Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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, 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
Study ID: NCT02379390
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Investigational Site Number 840030, Muscle Shoals, Alabama, United States
Investigational Site Number 840024, Anchorage, Alaska, United States
Investigational Site Number 840028, Anaheim, California, United States
Investigational Site Number 840004, Sacramento, California, United States
Investigational Site Number 840002, Boca Raton, Florida, United States
Investigational Site Number 840027, Lakeland, Florida, United States
Investigational Site Number 840006, Port Saint Lucie, Florida, United States
Investigational Site Number 840015, Ottawa, Illinois, United States
Investigational Site Number 840001, Covington, Louisiana, United States
Investigational Site Number 840017, Metairie, Louisiana, United States
Investigational Site Number 840012, Rockville, Maryland, United States
Investigational Site Number 840026, Omaha, Nebraska, United States
Investigational Site Number 840022, Canton, Ohio, United States
Investigational Site Number 840016, Myrtle Beach, South Carolina, United States
Investigational Site Number 124003, Edmonton, , Canada
Investigational Site Number 124010, Greenfield Park, , Canada
Investigational Site Number 124005, Hamilton, , Canada
Investigational Site Number 124004, London, , Canada
Investigational Site Number 124002, Montreal, , Canada
Investigational Site Number 124006, Montreal, , Canada
Investigational Site Number 124007, Ottawa, , Canada
Investigational Site Number 124009, Quebec, , Canada
Investigational Site Number 124008, Saskatoon, , Canada
Investigational Site Number 124001, Vancouver, , Canada
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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