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ACTIVE NOT RECRUITING Phase 3

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

NCT02489318 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Apalutamide
  • DRUG Androgen Deprivation Therapy (ADT)

Study Locations (20)

New York

  • — Brooklyn
  • — Poughkeepsie
  • — Syracuse

California

  • — San Bernardino
  • — San Diego

Indiana

  • — Fort Wayne
  • — Jeffersonville

Maryland

  • — Baltimore
  • — Rockville

Michigan

  • — Lansing
  • — Troy

Alabama

  • — Homewood

Arizona

  • — Tucson

Colorado

  • — Denver

Trial Details

FieldValue
Enrollment Target 1,052 participants
Start Date 2015-11-27
Est. Completion 2027-12-31
Phase Phase 3

Sponsor

Aragon Pharmaceuticals

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02489318

The ClinicalTrials.gov registry entry for NCT02489318 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 1,052 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 Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT02489318 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, California, Indiana. 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 NCT02489318 about?

NCT02489318 is a clinical study titled "A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC". The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

What is the current status of trial NCT02489318?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,052 participants. The study started on 2015-11-27. Estimated completion is 2027-12-31.

What conditions does trial NCT02489318 study?

This clinical trial studies the following conditions: Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02489318?

The interventions under investigation include: Placebo (DRUG), Apalutamide (DRUG), Androgen Deprivation Therapy (ADT) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02489318?

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 NCT02489318 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.

Related

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