NCT04557059

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 693 (actual)
• Sponsor: Janssen Pharmaceutica N.V., Belgium · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.
DRUG	LHRHa	Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12 or as a 6-monthly depot preparation within 3 days after randomization.
DRUG	Apalutamide	Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.

Timeline

• Start date: 2020-11-12
• Primary completion: 2029-08-27
• Completion: 2029-08-27
• First posted: 2020-09-21
• Last updated: 2026-04-13

Locations

141 sites across 21 countries: United States, Australia, Austria, Belgium, Brazil, Czechia, Denmark, Finland, Germany, Hungary, Italy, Jordan, Lebanon, Mexico, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Turkey (Türkiye)