For men whose prostate cancer comes roaring back after surgery or radiation, there’s finally some good news: a two-drug combination has been shown to cut the risk of death by more than 40%, according to results from a major international clinical trial.
The treatment pairs enzalutamide, a drug that blocks testosterone’s effects on cancer cells, with standard hormone therapy. After following more than 1,000 patients for eight years, researchers found the combination reduced deaths among men with aggressive, recurring prostate cancer. The findings were published October 19 in The New England Journal of Medicine and presented simultaneously at the European Society for Medical Oncology Congress in Berlin.
“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, director of the Center for Integrated Research in Cancer and Lifestyle at Cedars-Sinai Cancer, who co-led the study. “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.”
When PSA Levels Spell Trouble
The trial, called EMBARK, enrolled patients from 244 sites across 17 countries. All had what doctors call high-risk biochemically recurrent prostate cancer. That’s a mouthful, but here’s what it means: after their initial treatment with surgery or radiation, these men saw their PSA levels climb rapidly.
PSA, or prostate specific antigen, is a protein the prostate produces. It’s one of medicine’s more reliable early warning systems for prostate cancer. When PSA levels shoot up after treatment, it signals the cancer is likely returning and spreading, often to bones or the spine. These patients face a grim prognosis without effective intervention.
The study design was straightforward. Patients were randomly divided into three groups: one receiving standard hormone therapy alone, one getting enzalutamide by itself, and one getting both drugs together. The researchers then waited, tracking who lived and who didn’t.
Eight Years Later, A Clear Winner
The results took time to materialize, but they were worth the wait. After eight years, 78.9% of patients in the combination group were still alive, compared to 69.5% in the hormone-therapy-only group. That translated to a 40.3% lower risk of death for those taking both drugs.
“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.”
Interestingly, enzalutamide alone didn’t perform nearly as well. Men taking only the newer drug had an 8-year survival rate of 73.1%, which wasn’t significantly different from hormone therapy alone. The magic, it seems, lies in the combination.
Freedland noted that based on earlier results from the same trial, enzalutamide is already FDA-approved and appears in National Comprehensive Cancer Network treatment guidelines. These latest survival findings should cement the drug combination as the standard of care for this patient population.
The implications extend beyond statistics. For decades, doctors have had limited options for men whose prostate cancer returns aggressively. Standard hormone therapy keeps testosterone levels low, which can slow prostate cancer since the hormone fuels tumor growth. But it hasn’t extended lives. This study shows that adding enzalutamide changes that calculus.
“These important findings identify a treatment that prolongs survival in men with aggressive prostate cancer,” said Hyung Kim, 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 safety profile remained consistent with what researchers observed in earlier analyses. Side effects are manageable, which matters when patients may need to stay on treatment for years.
Prostate cancer remains one of the most common cancers in men, and while many cases are caught early and cured, recurrence is a persistent threat. For the subset of patients who see their cancer return with a vengeance, this combination therapy represents the first meaningful survival improvement in three decades. That’s not just a statistical victory. It’s extra years with family, more time to travel, additional birthdays to celebrate.
The study was sponsored by Pfizer and Astellas Pharma, the companies that developed enzalutamide. Freedland disclosed consulting relationships with both companies, along with several other pharmaceutical firms.
New England Journal of Medicine: 10.1056/NEJMoa2510310
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