more than simply surviving, and in many respects the term can undervalue the memory of those who, eventually, do not survive the disease. ANZUP is grateful to Ian Roos for all he did - for us and the broader cancer community - and we will remember him fondly.

We are looking at ways to honour Ian’s memory in a more enduring fashion and hope to have more information for you soon on this.

For now, we have a job to do and people to help. That is the best way to honour Ian and all the others we serve.

Ian Davis, Chair, ANZUP

Why personal experience is such a precious commodity

By ANZUP CAP Chair - Belinda Jago The ANZUP Consumer Advisory Panel (CAP) is formed from a diverse group of interested clinical trial advocates who bring their personal cancer experience as a patient, survivor or carer to the table when asked to review proposed clinical trial concepts from a consumer’s point of view.

clinicians and researchers, and hear them present their research. We walk away with a much better sense of who everyone is and feel more comfortable in expressing to them a consumer point of view when reviewing their research concepts.

With CAP members living across Australia, as well as one in New Zealand, we use teleconference to meet three times a year. Over a period of about an hour we follow an agenda and discuss items of interest in the urogenital and prostate cancer world with a focus on clinical trial research and what’s happening at ANZUP.

The best value of all for us is the ‘pre-ASM’ Sunday. The CAP has the opportunity to participate in a morning education session that covers a range of topics presented by experts in clinical trial research to assist us in being competent consumer advocates. The CAP looks forward to this session every year and values highly the learning and discussion that emerges. The afternoon is devoted to the ANZUP Community Engagement Forum. Leading clinicians and researchers talk about the benefits of clinical trials and provide updates on ANZUP trials’ status, while the consumer perspective is presented by a CAP member. It is fantastic to see community engagement grow each year given our objective to continue to raise the profile of clinical trials and their importance to the improvement of future patient outcomes.

We also use teleconference if we are asked to review a particular clinical trial concept, or to discuss our participation on ANZUP’s disease specific sub-committees.

Teleconferencing works well overall and is cost effective for a not-for-profit group such as ANZUP where funding is scarce and needs to be used wisely.

But there is nothing like being able to meet face to face. We get that opportunity at ANZUP’s Annual Scientific meeting (ASM) held in July each year over three days. It is a highlight on the CAP calendar and we all look forward to this important event.

The networking aspect of the ASM cannot be overlooked. It gives us the chance to get to know each other and what we do outside of “cancer”. Being connected like this helps us understand and appreciate one another for the experience we bring to ANZUP. We then feel more comfortable when teleconferencing and believe we communicate more effectively. We also get to meet with many of the ANZUP

CAP members are then welcome to stay for the two-day scientific program that follows. The panel also has the opportunity to present a CAP update in one of the sessions.

ANZUP is truly a multi-disciplinary group where you are welcomed and valued for your input. At the end of the ASM, panel members head home feeling positive they can use their cancer experience for the future benefit of other cancer patients.

So roll on July 2015. We have a great program and would love to see you at the Community Engagement Forum.

A LITTLE BELOW THE BELT 7

The journey

Medical Oncologist Dr Craig Underhill has proved a determined and successful advocate for the needs of rural and remote area cancer patients. Here he speaks about the importance and benefits of regionally-based clinical trials.

I have been a practising medical oncologist in AlburyWodonga for 17 years (gosh, where did the time go?) Before that, I worked as a research fellow in London and Melbourne.

I was keen to establish a clinical trials unit from the very first time I started practising in Albury-Wodonga. Clinical trials are important for a number of reasons. Firstly, they keep the doctors, nurses and other staff up-to-date with new treatments. They then learn to use these new treatments under a very controlled environment (by following the “protocol”). Second, they are able to interact with colleagues across Australia and internationally in discussing the design, implementation and evaluation of the clinical trials - it’s a great way to feel part of a network of health care professionals. Third, and most importantly, it gives patients in regional areas access to new drugs that they otherwise might be deprived.

My partners and I established a clinical trials unit back in 1999 and, to date, many hundreds of patients have been recruited. Thanks to connections made through the clinical trials process, practising oncology specialists in AlburyWodonga feel they are part of the greater whole rather than “stuck out on a limb”. We believe our patients have benefited greatly from access to these trials. Without them, there would have been no option locally; patients would have missed out or been forced to travel to the “big smoke” to access a trial.

We are very proud of the efforts of the doctors and nurses and administrative assistants who work in our trials unit.

And we are even more proud of the patients (and families) who decide to take part in trials. Sure, they might benefit themselves, but they also contribute to the future care of other cancer patients.

Our trials unit has twice won the NSW Premier’s award for clinical trials innovation. We enrol patients in national and international studies run by cooperative groups such as ANZGOG and pharmaceutical companies. We are part of Cancer Trials Australia based in Melbourne. We receive support from many of our patients and families, the cancer councils, and state governments of NSW and Victoria via the NSW Cancer Institute and The Victorian Cancer Agency.

There are many people involved in bringing trials to the oncology clinic, and there are robust systems in place, via various regulatory agencies, to ensure care is delivered safely.

There has been quite a lot in the media recently about some new approaches to treating cancer - so-called immunooncology treatments. In some ways this is a new field almost

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as different as chemotherapy is to surgery is to radiotherapy. Some of the early trials results are amazing and fill my heart with hope and excitement for the future. They don’t work for everyone, but when they do work they seem to work incredibly well. We have much to do to determine issues such as the best way to use these new drugs, the best combinations with chemotherapy and other targeted therapies, and to understand why some tumours respond and others don’t. Currently these treatments require intravenous infusions every two or three weeks, possibly for a patient’s lifetime All this means we face a small crisis if we keep doing things the same old way. We need to ensure all patients are able to access trials of these drugs more easily. We need more trials in regional areas. When there is proof that new drugs work, we need them fast-tracked on to the pharmaceutical scheme. We need more support from government and the pharmaceutical industry to expand capacity to do more clinical trials.

Unless we work together to achieve all this I fear many current patients will miss out on the opportunity to access potentially life-saving new treatments - with the most serious consequences. If you have the ear of your state and/or federal politicians, why don’t you give them a heads-up?

I am pleased to introduce this third edition of A little below the belt where we want to highlight that:

l Trials are available in a centre that may be closer

than a capital city;

l As a regional patient you will receive excellent care

from a trial;

l We acknowledge there are challenges and obstacles

that may impact on the decision the patient makes.

ANZUP members are acutely aware of the challenges confronting patients in regional areas compared with metropolitan area patients, such as travel, the cost and complexity of finding accommodation, and the need to be away from family and home support. We know that receiving care in a regional centre can often be easier and less stressful than needing to travel to metropolitan areas.

At every step on your journey you should ask your doctor if a trial is available that is suitable for your situation.

ANZUP trial information can also be accessed at www.anzup.org.au

The journey

ANZUP Trials In Action Regional ANZUP trials in action

Patients on two separate trials

Patients two separate trials tell ofon their journey tell of their journey

Brian Cooper lives an hour and half from the NSW regional centre of Orange.

The recently-opened Central West Cancer Centre means Brian can travel closer to home for treatment rather than the seven-hour trip to Sydney. Here, Brian shares his story of prostate cancer and his experience as he participates in the ANZUP-led ENZARAD clinical trial. We are grateful to Brian for his time, and for sharing his very personal story.

Mr Brian Cooper It’s the three words you never want to hear: “You have cancer”.

Just one year to the day from losing my mother to cancer of the oesophagus, that’s exactly what my doctor told me.

After a routine prostate examination and a follow-up test, it was revealed I had prostate cancer. More tests followed and, after talks with my doctors, it was found that the cancer had not progressed outside of the prostate. Surgery was the best option. It was explained that the operation was a lengthy procedure, and it came with its fair share of side effects. In the end, however, it meant the cancer would be completely removed, and this suited me.

