# 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)

Source: https://onco.cc/trials/nct02257736/  
OnCo record `nct02257736` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Apalutamide, Abiraterone acetate and Prednisone in prostate cancer, run by Aragon Pharmaceuticals, Inc., active and no longer recruiting.

## Summary

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) is a phase 3 interventional study registered as NCT02257736 by Aragon Pharmaceuticals, Inc., with 982 participants enrolled, started 2014-11-26 and due to reach its primary completion in 2018-03-19. Interventions recorded: Apalutamide, Abiraterone acetate, Prednisone and Placebo. Results have been posted on the registry.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: pipeline; ctgov-ingest
- Registry id: NCT02257736
- Phase: 3
- Setting: A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Sponsor: Aragon Pharmaceuticals, Inc.
- Enrolled: 982
- Outcomes: Radiographic Progression-free Survival (rPFS): Placebo+ Abiraterone Acetate - Prednisolone 16.59 months vs Apalutamide + Abiraterone Acetate - Prednisolone 23.98 months; Overall Survival (OS): Placebo+ Abiraterone Acetate - Prednisolone 33.71 months vs Apalutamide + Abiraterone Acetate - Prednisolone 36.17 months

## Sources

- ClinicalTrials.gov NCT02257736: https://clinicaltrials.gov/study/NCT02257736

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Androgen deprivation & AR pathway inhibitors](https://onco.cc/technologies/androgen-deprivation/)
- drugs: [Abiraterone acetate](https://onco.cc/drugs/abiraterone/), [Apalutamide](https://onco.cc/drugs/apalutamide/), [Prednisone](https://onco.cc/drugs/prednisone/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- key papers: [Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study](https://onco.cc/key-papers/paper-nct02257736-lancet-oncol-2021/)

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