- Posted October 22, 2025
Drug Combo Cuts Death Risk From Advanced Prostate Cancer
A powerful new drug combo has yielded a major breakthrough for men battling an aggressive form of prostate cancer.
Adding the drug enzalutamide to standard hormone therapy reduced the risk of premature death by more than 40% in patients whose prostate cancer had returned, a large international clinical trial has found.
The findings were simultaneously published in The New England Journal of Medicine and presented Sunday at a meeting of the European Society for Medical Oncology in Berlin.
The trial focused on patients with what's called high-risk biochemically recurrent prostate cancer. These are men who have already undergone surgery or radiation therapy, but whose blood tests show a rapid, concerning rise in prostate-specific antigen (PSA) levels.
A rapid increase in PSA indicates the cancer is highly likely to come back and spread quickly, often to the bones or spine.
“After initial treatment, some patients see their prostate cancer come back in an aggressive way and are at risk for their disease to spread quickly,” said researcher Dr. Stephen Freedland, director of the Center for Integrated Research in Cancer and Lifestyle at Cedars-Sinai Cancer in Los Angeles.
For decades, the standard approach for these patients has been hormone therapy alone, which aims to reduce testosterone — a fuel for prostate cancer.
But this approach has not consistently improved overall survival.
“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,” Freedland said in a news release.
The trial involved more than 1,000 patients from 244 sites across 17 countries, making the results applicable to a diverse global population.
Participants were randomly placed into one of three groups. One received standard hormone therapy (leuprolide) alone. A second group received enzalutamide alone, and the third group received both standard hormone therapy and enzalutamide.
Over an eight-year followup, the survival benefit of the combo therapy was clear.
Compared to the two other groups, patients who received the combination therapy had a 40.3% lower risk of premature death.
In all, researchers reported serious adverse events linked to the drug trial in 8.5% of patients who received the combo; 2.5% treated with leuprolide; and 7.6% in the enzalutamide-only group.
The eight-year overall survival was 78.9% in the combination group, and statisically similar in the leuprolide-alone group (69.5%), and the enzalutamide-alone group (73.1%).
“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," said Dr. Robert Figlin, interim director of Cedars-Sinai Cancer. "The result will be improved treatment and better outcomes for patients everywhere.”
Enzalutamide is already approved by the U.S. Food and Drug Administration (FDA) for use in other prostate cancer settings.
These latest findings are expected to strengthen treatment guidelines, solidifying the combination therapy as the new standard of care for men facing this aggressive cancer, Freedland noted.
More information
The National Cancer Institute provides comprehensive information on prostate cancer treatment and clinical trials.
SOURCES: Cedars-Sinai Medical Center, news release, Oct. 19, 2025; The New England Journal of Medicine, Oct. 19, 2025