I was given a date for surgery and went about the business of living. Fortunately, I hadn’t suffered any symptoms and apart from knowing, in the back of my mind, I had cancer, life seemed pretty normal. That’s when I was dealt a second blow.

I suffered a heart attack and was rushed to Orange hospital for immediate surgery. The recovery was slow and frustrating, but more importantly it also put on hold my impending prostate surgery. In the end, it was decided that my heart was too damaged, and the lengthy surgery would be too much of a risk. Given this information, the urologist and my heart specialist decided the best course of action would be for me to undergo radiation treatment.

Nearly a year after diagnosis, I was booked in to start radiation.

I was advised I would need to spend eight weeks in Orange for the radiation treatment and was asked if I would be interested in partaking in the ANZUP Cancer Trial Group’s Enzalutamide study, ENZARAD. I decided to be part of the study that would involve taking a course of tablets and hormone implants.

The ENZARAD study started about three months before the start of my radiation treatment. This involved three or four hour-and-a-half trips from Dubbo to Orange to see Radiation Oncologist, Dr Kandeepan Thuraisingam and Alison Coote (trial coordinator). They are supervising me through the study to make sure there are no side effects or other problems, and to provide support.

To my surprise, during this short time my prostate specific antigen level (PSA) had dropped from 8.8 to 1.5. That in itself made this study very beneficial. With the ongoing support before, during and after treatment, I am pleased I made the right decision to be involved in the ENZARAD study.

I believe we are very fortunate to be able to travel to Orange for treatment and to have the opportunity to be involved in the clinical studies of cancer. Before Orange hospital had the radiation machines we would have had to travel to Sydney for treatment. This meant seven hours of travel, expensive accommodation and possibly frustration at being away from the family for eight weeks; it is a long way to travel each weekend. I am lucky that I have not had to make the decision of whether or not to go to Sydney for my treatment as it would be a big financial strain and my wellbeing would suffer. I also acknowledge that under those circumstances I would not be involved in the ENZARAD study.

Treatment and peace of mind have been made much easier by needing to travel only to Orange. I can drive down at the start of the week and drive home on weekends to be with my family. I am not too far from home. I know that if I am needed I can travel home and be back for treatment in a few hours.

My radiation treatment started just over two weeks ago. At first it was a bit daunting, and I had a bit of anxiety about what was to come. Fortunately, the treatment has not been as bad as I thought it would be. It is essentially painless and hasn’t caused much discomfort.

Dr Kandeepan and Alison Coote have played a large part in putting my worries at ease with their support and helping me deal with my biggest worry – accommodation in Orange.

The Lodge, which is just a two-minute walk to the hospital, has also been beneficial in helping me meet other people going through the same thing.

Would you like to know more about the Enzalutamide studies? http://anzup.org.au/content.aspx?page=trials-prostate Please follow this link or call ANZUP on 02 9562 5033

A LITTLE BELOW THE BELT 9

Mr Steven Trigwell Steven Trigwell’s home seems like half a world away from the cancer treatment facilities he so sorely needs. Diagnosed with bladder cancer, he gives an insight into some of the issues faced by patients from remote regional centres, as well as giving thanks for his involvement in an ANZUP trial. We say thanks in turn to Steven for sharing his story.

We do, indeed, live in a wide, brown land – and Western Australia is wider than most.

It will take you more than 23 and a half hours to drive the 2,239 kilometres from the centre of Broome to the centre of Perth, assuming you don’t stop – not once.

To put it in perspective for those in the southern capitals, that is further than Adelaide to Brisbane, Sydney to Townsville, and a tad under the distance from Melbourne to Ayers Rock.

Those monumental distances serve to highlight just one of the difficulties involved in living in a remote centre and being diagnosed with a disease that requires ongoing treatment using facilities only available in a state capital.

That, plus the logistics of finding suitable accommodation for sometimes lengthy treatment regimens, and being separated by distance from family and friends.

With a typical, dyed-in-the-wool country optimism, Steven Trigwell reckons he is luckier than most.

He has a son in Perth so accommodation isn’t so much of a problem and there are air services between Broome and Perth that beat much of the tyranny of distance in around two hours and 40 minutes.

But that doesn’t stop him worrying about his wife of 33 years, Judie, how long they will be separated, the challenges she faces as recent carer for her mother with dementia – and quite how he will react, physically, to the treatment.

Steven, 59, has been diagnosed with non-muscle invasive bladder cancer and has a place on an ANZUP clinical trial to assess the efficacy of adding chemotherapy drug mitomycin to the best current treatment with Bacillus of Calmette-Guerin (BCG).

He has been doing it tough of late, but to have a laugh with him you wouldn’t know it. Born in Albany, a builder by trade since the age of 15, in his own business since the age of 18, he has lived in Broome for 28 years after stopping for a couple of week’s work “ and never leaving”.

“You know how it is,” he said.

“You get to a place and it feels right. I’d had four years in Cairns before the couple of weeks here and I was all ready to go back to Queensland - and it just never happened.”

Steven hasn’t been capable of much really physical work in the past three years and that has meant a big draw on the bank account just to keep things ticking over. First there was severe and debilitating diverticulitis, then his wife had her own health issues, and now …

Towards the end of last year he started to notice his urine had turned dark.

“First time I’d been at the fishing club and saw it when I went to the toilet. I kept an eye on things for a while and didn’t see anything.

“After about a fortnight, I was out fishing in the Christmas tinny competition and it happened again, so I thought ‘that’s it’, best get it checked, and went straight to the local GP.” Tests showed he had a growth in his bladder, and before he knew it he was on a plane to Perth for a cystoscopy and surgery. A followup biopsy showed his cancer was non-muscle invasive, which made him an ideal candidate for the ANZUP trial.

“We had a phone conference when I got back about the trial and they gave us lots of information about what it might mean and side-effects,” Steven said. “They were great about all that.”

As part of the trial he has been allocated to the second of two groups. The first will receive the current standard treatment of direct instillation of BCG into the bladder weekly for six weeks, and then monthly for 10 months. Participants in Steven’s group will receive BCG and mitomycin weekly for nine weeks, and then monthly for nine months.

Follow-up assessment will occur for up to five years.

Steven’s biggest worry is how the chemo will affect his ability to get to and from home to be with his wife.

“Until we get into it I just don’t know how it will go. If she needs to she will come to Perth, but I’m hoping that I’ll be ok to go back up after the nine weeks. We’ll see.”

He makes the point that he is lucky to have a son in Perth. “The government allowance for accommodation is $60 a day and if you don’t have relatives or friends, what do you do? You’d struggle to find a motel room for anything like $60. Over time, it turns into a lot of money you have to find.”

He reserves greatest praise for the medical and nursing staff who have looked after him so far. “The people have made me feel great – surgeons, nurses. They have been so good. Always ready to say hello and how are you going.”

Steven’s biggest hope is that the trial treatment sorts out his bladder cancer once and for all.

“It’s been a while since I’ve been fishing. It’ll be good to get back out,” he said.

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Soon to be announced trials The Pain Free TRUS B study has been a labour of love and determination for Melbourne Urologist Dr Jeremy Grummet. This trial highlights the challenges faced by ANZUP members in trying to source funding for a “great idea” that will help patients.

Colin O’Brien is a member of the ANZUP Consumer Advisory Panel (CAP) and is working with Dr Grummet to ensure the trial has patient input into the development of the trial as well as the more practical aspects of being a trial patient.

