Janssen's Phase 3 PROTEUS Study Shows Perioperative Apalutamide with Hormonal Therapy Significantly Reduces Risk of Metastasis or Death in High-Risk Localized Prostate Cancer

May 31, 2026,Johnson & JohnsonThe company announced the final analysis results of the Phase 3 PROTEUS study, showing that using apalutamide combined with hormone therapy for six months before and after prostate cancer surgery can improve clinical outcomes in patients with high-risk localized or locally advanced prostate cancer.

Compared with hormone therapy alone, combination therapy increased the likelihood of patients having minimal or no residual cancer cells in the prostate at the time of surgery by ninefold (pathological complete response/minimal residual disease rates were 8.9% and 1.0%, respectively), reduced the risk of metastasis or death by 20%, resulted in five-year metastasis-free survival rates of 78.2% and 73.5%, respectively, and extended the time to subsequent treatment to more than six years.

The study results will be presented in a plenary session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. The safety profile of apalutamide combined with hormonal therapy was consistent with previous studies; however, 39.6% of patients experienced grade 3 or 4 adverse events, which was higher than the 31.0% observed in the hormonal therapy-alone group.

Further analyses from the PROTEUS study will be monitored, which will comparatively evaluate differences from current standard of care and provide references for future treatment. Apalutamide combined with hormone therapy has not yet received regulatory approval for this indication.

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