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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2026

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At a glance

  • Drugs Abiraterone acetate (Primary) ; Apalutamide (Primary) ; Prednisolone; Prednisone
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PROTEUS
  • Sponsors Janssen Research & Development; Janssen-Cilag

Most Recent Events

  • 19 Mar 2026 Planned primary completion date changed from 10 Feb 2026 to 1 Dec 2026.
  • 08 May 2024 Planned primary completion date changed from 22 Apr 2024 to 10 Feb 2026.
  • 05 Dec 2023 Planned End Date changed from 7 Apr 2027 to 19 Jul 2029.

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