Dr Jeremy Grummet

Colin O’Brien

Urologist and ANZUP member

The patient's perspective on

"The Green Whistle Trial"

"The Green Whistle Trial"

I’d always been troubled by the pain I had inflicted on men when doing a transrectal prostate biopsy to diagnose prostate cancer. Even when you give local anaesthetic, it does nothing for the pain of inserting the ultrasound probe - not to mention the anxiety surrounding the whole procedure.

I first became involved with ANZUP and the CAP some years ago when I was invited to join as a consumer advocate. I had been on my own journey with cancer, a similar experience to other CAP members.

And I’d heard of too many patients coming back to the clinic years after prostate cancer treatment saying that the worst part of the whole journey was the biopsy!

So I jumped at it when a nurse at the day surgery I was working at suggested I try using Penthrox to help ease the pain and anxiety of TRUS biopsy. Penthrox is an inhaled painkiller that has been used by paramedics in Australia for years, but has only more recently been approved for minor procedures in hospital.

I started using Penthrox along with my colleague Prof Mark Frydenberg when we did TRUS biopsies together in Gippsland in regional Victoria. Our impression was that it helped, and it certainly seemed safe. We kept a record of our findings and have since published twice on our clinical experience.

But to really test the effectiveness of Penthrox in TRUS biopsy, we needed to perform a proper clinical trial – a randomised control trial. I didn’t have the time or expertise to carry out such a feat, so I went to ANZUP. ANZUP held a Concept Development Workshop at their annual conference, where I pitched my idea to them.

To my delight, they were very receptive! We formed a core group of ANZUP researchers to meet and develop a protocol for the trial, and eventually applied for competitive funding. This all took a lot of work from the team led by the tireless Ian Davis.

Unfortunately, our first application for a grant failed. This was obviously disappointing, but the grant reviewers gave us encouraging feedback. So we decided to have another crack the following year, and this time, we got it!

About $600,000 from Cancer Australia and the Prostate Cancer Foundation of Australia to fund a multi-centre, randomised control trial around Australia and New Zealand.

We were thrilled. But now the challenge lies ahead of us to roll this trial out this year and establish if Penthrox can make a real difference to improving the experience of prostate biopsy.

As an active member of a number of other cancer committees, I believe it is important to provide a consumer perspective for ANZUP. I am very happy to help in whatever way I can to assist other cancer patients practically and pragmatically.

The cancer journey is unique to each person diagnosed with the disease. These collective experiences are important in helping clinicians, when they develop trials, to ensure that they are not only relevant but that they also consider the impact upon cancer patients and their families.

The journey for patient, family and friends will be stressful.

CAP members provide important feedback for the development of proposals and during the trial itself. In my case, I was asked to be the consumer representative in the development of the Penthrox trials for prostate cancer biopsies. Reading drafts of the proposal I sometimes felt overwhelmed with the medical and scientific information.

But it was a salient and timely reminder that, as a consumer representative, I had to focus on how the trial would impact upon the consumer, the likely benefits, and clinical improvements.

Importantly, what benchmarks can be used to measure clinical outcomes against other procedures. I constantly remind myself that I am a consumer, not a scientist or clinician, and that my role is based on first-hand cancer experience.

Can the Penthrox trial encourage more men to step forward more willingly for a biopsy? As a former prostate cancer patient there is no doubt in my mind that such a trial, and positive outcome, will be another step forward in early diagnosis and improved outcomes.

CAP education sessions are always very enlightening and helpful, focussing on cancer research trends, proposed trials, and other developments. They help educate members about outcomes and successes that may lead to standard cancer diagnosis or treatment.

“Cancer” is not a word any person wants to hear from their doctor or specialist. But as our population ages, it is likely to be more common with one in three Australians diagnosed with the disease.

The earlier cancer can be detected, the greater the chance of survival and a longer, fulfilling life.

Information, education and awareness are the keys to early detection. The CAP education sessions are a very important part of this process. Greater consumer participation will lead to less fear and avoidance of the word “cancer”.

A LITTLE BELOW THE BELT 11

The journey

Daniel puts a comedy spin on a tale of faith and survival

Have you heard the one about the bloke who learned he had cancer, lost a testicle, beat off secondaries, and turned the whole episode into a life-changing example of how art really can imitate life? You are about to.

He is a soul-searching atheist Jew who found the strength to cheat and beat death with the help of a flawed messiah and, a decade later, found the inspiration to turn the whole heady mix into a critically acclaimed one-man comedy.

The diagnosis was somewhat less than accurate and, with hindsight, tragi-comedic in itself.

It’s understandable if you are doing a double-take.

After several nights of festival accommodation - sleeping in a tent in a caravan park – it became clear Daniel’s “gastro problem” wasn’t going away. So it was back to Melbourne and back to the GP who referred Daniel to a specialist.

Run that by you again?

Meet Daniel Tobias, writer, actor, musician, performer, comic, and the driving force behind The Orchid and The Crow, a personal tale of faith and redemption, life and love, mortality and masculinity, in the face of Stage 3 testicular cancer.

Nothing is taboo in what might be viewed as one of the more bizarre comedic subject, and that includes sex. Believe it or not, says Daniel, “girls don’t care that a bloke only has one ball”.

Girls cared so little, in fact, that he wrote a song about it.

But we are getting ahead of ourselves.

Wind back the clock just over a decade to a 20-something Melburnian with a love of performance but no formal training, picking up bits and pieces of work: small parts in soaps, such as Neighbours and Blue Heelers, mixed with making music in a couple of bands and taking to the stage in edgier, more experimental theatre.

Approaching the age of 30, and galvanised by a family trip to Europe – in part tracing ancestral roots – Daniel challenged a growing frustration that he had to “do something”.

“The trouble,” he says “is that I just didn’t know how to make it happen.”

“He told me to try some laxatives.”

That was the start of a one-year journey to recovery that effectively both saved and changed Daniel’s life.

After a battery of tests, there was confirmation of a testicular tumour and surgery to remove it. Then confirmation of secondaries in the abdomen, neck and chest. At just 29, Daniel was a very sick man.

His family, in search of the best care possible, sought out Guy Toner as an expert in the testicular cancer field. Daniel was transferred to Guy and underwent intensive chemotherapy and subsequently radiotherapy at the Peter MacCallum Cancer Centre.

(Associate Professor Toner, Consultant Medical Oncologist at Peter MacCallum and Associate Professor of Medicine at the University of Melbourne, is now deputy chair of ANZUP).

It was a year that allowed Daniel to both reflect on his life and his future, as well as draw inspiration from the people around him.

“No one prepares you for finding out you are diagnosed with cancer,” says Daniel.

That’s when the fates conspired.

“Apart from great support from family, hearing other people’s stories gave me great strength.”

Daniel had been experiencing some nagging stomach pain and went along to a GP to get it checked out. With a forthcoming role in an Adelaide Fringe show, he thought he had better be safe than sorry.

And so to Daniel’s flawed messiah: Lance Edward Armstrong, seven times Tour-de-France winner, testicular cancer survivor, founder of the Lance Armstrong Foundation cancer support group – and subsequent self-confessed drug-cheat.

12 A LITTLE BELOW THE BELT

The motivation to raise awareness burned brightly in Daniel’s push to bring his own story to the stage 10 years after his treatment and co-incidental with a 10-year check showing he is indeed cancer free.

Daniel Tobias

At the time Daniel stumbled upon Armstrong he was, of course, still the doyen of the cycling fraternity and a true hero to the millions of cycling race fans around the world.

The name meant little to Daniel until the day after his tumour was diagnosed and a nurse told him about Armstrong’s inspiring story of recovery from Stage 3.

“I got his book that night. At the time I needed the Lance Armstrong story. His story was so palpable. Remember, that was the year everyone started wearing the Lance Armstrong wristbands. Here was someone who had it all – it was a feel good story,” says Daniel.

