Those with prostate cancer that returns after surgery or radiation—and typically face a high risk of the disease spreading and death—could benefit from a new drug combination.
A Cedars-Sinai Medical Center-led clinical trial showed that the new treatment reduced deaths in patients with aggressive prostate cancer by some 40 percent.
The combination therapy adds the drug enzalutamide—which is already used to treat certain types of prostate cancer—to a commonly prescribed hormone therapy, leuprolide, and could offer a new treatment for patients who would traditionally have few options left.
The results—presented at the European Society for Medical Oncology Congress in Berlin on 19 October—are based on a trial of more than 1,000 patients from 244 sites in 17 countries.
“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 study author and urologist professor Stephen Freedland in a statement.
“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.”
Second only to skin cancer, prostate cancer is one of the most common cancers seen in men in the U.S., according to American Cancer Society. Nearly 314,000 new cases and some 36,000 deaths from the condition are predicted to occur this year.
The researchers’ study involved participants who had been diagnosed with “high-risk biochemically recurrent prostate cancer.”
After undergoing either surgery or radiation therapy to try and combat the disease, the levels of prostate-specific antigen in their blood had risen rapidly. Also known as PSA, this is a protein used to detect prostate cancer, meaning this rapid rise after treatment is a warning sign that the patient’s cancer is likely to return and spread to other parts of the body.
“We know these patients are at high risk of developing metastatic disease and dying of their cancer unless we offer a meaningful treatment option,” explained Freedland.
Participants were randomly selected to receive standard hormone therapy alone—which blocks or lowers the amount of testosterone in the body— enzalutamide alone, or a combination of the two.
After eight years, the scientists uncovered the risk of death was 40.3 percent lower in the group that recieved the combination of the two drugs than in the groups that recieved one alone.
Oncologist professor Robert Figlin—who is the interim director of Cedars-Sinai Cancer—said in a statement that work will lead to “improved treatment and better outcomes for patients everywhere.”
Enzalutamide is already approved by the Food and Drug Administration and listed in National Comprehensive Cancer Network treatment guidelines. The latest results, Freedland said, are likely to strengthen the network’s recommendation and solidify this drug combination as the standard of care for patients with high-risk biochemically recurrent prostate cancer.
“Overall survival was significantly longer with the combination of enzalutamide and leuprolide than with leuprolide alone among patients with prostate cancer with high-risk biochemical recurrence,” the researchers wrote in their paper. Enzalutamide alone, they continued, “monotherapy [this drug alone] “was not superior to leuprolide alone in the analysis of overall survival.”
Hyung Kim is a urologic oncologist at Cedars-Sinai. He said in a statement: “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.”
Newsweek has reached out to the authors for additional comment.
Do you have a tip on a health story that Newsweek should be covering? Do you have a question about prostate cancer? Let us know via health@newsweek.com.
Reference
Shore, N. D., de Almeida Luz, M., De Giorgi, U., Gleave, M., Gotto, G. T., Pieczonka, C. M., Haas, G. P., Kim, C.-S., Ramirez-Backhaus, M., Rannikko, A., Kalac, M., Sridharan, S., Rosales, M., Tang, Y., Tutrone, R. F., Jr., Venugopal, B., Villers, A., Woo, H. H., Wang, F., & Freedland, S. J. (2025). Improved survival with enzalutamide in biochemically recurrent prostate cancer. The New England Journal of Medicine. https://doi.org/10.1056/NEJMoa2510310
