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NCT04557059 · ClinicalTrials.gov registry record · Phase 3
A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
A Phase 3 study of Prostatic Neoplasms, sponsored by Janssen Pharmaceutica N.V., Belgium.
- Active
- Registry status
- Phase 3
- Development phase
- 693
- Enrollment target
- 20
- Study locations
NCT04557059 is a Phase 3 study of Prostatic Neoplasms that is active but no longer recruiting, run by Janssen Pharmaceutica N.V., Belgium. The registered enrollment target is 693 participants, above the 504-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT04557059, a Phase 3 study of Prostatic Neoplasms, is active but no longer recruiting, sponsored by Janssen Pharmaceutica N.V., Belgium.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 693 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 693 participants |
| Start Date | 2020-11-12 |
| Est. Completion | 2029-08-27 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 693 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 504-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (38% higher). The listed sponsor is Janssen Pharmaceutica N.V., Belgium, which has 6 total studies on file at ClinicalTrials.gov.
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.
NCT04557059 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Texas, Arizona.
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.
What interventions are being tested in trial NCT04557059?
The interventions under investigation include: Radiotherapy (RADIATION), Apalutamide (DRUG), LHRHa (DRUG).
Who is sponsoring clinical trial NCT04557059?
This trial is sponsored by Janssen Pharmaceutica N.V., Belgium, which has 6 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.