What is a clinical trial?
ANZUP heroes tell their stories How to get involved in a CLINICAL TRIAL
AN ANZUP CANCER TRIALS GROUP PUBLICATION
ISSUE 1 • MAR 2014
Welcome to the inaugural edition of the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group newsletter, written for patients, families, carers and supporters of those with testicular, prostate, kidney and bladder cancer.
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WHAT’S INSIDE 04 About ANZUP 05 Message from the Chair 06 Message from the CEO 07 Message from the CAP Chair 09 Cap member Ray Allen describes his role on the CAP 10 ANZUP clinical trials 11 Help us to fundraise 12 Hands up for ANZUP heroes 13 Craig McGowan’s story 14 Tash & Pearl Evans’ story 15 ANZUP news
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16 How donations help 18 Current clinical trials 22 Definitions
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About ANZUP The Australian and New Zealand Urogenital and Prostate Cancer Trials Group was formed in 2008, bringing together a world-leading multidisciplinary team of oncology, surgical, medical, radiation, nursing, psychology and allied health professionals working in urogenital cancer. Urogenital cancers are testicular, prostate, kidney and bladder. ANZUP’s work changes the way a patient with these cancers is treated. Our members and investigators are widely dispersed and busy, working in a range of disciplines. It is much more productive to get people together to work through the science, develop trial concepts and write the protocol documentation, and other things that need to be done, to bring a trial to fruition. All of this is separate from the other task of sourcing much larger amounts of money to support the actual trials themselves.
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research trials outcomes Message from the Chair IAN DAVIS
ANZUP is committed to keeping in touch with the general community and our community of supporters. This newsletter is one of the ways in which we hope to achieve this. ANZUP is the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. We are a group of health professionals involved in the care of people with cancers of the urinary system (prostate, kidney, bladder and testicles) and our members also include people performing research into these cancers. We are represented by all the relevant professional and scientific disciplines, in all states and territories of Australia and New Zealand, and with an important and growing international presence also. ANZUP exists to improve the outcomes of people with these cancers. We believe that the best way to do this is to: • Bring together the key people involved in this health care and research • Understand the needs of our patients and their families • Identify where the gaps are in the evidence we rely on to make treatment decisions • Constantly review the science to see what new opportunities might be out there • Support and train the next generation of clinician-researchers • Listen to what the community wants us to do
All of this enables us to plan and perform the clinical trials for which we see a need. Sometimes these might be conventional drug trials. Other trials might look at questions of surgical or radiation treatment or a combination of those treatments. It might also be about how best to support people with these cancers and their families. Through all of this, we seek out and listen to the expert advice of our members with input from the community. Community input most commonly comes through our fantastic and hardworking Consumer Advisory Panel (CAP), which provides input at every level of our organisation, but we are interested in hearing your thoughts as well. The work we do is important but it is also time consuming and expensive. We rely on a range of sources for our funding including government and other grants, but these do not allow us to do all that we want to do. ANZUP is now moving into the fundraising field, and although we recognise that there are a lot of other groups asking for resources for work that might seem similar, we are the only group actually undertaking clinical trials research for this group of cancers. Every bit of support is appreciated and goes directly towards helping us achieve our mission of improving outcomes for our patients. Please do not hesitate to contact us if you want further information about all this. Thanks for your interest and I hope you find this newsletter interesting and entertaining.
Message from the EO MARG MCJANNETT
ANZUP is a cancer cooperative trials group whose mission is to conduct clinical trial research to improve treatment of bladder, kidney, testicular and prostate cancers. Cooperative trials groups perform clinical research based on the clinical need and the strength of the science, as understood by our expert members and guidance from our community links.
Clinical trials are the only way to ensure a new treatment or approach to cancer management is safe, effective and, potentially, lifechanging. ANZUP’s clinical research aims to identify INNOVATIVE surgical procedures, EMERGING drug interventions and IMPROVED APPROACHES to management of urogenital and prostate cancers. Our Scientific Advisory Committee (SAC) and its subcommittees are the scientific engine room of our organisation. This is where our members bring new ideas and develop proposals that can turn into fully fledged protocols. Most recently we confirmed support for two very large international trials in prostate cancer involving Enzalutamide. You will read more about these exciting new studies later in the newsletter.
