drugset / Trial / NCT01591122

Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

NCT01591122

Phase 3 Completed 313 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).

Timeline

Start
2012-03-27
Primary completion
2016-12-31
Completion
2019-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 250 mg Oral
Comparator Prednisone Other / unclassified 5 mg Oral

Indications