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

NCT04557059 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 692

Last updated 2026-05-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica N.V., Belgium Clinical Trial · Janssen Pharmaceutica N.V., Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Hungary
  • Italy
  • Jordan
  • Lebanon
  • Mexico
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04557059 on ClinicalTrials.gov