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We welcome the funding from the Australian government through Cancer Australia to support our infrastructure, but each clinical trial needs its own funding stream in order to get the work done. At the moment, we rely on applying for grants from various sources, which can take several years and even then might not be successful. It would be far more preferable to have resources that allow us to begin and continue trials in a much more timely fashion. We have established an ambitious program of fundraising activities to help ensure our financial sustainability. One example has been fundraising through the EveryDay Hero initiative (www.everydayhero.com.au look for ANZUP). These events have been very successful, raising much needed funds that go directly to support our research activities, but also have been a great platform for raising our profile in the community. It has been inspirational to hear and read some of the reasons that donors have made ANZUP their preferred charity. If you have any suggestions or ideas, or if you know someone who might be interested in supporting us, please don’t hesitate to contact us on (02) 9562 5033 or email margaret@anzup.org.au.
If you woke with bleary eyes on Sunday 17 November and tuned into the Seven Network Weekend Sunrise program you would have been greeted by the radiant smile of Belinda Jago and her team of ‘Bec’s Troops’ who were preparing to run and walk the City 2 Sea event in Melbourne. ‘Bec’s Troops’ were an enormous group of family and friends totalling 104 people. Together they raised more than $11,500 for ANZUP. You can see Belinda’s interview on Weekend Sunrise on the ANZUP website: www.anzup.org.au. Belinda is the Chair of our ANZUP Consumer Advisory Panel (CAP)
BELINDA JAGO AND ‘BEC’S TROOPS’ AT THE CITY 2 SEA EVENT.
A message from the ANZUP CAP Chair BELINDA JAGO
WHAT IS THE CAP? The Consumer Advisory Panel (CAP) provides input on research priorities, communication strategies, engagement within the community and trial design and conduct. It consists of people who have been touched by testicular, prostate, kidney or bladder cancer and now devote their time and energies to ensuring that others will reap the benefits of the work that ANZUP does. A CAP member may be a patient, cancer survivor, the partner of someone who has had cancer or the carer of a family member or friend. At some point during their cancer experience, CAP members will have expressed an interest in taking on a voluntary role to advocate on behalf of cancer patients by being able to use their experience in a positive way. Through their involvement on the CAP, they help to ensure we consider the patients’ perspective when developing clinical trials.
The ANZUP CAP is one of the larger consumer groups. We cover the four urogenital cancer types bladder, kidney, testicular and prostate cancer. This brings with it vast experience and wonderful opportunities to enhance our trial development with a focus on patient care. The CAP’s key focus is their commitment to improving the outcomes of those affected by cancer. This includes supporting and promoting every person’s right to information concerning trials and their right to make a personal, informed choice. As consumer advisers, we are not expected to have specific expertise about the scientific or medical merits of a trial but we are asked to provide the perspective of someone who has been through a similar or related experience. CAP members participate in regular disease-specific sub-committees where ideas for clinical trials are discussed. They are able to offer comments, ideas and suggestions for improvement of any idea being considered for development.
‘IT IS NOT JUST ABOUT THE SCIENCE - IT IS ABOUT YOU THE PATIENT.’
As the voice of our community, the CAP reviews proposed clinical trials. We consider: • Will the proposed clinical trial treatment be of more benefit to the patient than the current standard treatment? •
Will it offer fewer side effects?
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Will it make a procedure more comfortable?
• Will a new and less invasive surgical option reduce hospital and recovery time? • Is the trial criteria too narrow to include the patient population? • Will the treatment schedule be hard to manage in terms of time and travel for patients? • Is the treatment taken at home or in an outpatient/inpatient setting? One of the really important areas that the CAP reviews is the Patient Information and Consent Forms (PICF). All patients receive a PICF when they are considering whether a clinical trial may be their best option. The CAP reviews these PICFs to make sure the information provided to the patient is well written in plain, non-
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technical language with a minimum of acronyms, and with consideration for patients where English is a second language. The CAP looks at the treatment information given to a patient to make sure it is clear, and explains what the patient needs to know to make an informed decision as to whether the trial is suitable for them. The ANZUP CAP has offered constructive ideas in the review process of these PICFs. Our suggestions have been taken on-board by the lead investigators who made changes to the form and the process based on our advice. The ANZUP CAP is committed to working as advocates on behalf of our community to ensure that well-balanced and meaningful clinical trials are developed to continue improving patient outcomes in the future. I hope this overview gives you a greater understanding of how much complex work goes into bringing a clinical trial to the patient recruitment stage. It is not just about the science - it is about you, the patient.
