Overview

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

Status:
Recruiting

Trial end date:
2026-02-11

Target enrollment:

Participant gender:

Summary

The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) based on conventional imaging, as compared to placebo plus ADT.

Phase:

Phase 3

Details

Lead Sponsor:

Janssen Research & Development, LLC

Treatments:

Abiraterone Acetate
Androgens
Prednisone