Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-18-096
Prinicipal Investigator
Joshi, Monika
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
EA8153
Title
Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial
Objective
Primary Objective
To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can improve PFS compared to abiraterone acetate alone.
Secondary Objectives
To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can increase the percentage of change in PSA from baseline to week 12 of treatment as well as the maximum decline in PSA that occurs at any point after treatment compared to abiraterone acetate alone.
To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel for HSPC can prolong time to PSA progression compared to abiraterone acetate alone.
To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel for HSPC can improve radiographic response (per RECIST 1.1) compared to abiraterone acetate alone.
To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can prolong the overall survival (OS) compared to abiraterone acetate alone.
To assess safety and tolerability of the combination of 6 cycles of cabazitaxel and abiraterone acetate.
Applicable Disease Sites
Prostate
Status
Open
Participating Institutions
Hershey Medical Center