CAP Member Ray Allen
DESCRIBES HIS ROLE ON THE CAP
WHEN RAY ALLEN BECAME A MEMBER OF THE ANZUP CAP IN JULY 2012, HE BECAME AN ADVOCATE FOR PATIENTS CONSIDERING BECOMING INVOLVED IN A CANCER CLINICAL TRIAL. THE JOB REQUIRES HIM TO PUT HIMSELF IN THE POSITION OF THE TRIAL PARTICIPANT, IN THE WAITING ROOM SO TO SPEAK, WITH ALL THE UNCERTAINTIES, FEARS AND HOPES THAT GO WITH DEALING WITH THEIR ILLNESS. THANKS TO RAY FOR THESE INSIGHTS.
“As a trial participant, I am unlikely to have any degree of medical training. The extent of my knowledge is likely to be what I have gleaned through my own experience and efforts towards survival. I am potentially frightened, physically ill and under stress. I am reliant on the skills, knowledge and the shared goals of those conducting the trials. I am a person, not a number, and certainly not a lab rat. I am hopeful that the trial might help me directly but ultimately I am here to help.
One particular area of recent involvement relates to the ‘Quality of Life’ (QOL) questionnaires that participants will be asked to complete at various intervals. I was able to comment on areas that I believed to be confronting, ambiguous and frustrating. Most importantly, I was able to highlight a potential misalignment in how a trial participant might perceive the questionnaires being used. I’m looking forward to opportunities to do more to improve this important area of trial management.
My job as a member of the CAP is to look at a particular trial and provide input to ANZUP where I believe the interests of the trial participant may not have been adequately considered or where I think that something could be done better. I don’t pretend to have the expertise of the health professionals and researchers but I am not afraid to look for clarification or suggest changes.
The role of the CAP, and my small part in it, helps to align the objectives of the participants and the managers of a cancer trial. I’m encouraged by the positive approach that ANZUP brings to this. It’s ultimately about encouraging trial participation to improve outcomes for people affected by cancer.“
Many years in business has taught me that most problems can be avoided through timely, honest and informative communication. And, that is certainly also the case in the world of clinical trials.
“IT’S ULTIMATELY ABOUT ENCOURAGING TRIAL PARTICIPATION TO IMPROVE OUTCOMES FOR PEOPLE AFFECTED BY CANCER.”
ANZUP clinical trials
THE TECHNICAL EXPLANATION OF A CLINICAL TRIAL IS: TO WORK OUT THE EFFECT OF SOME FORM OF INTERVENTION ON A GROUP OF PEOPLE WITH A DEFINED CONDITION. THAT IS, EACH STUDY IS DESIGNED TO ANSWER SCIENTIFIC QUESTIONS AND FIND NEW OR BETTER WAYS TO HELP PATIENTS WITH TESTICULAR, KIDNEY, BLADDER OR PROSTATE CANCER.
The following examples provide an overview of a clinical trial. Perhaps you have a new drug that you think is going to work in cancer. You want to know how safe it is, how often it works and how often it shrinks the cancer. Does it make people live longer? Is it safe? Does it make them feel better? And how does it stack up against the treatments that are already used? ANZUP has a strong record of successful clinical trials. Many of the trials we do don’t involve big blockbuster drugs. As an example, in testicular cancer, we did a clinical trial that showed giving the same drugs one way was better than giving them another way. It doesn’t sound very interesting but think about it like this; - this is a common cancer, these drugs don’t bring in large amounts of revenue for the drug company, so they won’t want to investigate the question. ANZUP did a clinical trial comparing the two types of treatments and we proved that one way was better than the other.
THIS IS NOW THE STANDARD WAY THIS TREATMENT IS GIVEN AROUND THE WORLD. If you are a patient involved in a clinical trial, you are going to receive new treatments not yet available elsewhere. All patients who sign up to a clinical trial are carefully monitored throughout the trial and followed up after the trial. You would more than likely be in a trial that is being carried out in major cancer centres throughout Australia and New Zealand. Throughout your trial, the ANZUP members (doctors, nurses, researchers, radiologists and psychologists specialising in urogenital and prostate cancers) will pull their concepts and experience together to design and monitor the trial.