“Yes, he has turned out to be a liar and a cheat when it comes to his racing, but there is still some empathy in his cancer story for people who do use faith to get through.

“Yes, he was my messiah figure and despite what has happened there is no denial of that.

“There are plenty of other flawed heroes. For example, the composer Wagner was an anti-Semite, but that doesn’t stop many of us appreciating his music.

“Lance Armstrong’s story is fascinating and complex and you have seen how his story has raised awareness of cancer treatment and recovery.”

The motivation to raise awareness burned brightly in Daniel’s push to bring his own story to the stage 10 years after his treatment and co-incidental with a 10-year check showing he is indeed cancer free.

We may have had the show years earlier but for Daniel’s admission he ran a mile from his story after a press report turned a cancer-awareness venture into a celebrity grab about a soap star with testicular cancer.

“Shortly after my treatment, I was working with an ‘80s tribute band I had worked with on and off previously. Peter MacCallum asked if the band could play. A publicist asked if I would do an interview to raise awareness of the OnTRAC at Peter Mac (adolescent cancer) program.

“I felt I had nothing to hide and was really candid in the interview, and wanted to help in making people aware about OnTRAC. But it turned into a celeb piece about a soap star and cancer which was ridiculous. I’d only appeared in Neighbours a couple of times in small parts.

“It made me feel I wasn’t in control of telling my story. I wasn’t interested at all in being famous. It made me feel really strange.

“I am grateful in a way because it made me learn what I want to do on stage.”

Audiences around the world are grateful, too, because that “running a mile” led to Daniel’s involvement with

performance colleague Clare Bartholomew to deliver the creative force behind the award-winning German punk parody rock act, Die Roten Punkte.

Daniel had worked on an off with Clare before his diagnosis and says he “pestered her” into working with him again once he had worked out the direction he wanted to go.

Since 2007, the group has appeared in Australia, New Zealand, Europe and the UK, and North America and until The Orchid and The Crow Daniel and Clare had been more or less constantly on the road.

The first performance of the new show in Melbourne in February was the culmination of about two-year’s work that started with an intensive taped interview process about Daniel’s experiences. Hours of transcript were edited to deliver around an hour of material.

“Then I saw shows where things switched from stand-up to song and dance, and saw there was a way to put together a narrative in the most interesting way possible. The show is theatre, cabaret and stand up,” says Daniel.

There is music by Daniel, Clare, Jherek Bischoff and John Thorn, working alongside Casey Bennetto, David Quirk and Christian Leavesly .

Lance Armstrong makes an “appearance”, of course, Daniel’s messianic foil to an apparently angry God, unhappy with this atheist Jew pursuing a secular, artistic lifestyle – so unhappy that he gives him Stage 3 cancer.

The path to recovery and redemption highlights the fickle nature of life and the hand it deals us all.

“It’s not so much a show about cancer but about faith. It’s not dark. It can be raw, but it’s a bit of a romp,” says Daniel.

That romp includes confronting the issue of sex and masculinity, challenging assumptions about sexual function after the removal of a testicle. Hence the song Girls Don’t Care. Guy Toner liked the song so much he wants it released to help support the work of raising cancer awareness.

Daniel is full of admiration for Guy and ANZUP, its research work and cancer support, and is determined to use the show to further raise awareness about the battle to improve treatment and outcomes.

The run in Melbourne now complete, the show is destined for venues in Canada then the Edinburgh Festival before returning to Australia and another season in Melbourne, and a run in Sydney. After that, and subject to funding assistance, there are hopes for a regional tour and other capital cities.

Finally, the story behind the title for the less medically conversant.

The Orchid, says Daniel, is a reference to Orchiectomy – removal of the testicle.

The Crow is a symbol of death.

His show just goes to show that you can beat both with great treatment, self-belief, resilience - and a whole lot of humour.

A LITTLE BELOW THE BELT 13

DO YOU HAVE A STORY YOU COULD SHARE WITH OTHERS? Share your story with us here anzup@anzup.org.au Create awareness and let others know that they are not alone

FIGHT CANCER

BELOW THE BELT • T E S T I C U L A R • P R O S TAT E • B L A D D E R • K I D N E Y • 14 A LITTLE BELOW THE BELT

Telehealth a revolution in health care

Associate Professor Nick Brook is a Urologist based at the University of Adelaide, and Consultant Urologist and Director or Urological Cancer at the Royal Adelaide Hospital.

Nick Brook with Dr Rajiv Singal has granted permission for this article to be reproduced.

It appeared on Associate Professor Brook's blog www.nickbrookurogology.com

Video consults for distant patients offer many advantages for those who live long distances from their specialists.

This article is written by Nick Brook and Rajiv Singal, and covers many of the issues for this exciting development in healthcare.

What is Video Telehealth?

There is nothing clever about Telehealth, and it is remarkable that uptake has been so slow. The technology, as voiceover-internet protocol (VOIP), has been available for a long time - Skype was released 11 years ago. Telehealth simply uses similar or identical technology to link doctors and other health professionals to patients. Travel for remote patients and associated costs are reduced and, in urgent settings, Telehealth can provide rapid access to expert medical opinion.

What are the advantages in big countries such as Australia and Canada?

Australia is a big place; the sixth largest country after Russia, Canada, China, the USA, and Brazil. Its land size is 7,692,024 km2 with a small population (24.5million). Eleven per cent of the population is classified as living in remote/country/rural areas. Canada shares the same challenges as Australia with a similar population spread out over an even greater area.

There is a marked disparity in health provision between urban and remote areas of Australia.

Primarily, this disparity relates to the practicalities and economics of provision of comprehensive health care in remote areas, and is by no means unique to Australia. South Australia is a stand out example of how and why Telehealth can help distant patients. SA has a population of only 1.67m.

The Australian Bureau of Statistics give the following figures for population distribution:

South Australia Major Cities Inner regional Outer regional Remote Very remote 72.7%

12%

11.5%

2.9%

0.9%

SA has traditionally had a close relationship with the Northern Territory in terms of health care provision, and many patients travel to Adelaide from the NT for secondary and tertiary care. You can see that travel distances involved for some patients are huge. Much of the care provided must, by its nature, be delivered at metropolitan centres, but much work up and follow up could be performed by Telehealth, reducing costs (economic and social) for patients and government.

As an example, a typical series of encounters for a prostate cancer patient, from GP referral to surgery, is as follows:

l l l l

l l l l

Initial consult Biopsy appointment Biopsy results CT/MRI/Bone scan (often can’t be arranged at the same visit) Appointment for results Second clinic for decision Pre-anaesthetic clinic Day of surgery

A LITTLE BELOW THE BELT 15

After surgery and the initial recovery phase many traditional post operative visits could be conducted electronically, particularly when a stable situation is apparent Nick Brook

Those highlighted in orange could possibly be replaced with Telehealth appointments. The potential advantages become crystal clear when we consider that some patients make a 2000 km round trip for a hospital appointment.

As well as distant patients, there are potential advantages for Residential Aged Care Facility (RACF) residents, and Medicare Australia has made special allowances for Telehealth to such patients.

It similarly follows that after surgery and the initial recovery phase many traditional post operative visits could be conducted electronically, particularly when a stable situation is apparent and monitoring of blood work is the main task. Another good fit for urology would be stone follow up for patients on surveillance programs for renal calculi.

Are there any disadvantages to Telehealth?

Inherent in electronic communication is the inability to make physical contact with patients. Nothing can replace an in-person consultation for building the patient-doctor relationship and establishing trust. A handshake is the foundation of consultation, and the ability to examine is lacking. If a patient-end doctor is present, this can be circumvented to some extent, but the quality of interaction is less. Nevertheless it is clear that patients are generally grateful for email access with their treating physicians. A robust Telehealth service would potentially improve upon that.

