clinical trial · NCT03767244
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Janssen Research & Development, LLC·phase3·active not recruiting·n = 2,517
Prostatic NeoplasmsApalutamideAndrogen Deprivation Therapy (ADT)Placebo
brief 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) as compared to placebo plus ADT.
started
Jun 11, 2019
primary completion
Dec 1, 2026
completion
Oct 13, 2028
last updated
Jul 6, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol