J&J Phase 3 prostate cancer study: ERLEADA before and, after surgery cuts metastasis, death

 

• Patients were nine times more likely to have little to no cancer remaining in the prostate after surgery, with a 20% reduction in the risk of developing metastasis or death 
• Data selected to open the plenary presentation at ASCO 2026 and published in The New England Journal of Medicine

Johnson & Johnson (NYSE:JNJ) today announced results from the final analysis of the Phase 3 PROTEUS study showing the investigational use of apalutamide plus hormone therapy (androgen deprivation therapy, ADT), given for six months before and after prostate cancer surgery, significantly improved key short- and long-term clinical outcomes for patients with high-risk localized or locally advanced disease. The trial met both primary endpoints. Patients treated with apalutamide plus hormone therapy were nine times more likely to have little to no cancer remaining at the time of surgery compared with hormone therapy alone (8.9 percent vs. 1.0 percent; pathologic complete response/minimal residual disease). The combination also reduced the risk of developing metastasis or death by 20 percent and extended the time before patients required subsequent therapy to more than six years. These findings will be presented in a plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Oral Abstract #LBA1) and published simultaneously in The New England Journal of Medicine.

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