11 minute read
The role of the Prostate Cancer Subcommittee
Professor Lisa Horvath is the chair of the ANZUP Prostate Cancer subcommittee and Professor Jarad Martin is the deputy chair. They lead the subcommittee and provide oversight of trials within the Prostate Cancer trials portfolio, as well as development of new trial concepts. The Prostate Cancer Subcommittee is made up of over 500 members of different disciplines from around Australia and New Zealand.
Meet the Professors!
Professor Lisa Horvath
Professor Lisa Horvath is the Director, Department of Medical Oncology, and inaugural Director of Research at the Chris O’Brien Lifehouse. She is also the Professor of Medical Oncology (Genitourinary cancer) at the University of Sydney and Head of Advanced Prostate Cancer Research at the Garvan Institute for Medical Research. She has an active clinical practice and is involved with a large number of clinical trials in prostate and colorectal cancers in addition to phase I trial work.
Having completed medical school at the University of Sydney and trained in medical oncology at Royal Prince Alfred Hospital, she subsequently worked at the Garvan Institute completing her PhD in translational research in 2004. She has authored over 100 original research papers published in peerreviewed journals in the last 20 years across the fields of cancer biology, biomarkers and clinical trials.
Prof Horvath has been involved in numerous ANZUP clinical trials over the last 10 years as well as an author on the ENZAMET study. She is a board director for ANZUP, and a member of the ANZUP Scientific Advisory Committee.
Professor Jarad Martin
Professor Jarad Martin is a Radiation Oncologist and departmental Director of Research working at the Calvary Mater Newcastle. He completed his fellowship in 2005 and undertook a genitourinary oncology clinical research fellowship at the Princess Margaret Hospital in Toronto, winning the academic excellence in research award from that institution. His primary clinical and research interests are in urologic and gastrointestinal cancers, including the application of stereotactic radiotherapy for genitourinary tumours. In 2006 he accepted a position in Regional Queensland in Toowoomba and established the Toowoomba Cancer Research Centre (TCRC).
Prof Martin assumed the Australasian Primary Investigator role for the successful PROFIT clinical trial randomising men with prostate cancer to receive either a standard 8 week course or an experimental 4 weeks’ regimen of radiotherapy. He relocated to Newcastle in 2012 and continued to develop a number of senior roles in national bodies. He was the Clinical Liaison for Trans-Tasman Radiation Oncology Group (TROG) from 2012-2015 and was the chair of the Faculty of Radiation Oncology Research Committee from 2011-2015. He has been on the executive committee of the Faculty of Radiation Oncology Genitourinary Group (FROGG) as well as the Scientific Advisory Committee of ANZUP.
Prof Martin has several currently accruing multicentre prospective clinical trials, over 70 peer reviewed publications, and has also recently completed a PhD.
Q&A with Professor Lisa Horvath
A: Can you tell us why you are involved in the Prostate Cancer Subcommittee?
Lisa Horvath (LH): I became involved as I wanted to contribute to prostate cancer clinical trials, and ANZUP as the peak body was the obvious vehicle to do this. I have worked in Prostate Cancer for 20 years and always enjoyed research and clinical trials.
Why is the subcommittee important to ANZUP and its trials portfolio?
LH: With all of ANZUP’s subcommittees, we need to concentrate on the tumour type. We need to work on new ideas, and bring new ideas to the table, new drugs, improved lifestyle and quality of life for our patients. More research into biomarkers and different therapeutic approaches to improve people’s longevity and improving their quality of life.
What are the roles and responsibilities of the subcommittee?
LH: The subcommittee provide input into new protocols. The subcommittee is also there to provide enthusiasm, interest and discussion, sparking ideas for new trials. This is a forum to bring different disciplines together, to discuss ideas and see if they are going to work. These subcommittees have input with a multidisciplinary approach.
If someone is thinking of joining the committee what would you say to them/what do they need to know?
LH: Please join us. The subcommittee is inclusive to all healthcare professionals working in the prostate cancer space.
Over the next 12 months, what do you hope to achieve leading the Prostate Cancer Subcommittee?
LH: Enhance the multidisciplinary approach to prostate cancer clinical trials, including getting more surgeons, nurses and allied health involved in clinical trials.
I would really like to see nursing / allied health led studies. Encourage nurses and allied health to put forward concepts to be considered at the concept development workshops. Look at different techniques, supportive care and quality of life. How we get the best nursing care to our patients.
Anything else you would like to add?
LH: Onwards and upwards. Roll on 2021, may the world be a calmer and happier place.
