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Clinical Trial Active — Not Recruiting Phase III NCT02531516

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

An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS — Active Not Recruiting • Phase III • Oncology •…

📅 06 Jul 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT02531516
Start
2015-11-19
Completion
2026-06-30
ClinicaliQ Trial Snapshot
  • An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS — Active Not Recruiting • Phase III • Oncology • NCT02531516.
  • Apalutamide combined with hormone therapy improved metastasis-free survival in high-risk prostate cancer patients receiving radiotherapy.

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What This Trial Is Studying

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: Apalutamide, Bicalutamide, Bicalutamide Placebo, Apalutamide Placebo, GnRH (agonist), 74-80 Grays (units of radiation) Lead Sponsor: Aragon Pharmaceuticals, Inc. Planned Enrollment: 1503 participants

Full Trial Details
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Eligibility criteria, protocol, and results when available
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