Australian Organisation Launches Large International Clinical Trials in Prostate Cancer Media Release Sydney 8 April, 2014: The Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group will be the international lead for two of the largest clinical trials for sufferers of the world s most commonly diagnosed form of cancer, prostate cancer. The international trials, which have the potential to radically change the way prostate cancer is treated, will together involve over 1,900 patients across Australia, New Zealand, Ireland, United Kingdom, and Canada. The trials involve a new hormone treatment, Enzalutamide. Enzalutamide is not currently approved in Australia for use in prostate cancer but has been shown to be effective in treating late stages of the disease. ANZUP is an active and emerging cancer cooperative clinical trials group, established to bring together all the professional disciplines and groups involved in researching and treating urogenital and prostate cancers. The ENZAMET study will involve about 1100 men with prostate cancer that has spread but has not yet been treated with hormones. The ENZARAD study will include about 800 men with prostate cancer that has not spread and that is planned for treatment with radiotherapy. Men with prostate cancer who are in either of these situations are encouraged to discuss these trials with their doctor or refer to the ANZUP website (www.anzup.org.au) for the trials, which commenced across Australia last week. 28 hospital sites in Australia and 2 in New Zealand will include over 350 patients for the ENZAMET study, and 25 hospital sites in Australia and 2 in New Zealand will include more than 250 patients for the ENZARAD trial. Overall 1,900 patients will participate in these trials worldwide. Professor Ian Davis, Chair of ANZUP said the trials might be opportunities to change the lives of prostate cancer sufferers around the world. Clinical trials are imperative. All the medical research in the world means nothing if we can t improve outcomes for our patients. Clinical trials are how we find out whether something works, how best to use it, and how it stacks up against what we are already doing he said. These two trials aim to answer basic questions that patients and their doctors face every day in the clinic: what is the best way of treating men with prostate cancer? They will be two of the largest trials in prostate cancer and people around the world are already intensely interested in them and what their outcomes might be. These trials demonstrate once again that Australia punches above its weight in medical research, he added. We have to do trials in Australia. Our health systems are not the same as the US or Europe. We need to know how a treatment could or should be used in the Australian setting. A clinical trial is also often a good way of getting access to new treatments for our patients. 1
Australian research is recognised around the world as being of the highest quality. Even if you look at it in the most basic economic level we know that every dollar invested in Australia in medical research returns about $6 to the economy and in terms of savings in health care costs he said. END. For more information contact: Professor Ian Davis 0417 127 147 Margaret McJannett EO ANZUP 0402 426 454 Liz Thorp Marketing and Communications 0414 386 092 2
About ANZUP The Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group Ltd is a cooperative clinical trials group leading research into urogenital cancers. Urogenital cancers include cancers of the prostate, testis, kidney and bladder and other cancers associated with the urinary system. Cooperative clinical trials groups are led by clinicians and scientists. They do clinical and basic research to answer questions that pharmaceutical companies are unwilling or unable to address. ANZUP was formed to bring together the researchers, professionals and organisations that conduct and support prostate, testicular, bladder and kidney cancer research to improve patient treatment and care. ANZUP was founded in 2007 and became a company limited by guarantee in 2008. It is a not-for-profit organisation with over 700 members across all disciplines, and links to the key stakeholder groups including the Prostate Cancer Foundation of Australia (PCFA) and the Urological Society of Australia and New Zealand (USANZ), the federally funded prostate cancer centres, prostate cancer tissue biorepositories, and community/consumer/advocacy bodies. ANZUP s members include key clinical sites and basic genitourinary cancer research laboratories in Australia. ANZUP members volunteer their time to this research. ANZUP aims to develop, foster and promote urogenital and prostate cancer research by: providing access to clinical trials for all appropriate Australian and New Zealand patients increasing involvement of and collaboration with various professional disciplines in clinical and preclinical research providing opportunities for clinical research building systems to simplify and streamline clinical research of the highest quality fostering a culture of research amongst all clinicians involved in the care of patients with urogenital cancers providing training opportunities for the next generation of clinical researchers providing for translational studies in prostate and other urogenital cancers, including tissue banking and from clinical trials for further studies 3
Medical Background ENZAMET: Randomised phase 3 trial of Enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer 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. This study has been designed to assess a new anti-androgen called Enzalutamide. Enzalutamide is much stronger than older anti-androgens. 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 castrate resistant prostate cancer ) and are subsequently treated with chemotherapy. Recent clinical trials of the use of Enzalutamide in men with castrate resistant 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. Further, 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 might 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 benefit in terms of living longer if Enzalutamide is added to standard ADT? Study design: This trial will have 2 arms: 1. Investigational arm: Patients will get LHRHA and Enzalutamide 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. If we knew that already we would not need to do the trial! The comparison arm is a standard way of using current treatments and we have no reason at this stage to think that people will be disadvantaged if they receive that 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 1,100 participants from these countries. Participants will stay on the study drug until there is evidence of progression and will be monitored for a minimum of 3 ½ years from entering the trial. 4
ENZARAD: Randomised phase 3 trial of Enzalutamide in androgen deprivation therapy with radiation therapy for high risk clinically localised prostate cancer 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 conventional treatment but that have not shown any evidence yet 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 are often combined with tablets called anti-androgens. Enzalutamide is a new and stronger anti-androgen 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. ENZARAD will answer this question: will men with prostate cancer apparently confined to the prostate but at high risk of coming back elsewhere benefit, in terms of living longer, from adding Enzalutamide to radiotherapy plus ADT? Study design: All participants in this trial will get standardised radiotherapy and ADT as per recognised standard treatment. Radiotherapy will be planned to 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 6 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 the study drug until there is evidence of progression and will be monitored for a minimum of 3 ½ years from entering the trial. 5
Non-medical background About Enzalutamide Studies ENZAMET and ENZARAD ENZAMET Trial Enzalutamide is a new hormone treatment taken as tablets. Previous trials have proven that Enzalutamide improves survival and quality of life in men with prostate cancer that has stopped responding to standard hormone treatments and chemotherapy. This large, international randomised trial will determine if treatment with Enzalutamide can improve survival and quality of life in men starting hormone treatment for newly diagnosed prostate cancer that has spread beyond the prostate. The trial is being led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. It will involve 1,100 men from Australia, New Zealand, Canada, the US, Ireland, and the UK. ENZARAD Trial Enzalutamide is a new hormone treatment taken as tablets. Previous trials have proven that Enzalutamide improves survival and quality of life in men with prostate cancer that has stopped responding to standard hormone treatments and chemotherapy. This large, international randomised trial will determine if treatment with Enzalutamide can improve survival and quality of life in men starting radiation and hormone therapy for prostate cancer that does not seem to have spread beyond the prostate. The trial is being led from Australia by ANZUP in collaboration with the NHMRC Clinical Trials Centre. It is planned to include 800 men from Australia, New Zealand, Canada, the US, Ireland, and the UK. 6