CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 982 enrolled / 982 target
Drug / intervention
Apalutamide +3 moredrug
Likely dose
Apalutamide 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02257736
NCT02257736Phase 3ActiveUpdate Overdue (7.1/mo)Completion was 99mo ago
CompareCT.gov

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)

Aragon Pharmaceuticals, Inc.·interventional·Posted Oct 6, 2014·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating Apalutamide, Abiraterone acetate, and 2 other interventions for Prostatic Neoplasms. Active but no longer recruiting, targeting 982 participants across 173 sites in 16 countries.

Signals

Enrollment appears stalled

Detailed 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 \[gland that makes fluid that aids movement of sperm\]).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms
CountriesArgentina, Australia, Belgium, Brazil, Canada, France, Germany, Japan, Mexico, Netherlands, Russia, South Africa, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
20152016201720182019202020212022202320242025202620272028
First PostedOct 6, 2014
Enrollment StartNov 26, 2014
Primary CompletionMar 19, 2018
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 11.7 years ago

Arms & Interventions

Group 1: AAP and apalutamideexperimental

Participants will receive apalutamide 240 milligram (mg) (4\*60 mg tablets) and abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily, until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the Open-Label Extension (OLE) or Long-Term Extension (LTE) phase (AAP + open label apalutamide or AAP alone).

Drug: ApalutamideDrug: Abiraterone acetateDrug: Prednisone
Group 2: AAP and Placeboplacebo_comparator

Participants will receive matching Placebo of apalutamide and abiraterone acetate (AA) 1000 mg (4\*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the OLE or LTE phase (AAP + open label apalutamide or AAP alone).

Drug: Abiraterone acetateDrug: PrednisoneDrug: Placebo

Interventions

Apalutamidedrug

Participants will receive 240 mg (4\*60 mg tablets) of apalutamide once daily orally.

Abiraterone acetatedrug

Participants will receive 1000 mg (4\*250 mg tablets) of abiraterone acetate (AA) once daily orally.

Prednisonedrug

Participants will receive 5 mg tablet of prednisone twice daily orally.

Placebodrug

Participants will receive matching placebo to apalutamide once daily orally.