Co-ordination of appointments can be challenging, as there should be a health-care provider at the patient end. Patients may still need to travel large distances to get to a health care provider with Telehealth facilities.

Electronic communications can break down, although this is rare. More important are potential security issues, which are discussed below.

Why has it taken so long to get this going?

This is difficult to answer. Perhaps established patterns of behaviour are hard to break; as medics, we have become wedded to the in-person consultation. Clearly, advantages and disadvantages of both in-person and Telehealth consults need to be weighed carefully for individual patients.

Set-up costs are minimal, and most specialist and GP practices will have easy access to the readily available technology.

Although government has been leading the Telehealth drive, patient demand is increasingly a factor in health care policy, but rural/country/distant patients may be the least vocal in terms of health care requirements, despite often having the greatest need.

16 A LITTLE BELOW THE BELT

Financial Incentives/reimbursements for Doctors Various financial incentives are in place from Medicare Australia, through the Medicare Benefits Schedule, with the aim of driving Telehealth uptake. These are categorised as follows:

l Telehealth On-Board Incentive l Telehealth Service Incentives l Telehealth Bulk Billing Incentives l RACF On-Board Incentive l RACF Hosting Service Incentives These taper over time, and more information can be found at http://www.mbsonline.gov.au/internet/mbsonline/publishing. nsf/Content/connectinghealthservices-Program%20Overview.

Interestingly, rebates for Telehealth are actually higher than for in-person consultations, and this is said (by Medicare) to reflect the infrastructure costs involved.

Systems in use There is a range of complexity in Telehealth technology.

At the top end, very fast connections (where available), combined with fully integrated complex software and hardware, allow monitoring of medical information from skin, eyes, ears, pharynx, heart, lungs and other parts of body.

Advanced telemedicine can also manage ECG, spirometry, dermatoscopy, pharyngoscopy and endoscopy sessions.

Less complex and costly are installed systems, which essentially build on business teleconferencing platforms.

Digital quality is high, and this standard is needed if there is need for diagnosis beyond history-taking. These systems still require substantial investment and on-going cost.

The easiest to install, run and pay for, are widely utilised software programs such as Skype and Facetime. Most computerised practices will be able to set these up easily, and most health care providers are conversant in their use, so no additional training is required. Quality can be low, and these systems are only really suitable for communication based on discussion and history-taking. For example, clinical signs cannot be reliably demonstrated. However, on the principle of ‘the greatest good for the greatest number’, this method of Telehealth probably will have the greatest uptake.

Security issues Just as in a standard face-to-face consultation, privacy (and digital security) must be absolutely respected. Medical records made at the time of video consultation are recorded and stored in exactly the same way as a standard consultation.

In summary, it is highly unlikely (although theoretically possible) that a Telehealth consultation could be breached, but the risk is probably no greater than the risk of standard computerised medical records being breached by a ‘professional’ and determined hacker. It is the health care provider’s responsibility to ensure the privacy and security of the consultation, that the technical system is reliable, secure and fit for clinical purpose, and that risk management protocols are in place.

The foreseeable future Increased utilisation of Telehealth may be one of the strategies to help address the huge and unprecedented growth in health care need, which is forecast to continue.

The tables below are taken from the MBS Telehealth Statistics.

The first demonstrates a steep uptake of Telehealth since 2011, but perhaps a developing plateau, which would be typical of saturation of the technology-savvy medics.

Hopefully, over time, the service will expand further, but this will rely on patient acceptance and satisfactory feedback.

Services by year and quarter - claims processed as at 31 March 2014

The second table shows claims processed by specialty, and it is encouraging to see urology near the top. Further expansion in our specialty will be partly patient driven, but also requires support from specialty bodies.

Subspecialty Providers Obstetrics & Gynaecology

79

Orthopaedic surgery

131

Urology

120

ENT

65

Anaesthetics

182

Psychiatry

519

Dermatology

138

Cardiology

195

Endocrinology 144 Gastroenterology 167 Neurology

124

Paediatric medicine

271

Rheumatology 110 Thoracic medicine

Year Quarter

Services

2011 July-September

1,809

October-December 5,220

2012 January-March

6,096

April-June

12,937

July-September 16,524

152

Summary: Essentially, the aim of Telehealth is to improve access to health care for patients who are disadvantaged by their location; it’s all about taking health care delivery in the direction where we can better scale the doctor to patient time.

2014 January-March

25,489

Nick Brook is an Associate Professor in Surgery at the University of Adelaide, and Consultant Urologist and Director of Urological Cancer at the Royal Adelaide Hospital in South Australia.

You can follow Nick @nickbrookMD on Twitter Rajiv Singal leads the Surgical Robotics Program (jointly run by Toronto East General Hospital and Sunnybrook Health Sciences Centre) and is an Assistant Professor in the Department of Surgery at the University of Toronto. He supervises the Clinical Endourology Fellowship program at TEGH under the umbrella of the University of Toronto.

Total

169,602

You can follow him @DrRKSingal on Twitter

October-December 19,111

2013 January-March

15,398

April-June

20,300

July-September 22,610

October-December 24,108

A LITTLE BELOW THE BELT 17

Fundraising champions Anne Wallington - Victoria How one person’s commitment has helped raise funds and awareness

Fundraisers take many shapes and forms and they do it for so many reasons; loved ones, friends, personal goals.

Running to keep fit was the furthest thing from Anne Wallington’s mind as she followed the black line up and down the swimming pool, lap by lap, on her exercise routine of choice.

An injury changed all that.

Forced from the pool for a period of recovery, Anne knew she had to find an alternative to keep fit. So she started to jog. Then she started to run. Then she started to run further.

Now she runs half Marathons.

“I was a swimmer. I didn’t run. Then I couldn’t swim for a while so took up jogging. Then I started to push myself and began running,” Anne said.

ANZUP is delighted Anne took to pounding the pavement because she has become one of those committed fund-raisers who make all the difference to the group’s ability to get on with its job.

ANZUP is delighted Anne took to pounding the pavement because she has become one of those committed fund-raisers who make all the difference to the group’s ability to get on with its job.

Anne, head of senior school at Methodist Ladies’ College, Melbourne, uses the vehicle of annual charity fun runs to help raise money for ANZUP as part of the Bec’s Troops fund-raising team.

Bec’s Troops was formed by Belinda Jago whose daughter Bec succumbed to kidney cancer at the age of 19. Belinda is currently chair of the ANZUP Consumer Advisory Panel.

18 A LITTLE BELOW THE BELT

Anne ran the first two Melbourne City2Sea events in 2011 and 2012. She heard about Belinda, and Bec, through friendship with Bec’s Godmother and went on to learn more about ANZUP, its research and fund raising.

From there, Anne knew where she would direct her charity run fund-raising efforts which come via sponsorship of race entries. She ran City2Sea to raise money for ANZUP in November 2013 and last year, as well as fitting in the RunMelbourne event in July. So far, she has raised more than $1000 for the cause.

“There is a really competitive field for the fund-raising dollar and lots of really good causes,” said Anne. “I really became interested in helping ANZUP when I became aware of Belinda and Bec about six months before Bec died.

“It is good to know that fundraising like this is also helping someone else.

“Belinda gets a huge group together for the City2Sea. In November last year the team was 80-strong."

Anne now runs two mornings a week with a long run on Sundays to help maintain her fitness levels. As just reward for all her efforts, she ran a personal best in the 2014 City2Sea, run for the first time over a longer, 15km course.

The 15km starts outside the MCG and finishes in St Kilda via Federation Square and a loop around Albert Park.

To date the City2Sea has raised more than $1 million for more than 600 charities. Last year the run attracted around 12,000 participants.

So does all this running mean Anne is setting her sights on a full marathon sometime?

“No. Not a bit of it. I’m not pitching for a full one. I’m just aiming to get my time down,” she said.

And to help raise money for ANZUP, of course.

Jenni is a recognised Social Media commentator

Searching for Credible Health Information Social media expert Jenni Beattie provides an insight into how to find credible health information online.

The power of the internet means that today, more than ever, there is a wealth of information available to help inform our health decisions. While this offers big advantages, it can also leave us feeling overwhelmed. In this article, we hope to provide some tips to help you navigate your way around this increasingly complex information environment.

‘Social media’, ‘online media’, ‘websites’ .… the range of online health information is dizzying! If you have ever searched for health information online you will appreciate that, at times, making the best choices can be both time consuming and stressful.

Over the past five years, there has been a dramatic shift in patients playing a more active role in decision making and searching for more health information. Patients and carers are also sharing their own experiences via online blogs, Twitter or Facebook, and online patient communities.

People are now equipped, engaged and empowered, but education is key to ensuring they get the most reputable information. So let’s start!

Top 10 Tips for Finding Credible Information 1. The URL (web address) is a good signpost to a site’s credibility. Sites that have an address containing these elements will be reputable: .gov Government sites .edu University/medical school/educational institutions .org Not-for-profit groups with a focus on research 2. Identify, follow and source respected institutions in the relevant field (we have some cancer sites listed for you at the end of this article).

3. Seek out and check references and citations (basis of the research and sources). Make sure material is ‘evidence-based’.

4. If possible, look for any ‘declarations of interest’ in relation to the source of any financial assistance towards the production of the information.

5. Always remember to discuss the information you have found with your GP and medical specialist.

6. Beware of websites selling cures or health remedies.

7. Is there a privacy policy on the website? Ensure there is a privacy policy in place if a site requires you to register otherwise provide personal information such as your name or

e-mail address, Also ensure your personal information and anonymity are protected and are not being provided or sold to other companies.

8. Check the ‘currency’ of the material: what is the date of publication; is it the most recent version?

9. Never divulge personal information online such as phone numbers, date of birth and addresses.

10. Be careful when and where you comment on information.

Google archives everything! Be sure you are happy with what is said before you “publish”. Always re-read what you write and ask yourself if you will be happy with your comments in the future.

Websites and Hashtags of Note l l l l l l l l l

http://www.anzup.org.au http://www.cancer.org.au http://www.prostate.org.au http://canceraustralia.gov.au http://www.cancercouncil.com.au http://www.cancervic.org.au http://www.kidney.org.au http://www.cancerinstitute.org.au http://www.mskcc.org

If you are an active Twitter user, there are also Twitter chats that you can follow. Please view this website to see what is available http://www.symplur.com/healthcare-hashtags/ tweet-chats/ The following hashtags can also be followed on Twitter, particularly during the ASCO ASM and are a useful way to aggregate particular interest areas:

#tscsm Testicular cancer

#PCSM Prostate cancer

#kcsm Kidney cancer

#blcsm Bladder cancer

A LITTLE BELOW THE BELT 19

Current ANZUP trials If you would like to know more about any of these trials please discuss it with your GP or specialist

Ask questions

Questions you may consider if you participate in a clinical trial If you are thinking about taking part in a clinical trial, here are some important questions to ask: l What is the purpose of the study? l What does the study involve? What kinds of tests and treatments? (Find out what is done and how it is done) l What is likely to happen to me with or without this new research treatment? What could the cancer do and what could this treatment do? l What are my options and what are their advantages and disadvantages? l Are there standard treatments for my case and how does the study compare with them? l How could the study affect my daily life?

20 A LITTLE BELOW THE BELT

l What side effects could I expect from the study?

(There can also be side effects from standard treatments and from the disease itself) l How long will the study last? Will it require an extra time commitment on my part? l Will I have to be hospitalised? If so, how often and for how long? l Will I have any costs? Will any of the treatment be free? l If I am harmed as a result of the research, what treatment would I receive? l What type of long-term follow-up care is part of the study?

Current ANZUP trials

Testicular Cancer/Germ Cell* Tumours PHASE III Accelerated BEP Trial

The current standard practice for the treatment of germ cell tumours is the use of the chemotherapy combination called BEP, which consists of three chemotherapy agents – Bleomycin, Etoposide and Cisplatin – administered on a three-weekly cycle. BEP is given with a drug called pegylated G-CSF ( or pegfilgrastim) that stimulates white blood cell production.

The purpose of this study is to determine whether giving the same dose of BEP on a two-weekly schedule will be more effective than a three-weekly schedule, and will be well tolerated. The two-weekly schedule is called “accelerated BEP’ and the three-weekly schedule is called “standard BEP”.

Up to 500 patients will be enrolled in the study in Australia, New Zealand and other countries. Currently we have 29 sites open in Australia and New Zealand that are recruiting participants at a steady rate. We are also undergoing negotiations to set up the trial in Ireland with the support of the All-Ireland Clinical Research Group (ICORG) and the Medical Research Council, Cambridge University, UK. This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. asp?page=trials-p3bep.

ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).

Funding for this trial is provided by Cancer Australia.

Current site locations for the P3BEP ANZUP clinical trial are: QLD • ICON Cancer Centre (HOCA Wesley) • Princess Alexandra Hospital • Royal Brisbane & Women’s Hospital

SA

*Germ Cells are the cells in the body that develop into sperm or eggs

• Flinders Medical Centre • Royal Adelaide Hospital TAS • Royal Hobart Hospital NSW • Calvary Mater, Newcastle • Chris O'Brien Lifehouse • Concord Repatriation General Hospital • Macquarie Cancer Clinical Trials • Nepean Hospital • Princes of Wales Hospital • Royal North Shore Hospital • Sydney Adventist Hospital • The Tweed Hospital • Westmead Hospital VIC • Austin Health • Box Hill Hospital • Peter MacCallum Cancer Centre • Royal Melbourne Hospital WA • Fiona Stanley Hospital NZ • Auckland Hospital • Christchurch Hospital • Dunedin Hospital • Palmerston North Hospital ANZUP has been awarded funding from the Sydney Catalyst Translational Cancer Research Centre for the Phase III Accelerated BEP translational sub-study. This will involve the collection of blood and tissue from participants for future correlative studies.

ACT: • Canberra Hospital

A LITTLE BELOW THE BELT 21

Current ANZUP trials

Bladder Cancer BCG + MMC

BL12

Non-muscle invasive bladder cancer is common and causes substantial suffering. It requires removal or irradiation of the bladder within five years in more than 30% of people with high-risk tumours, despite best current treatment.

Recent preliminary studies show promising results from adding Mitomycin, a chemotherapy drug, to current treatment with BCG (bacillus calmette-guerin – a strain of modified bacteria which stimulates an immune response to early cancer cells).

Search for more effective urothelial cancer drugs pull out quote

This randomised trial will determine the effects of adding Mitomycin on cure rates, survival, side effects and quality of life. This could potentially provide a simple and costeffective treatment for patients who suffer from this cancer.

Earlier in the year there had been a worldwide shortage of the BCG but, fortunately, this has not affected the trial significantly - we are able to continue to get supplies to ensure the trial can continue.

It is anticipated that 500 patients will be enrolled in the study in Australia and New Zealand. To date 34 patients have been recruited from 12 sites.

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. asp?page=trials-bcgmmc

Urothelial cancer occurs in specialised cells seen in the urinary system: the kidney, the bladder and associated structures such as the ureters which connect the kidneys to the bladder. A new treatment called nab-paclitaxel is being studied for use in urothelial cancer. It will be compared with paclitaxel, which is currently one of the chemotherapy drugs used as standard for this type of cancer.