The role of the ANZUP subcommittees
The Scientific Advisory Committee (SAC) consists of a core group of members representing the major disciplines relevant to ANZUP, nominated and appointed upon the recommendation of those groups. In addition, chairs of the SAC subcommittees are members of the SAC by virtue of their appointment as Chair. The SAC meets by teleconference quarterly with one annual face-to-face meeting during the Annual Scientific Meeting.
The SAC is advised by disease specific subcommittees (Prostate, Renal, Germ Cell and Bladder/Urothelial/Penile) and non-disease-specific subcommittees (Quality of Life & Supportive Care and Translational Research). The disease specific subcommittees are responsible for oversight of trials within their portfolios, as well as development of new trial concepts. These subcommittees meet by teleconference quarterly and intend to meet face-to-face at least once per year.
The non-disease-specific subcommittees are involved as required in trial development and management in order to ensure maximum value is added to every trial. These subcommittees meet by teleconference as required and intend to meet face to-face at least once per year.
ANZUP are currently running a number of prostate cancer trials. For more details information about these trials, go to the ANZUP prostate cancer trials web page: https://anzup.org.au/content.aspx?page=trials-prostate
ENZA-p
Status: Open and recruiting
Location: Australia wide
Planned sites: 13
Patients recruited: 13 • Patients required: 160
Enzalutamide is a potent hormone therapy that prevents testosterone from reaching prostate cancer cells, thereby stopping cancer growth. It is already widely used in men with prostate cancer that has stopped responding to standard hormone treatments (castration-resistant prostate cancer). However, most cancers become resistant to enzalutamide over time, with almost 1 in 4 being resistant from the start of treatment.
Many prostate cancers, in particular those that have spread or become resistant to hormonal therapies, have a substance on their cell surface called prostate specific membrane antigen (PSMA). Lutetium-177 PSMA (LuPSMA for short) is a new treatment in advanced prostate cancer. Lu-PSMA is a radioactive molecule that attaches to the surface of prostate cancer cells throughout the body. This drug is given as an injection through the vein and allows targeted radiation to be delivered directly to prostate cancer cells.
Smaller pre-clinical studies have demonstrated synergistic effects by combining Lu-PSMA with enzalutamide. It is possible that Lu-PSMA can prevent early resistance to enzalutamide, extending the time that men benefit from treatment. The ENZA-p clinical trial aims to compare the effectiveness of enzalutamide in combination with LuPSMA, versus enzalutamide alone for the treatment of prostate cancer. This is a randomised study, so half the men in this trial will be randomly allocated to receive Lu-PSMA and enzalutamide, and the other half will be randomly allocated to receive enzalutamide alone. We plan to enrol 160 participants across Australia.
https://anzup.org.au/content.aspx?page= prostatecancertrialdetails
Current locations for the ENZA-p trial:
NSW •St Vincent’s Hospital
VIC •Austin Health •Peter MacCallum Cancer Centre
QLD •Royal Brisbane
SA •Royal Adelaide Hospital ENZA-p is funded through the Prostate Cancer Research Alliance (PCRA) – a program jointly funded by the Australian Government and the Movember Foundation (Movember).
DASL-HiCaP
Status: Open and recruiting
Location: Australia & Internationally
Activated sites: 22
Patients recruited: 89 • Patients required: 1100
The purpose of this study is to see if a new tablet drug, darolutamide, combined with the current best treatments, can improve outcomes for men with high risk prostate cancer that has not spread beyond the prostate area.
Previous studies have shown promising results for darolutamide preventing disease progression and improving survival for men with advanced prostate cancer.
This is a randomised controlled trial, which means that, in addition to best standard treatments, half the participants on the study will receive darolutamide, and the other half will receive placebo.
DASL-HiCaP is being led internationally by ANZUP with another exciting opportunity to collaborate with our partners at the NHMRC Clinical Trials Centre, the Canadian Cancer Trials Group, Cancer Trials Ireland (Ireland and UK), and the Memorial Sloan Kettering Cancer Center and Prostate Cancer Clinical Trials Consortium in the US. The University of Sydney is the Sponsor and and the NHMRC Clinical Trials Centre is the global coordinating centre. We plan to enrol 1,100 men from Australia, New Zealand, Canada, US, Ireland, and the UK.
