NCT02531516

An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,503 (actual)
• Sponsor: Aragon Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Apalutamide
DRUG	Bicalutamide
DRUG	Bicalutamide Placebo
DRUG	Apalutamide Placebo
DRUG	GnRH (agonist)
RADIATION	74-80 Grays (units of radiation)

Timeline

• Start date: 2015-11-19
• Primary completion: 2026-06-30
• Completion: 2028-12-29
• First posted: 2015-08-24
• Last updated: 2026-04-13

Locations

263 sites across 23 countries: United States, Argentina, Belgium, Brazil, Canada, China, Czechia, France, Germany, Israel, Malaysia, Mexico, Netherlands, Poland, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom