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An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
NCT02531516 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02531516
The ClinicalTrials.gov registry entry for NCT02531516 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 1,503 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aragon Pharmaceuticals, which has 5 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 5 interventions — of which Apalutamide 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: NCT02531516 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02531516?
This trial is sponsored by Aragon Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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