The Prostate Cancer Clinical Trials Consortium Contributes to Landmark Global Trial Showing New Treatment Prevents Relapse of Very High-Risk Local and Locally Advanced Prostate Cancer

Interim findings from the DASL-HiCaP trial (ANZUP 1801), a global study co-led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) and the Sydney Clinical Trials Centre (formerly the NHMRC Clinical Trials Centre) at the University of Sydney — and conducted in North America in collaboration with the Prostate Cancer Clinical Trials Consortium (PCCTC) and the Canadian Cancer Trials Group — report that adding darolutamide (Nubeqa®), an oral androgen receptor inhibitor, to standard of care decreases the risk of spread of prostate cancer in people affected with very high-risk localized or locally advanced prostate cancer.¹ The findings have been presented in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress (23–27 October) in Madrid on 24 October by the study global co-chair Associate Professor Tamim Niazi, signifying the global significance and practice-changing implications of this study for prostate cancer treatment and patient outcomes.

Current standard treatment for people affected by prostate cancer that has not spread beyond the pelvis combines radiation therapy with androgen deprivation therapy (ADT), which lowers testosterone levels. While this approach improves outcomes, there remains a need for new treatment strategies that can further reduce the risk of disease progression.

The DASL-HiCaP trial investigated whether adding an oral androgen receptor inhibitor (darolutamide) to this standard treatment could decrease the risk of the cancer spreading to other parts of the body.¹ The trial’s primary endpoint was metastasis-free survival, defined as the time from the start of treatment until cancer recurrence or spread was detected on standard scans, or death from any cause.¹

According to this positive analysis, participants who received darolutamide experienced longer metastasis-free survival than those who received placebo.¹ The analysis also observed fewer prostate cancer deaths and fewer patients in whom their prostate-specific antigen (PSA) levels rose, indicating a recurrence.¹ These results, from the first planned analysis of the trial, establish the trial’s main finding. Follow-up of participants is continuing to provide further information on longer-term outcomes, including overall survival, with a further analysis planned when approximately 130 metastasis-free survival events have occurred.

The PCCTC played a central role in the successful execution of this trial across the United States, coordinating site activation, patient enrollment, and data collection at U.S. investigational sites as part of its collaboration with global trial leads ANZUP and the Sydney Clinical Trials Centre, as well as the Canadian Cancer Trials Group, Cancer Trials Ireland, and Memorial Sloan Kettering Cancer Center.

Jake Vinson, CEO of the Prostate Cancer Clinical Trials Consortium, said: “The DASL-HiCaP trial represents exactly the kind of high-impact, international collaboration that the PCCTC exists to support. We are proud to have contributed to the North American execution of this landmark study, and these results are a testament to what can be achieved when leading clinical trials organizations around the world work together toward a common goal. For patients in the U.S. living with very high-risk prostate cancer, these findings bring real hope that we can reduce the chance of their disease spreading and ultimately improve long-term outcomes.”

Professor Christopher Sweeney, DASL-HiCaP Study co-Chair said, “These findings show that adding darolutamide to standard radiation therapy and hormone therapy reduces the risk of cancer recurring in people with a very high-risk prostate cancer. From prior work we know major decreases in recurrences ultimately leads to a decreased chance of dying from prostate cancer. We will therefore continue the study to detail the impact on long-term survival. We look forward to presenting the full results of the first analysis at ESMO and discussing their implications with the international medical community.”

Added Sean McBride, MD, MPH, DASL-HiCaP Study Lead at Memorial Sloan Kettering Cancer Center, “I think our study results represent a significant step forward in men with DASL high-risk prostate cancer treated with radiotherapy. The addition of Darolutamide to Androgen Deprivation Therapy and Radiation should be considered a new standard of care in this setting”

To learn more about the PCCTC’s mission to accelerate the development of new therapies for prostate cancer patients, visit [www.pcctc.org].

Issued on behalf of the Prostate Cancer Clinical Trials Consortium.

For further information, please contact Kristofer Prepelica, PhD, Medical Communications Manager (prepelik@mskcc.org).

About the PCCTC

The Prostate Cancer Clinical Trials Consortium (PCCTC) is a premier clinical trials network dedicated to advancing the treatment of prostate cancer through innovative, high-quality research. The PCCTC coordinates and conducts clinical trials across a network of leading U.S. academic and research institutions, working collaboratively with national and international partners to accelerate the development of new therapies and improve outcomes for patients with prostate cancer. For further details, please visit its website at https://www.pcctc.org/.

About DASL-HiCaP trial (ANZUP 1801)

The DASL-HiCaP trial is investigator-initiated and one of the largest of its kind, enrolling 1,106 participants across Australia, New Zealand, Canada, the United States, Ireland and the United Kingdom. It is an international, randomised, placebo-controlled, double-blind study. All participants received state-of-the-art standard treatment (radiation therapy plus ADT) and were then randomly assigned to also receive either the study medicine or an identical placebo tablet. The trial has closed to recruitment, and participants will continue to be followed over the longer term. The North American component of the trial was coordinated in the United States by the PCCTC and in Canada by the Canadian Cancer Trials Group.

About ANZUP

ANZUP (https://www.anzup.org.au) is the leading cancer-cooperative trials group bringing together all of the professional disciplines and groups involved in researching and treating urogenital cancers to conduct high-quality cancer research. ANZUP’s mission is to improve the lives of people affected by bladder, kidney, testicular, penile, and prostate cancers, towards a vision of living life without fear of cancer. ANZUP identifies gaps in evidence and areas of clinical need, collaborates with the best clinicians and researchers in genitourinary cancer and communicates frequently and effectively with the broader community along the way. ANZUP receives valuable infrastructure support from the Australian Government through Cancer Australia and research funding from Prostate Cancer Foundation of Australia.

About the Sydney Clinical Trials Centre

The Sydney 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 Sydney Clinical Trials Centre has health economics, biostatistics, systematic reviews and biomarker teams that 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

References

Niazi T et al, Darolutamide with androgen-deprivation therapy and definitive or salvage radiation therapy for localised, very high-risk prostate cancer: an international, placebo-controlled, randomised phase 3 trial (DASL-HiCAP; ANZUP 1801). Abstract accepted for presentation in a Presidential Symposium at: European Society for Medical Oncology (ESMO) Congress 2026; 23–27 Oct 2026; Madrid, Spain.