Abiraterone Acetate in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01503229|
Recruitment Status : Completed
First Posted : January 2, 2012
Results First Posted : May 14, 2021
Last Update Posted : May 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hormone-Resistant Prostate Cancer Metastatic Prostate Carcinoma Recurrent Prostate Carcinoma Stage IV Prostate Adenocarcinoma||Drug: Abiraterone Acetate Other: Laboratory Biomarker Analysis Other: Pharmacological Study Drug: Prednisone||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Pharmacodynamic Study of Abiraterone Acetate in the Treatment of Metastatic, Castration Resistant Prostate Cancer|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||March 12, 2020|
|Actual Study Completion Date :||March 12, 2020|
Experimental: Treatment (abiraterone acetate and prednisone)
Patients receive abiraterone acetate orally once daily and prednisone orally twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Abiraterone Acetate
Given by mouth
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Change in Tissue Testosterone and Dihydrotestosterone [ Time Frame: From baseline to week 4 ]Tissue testosterone will be measured in biopsy tissues
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503229
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Robert Montgomery||Fred Hutch/University of Washington Cancer Consortium|