Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01845792|
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Cabazitaxel with Abiraterone Acetate Drug: Cabazitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel, Compared to Cabazitaxel Alone, in Patients With Metastatic Castrate Resistant Prostate Cancer.|
|Actual Study Start Date :||July 2013|
|Primary Completion Date :||February 2017|
|Study Completion Date :||February 2017|
Experimental: Cabazitaxel with Abiraterone Acetate
Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.
Drug: Cabazitaxel with Abiraterone Acetate
Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.
Active Comparator: Cabazitaxel Alone
Cabazitaxel administered as a single intravenous dose every 3 weeks
Cabazitaxel intravenously every 3 weeks
Other Name: Jevtana
- Progression-Free Survival [ Time Frame: 3 months ]To assess the anti-cancer efficacy of abiraterone acetate and cabazitaxel, compared with cabazitaxel alone, in patients with castrate-resistant prostate cancer (CRPC).
- To assess the anti-cancer activity of cabazitaxel vs. cabazitaxel with abiraterone acetate in patients with CRPC, after prior treatment with docetaxel and abiraterone acetate [ Time Frame: 2 years ]Efficacy will be determined by Prostate specific antigen (PSA) response, maximum PSA decline at anytime during study treatment, time to PSA and radiographic progression, radiographic objective response, median progression-free survival, and overall survival.
- To assess the relationship between toxicities and cabazitaxel in combination with abiraterone acetate [ Time Frame: Every 3 weeks for 48 months ]Safety and tolerability as assessed by regular recording of toxicities via physical exam and laboratory analysis using the CTCAE v4.1 guidelines
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845792
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Elaine Lam, MD||University of Colorado, Denver|