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

Summary:

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 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 and duration of tumour 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 Tumour Cells (CTCs). - To evaluate safety in the 2 treatment arms.

Trial Description

Primary Outcome:

  • Radiographic Progression-Free Survival (rPFS) defined as the time from randomization to the occurrence of radiological tumour progressions using RECIST 1.1 and PCWG2 criteria
  • Radiographic Progression-Free Survival (rPFS) defined as the time from randomization to the occurrence of death due to any cause
Secondary Outcome:
  • Number of patients achieving PSA decline >=50%
  • Progression-free survival-Time
  • Overall Survival defined as the time interval from the date of randomization to the date of death due to any cause
  • Time to PSA progression defined as the time interval between the date of randomization and the date of PSA progression using PCWG2 definition
  • Number of patients 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
  • Number of patients with symptomatic skeletal event (SSE)
  • Number of patients with treatment-emergent adverse events (TEAE)
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.

View this trial on ClinicalTrials.gov

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Resources

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