drugset / Trial / NCT02531516

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

NCT02531516

Phase 3 Active not recruiting 1503 enrolled Aragon Pharmaceuticals, Inc.
RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2015-11-19
Primary completion
2026-06-30
Completion
2028-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Apalutamide Small molecule 240 mg Oral
Comparator Bicalutamide Other / unclassified 50 mg Oral

Indications