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How can I find out more about a trial? Before you and your doctor make a decision about your treatment (whether it is in a clinical trial or not), your type of cancer will be diagnosed and ‘staged.’ Staging tells how far the disease has spread. Deciding on treatment depends on many things, including the stage of the disease and your general health. You would most likely be referred to a trial by your own doctor or by a doctor who knows your case. Some patients find out about trials from other sources. In any case, you must have a reasonable understanding of your role in a research study and be freely willing to take part in it. Every clinical trial is designed to answer a set of research questions. If you fit the guidelines for a trial, you may be eligible to take part. Each study enrolls patients with certain types and stages of cancer, and a certain health status. A study that involves two or more treatments can only yield reliable answers if all the patient cases are the same, so they can be compared with each other. When you see your doctor ask them “Is there a clinical trial that might be suitable for me?” There may not be one available, but if there is, it might be useful for your treatment. Your doctor will then go through all the information related to that clinical trial; what it involves in terms of your time, the tests that are done, how many visits to hospital, the possible side effects of treatment and any other relevant information you may require. If you agree, you will be asked to sign a consent form. The consent form means you have given permission for a drug to be used in a way that it is not ordinarily used, or to use an experimental drug. You would then take part in the clinical trial. If, at any time, you want to come off the trial, you can. You are not locked in. There are many types of clinical trials. Some involve you having to go to hospital and others can be taken at home and you may have to visit the hospital just to make sure everything is going well, and there have been no side effects. Other clinical trials don’t involve a treatment. Some of the trials we are doing involve supportive care questions. In other words, how well are people managing with their diagnosis of cancer and how can we support people better through the process of treatment and after treatment? In this case, there may be very few visits to the hospital. Some of these trials are done online or over the phone.
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:
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What is the purpose of the study?
• What does the study involve? What kinds of tests and treatments? (Find out what is done and how it is done) • 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?
• What side effects could I expect from the study? (There can also be side effects from standard treatments and from the disease itself) • How long will the study last? Will it require an extra time commitment on my part? • Will I have to be hospitalised? If so, how often and for how long?
• What are my options and what are their advantages and disadvantages?
• Will I have any costs? Will any of the treatment be free?
• Are there standard treatments for my case and how does the study compare with them?
• If I am harmed as a result of the research, what treatment would I receive?
• How could the study affect my daily life?
• What type of long-term follow-up care is part of the study?
Love a good fun run, swim or walk? ANZUP has fundraising pages with Everday Hero and GoFundraise. If you, or someone you know, is participating in the City 2 Surf, City 2 Sea or any other local or national community event across the country, you can easily set up a supporters page that enables you to raise money for ANZUP - no fuss and all tax deductible!
Hands up for ANZUP Heroes OVER THE PAST TWELVE MONTHS, MORE THAN $23,000 HAS BEEN RAISED IN SUPPORT OF ANZUP. TWO OF OUR COMMUNITY FUNDRAISERS SHARE THEIR STORIES AND THEIR REASONS FOR CHOOSING ANZUP. WE THANK THEM FOR THEIR CONTINUED SUPPORT.
EVERY DOLLAR YOU RAISE IS USED DIRECTLY IN ANZUP CLINICAL TRIALS.
Improving kidney,Bladder bladder&&Testicular testicularCancers. cancers. Improvingoutcomes outcomes for for prostate, Prostate, Kidney, 012
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With a mate in mind CRAIG MCGOWAN
With each pounding step in training and while racing, 32-year-old Craig McGowen thought a lot about his friend Sam Brown, who died earlier last year from a rare kidney cancer. Craig ran his first marathon, all 42.195 kms, around Sydney in the Blackmore’s Sydney Marathon. He raised $3,000, all of which was donated to ANZUP through Gofundraise. We recently caught up with Craig to find out what his motivation was to do this run and why he chose ANZUP. Craig and Sam knew each other through playing cricket on Sydney’s Lower North Shore. Like many young men of their age, they made the pilgrimage to London for work and to have a great adventure. Sam pulled Craig aside one day to ask his opinion on a strange and persistent rash that was across his lower back. They both noted how ugly and raw it was. Over the following months, Sam became increasingly unwell and, upon coming home sought help. Sam was diagnosed with a rare hereditary kidney cancer and was under the care of ANZUP member Dr Nick Pavlakis and The Royal North Shore Hospital. Sam turned 30 in March last year and had a huge party to celebrate the milestone. The cancer had spread to his liver and bones. After a brave fight, lasting 5 years, Sam died less than a month later on 20 April 2013. On the morning of Sam’s funeral, Craig went for a long run – something he hadn’t done in a long time. That day he decided to run the Sydney Marathon for Sam. When Craig arrived at Sam’s funeral, the Brown family had organised for ANZUP envelopes to be available for mourners. They felt they needed somewhere to direct the generosity and grief of their friends. Rather than flowers and food, they asked people make a donation to ANZUP to honour Sam’s memory. Craig knew then not only would he run but he would run for Sam and raise funds for ANZUP.
The training regime was not easy. He ran most afternoons after work, building up to the 42 kilometres in slow increments. “It hurt but also felt great”, Craig said when we met in October. You could tell by the look on his face, there was a greater motivation than personal satisfaction as he told his story. “When I made it to 30 kilometres in my training sessions, I started to taper off in preparation for the run on 22 September around Sydney Harbour”. Craig ran the marathon in 3 hours and 41 minutes - a great time for a first marathon. Craig recounted, “The last 8 kilometres were undoubtedly the hardest. I had tears through delirium. Throughout, I thought of Sam often and I could hear the cheering crowds and that motivated me to make it across that line.” Despite the overwhelming pain endured through a run of that distance, Craig had three highlights that he remembers fondly. Champion runner and former MP, Pat Farmer, was a pace runner. His job was to run at a pace so that people with a goal of 3 hours 40 minutes knew how they were travelling. Craig was able to run with Pat for over 5 kms. With a lap or two to go himself, he was passed by the leading female wheelchair athlete and, the greatest thrill of all was running past (in the opposite direction) the elite runners who were finishing the race. While not really understanding exactly what ANZUP did, he was still happy and proud to run for us. Executive Officer Margaret McJannett had been in touch with Craig prior to the race and we were delighted he chose to run in an ANZUP running shirt. Craig was so proud of Sam and how he lived the last few years of his life. He was very proud to have achieved his own personal goal of running a marathon and doing it in under four hours and we are so grateful for the amazing generosity of his fundraising efforts. Thanks to Craig McGowen and the Brown family for their generosity and for sharing their story with ANZUP.
Tash & Pearl Evans
LET’S HEAR IT FOR BLACKWATER When someone makes a donation to ANZUP through Everyday Hero, we receive an email with their name and the event they are participating in. We aren’t provided with any details about why someone has chosen us. In November, the ANZUP office was delighted to meet Tash and Pearl Evans from the tiny North Queensland town of Blackwater. Tash and Pearl had heartbreaking news a few weeks before the Walk to Work fundraising event. A close friend had been diagnosed with kidney cancer and they wanted to do something to express their grief. Through the National Walk to Work Day they decided to support ANZUP. “I found ANZUP conducts clinical trial research to improve the treatment of bladder, kidney, testicular and prostate cancers,” Tash said. “This organisation really hit close to home as my grandparents on Mum’s side died from bladder cancer and we also have other family members suffering from cancer.” Through their efforts, Tash and Pearl have become the top national fundraisers for the National Walk to Work Day. “Our goal was $1000 and we thought that was ambitious... but now we are at $2,500,” Tash told ANZUP. Tash and Pearl have stayed in touch with ANZUP and we were delighted to send them the ANZUP walking shirts. We would like to thank Tash and Pearl, for not only choosing ANZUP but for sharing their story with ANZUP and the Blackwater Herald’s Di Stanley.
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ANZUP news
ON THE MOVE ANZUP has recently moved offices. We are now located at L6, Lifehouse Building, 119-143 Missenden Road, Camperdown.
DID YOU KNOW? Did you know: ANZUP Members work on clinical trials in a voluntary capacity - meaning, they still work as medical oncologists, radiologists, urologists, nurses, psychologists and other allied health professionals at the same time they volunteer their time and expertise to ANZUP trials.
ANZUP ON YOUTUBE Courtesy of the generosity of documentary filmmaker Harley Oliver and editor Michael Newling, of Venice Digital, ANZUP has been able to produce a series of informative videos that are now on YouTube. In this series, Professor Ian Davis explains more about ANZUP, clinical trials, the funding process and how an idea becomes a new treatment for urogenital and prostate cancer patients. Go to YouTube and search for ANZUP. If you would like to learn more about your cancer, or ANZUP, you can find the videos on the ANZUP website under Frequently Asked Questions, www.anzup.org.au.
