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ACTIVE NOT RECRUITING Phase 3

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

NCT04557059 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • RADIATION Radiotherapy
  • DRUG Apalutamide
  • DRUG LHRHa

Study Locations (20)

Other

  • Bundaberg Hospital — Bundaberg
  • Hervey Bay Hospital — Bundaberg
  • Epworth Healthcare — East Melbourne
  • St Vincent's Hospital - Melbourne — Fitzroy
  • Genesis Care Hurstville — Hurstville
  • Macquarie University Hospital — North Ryde
  • Calvary Mater Newcastle — Waratah

Texas

  • Urology Austin — Austin
  • Houston Metro Urology — Houston

Arizona

  • Arizona Urology Specialists — Tucson

Arkansas

  • Arkansas Urology — Little Rock

Colorado

  • Colorado Clinical Research — Lakewood

Florida

  • Urological Research Network — Hialeah

Indiana

  • First Urology, PSC — Jeffersonville

Michigan

  • Michigan Institute of Urology — Troy

Trial Details

FieldValue
Enrollment Target 693 participants
Start Date 2020-11-12
Est. Completion 2029-08-27
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04557059

The ClinicalTrials.gov registry entry for NCT04557059 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 693 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Pharmaceutica N.V., Belgium, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 3 interventions — of which Radiotherapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04557059 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Texas, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04557059 about?

NCT04557059 is a clinical study titled "A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer". 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...

What is the current status of trial NCT04557059?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 693 participants. The study started on 2020-11-12. Estimated completion is 2029-08-27.

What conditions does trial NCT04557059 study?

This clinical trial studies the following conditions: Prostatic Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04557059?

The interventions under investigation include: Radiotherapy (RADIATION), Apalutamide (DRUG), LHRHa (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04557059?

This trial is sponsored by Janssen Pharmaceutica N.V., Belgium, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04557059 being conducted?

This trial has 20 study locations across Arizona, Arkansas, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial