drugset / Trial / NCT01314118

IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

NCT01314118 ↗

Phase 2 Completed 131 enrolled Janssen Biotech, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.

Timeline

Start
2011-05-04
Primary completion
2013-12-24
Completion
2024-12-02

Outcome

Met primary endpoint

release “Abiraterone acetate (ZYTIGA®) plus prednisone demonstrated statistically significant reductions in PSA levels at six months, the primary endpoint of the IMAAGEN trial” jnj.com ↗

Drugs

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

Indications