COMMUNITY ENGAGEMENT FORUM 2014 Each year, ANZUP holds an Annual Scientific Conference for its members. On the day prior to the conference, a forum is held by the leading experts from ANZUP for members of the community. This free event is an open forum for anyone suffering from testicular, prostate, kidney or bladder cancer along with their family and carers. The forum provides information about the importance of clinical trials and the impact that a diagnosis of these cancers can have on a person and their family. If you are interested in attending this year’s Community Engagement Forum ‘A Little Below the Belt’, it will be held at the Hilton on the Park, Melbourne, on Sunday 13 July from 1pm to 4pm. Once you are registered, you will be invited to submit questions prior to the event. These will be reviewed by our expert panel and, where possible, answered on the day.
How is ANZUP funded? ANZUP’s infrastructure and operational budget is supported by funding through Cancer Australia, a Federal Government initiative. ANZUP is not allowed to use any of the Cancer Australia money to conduct a clinical trial. Each time an ANZUP member develops an idea, we need to go out and find the funding to do that study. This might happen through a grant, it might be through fundraising and donations or it might be through support from a company or individual, but we have to gather the resources to do those clinical trials for each and every project. We are very conscious that there are many other groups raising funds for cancer. Organisations like the Cancer Council, Movember and the Prostate Cancer Foundation of Australia. These are all wonderful organisations, doing fantastic work, and in some areas we overlap.
Where ANZUP is distinct is in the area of clinical trials. No other organisations are doing the clinical trials that lead to the evidence that will make a difference to our patients.
Why fundraising makes a difference As a group, we must raise funds to conduct every study. Typically, it takes betwen two and three years from the initial idea for ANZUP to know whether they will receive funding. This is before any trial can take place. The trial itself is then added to those years. That’s a long time between coming up with a potentially life-changing solution and implementing it as a new practice. If ANZUP raised enough money to be self-funding, we could begin a trial within a much shorter time frame. This means we could have the evidence and change outcomes for our patients in a lot less time than it currently takes.
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What does a donation look like? We are so grateful to those who have already put their hands up for ANZUP. We would also like to thank the many people who have made personal donations directly to ANZUP. Your contributions are making a difference.
$50k - $250k
Kick off a pilot study Invest in a pilot study to test the feasibility of promising drug therapies, surgical methods, postoperative care and palliative care options.
$10k - $500k
Give a grant or fund a scholarship Inspire our culture of research by providing a grant or scholarship to clinicians involved in the care of patients with urogenital and prostate cancer.
Be kind in kind
$1m - $5m
Support a clinical trial Invest in a clinical trial to test the effectiveness, side effects and best dose of potential treatments for urogenital cancers.
Why in kind makes a difference? Investment and support can come in all shapes and sizes. In kind donations include providing the budget for a specific staff member, meeting room use, auctionable goods for fundraising, advertising support and creative support, and can help us deliver more interesting and educational information.
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. If you are interested in holding an event to support ANZUP or are considering joining an event such as the City 2 Surf, City 2 Sea, Sydney Marathon, Walk to Work Day or any other community event, please let us know and we will help you find the fundraising pages on GoFundraise and Everyday Hero. 100% of every donation made to ANZUP goes towards producing a clinical trial to improve the treatment of bladder, kidney, testicular and prostate cancers.
Donate Now
Current ANZUP trials WE CURRENTLY HAVE SIX CLINICAL TRIALS IN PROGRESS ACROSS BLADDER, TESTICULAR AND PROSTATE CANCER.
Bladder Cancer BCG+MMC Trial Non-muscle invasive bladder cancer is common and can cause substantial suffering. If the cancer is high-risk then, in over 30% of people it can turn into a more aggressive form of bladder cancer that requires treatment such as removal or radiotherapy to the bladder within five years. This risk can be reduced by placing BCG bacteria into the bladder. Recent preliminary studies show promising results from also placing miotmycin C (a chemotherapy drug) into the bladder along with the BCG treatment. This large-scale, randomised trial will determine the effects of adding mitomycin C to BCG on cure rates, survival, side effects and quality of life.
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 – Blemycin, Etoposide and Cisplatin – administered on a 3-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 2-weekly schedule will be more effective than a 3-weekly schedule and will it be well tolerated. The 2-weekly schedule is called ‘accelerated BEP’. This trial is in development.
This trial is currently active and recruiting. If this is something you or someone you know is interested in please speak with your doctor.
For more information go to the trials page on our website www.anzup.org.au.
For more information go to the trials page on our website www.anzup.org.au.
ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).
ANZUP collaborates with the University of Sydney through the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC).
(Germ cells are cells in the body that develop into sperm or eggs.)
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Prostate Cancer Living Well with Prostate Cancer
Prostate Cancer in Gay & Bisexual Men and their Partners
Prostate cancer is the most common male cancer in developed countries. There are approximately 22,000 men living with advanced prostate cancer today. Research into the impact of advanced prostate cancer shows that men report higher levels of psychological distress, poorer quality of life and have an increased risk of suicide compared to men with localised disease. Additionally, many men report they do not receive enough support after their diagnosis. This project is trialling a professionally-led telephone session delivering mindfulnessbased cognitive therapy group intervention for men with advanced prostate cancer.
It is estimated that 600 - 1000 Australian gay men are diagnosed with prostate cancer each year. This study, a collaboration between the University of Western Sydney (UWS) and ANZUP, aims to examine the psychological burden of changes to sexual wellbeing, sexual identity and intimate relationships in gay and bisexual men with prostate cancer and their male partners.
This trial is active and recruiting. If this is something you or someone you know is interested in please speak with your doctor.
This trial is active and recruiting. If this is something you or someone you know is interested in please speak with your doctor.
ANZUP collaborates with Griffith University and Cancer Council Queensland.
For more information go to the trials page on our website www.anzup.org.au. ANZUP collaborates with University of Western Sydney, ACON, Victoria AIDS Council (VAC).
RAVES Trial Radical prostatectomy is the most common curative approach offered to men with newly-diagnosed prostate cancer. Unfortunately, up to half of these patients will have factors placing them at high risk of cancer reoccurring. Having radiotherapy after an operation is known to improve cure 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 Phase III trial 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 New Zealand and Australia will participate. This trial is active and recruiting. If this is something you or someone you know is interested in please speak with your doctor. For more information go to the trials page on our website www.anzup.org.au. ANZUP collaborates with Trans-Tasman Radiation Oncology Group (TROG) and Urological Society of Australia and New Zealand (USANZ).
CURRENT ANZUP TRIALS
This program is designed to assist men with stress management and improve their psychological wellbeing. Its effectiveness will be compared to an educational program consisting of the best available resources for men with advanced prostate cancer.
Sexuality and intimacy are important aspects of an individual’s quality of life. Changes to sexual functioning, relationships and a sense of self are reported as the most negative influences on the wellbeing of men with prostate cancer. However, the focus of previous research has been on heterosexual men, with gay and bisexual men with prostate cancer being described as an ‘invisible diversity’, or a ‘hidden population’. This has led to a plea for research on the impact of important differences in sexuality, identity, and intimate relationships on gay and bisexual men’s experience of prostate cancer. This can be used to inform health education and health promotion as well as lead to targeted psycho-social interventions.
WORLD LEADING
Prostate Cancer ENZAMET Trial
CURRENT ANZUP TRIALS
Randomised Phase III trial of Enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer.
Study design
The treatment of prostate cancer that has spread beyond the prostate gland in to other parts of the body starts with medications that manipulate the hormone levels in the body. This is called Androgen Deprivation Therapy (ADT). ADT is often in the form of injections called LHRHA (luteinizing hormone releasing hormone analogues) and are often combined with tablets called anti-androgens.
1. Investigational arm: Patients will get LHRHA and Enzalutamide
This study has been designed to assess a new anti-androgen called Enzalutamide. Enzalutamide is much stronger than older antiandrogens. Enzalutamide has also been shown to work in prostate cancers that are resistant to other anti-androgens. Despite best treatments, men with metastatic prostate cancer do develop resistance to hormonal manipulation (i.e. so-called ‘castrateresistant prostate cancer’) and are subsequently treated with chemotherapy. Recent clinical trials of the use of Enzalutamide in men with castrateresistant prostate cancer and those who have previously been treated with chemotherapy have shown that 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 for men was significantly better on Enzalutamide. It might be that the use of Enzalutamide earlier in the course of prostate cancer may be of even more benefit. The ANZUP ENZAMET trial will answer this question: will men with prostate cancer that has spread but who have not had ADT, live longer if Enzalutamide is added to standard ADT?
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This trial will have 2 arms:
2. Comparison arm: Patients will get LHRHA and a standard anti-androgen Treatment will continue until the cancer starts to grow or there is some other reason to stop treatment. All men will continue to be followed up even after trial treatment finishes. We do not yet know if Enzalutamide used in this way will be helpful. The comparison arm is a standard way of using current treatments. We have no reason to think people will be disadvantaged if they receive the comparison treatment, as it is similar to what they would get if they were not on the trial. 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. This trial is currently active and recruiting. If this is something you or someone you know is interested in please speak with your doctor. For more information go to the trials page on our website www.anzup.org.au. ANZUP collaborates with NHMRC CTC.
