NCT01503229

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hormone-Resistant Prostate Cancer
• Metastatic Prostate Carcinoma
• Recurrent Prostate Carcinoma
• Stage IV Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Given by mouth
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Prednisone	Given PO

Timeline

• Start date: 2012-12-01
• Primary completion: 2020-03-12
• Completion: 2020-03-12
• First posted: 2012-01-02
• Last updated: 2021-05-14
• Results posted: 2021-05-14

Locations

1 site across 1 country: United States