PROTEUS — Neoadjuvant and Adjuvant Apalutamide plus Androgen Deprivation Therapy around Radical Prostatectomy in High-Risk Localized or Locally Advanced Prostate Cancer

Phase 3 · 2025 · Prostate Cancer

Design

Randomized, double-blind, placebo-controlled trial of apalutamide plus androgen deprivation therapy (ADT) given before and after radical prostatectomy versus placebo plus ADT.

Population

High-risk localized or locally advanced prostate cancer planned for radical prostatectomy.

Primary Endpoint

pathologic complete response (pCR) and metastasis-free survival (MFS)

Key Result

Perioperative apalutamide plus ADT significantly improved pathologic complete response / minimal residual disease and reduced the risk of metastasis or death versus ADT alone; long-term outcomes continue to be tracked.

Guideline Impact

Perioperative therapy for high-risk localized/locally advanced prostate cancer