Men with recurrent prostate cancer after surgery or radiation may benefit from a new drug combination that has shown a significant reduction in the risk of death, according to a recent clinical trial. The combination of enzalutamide and standard hormone therapy reduced deaths by over 40% in patients whose cancer had returned and for whom other treatments were no longer viable. The results were published in The New England Journal of Medicine and presented at the European Society for Medical Oncology Congress in Berlin.
Stephen Freedland, MD, director of the Center for Integrated Research in Cancer and Lifestyle at Cedars-Sinai Cancer and co-principal investigator of the study, said, “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. 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.”
The trial enrolled more than 1,000 patients across 244 sites in 17 countries. All participants had high-risk biochemically recurrent prostate cancer, characterized by rapidly rising levels of prostate specific antigen (PSA) in the blood after surgery or radiation. This increase in PSA is a marker for the likely return and spread of cancer, often to the bones or spine.
Freedland explained, “We know these patients are at high risk of developing metastatic disease and dying of their cancer unless we offer a meaningful treatment option.” Patients in the study were randomly assigned to receive hormone therapy alone, enzalutamide alone, or both drugs together. After eight years, the combination therapy group had a 40.3% lower risk of death compared to the other groups.
Robert Figlin, MD, interim director of Cedars-Sinai Cancer, commented, “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. The result will be improved treatment and better outcomes for patients everywhere.”
Enzalutamide is already approved by the Food and Drug Administration and is included in National Comprehensive Cancer Network treatment guidelines. Freedland said the new results will likely reinforce the network’s recommendation and help establish the drug combination as the standard of care for patients with high-risk biochemically recurrent prostate cancer.
“These important findings identify a treatment that prolongs survival in men with aggressive prostate cancer,” said Hyung Kim, MD, a urologic oncologist and 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.”
The study was sponsored by Pfizer Inc. and Astellas Pharma Inc., the co-developers of enzalutamide. Stephen J. Freedland disclosed consulting roles with several pharmaceutical companies, including Astellas Pharma Inc. and Pfizer Inc.
Cedars-Sinai Medical Center, located in Los Angeles, California, was founded in 1902. The hospital, led by president Thomas M. Priselac, is also a training facility and treated over 50,000 patients in 2022. More information about Cedars-Sinai Health Sciences University’s research and education programs can be found on their website.
