drugset / Trial / NCT02217566

Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy

NCT02217566

Phase 2 Completed 46 enrolled Janssen Research & Development, LLC
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer cells from one part of the body to another) castration (any action, surgical, chemical, or otherwise, by which a male loses the functions of the testes) resistant prostate cancer (cancer in prostrate; a gland that makes fluid that aids movement of sperm) (mCRPC), chemo-naive (treatment of cancer is not done using drugs), who received a prior diethylstilbestrol therapy (DES).

Timeline

Start
2014-09-23
Primary completion
2018-10-26
Completion
2018-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule 1000 mg Oral
Background Goserelin Other / unclassified
Background Leuprolide Other / unclassified
Background Prednisone Other / unclassified 5 mg Oral

Indications