Last updated on August 2018

Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent


Brief description of study

Primary Objective:

To compare the radiographic progression-free survival (rPFS) [using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause] with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC patients who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (12 months, either before or after docetaxel).

Secondary Objective:

  • 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 event (SSE) rate and time to occurrence of any SSE.
  • Health status and Health-related Quality of Life (HRQOL).
  • To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs.
  • To evaluate safety in the 2 treatment arms.

Detailed Study Description

The duration of the study per patient will be approximately 2 years. Each patient will be treated until radiographic disease progression, unacceptable toxicity, or patient's refusal of further study treatment, and each patient will be followed after completion of study treatment until death, study cutoff date, or withdrawal of patient consent.

Clinical Study Identifier: NCT02485691

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