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 Enzalutamide

Official Title

Phase II, Randomized, Open-label, Multicentre Study in Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Who Have PRIMary Resistance to Abiraterone Acetate or Enzalutamide Treatment Comparing the Anti-tumour Effect of CABazitaxel to Alternative Androgen Receptors (AR) Targeted Therapy


Primary Objective: To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B) in chemotherapy-naïve participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving androgen receptor (AR) targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months of treatment initiation (≤12 months). 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). - Tumour response rate in participants with measurable disease (RECIST 1.1) - 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 Tumour Cells (CTCs). - To evaluate safety in the 2 treatment arms.

Trial Description

Primary Outcome:

  • Radiographic Progression-Free Survival (rPFS)
Secondary Outcome:
  • Number of Participants With Prostate Specific Antigen (PSA) Response
  • Progression-free Survival (PFS)
  • Overall Survival
  • Time to PSA Progression
  • Number of Participants Achieving Tumour Response
  • Duration of Tumour Response
  • Pain Response Using Brief Pain Inventory-Short Form (BPI-SF) for Pain Intensity Score
  • Time to Pain Progression
  • Percentage of Participants With Symptomatic Skeletal Event (SSE)
  • Time to Occurrence of Any Symptomatic Skeletal Events (SSE)
The duration of the study per participant was approximately 2 years. Each participant was treated until radiographic disease progression, unacceptable toxicity, or participants refusal of further study treatment, and each participant was followed after completion of study treatment until death, study cutoff date, or withdrawal of participant consent.

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