It dramatically improves survival in men whose cancer returns
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Adding the drug enzalutamide to standard hormone therapy reduced deaths by more than 40% in men with recurrent prostate cancer.
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The international study, published in The New England Journal of Medicine, involved more than 1,000 patients across 17 countries.
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Experts say the results could establish the combination as a new standard of care for aggressive prostate cancer that returns after surgery or radiation.
A new drug treatment has shown remarkable promise for men whose prostate cancer returns after initial treatment, cutting the risk of death by more than 40% compared with existing therapies.
The findings, published in The New England Journal of Medicine and presented at the European Society for Medical Oncology Congress (ESMO) in Berlin, could reshape how physicians treat high-risk prostate cancer that no longer responds to traditional methods.
Researchers found that adding enzalutamide, a hormone-blocking medication, to standard hormone therapy significantly improved long-term survival in men with biochemically recurrent prostate cancer, a form of the disease that resurfaces after surgery or radiation therapy and is often a precursor to metastatic cancer.
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 Dr. Stephen Freedland, co-principal investigator and director of the Center for Integrated Research in Cancer and Lifestyle at Cedars-Sinai Cancer.
Hormone therapy, which is what weve been offering patients for 30 years, has not improved survival and neither has anything else. That makes these findings a real game changer.
A global effort and clear result
The trial enrolled more than 1,000 men from 244 sites across 17 countries, all diagnosed with high-risk biochemically recurrent prostate cancer. After initial therapy, these patients experienced rapid increases in levels of prostate-specific antigen (PSA), a protein that signals potential cancer recurrence and spread.
Participants were randomly assigned to receive either hormone therapy alone, enzalutamide alone, or a combination of both. After eight years of follow-up, those who received the combination treatment had a 40.3% lower risk of death compared with patients in the other groups.
We know these patients are at high risk of developing metastatic disease and dying of their cancer unless we offer a meaningful treatment option, Freedland said.
Enzalutamide, already approved by the U.S. Food and Drug Administration and included in National Comprehensive Cancer Network (NCCN) guidelines for other stages of prostate cancer, could soon see its use expanded based on these results. Freedland said the new data are likely to solidify the drugs role as a standard of care for men with high-risk recurrent disease.
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.
Posted: 2025-10-22 12:23:54
