drugset / Trial / NCT01314118
IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |