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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: Active Phase 3 study of Prostatic Neoplasms, sponsored by Janssen Pharmaceutica N.V., Belgium.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
ppMPFS is defined as the appearance of at least one new PSMA-PET-positive distant lesion compared with the previous scan as assessed by blinded independent central review (BICR) or death.
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 |
What the registry record for NCT04557059 still lists
NCT04557059 is an interventional study that assigns participants to a tested intervention. The registered 693 participants enrollment target is mid-sized for trials with a published cap, above the 504-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (38% higher).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Prostatic Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04557059's enrollment target sits among peer trials
693 24th of 65 higher than 42 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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