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

Prostatic Neoplasms Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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 based on conventional or prostate specific membrane antigen-positron emission tomography (PSMA-PET) imaging evaluated by blinded independent central review (BICR).

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, multicenter study of apalutamide plus GnRH agonist compared with GnRH agonist among participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT). The study will include a Screening Phase, Treatment Phase, a Posttreatment Phase, and a Long-term Follow-up Phase. Participants will either receive either apalutamide (experimental) or bicalutamide 50 milligram (mg) capsule plus placebo as control group. Safety will be monitored throughout the study. ;

Related Conditions & MeSH terms

• Prostatic Neoplasms

• NCT number: NCT02531516
• Study type: Interventional
• Source: Aragon Pharmaceuticals, Inc.
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 19, 2015
• Completion date: December 29, 2028