clinical trial · NCT02531516
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
Aragon Pharmaceuticals, Inc.·phase3·active not recruiting·n = 1,503
Prostatic NeoplasmsApalutamideBicalutamideBicalutamide PlaceboApalutamide PlaceboGnRH (agonist)74-80 Grays (units of radiation)
brief summary
The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) based on conventional imaging assessed by blinded independent central review (BICR).
started
Nov 19, 2015
primary completion
Jun 30, 2026
completion
Dec 29, 2028
last updated
Jul 6, 2026
official title
ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol