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Full Trial Details: ClinicalTrials.gov
Condition: Prostate Cancer
Study Type: Interventional
Phase: Phase II
Study Start Date: 02/27/2015
Study Completion Date: TBD
Primary Objective: To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel versus either enzalutamide or abiraterone plus prednisone in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving AR targeted therapy (abiraterone plus prednisone or enzalutamide) within 6 months of treatment initiation (≤6 months).
Secondary Objectives: To compare efficacy for:
- Prostate-specific antigen (PSA) response rate and Time to PSA progression (TTPP).
- Progression Free Survival (PFS).
- Overall Survival (OS).
- Tumor response rate and duration of tumor response.
- Pain response and time to pain progression.
- Symptomatic skeletal events (SSE) rate and time to occurrence of any SSE. To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs).
To evaluate safety in the 2 treatment arms.