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NCT02489318 · ClinicalTrials.gov registry record · Phase 3
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
A Phase 3 study of Prostate Cancer, sponsored by Aragon Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 1,052
- Enrollment target
- 20
- Study locations
NCT02489318: Active Phase 3 study of Prostate Cancer, sponsored by Aragon Pharmaceuticals.
NCT02489318 is a Phase 3 study of Prostate Cancer that is active but no longer recruiting, run by Aragon Pharmaceuticals. The registered enrollment target is 1,052 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02489318, a Phase 3 study of Prostate Cancer, is active but no longer recruiting, sponsored by Aragon Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,052 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
rPFS as assessed by the investigator was defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,052 participants |
| Start Date | 2015-11-27 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
What the registry record for NCT02489318 still lists
NCT02489318 is an interventional study that assigns participants to a tested intervention. Its 1,052 participants enrollment target places it among the larger protocols in the corpus, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (73% higher).
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.
NCT02489318 names 20 study sites across 14 states, led by New York, California, Indiana.
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.
What interventions are being tested in trial NCT02489318?
The interventions under investigation include: Placebo (DRUG), Apalutamide (DRUG), Androgen Deprivation Therapy (ADT) (DRUG).
Who is sponsoring clinical trial NCT02489318?
This trial is sponsored by Aragon Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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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 NCT02489318's enrollment target sits among peer trials
1,052 51st of 735 higher than 685 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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