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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 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.

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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).

Conditions Studied

Prostatic Neoplasms

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

FieldValue
Enrollment Target 1,503 participants
Start Date 2015-11-19
Est. Completion 2028-12-29
Phase Phase 3

Sponsor

Aragon Pharmaceuticals

12 total trials

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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, categorized as Phase 3. The registered enrollment target is 1,503 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 491-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (206% higher). The listed sponsor is Aragon Pharmaceuticals, which has 12 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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

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.