drugset / Trial / NCT02531516
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apalutamide | Small molecule | 240 mg | Oral |
| Comparator | Bicalutamide | Other / unclassified | 50 mg | Oral |