A new clinical trial has found that combining the drug enzalutamide with standard hormone therapy can dramatically reduce the risk of death in men whose prostate cancer returns after surgery or radiation therapy. The results, published in The New England Journal of Medicine and presented at the European Society for Medical Oncology Congress (ESMO) in Berlin, show a more than 40 percent drop in mortality for patients receiving the combination therapy.
Study Overview and Patient Group
The trial involved over 1,000 men with high-risk biochemically recurrent prostate cancer across 244 medical sites in 17 countries. These were patients who had already undergone surgery or radiation therapy but later experienced a sharp increase in prostate-specific antigen (PSA) levels—a key indicator that their cancer might return or spread aggressively.
Understanding PSA and Disease Recurrence
PSA, or prostate-specific antigen, is a protein produced by both normal and malignant prostate cells. It is measured through a PSA test, which is widely used to detect prostate cancer and monitor treatment success. A rapid rise in PSA levels after initial therapy is often a sign that cancer cells have survived and may soon metastasize to bones or other organs.
Dr. 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, explained the significance: “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.”
How the Trial Was Conducted
Patients were randomly assigned to receive either standard hormone therapy alone, enzalutamide alone, or a combination of both. Over an eight-year follow-up period, the results showed that those who received the combination treatment experienced a 40.3 percent lower risk of death compared to the other two groups.
According to Dr. Freedland, “We know these patients are at high risk of developing metastatic disease and dying of their cancer unless we offer a meaningful treatment option.” The addition of enzalutamide appears to provide that meaningful option, altering the disease course for men with recurrent prostate cancer.
Clinical and Scientific Significance
This study is part of Cedars-Sinai Cancer’s ongoing translational research initiatives, which aim to move scientific discoveries rapidly from the laboratory to clinical practice. Dr. Robert Figlin, MD, interim director of Cedars-Sinai Cancer, said, “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.”
Dr. Hyung Kim, MD, chair of the Department of Urology at Cedars-Sinai, also emphasized the broader implications: “These important findings identify a treatment that prolongs survival in men with aggressive prostate cancer. 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.”
FDA Approval and Clinical Guidelines
Enzalutamide, previously approved by the U.S. Food and Drug Administration (FDA), is already included in the National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer treatment. The new data are expected to further strengthen these recommendations, positioning the enzalutamide-hormone therapy combination as the new standard of care for men with recurrent prostate cancer and rapidly rising PSA levels.
What This Means for Patients
For men whose prostate cancer has returned despite surgery or radiation, these findings offer a renewed sense of hope. Combination therapy with enzalutamide provides a scientifically proven strategy to extend life and delay disease progression.
Patients with rising PSA levels after treatment should consult their oncologists about whether this new therapy could be suitable for them. Early detection through regular PSA testing remains critical to identifying recurrence before the cancer spreads further.
Conclusion
As more research confirms the benefits of enzalutamide in different stages of prostate cancer, oncologists expect significant improvements in long-term outcomes. The Cedars-Sinai-led study represents a pivotal step in advancing care for men facing this disease.
With global collaboration, rigorous clinical data, and evolving treatment protocols, prostate cancer management continues to move toward more personalized and effective approaches.
