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Clinical Trial Details

PRIMCAB

Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enz (PRIMCAB)

Purpose/Objective

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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.

NCT Number
NCT02379390
Principal Investigator(s)
Manish Agarwal, MD
Sponsor(s)
Sanofi
Participant Eligibility
  • Age: 18 - No Maximum
  • Gender: Male

Location

  • Shady Grove Adventist Aquilino Cancer Center
    9905 Medical Center Drive
    Rockville, MD 20850
    Main: 240-826-6297

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