Spots Global Cancer Trial Database for Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Official Title: Open Label Pharmacodynamic Study of Abiraterone Acetate in the Treatment of Metastatic, Castration Resistant Prostate Cancer

Study ID: NCT01503229

Conditions

Hormone-Resistant Prostate Cancer

Metastatic Prostate Carcinoma

Recurrent Prostate Carcinoma

Stage IV Prostate Adenocarcinoma

Interventions

Abiraterone Acetate

Laboratory Biomarker Analysis

Pharmacological Study

Prednisone

Study Description

Brief Summary: This phase II trial studies how well abiraterone acetate works in treating patients with hormone-resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic). Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the magnitude of tissue testosterone suppression by abiraterone acetate in metastatic castrate-resistant prostate cancer (CRPC) (resistant to luteinizing hormone-releasing hormone \[LHRH\] agonist or orchiectomy ± antiandrogen) after one month of treatment to establish tissue based mechanism of action. OUTLINE: Patients receive abiraterone acetate orally once daily and prednisone twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.