Research is needed to identify more effective treatment after urolithelial cancers become refractory to prior chemotherapy agents. Nab-Paclitaxel is a formulation of the chemotherapy drug paclitaxel which is combined with a human protein albumin. Potentially, the different formulation creates a less toxic and more effective drug in the treatment of urothelial cancer. Nab¬-paclitaxel is currently approved in Australia for use in metastatic breast, lung and pancreatic cancer.

Neither drug has been approved in Australia for use in urothelial cancer. The aim of the study is to see if nab-paclitaxel can improve outcomes for patients with urothelial cancer that has progressed.

Approximately 100 participants from 27 Australian sites will take part.

ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

Funding for this trial is provided by Cancer Australia.

For more information please go to the trials page on the ANZUP website: https://www.anzctr.org.au/Trial/ Registration/TrialReview.aspx?id=366944

Current site locations for the BCG + Mitomycin trial are:

ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC) and the NCIC (Canada). Funding is also provided by NCIC CTG.

NSW • Concord Repatriation General Hospital • Northern Cancer Institute • Sydney Adventist VIC • Austin Health • Box Hill Hospital • Footscray Hospital • Frankston Hospital • Royal Melbourne Hospital • The Alfred Hospital WA • Fiona Stanley Hospital

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Current locations for the BL12 trial are: NSW • Calvary Mater, Newcastle • Concord Cancer Centre • Prince of wales Hospital SA • Ashford Cancer Centre • Flinders medical Centre VIC • Epworth Freemasons Hospital • Peninsula Health, Frankston Hospital • St Vincent’s Hospital, Melbourne

Current ANZUP trials

Prostate Cancer ENZAMET The treatment of metastatic prostate cancer (prostate cancer that has spread beyond the prostate gland to other parts of the body), starts with medications that manipulate the hormone levels in the body. Hormonal manipulation occurs in the form of injections called LHRHA (luteinizing hormone releasing hormone analogues) which are often combined with tablets called anti-androgens. These medications often work very well for prostate cancer, but only for a limited time. Eventually, the metastatic prostate cancer develops resistance to hormonal manipulation (i.e. so-called “castrate resistant prostate cancer”) and requires different hormonal therapy, or chemotherapy.

This study is designed to assess a new anti-androgen tablet called Enzalutamide. Enzalutamide has been shown, in international trials, to improve outcomes for men with metastatic prostate cancer. These trials have demonstrated that when men develop castrate resistant prostate cancer, Enzalutamide can decrease PSA levels and shrink or stabilise cancer that has spread to other parts of the body such as bones or lymph nodes. Furthermore, quality of life was significantly improved.

The purpose of the ENZAMET trial is to establish if the use of Enzulatmide earlier in the course of treatment for metastatic prostate cancer may improve life expectancy and quality of life compared to older anti-androgens.

ENZAMET will be an international trial run by ANZUP in multiple centres in Australia, New Zealand, Canada, Ireland and the UK. The aim is to have 1100 participants from these countries. Participants will stay on the study drug until there is evidence of progression and will be followed for a minimum of 3.5 years from entering the trial.

To date 33 sites have been activated with another seven Australian and New Zeland sites in the process of being activated. To date, 164 patients have been recruited. There are currently eight sites open in Ireland and the UK led by the collaborative group, Ireland Cooperative Oncology Research Group (ICORG). One site has been opened in Canada led by the collaborative group, National Cancer Institute Canada (NCIC), and negotiations are under way for further sites to be opened in Europe and USA. This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. aspx?page=trials-prostate ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).

Funding for this trial is provided by Astellas Pharma Australia

Current site locations for the ENZAMET clinical trial are: NSW • Central West Cancer Services • Chris O’Brien Lifehouse • Concord Cancer Centre • Nepean Cancer Care Centre • Northern Cancer Institute • Port Macquarie Base Hospital – NCCI • Prince of Wales Hospital • Riverina Cancer Centre • St George Hospital • St Vincent’s Hospital, Sydney • Sydney Adventist Hospital • Tamworth Hospital • The Tweed Hospital • Wollongong hospital NT • Royal Darwin Hospital QLD • Gold Coast Hospital • Nambour General Hospital • Princess Alexandria Hospital, Brisbane • Royal Brisbane and Women’s Hospital • Townsville Hospital SA • Ashford Cancer Centre • Flinders Medical Centre • Royal Adelaide Hospital TAS • Royal Hobart Hospital VIC • Austin Hospital • Australia Urology Associates • Box Hill (Eastern Health) • Goulburn Valley Health • Monash Cancer Centre – Moorabbin • Peninsula South Eastern Haematology and Oncology Group (PSEHOG) • Peter MacCallum Cancer Centre- East Melbourne • St Vincent’s Hospital WA • Fiona Stanley Hospital UK • Aberdeen Royal Infirmary • Royal Cornwall Hospital USA • Dana-Farber Cancer Institute Canada • Algoma District Cancer Program Sault Area Hospital • Cross Cancer Institute • QEII Health Sciences Centre CDHA A LITTLE BELOW THE BELT 23

Current ANZUP trials

Prostate Cancer ENZARAD Prostate cancer is often treated with powerful X-rays (Prostate cancer is often treated with powerful X-rays (radiotherapy) instead of surgery. The reasons for choosing radiotherapy or surgery are complex, and are the focus of a discussion that men should have with their treating doctors.

We will specifically look at men whose cancers have higher risk of returning after treatment but have not yet shown any evidence of spread outside the prostate. In this situation we are aiming for a cure, if possible, and the evidence shows that this is more likely when radiotherapy is combined with hormone treatment. This treatment is called Androgen Deprivation Therapy (ADT). ADT is often in the form of injections called LHRHA (luteinizing hormone releasing hormone analogues) and combined with tablets called anti-androgens. Enzalutamide is a new and stronger antiandrogen that has also been shown to work against prostate cancers that are resistant to other anti-androgens.

ENZARAD is a clinical trial for men with this type of prostate cancer where a decision has been made that radiotherapy is the best treatment. This trial is for those who, after discussion with their specialists, were not recommended for radical prostatectomy due to their pathology or core morbidities. Men who have both testes removed also will not be eligible. The purpose of the ENZARAD trial is to find out if the addition of Enzalutamide to radiotherapy, plus ADT, will increase survival in men with a prostate cancer apparently confined to the prostate but at high risk of return elsewhere.

It is an international trial run by ANZUP in multiple centres in Australia, New Zealand, Canada, Ireland and the UK. The aim is to have 800 participants from these countries.

Participants will stay on the study drug until there is evidence of progression, and will be followed for a minimum of 3.5 years from entering the trial.

To date 33 sites have been activated with another seven Australian and New Zealand sites in the process of being activated. To date, 83 patients have been recruited.

There are currently four sites open in Ireland lead by the collaborative group, Ireland Cooperative Oncology Research Group (ICORG) and negotiations are under way for further sites to be opened in Europe.

This study is currently active and recruiting. Please speak with your doctor if this is of interest to you or someone you know.

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/content. aspx?page=trials-prostate.

ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC) and the Trans-Tasman Radiation Oncology Group (TROG).

This trial is funded by Astellas Pharma Australia

24 A LITTLE BELOW THE BELT

Current site locations for the ENZARAD trials are: NSW • • • • • • • • •

Calvary Mater, Newcastle Campbelltown Hospital Central West Cancer Services Chris O’Brien Lifehouse Gosford Hospital Liverpool Hospital Prince of Wales Hospital Tamworth Hospital Westmead Hospital

QLD • Mater Adult Hospital • Nambour General Hospital • Princess Alexandra Hospital, Brisbane • Royal Brisbane and Women's Hospital • Toowomba Hospital SA • Ashford Care Research • Flinders Medical Centre and Repatriation General Hospital TAS • Royal Hobart Hospital VIC • Austin Hospital • Box Hill (Eastern Health) • Epping Radiation Oncology Centre • Epworth Health Care - Richmond • Epworth Health Care - Freemasons • Frankston Radiation Oncology Centre • Peter MacCallum Cancer Centre (East Melbourne) • Peter MacCallum Cancer Centre (Moorabbin Campus) • Ringwood Radiation Oncology Centre • Western Radiation Oncology Centre Footscray NZ • Christchurch Hospital • Auckland City Hospital Ireland • Cork University Hospital • Galway University Hospital • Mater Misericordiae University Hospital • Mater Private Hospital USA • Dana Farber Cancer Institute

Current ANZUP trials

Prostate Cancer RAVES Radical prostatectomy is the most common curative approach offered to men with newly-diagnosed prostate cancer. Unfortunately, up to half these patients will have factors placing them at high risk of cancer recurring. Undergoing radiotherapy after an operation is known to improve care rates, but what is not known is whether it should be given immediately after the operation or only if PSA rises after surgery – indicating active cancer.

Immediate radiotherapy may not benefit all men and can cause serious side effects such as bladder problems and impotence.

International lack of consensus on the optimal timing of radiotherapy has resulted in varied clinical practice.

This Trans-Tasman Radiation Oncology Group (TROG) led Phase III trial, in collaboration with ANZUP and USANZ, will compare the two approaches.

If radiotherapy at recurrence results in equivalent outcomes and improved quality of life, it would become the standard treatment.

A total of 470 men from Australia and New Zealand will participate.

This study is currently active and recruiting.

Please speak with your doctor if this is of interest to you or someone you know.

For more information please go to the trials page on the ANZUP website: http://www.anzup.org.au/ content.aspx?page=trials-prostate This trial is funded by The National Health and Research Council, Royal Australian and New Zealand College of Radiologists, Auckland City Hospital, Cancer Council Victoria, Cancer Council NSW, Nwe zealand Health and Research Council and the Trans Tasman Radiation Oncology Group.

Current site locations for the Raves trial are: NSW • Calvary Mater, Newcastle • Campbelltown Hospital • Central West Cancer Centre • Liverpool Hospital • Nepean Hospital • Port Macquarie Base Hospital • Riverina Cancer Care Centre • Royal North Shore Hospital • Royal Prince Alfred Hospital • St George Hospital • St Vincent’s Hospital, Sydney • Sydney Adventist Network: Gosford and Wahroonga • Westmead Hospital VIC • The William Buckland Radiotherapy Centre, The Alfred • Austin Hospital • Bendigo Hospital (Peter MacCallum Radiotherapy Centre) • Peter MacCallum Cancer Centre (East Melbourne) • Peter MacCallum Cancer Centre (Moorabbin Campus) • Peter MacCallum Cancer Centre QLD • Genesis Cancer Care Queensland • Mater Centre • Nambour General Hospital • Princess Alexandra Hospital • Radiation Oncology Mater Centre • Radiation Oncology Queensland Gold Coast • Toowoomba Cancer Research Centre • Royal Brisbane & Women’s Hospital • Toowomba Cancer Research Centre • Townsville Hospital WA • Perth Radiation Oncology Centre • Royal Perth Hospital • Sir Charles Gairdner Hospital NZ • Auckland City Hospital • Auckland Radiation Oncology • Christchurch Hospital • Dunedin Hospital • Palmerston North Hospital • Waikato Hospital • Wellington Hospital

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Innovation & Education

ClinTrial App In July 2014 ANZUP released its first trial based App. This application was designed for the specialists but will also be a very useful tool for consumers. If you are looking for a trial for your particular cancer you can refer to either the ANZUP website or the new ClinTrial Refer.

The ClinTrial Refer ANZUP app provides a current list of all ANZUP and ANZUP co-badged 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.

WOULD YOU LIKE TO HELP US? Any donation to ANZUP over $2 is fully tax deductible. If you would like to donate to ANZUP, you can donate through our website www.anzup.org.au or by calling ANZUP on +61 2 9562 5033.

100% of every donation made to ANZUP goes towards producing a clinical trial to improve the treatment of bladder, kidney, testicular and prostate cancers.

We hope this will help the community to identify trials that might be suitable.

To download the free app, please visit:

DONATE NOW

• 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 Or go to the App/Android store and type in ANZUP

ANZUP wishes to thank our corporate supporters and partners for 2015

26 A LITTLE BELOW THE BELT

About clinical trials

Ask the Dr Why are randomised trials necessary?

Randomised trials are the only way to reliably answer the question “how much better will you do on one treatment versus another”. The alternative is to compare a group of people that doctors chose to give one treatment, versus another group of people that doctors chose to give a different treatment. The problem is that the two groups of people are unlikely to be similar, and the differences between people themselves are usually more important than the differences between the treatment they are given. Doctors are good at recognising people who are likely to do better or worse, and the treatments they choose to give are often influenced by this knowledge.

When we compare the results in two groups of people, the big question is: how much of the difference in results we observed is due to the treatment, and how much of it is due to the differences between the individuals themselves? The best way of ensuring that groups of people are as similar as possible is to allocate people to the groups, and therefore treatments, by chance. This is what randomisation does.

Professor Martin Stockler – Medical Oncologist,

Am I going to be a guinea pig?

One of the most commonly asked questions to me is whether it will cost a person anything and “am I going to be a guinea pig”. Obviously there should be no cost above normal treatment costs, and in some instances there may be no cost at all.

Many people when confronted with a clinical trial for the first time may think they are being treated as a guinea pig, but all the evidence shows that people who are participating in clinical trials are receiving the best level of clinical care and have, in general, better outcomes than those who are not participating.

Associate Professor Guy Toner, ANZUP Deputy Chair

What if I get the placebo?

In randomised trials, people are allocated either to a promising new treatment, or to a standard treatment. All clinical trials conducted by ANZUP and other research groups in Australia and New Zealand must ensure that the standard treatment is the very best standard care available.

A placebo is never given by itself when there is a proven treatment available.

Dr Peter Grimison, Staff Specialist

Clinical trial phases The National Health and Medical Research Council defines the phases of trials as: PHASE III

studies are done to study the efficacy of an intervention in large groups of trial participants (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions (or to noninterventional standard care) as well as to monitor adverse effects and to collect information that will allow the intervention to be used safely.

PHASE I

clinical trials are done to test a new biomedical intervention for the first time in a small group of people (from 20 up to 80) to evaluate safety (e.g. to determine a safe dosage range and identify side effects).

PHASE IV

studies are done after an intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use over longer periods of time.

PHASE II

clinical trials are done to study an intervention in a larger group of people ( up to several hundred) to determine efficacy (whether it works as intended) and to further evaluate its safety.

A LITTLE BELOW THE BELT 27

REGISTER TO RIDE RIDING

FOR

U R O G E N I TA L

CANCERS

EVENT OVERVIEW

Riding for 4 hours to defeat 4 cancers Testicular, prostate, kidney & bladder cancers

EVENT DETAILS: Tuesday 1st September 2015 7:30am: Registration 8:30am: Event & Safety Briefing 9:00am: 3 Hour Team Challenge 12:00pm: Sprint Challenge 1:00pm: Lunch, Awards, Celebration Cost: $2,000 per team excl GST

#BTBpedal15

As a young adult, I never considered I would be diagnosed with testicular cancer. The good news is that through early detection and the incredible medical advice provided by ANZUP, I am able to carry on with my life as though very little happened. Others are not so fortunate.

That’s why I founded the Below the Belt Pedalthon.

Good luck in 2015 and thank you for your support.

Simon Clarke

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

www.belowthebelt.org.au