- 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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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