NCT02379390

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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). * Tumor 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 Tumor Cells (CTCs). * To evaluate safety in the 2 treatment arms.

Detailed description

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.

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Cabazitaxel XRP6258
DRUG	Ezalutamide
DRUG	Abiraterone acetate
DRUG	Prednisone

Timeline

• Start date: 2015-06-17
• Primary completion: 2018-05-10
• Completion: 2018-05-10
• First posted: 2015-03-04
• Last updated: 2019-06-21
• Results posted: 2019-06-21

Locations

24 sites across 2 countries: United States, Canada