WORLD LEADING
Prostate Cancer ENZARAD Trial Randomised Phase III trial of Enzalutamide in androgen deprivation therapy with radiation therapy for high risk clinically localised prostate cancer.
This is not an alternative treatment to radical prostatectomy. If you are offered a radical prostatectomy, you will not be eligible for this trial. ENZARAD is a clinical trial for men where a decision has been made that radiotherapy is the best treatment because they are not suitable for radical prostatectomy due to their pathology or core morbidities. ENZARAD will answer this question: will men with prostate cancer confined to the prostate, but at high risk of coming back, live longer by adding Enzalutamide to radiotherapy plus ADT?
All participants in this trial will get standardised radiotherapy and ADT as per recognised standard treatment. Radiotherapy will start 16 weeks after the participant commences hormonal manipulation. There are two arms in this trial: 1. Investigational arm: Patients will also get Enzalutamide for a total of 24 months 2. Comparison arm: Patients will also get an older, conventional anti-androgen for a total of six months ENZARAD 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 800 participants from these countries. Participants will stay on study drug until there is evidence of progression and will be followed for a minimum of 3.5 years from entering the trial. This trial is currently active and recruiting. If this is something you or someone you know is interested in please speak with your doctor. For more information go to the trials page on our website www.anzup.org.au. ANZUP collaborates with NHMRC CTC.
CURRENT ANZUP TRIALS
Prostate cancer is often treated with powerful X-rays (radiotherapy) instead of surgery. The reasons for choosing radiotherapy or surgery are complex and this is a discussion that men should have with their treating doctors. We will specifically look at men whose cancers have higher risks of coming back after treatment but have not 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 often 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.
Study design
BY WAY OF DEFINITION Each newsletter, we will be exploring a few terms that you may have come across regarding clinical trials.
What is a clinical trial? The information below is provided on the National Health and Medical Research Council website www.australianclinicaltrials.gov.au. Information was accessed 23 January, 2014. Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention and what side effects might occur. This helps determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available. Clinical trials might also compare existing interventions, test new ways to use or combine existing interventions or observe how people respond to other factors that might affect their health (such as dietary changes). The World Health Organization (WHO) definition for a clinical trial is:
“Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
Clinical trial interventions include but are not restricted to: • experimental drugs • cells and other biological products • vaccines • medical devices • surgical and other medical treatments and procedures • psychotherapeutic and behavioural therapies • health service changes • preventive care strategies • educational interventions Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease.
Randomised This means each patient is randomly assigned to receive either the drug being used in the study or a placebo.
Blind This means the patient doesn’t know what they are receiving. If the study is double-blind the researchers also don’t know which treatment is being given to each patient. The idea behind having a blind study is to prevent bias in the treatment.
Placebo controlled The use of a fake treatment allows researchers to isolate the effect of the drug being used for the trial against the fake treatment. This is known as the placebo effect.
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The National Health and Medical Research Council defines the phases of trials as:
Phase IV 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 III 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 non-interventional standard care) as well as to monitor adverse effects and to collect information that will allow the intervention to be used safely.
Phase II Phase II clinical trials are done to study an intervention in a larger group of people (several hundred) to determine efficacy (whether it works as intended) and to further evaluate its safety.
INCREASING SIZE AND COST
Phase I Phase I clinical trials are done to test a new biomedical intervention for the first time in a small group of people (20-80) to evaluate safety (e.g. to determine a safe dosage range and identify side effects).
What is a trial investigator? This is the person who will be organising the trial in your hospital.
Community Engagement Forum ‘A little below the belt’ Hilton On The Park Melbourne Sunday 13 July, 2014 1:00pm - 4:00pm The Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group invites you to attend our Community Engagement Forum, ‘A little below the belt’. This forum will provide information, and the opportunity to discuss the importance of clinical trials and the impact that a diagnosis of a prostate, bladder, kidney or testicular cancer can have on a person and their family. Entry is free, however booking is essential as seating is limited. Registrations open now. Further Information: www.anzup.org.au Email: anzup@yrd.com.au Phone: 02 9562 5033
ANZUP wishes to thank our corporate supporters for 2014