Global trial confirms enzalutamide-hormone therapy combo as a new standard for high-risk recurrent prostate cancer.
A landmark international clinical trial has revealed that combining enzalutamide with standard hormone therapy reduces death rates in men with high-risk biochemically recurrent prostate cancer by 40.3%.
This breakthrough is poised to redefine global treatment protocols and reshape oncology policy frameworks.
The research, led by Cedars-Sinai Medical Centre, was published on October 19 in the New England Journal of Medicine (NEJM) and presented at the European Society for Medical Oncology Congress (ESMO) in Berlin. It was also featured in ScienceDaily.
The study followed more than 1,000 patients across 244 medical centres in 17 countries. All participants had high-risk biochemically recurrent prostate cancer—a condition marked by rapidly rising prostate-specific antigen (PSA) levels after surgery or radiation.
PSA is a protein used to monitor prostate cancer activity, and a sharp increase often signals the disease’s return and potential spread to bones or the spine.
Researchers tested three approaches: hormone therapy alone, enzalutamide alone, and a combination of both. After eight years of follow-up, the combination therapy group showed a 40.3% lower risk of death compared to the other groups.
“After initial treatment, some patients see their prostate cancer come back aggressively and are at risk for their disease to spread quickly,” said Dr Stephen Freedland, Director of the Centre for Integrated Research in Cancer and Lifestyle at Cedars-Sinai Cancer and co-principal investigator of the study.
“Hormone therapy, which is what we’ve been offering patients for 30 years, has not improved survival, and neither has anything else. That makes these findings a real game changer.”
“This clinical trial, one of many that Cedars-Sinai Cancer has offered to its patients, is an example of the translational work being done by our physician-scientists,” added Dr Robert Figlin, Interim Director of Cedars-Sinai Cancer.
“The result will be improved treatment and better outcomes for patients everywhere.”
Dr Freedland noted that enzalutamide is already approved by the Food and Drug Administration and included in National Comprehensive Cancer Network treatment guidelines based on earlier research by the same team.
These new results are expected to strengthen those recommendations and help establish the combination therapy as the new standard of care for patients with aggressive recurrence.
“These important findings identify a treatment that prolongs survival in men with aggressive prostate cancer,” said Dr Hyung Kim, Chair of the Department of Urology at Cedars-Sinai.
“The latest analysis complements previous studies that found enzalutamide significantly improved survival in other prostate cancer settings, and will change how we take care of our patients.”