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NCT02531516 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
A Phase 3 study of Prostatic Neoplasms, sponsored by Aragon Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 1,503
- Enrollment target
- 20
- Study locations
NCT02531516: Active Phase 3 study of Prostatic Neoplasms, sponsored by Aragon Pharmaceuticals.
NCT02531516 is a Phase 3 study of Prostatic Neoplasms that is active but no longer recruiting, run by Aragon Pharmaceuticals. The registered enrollment target is 1,503 participants, above the 491-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (206% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02531516, a Phase 3 study of Prostatic Neoplasms, is active but no longer recruiting, sponsored by Aragon Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,503 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) based on conventional imaging assessed by blinded independent central review (BICR).
Primary Outcome
MFS is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging assessed by blinded independent central review (BICR), histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.
Conditions Studied
Interventions
- DRUG Apalutamide
- DRUG Bicalutamide
- DRUG Bicalutamide Placebo
- DRUG Apalutamide Placebo
- DRUG GnRH (agonist)
Study Locations (20)
Florida
- - Bradenton
- - Daytona Beach
- - Fort Myers
- - Hialeah
- - Lakewood Rch
- - Naples
- - Plantation
California
- - Bakersfield
- - Los Angeles
- - Orange
- - San Bernardino
- - San Diego
- - San Francisco
Arizona
- - Chandler
- - Scottsdale
- - Tucson
Colorado
- - Aurora
- - Denver
Alabama
- - Homewood
Connecticut
- - Middlebury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,503 participants |
| Start Date | 2015-11-19 |
| Est. Completion | 2028-12-29 |
| Phase | Phase 3 |
What the registry record for NCT02531516 still lists
NCT02531516 is an interventional study that assigns participants to a tested intervention. Its 1,503 participants enrollment target places it among the larger protocols in the corpus, above the 491-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (206% higher).
The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Apalutamide is the first listed.
NCT02531516 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT02531516 about?
NCT02531516 is a clinical study titled "An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS". The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) based on conv...
What is the current status of trial NCT02531516?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,503 participants. The study started on 2015-11-19. Estimated completion is 2028-12-29.
What conditions does trial NCT02531516 study?
This clinical trial studies the following conditions: Prostatic Neoplasms.
What interventions are being tested in trial NCT02531516?
The interventions under investigation include: Apalutamide (DRUG), Bicalutamide (DRUG), Bicalutamide Placebo (DRUG), Apalutamide Placebo (DRUG), GnRH (agonist) (DRUG).
Who is sponsoring clinical trial NCT02531516?
This trial is sponsored by Aragon Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02531516 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02531516's enrollment target sits among peer trials
1,503 3rd of 65 higher than 63 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.
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