New Drug Combo Reduces Prostate Cancer Deaths by Over 40% in Groundbreaking Study
A groundbreaking clinical trial led by Cedars-Sinai researchers has demonstrated that combining enzalutamide with standard hormone therapy reduces death risk by over 40% in men with recurring prostate cancer. The international study followed more than 1,000 patients across 17 countries and represents a significant advancement in treating aggressive prostate cancer that returns after initial treatment. This combination therapy is poised to become the new standard of care for high-risk biochemically recurrent prostate cancer patients.
Prostate cancer treatment has taken a significant leap forward with the announcement of groundbreaking clinical trial results that could reshape how doctors manage recurring cases of the disease. A new therapeutic approach combining enzalutamide with standard hormone therapy has demonstrated remarkable efficacy in reducing mortality among men facing aggressive prostate cancer recurrence.
Breakthrough Clinical Trial Results
The international clinical trial, published in The New England Journal of Medicine and presented at the European Society for Medical Oncology Congress in Berlin, followed more than 1,000 men from 244 medical centers across 17 countries. All participants had high-risk biochemically recurrent prostate cancer, a condition characterized by rapidly rising prostate specific antigen (PSA) levels after initial surgery or radiation treatment.
According to Dr. Stephen Freedland, director of the Center for Integrated Research in Cancer and Lifestyle at Cedars-Sinai Cancer and co-principal investigator of the study, the combination therapy achieved what previous treatments had failed to accomplish. "Hormone therapy, which is what we've been offering patients for 30 years, has not improved survival and neither has anything else," Freedland explained. "That makes these findings a real game changer."
Understanding High-Risk Biochemical Recurrence
High-risk biochemically recurrent prostate cancer represents a particularly challenging clinical scenario. When PSA levels rise sharply after initial treatment, it often signals that the disease is likely to return and spread, frequently to bones or the spine. These patients face limited treatment options and historically poor outcomes with conventional approaches.
Dr. Freedland emphasized the critical nature of this patient population, stating, "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 study specifically targeted this high-risk group, where the need for effective interventions is most urgent.
Treatment Protocol and Outcomes
In the randomized clinical trial, participants received either hormone therapy alone, enzalutamide alone, or the combination of both treatments. After eight years of follow-up, the results were striking: patients who received the combination therapy demonstrated a 40.3% lower risk of death compared to those in the other treatment groups.
The significance of these findings extends beyond the immediate survival benefits. As Dr. Robert Figlin, interim director of Cedars-Sinai Cancer, noted, "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."
Implications for Future Treatment Guidelines
The study's findings are expected to have immediate clinical implications. Enzalutamide is already approved by the Food and Drug Administration and included in National Comprehensive Cancer Network treatment guidelines based on earlier research by the same team. These new results will likely strengthen those recommendations and help establish the enzalutamide and hormone therapy combination as the new standard of care.
Dr. Hyung Kim, a urologic oncologist and chair of the Department of Urology at Cedars-Sinai, highlighted the broader impact of these findings: "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."
Conclusion
The development of this effective combination therapy represents a major advancement in prostate cancer treatment, particularly for patients facing disease recurrence. With a demonstrated 40% reduction in mortality risk and the potential to become the new standard of care, this approach offers renewed hope for men with high-risk biochemically recurrent prostate cancer. As these findings become integrated into clinical practice, they promise to significantly improve survival outcomes and quality of life for patients worldwide.
