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NCT02257736 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Phase 3 study of Prostatic Neoplasms, sponsored by Aragon Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
982
Enrollment target
20
Study locations

NCT02257736: Active Phase 3 study of Prostatic Neoplasms, sponsored by Aragon Pharmaceuticals.

NCT02257736 is a Phase 3 study of Prostatic Neoplasms that is active but no longer recruiting, run by Aragon Pharmaceuticals. The registered enrollment target is 982 participants, above the 499-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (97% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02257736, 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
982 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy \[treatment of cancer using drugs\]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland \[gland that makes fluid that aids movement of sperm\]).

Primary Outcome

The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2

Conditions Studied

Prostatic Neoplasms

Interventions

  • DRUG Placebo
  • DRUG Apalutamide
  • DRUG Prednisone
  • DRUG Abiraterone acetate

Study Locations (20)

California

  • - La Mesa
  • - Los Angeles
  • - Modesto
  • - San Diego
  • - San Francisco
  • - Santa Barbara

Florida

  • - Jensen Beach
  • - Lakeland
  • - New Port Richey
  • - Ocala

Louisiana

  • - Marrero
  • - New Orleans
  • - Shreveport

Colorado

  • - Aurora
  • - Denver

Illinois

  • - Melrose
  • - Niles

Arizona

  • - Phoenix

Georgia

  • - Atlanta

Maine

  • - Auburn

Trial Details

FieldValue
Enrollment Target 982 participants
Start Date 2014-11-26
Est. Completion 2027-12-31
Phase Phase 3
Aragon Pharmaceuticals

12 total trials

What the registry record for NCT02257736 still lists

NCT02257736 is an interventional study that assigns participants to a tested intervention. The registered 982 participants enrollment target is mid-sized for trials with a published cap, above the 499-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (97% higher).

The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT02257736 names 20 study sites across 8 states, led by California, Florida, Louisiana.

Frequently Asked Questions

What is clinical trial NCT02257736 about?

NCT02257736 is a clinical study titled "An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)". The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy \[treatment o...

What is the current status of trial NCT02257736?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 982 participants. The study started on 2014-11-26. Estimated completion is 2027-12-31.

What conditions does trial NCT02257736 study?

This clinical trial studies the following conditions: Prostatic Neoplasms.

What interventions are being tested in trial NCT02257736?

The interventions under investigation include: Placebo (DRUG), Apalutamide (DRUG), Prednisone (DRUG), Abiraterone acetate (DRUG).

Who is sponsoring clinical trial NCT02257736?

This trial is sponsored by Aragon Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02257736 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Prostatic Neoplasms

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 NCT02257736's enrollment target sits among peer trials

982 17th of 65 higher than 49 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02257736, the US trial registry maintained by the National Library of Medicine. NCT02257736 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.