For more information please refer to https://www.anzup. org.au/content.aspx?page=trials-prostate. Current locations for the DASL-HiCAP trial:
AUSTRALIA
NSW •Border Medical Oncology •Calvary Mater Newcastle •Campbelltown Hospital •Chris O’Brien Lifehouse •GenesisCare Newcastle •Gosford Hospital •Liverpool Hospital •Prince of Wales Hospital •St George Hospital •St Vincent’s Hospital
VIC •Peter MacCallum Cancer Centre • Peter MacCallum Cancer Centre (Bendigo Campus) • Peter MacCallum Cancer Centre (Moorabbin Campus)
QLD •Icon Cancer Centre-Gold Coast University Hospital •Princess Alexandra Hospital • Radiation Oncology Princess Alexandra Hospital
Raymond Terrace • Royal Brisbane and Women’s Hospital • Townsville Hospital
SA • Ashford Cancer Centre Research
WA • Fiona Stanley Hospital
TAS • Royal Hobart Hospital
NEW ZEALAND • Auckland City Hospital
#UpFrontPSMA
Status: Open & recruiting
Location: Australia wide
Activated sites: 5
Patients recruited: 13 • Patients required: 140
Most prostate cancer cells have a molecule on their surface called prostate cancer specific membrane antigen (PSMA). PSMA can be targeted with Lutetium-177 PSMA (Lu-PSMA), a radioactive drug that kills prostate cancer cells anywhere in the body. This investigational drug is not approved for use in Australia by the Federal Government’s Therapeutic Goods Administration (TGA). It is a new form of treatment that is effective in some patients with metastatic prostate cancer. It is a radioactive substance that, after injection into a vein, attaches to prostate specific membrane antigen (PSMA). The treatment enables delivery of highly targeted radiation to cancer cells. The emitted radiation only travels about 1mm, which means it mainly causes the death of cancer cells, while avoiding healthy cells, and seems to be well tolerated with few side effects. This is called radionuclide therapy or theranostic therapy. The purpose of this randomised controlled clinical trial is to compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own. Previous clinical trials have shown promising activity of Lu-PSMA in treatment of patients with metastatic prostate cancer. Docetaxel is a chemotherapy drug that is approved by the TGA to treat prostate cancer and has been used for many years in the treatment of metastatic prostate cancer. Since Lu-PSMA radiotherapy and docetaxel chemotherapy are both effective in treating metastatic prostate cancer, it is possible that using Lu-PSMA in addition to standard docetaxel chemotherapy at the beginning of the treatment course may improve patient outcomes when compared to treatment with docetaxel alone. A recent phase 2 clinical trial, showed the effectiveness of Lu-PSMA when used as a last treatment option and helped control disease progression.This study brings the use of Lu-PSMA forward as a first option to patients, with the hope of disease eradication and potential cure.
The trial is open and recruiting.
For more information please refer to https://anzup.org. au/content.aspx?page=prostatecancertrialdetails
Current locations for the #UpfrontPSMA trial:
NSW •St Vincent’s Hospital Sydney
QLD •Royal Brisbane and Women’s Hospital
VIC •Peter MacCallum Cancer Centre •Austin Hospital
NINJA
Status: Open & recruiting
Location: NSW and VIC
Activated sites: 12
Patients recruited: 81 • Patients required: 474
The NINJA clinical trial aims to compare two emerging schedules of radiotherapy in the treatment of intermediate or high risk prostate cancer. Participants will be randomly assigned to one of two radiotherapy schedules as part of this study. In schedule 1 (called Stereotactic Body Radiotherapy) participants will receive 5 radiotherapy treatments over 2 weeks, and in schedule 2, (called Virtual High Dose Rate Boost), participants will receive Stereotactic Body Radiotherapy delivered in 2 treatments over 1 week followed by 12 treatments of conventional external beam radiotherapy over 2 and a half weeks. It is hoped this research will potentially improve the accuracy and quality of radiotherapy treatment in prostate cancer.
This study will include 474 men. Currently we have active sites across Australia and New Zealand with 81 patients enrolled.
This trial is open and recruiting. If you are interested in participating in the trial, please refer to http://anzup.org. au/content.aspx?page=trials-prostate.
This study is being led by the TransTasman Radiation Oncology Group and co-badged with ANZUP. The study is being funded by Cancer Australia, and we acknowledge MDI for providing the study drug. Current locations for the NINJA trial:
NSW •Calvary Mater Newcastle •Campbelltown Hospital •GenesisCare Hurtsville •GenesisCare Newcastle •Liverpool Hospitals •Illawarra Cancer Centre •St George Hospital •Westmead Hospital
VIC •Peter MacCallum Cancer Centre (Parkville) •Peter MacCallum (Moorabbin)
QLD •Princess Alexandra Hospital •Princess Alexandra (ROPART)
