drugset
drugset / Trial / NCT04557059

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

NCT04557059 ↗

Phase 3 Active not recruiting 692 enrolled Janssen Pharmaceutica N.V., Belgium
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-11-12
Primary completion
2029-08-27
Completion
2031-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Apalutamide Small molecule 240 mg Oral
Background Goserelin Other / unclassified — —
Background Leuprolide Other / unclassified — —
Background Triptorelin Other / unclassified — —

Indications

prostate neoplasm