A combination of enzalutamide and hormone therapy has reduced the risk of death by more than 40% in men with recurring prostate cancer, according to a major clinical trial. The study, involving over 1,000 patients worldwide, was led by researchers at Cedars-Sinai and presented at a medical congress in Berlin. Experts describe the findings as a game changer for treating aggressive cases.
Men whose prostate cancer returns after initial surgery or radiation may now have a more effective treatment option. Researchers tested a therapy combining enzalutamide, an existing cancer drug, with standard hormone therapy. This approach significantly lowered death rates among patients with few remaining options, as detailed in a study published in The New England Journal of Medicine and presented at the European Society for Medical Oncology Congress on October 19 in Berlin.
The international trial followed more than 1,000 men from 244 medical centers across 17 countries. All participants had high-risk biochemically recurrent prostate cancer, characterized by rapidly rising prostate-specific antigen (PSA) levels after treatment. PSA is a protein that monitors cancer activity, and sharp increases often signal the disease's likely spread to bones or the 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 Stephen Freedland, MD, director of the Center for Integrated Research in Cancer and Lifestyle at Cedars-Sinai and co-principal investigator. "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."
Participants were randomly assigned to receive hormone therapy alone, enzalutamide alone, or the combination. After eight years of follow-up, the combination group showed a 40.3% lower risk of death compared to the others.
"We know these patients are at high risk of developing metastatic disease and dying of their cancer unless we offer a meaningful treatment option," added Freedland, professor of Urology at Cedars-Sinai.
Enzalutamide is already approved by the Food and Drug Administration and included in National Comprehensive Cancer Network guidelines based on prior research. These results are expected to strengthen those recommendations and establish the combo as the new standard for high-risk cases.
"These important findings identify a treatment that prolongs survival in men with aggressive prostate cancer," said Hyung Kim, MD, chair of Urology at Cedars-Sinai. "The latest analysis complements previous studies... and will change how we take care of our patients."
The study was sponsored by Pfizer Inc. and Astellas Pharma Inc., co-developers of enzalutamide. Freedland disclosed consulting roles with several pharmaceutical companies, including the sponsors.