Adding darolutamide to standard treatment for aggressive prostate cancer reduced the risk of the disease spreading in an international Phase 3 trial.
"Our findings have the potential to influence the standard of care for patients with very high-risk prostate cancer worldwide," said Dr. Tamim Niazi, Associate Professor in McGill University's Department of Oncology and Principal Investigator at the Lady Davis Institute for Medical Research of the Jewish General Hospital University Health Centre. "If supported by longer-term data, this approach offers a meaningful opportunity to extend the time patients live without cancer progression."
Niazi co-chaired the trial, which was led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group.
The interim results were presented at the Presidential Symposium of the European Society for Medical Oncology (ESMO) Congress in Madrid, a session reserved for studies with the potential to change clinical practice.
Prostate cancer is the most commonly diagnosed cancer among Canadian men. An estimated 29,300 new cases and 5,300 deaths are expected in 2026.
While radiation therapy combined with androgen deprivation therapy can be effective, a meaningful percentage of patients with very high-risk features still see their cancer return or spread. The patients enrolled in this study were at higher risk of cancer recurrence.
Researchers tested whether adding darolutamide (Nubeqa®), a drug that blocks hormone signals that fuel prostate cancer growth, to standard androgen deprivation therapy could improve outcomes for patients at high risk of recurrence.
The double-blind, placebo-controlled study enrolled 1,106 patients across six countries, including Canada, making it one of the largest international trials of its kind.
Participants who received darolutamide went longer without their cancer spreading than those who received a placebo. Researchers also observed fewer deaths from prostate cancer and fewer rises in PSA, a blood marker that can signal the disease has returned.
The results are based on an analysis conducted before all patients had completed follow up. Researchers will continue monitoring participants to determine whether the benefits persist over time and translate into longer overall survival.
About the study
The DASL-HiCaP trial was jointly led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group and the Sydney Clinical Trials Centre (formerly the NHMRC Clinical Trials Centre), in collaboration with the Canadian Cancer Trials Group, Cancer Trials Ireland, Memorial Sloan Kettering Cancer Center and the Prostate Cancer Clinical Trials Consortium in the United States. The study was funded by Bayer.
