FIRST OF ITS KIND COMBINATION TREATMENT APPROACH IMPROVES SURVIVAL RATES IN AUSTRALIANS WITH METASTATIC PROSTATE CANCER
New research findings were reported today from the ENZA-p study (ANZUP 1901), led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) in collaboration between ANZUP, the NHMRC Clinical Trials Centre at the University of Sydney and the Australasian Radiopharmaceutical Trials Network. The findings reveal that a world-first combination treatment approach improved both survival and quality of life, compared to the standard of care therapy for people living with a poor prognosis prostate cancer known as castration-resistant prostate cancer (mCRPC).1
LuPSMA is a treatment that can precisely target prostate cancer cells with a radioactive substance that can kill those cells. ENZA-p is a world-first clinical trial to test the combination of LuPSMA with a standard best practice hormonal treatment (enzalutamide), and was specifically designed to try to help people who might have been less likely to benefit from enzalutamide.1 The trial also tested an innovative world-first treatment approach called ‘adaptive dosing,’ which uses imaging and blood results to identify patients who are responding to the treatment and determine those patients who were most likely to benefit from continued treatment, tailoring the treatment approach for each patient. Results from ENZA-p were published in The Lancet Oncology and presented at American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in San Francisco.
Professor Louise Emmett, ENZA-p Study Chair and Director of Theranostics and Nuclear Medicine at St Vincent’s says, “We are excited to present the positive results of our ENZA-p study internationally. Our findings show that participants who received the new treatment combination experienced longer and better lives in terms of increased overall survival and improved pain and fatigue for those with an otherwise poor prognosis.”
“The study opens the door for exploring this combination of treatments earlier in metastatic prostate cancer.”
mCRPC is an advanced form of prostate cancer where the tumour has spread to other areas in the body.2 Those living with the disease have approximately a 3 in 10 chance of surviving 5 years. Currently, there are very few options to treat mCRPC.2,3
Prostate cancer is the most diagnosed cancer in Australians. 4 It is estimated 26,400 prostate cancer cases will be diagnosed, 3,900 deaths will be recorded and around 42,000 years of life lost to prostate cancer in 2024 alone. 4,5 By 2040, there will be 372,000 people living with prostate cancer in Australia, representing the greatest number of people diagnosed with any single cancer.6
Australian and New Zealand Urogenital and Prostate Cancer Trials Group CEO, Samantha Oakes says, “Our mission at ANZUP is to improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers, as the leading non-for-profit research charity funding multidisciplinary collaborative clinical trials for these ‘Below the Belt’ cancers. Since our inception in 2008, ANZUP has funded 33 Below the Belt cancer trials across 772 global sites providing over 8,000 participants access to innovative clinical trials.”
“We are proud to showcase our Australian-led first-of-its-kind research on an international stage. The discoveries through the ENZA-p study will pave the way for more effective combination therapies that can improve survival outcomes and revolutionise care for people with advanced prostate cancer with poor prognosis.”
The full ENZA-p research results were presented at The American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers
Symposium from February 13–15, 2025 at the Moscone West Conference Center in San Francisco, California.
About ENZA-p study (ANZUP 1901)
ENZA-p (ANZUP 1901, NCT04419402) is an investigator-initiated trial led by the ANZUP Cancer Trials Group in partnership with the Prostate Cancer Research Alliance, a joint initiative between the Australian Federal Government and the Movember Foundation. ENZA-p is a collaboration between ANZUP, the NHMRC Clinical Trials Centre at the University of Sydney and the Australasian Radiopharmaceutical Trials Network with supply of Precursors and funding support from Endocyte (a Novartis company), St Vincent’s Clinic Foundation, GenesisCare, and Roy Morgan Research. Astellas provided drug support for the trial. ANZUP receives infrastructure funding from Cancer Australia.
ENZA-p is a multicentre, open label, randomised, phase 2 trial performed at 15 Australian sites. The trial had 162 participants who received enzalutamide 160 mg daily alone, or in combination with adaptive dosed LuPSMA (2 or 4 doses). Eligible participants had mCRPC not previously treated with chemotherapy or an androgen receptor pathway inhibitor for mCRPC, and at least 2 risk factors for early disease progression on enzalutamide alone. Health related quality of life was rated with the EORTC core quality-of-life questionnaire every 6 weeks until radiological progression.
About Movember
Movember is the leading charity changing the face of men’s health globally. Since 2003, Movember has raised over $1.5 billion, funding 1,320 men’s health projects across the world. Mental health and suicide prevention, prostate cancer and testicular cancer – Movember are taking them all on. Find out more at movember.com.
About the NHMRC Clinical Trials Centre, University of Sydney
The NHMRC Clinical Trials Centre is a flagship research centre of the Faculty of Medicine and Health at the University of Sydney that designs and manages clinical trials. This includes responsibility for study coordination, monitoring, data acquisition and management and statistical analysis. The NHMRC Clinical Trials Centre has health economics, biostatistics, systematic reviews and biomarker teams work with trial data and inform healthcare providers about best practice. For further details, please visit its website at https://www.ctc.usyd.edu.au/.
About the University of Sydney
As Australia’s first university – founded in 1850 – the University of Sydney has a proud history of global leadership in education and research and inspiring people from all backgrounds to contribute to positive real-world change. The University of Sydney is a world-renowned teaching and research institution – our research combines the expertise and talents of scholars from many disciplines. For further details, please visit its website at https://www.sydney.edu.au/about-us.html.
- Overall survival and quality of life with [177Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): secondary outcomes from a multicentre, open-label, randomised, phase 2 trial – The Lancet Oncology
- 6Sartor, O et al. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021;385(12),1091–1103. Available at: https://doi.org/10.1056/NEJMoa2107322 . Accessed in February 2025.
- Eric Powers, Georgia Sofia Karachaliou, Chester Kao, Michael R. Harrison, Christopher J. Hoimes, Daniel J. George, Andrew J. Armstrong & Tian Zhang, Journal of Hematology & Oncology volume 13, Article number: 144 (2020). Novel therapies are changing treatment paradigms in metastatic prostate cancer. Novel therapies are changing treatment paradigms in metastatic prostate cancer | Journal of Hematology & Oncology | Full Text (biomedcentral.com) Accessed in February 2025.
- AIHW 2024, Cancer data in Australia. Available at: aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/about. Accessed in February 2025.
- AIHW 2024, Australian Burden of Disease Stu Available at https://www.aihw.gov.au/reports-data/health-conditions-disability-deaths/burden-of-disease/data. Accessed in February 2025.
- Prostate cancer in Australia – what do the numbers tell us? Prostate Cancer Foundation Australia (PCFA). Available at: Prostate cancer in Australia – what do the numbers tell us? | PCFA . Accessed in February 2025.