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A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)-Targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD)
Primary Objective: To compare the radiographic progression-free survival (rPFS) (using Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause) with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC participants who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (less than or equal to \[\<=\]12 months, either before or after docetaxel). 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 and duration of tumor response. * Pain response and time to pain progression. * Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE. * Health status and Health-related Quality of Life (HRQOL). * To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs. * To evaluate safety in the 2 treatment arms.
The duration of the study per participant was approximately 2 years. Each participant was treated until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment, and each participant was followed after completion of study treatment until death, study cut-off date, or withdrawal of participant consent.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Investigational Site Number 040002
Linz, Austria
Investigational Site Number 040003
Vienna, Austria
Investigational Site Number 040004
Vienna, Austria
Investigational Site Number 056013
Bruges, Belgium
Investigational Site Number 056003
Brussels, Belgium
Investigational Site Number 056007
Brussels, Belgium
Investigational Site Number 056006
Charleroi, Belgium
Investigational Site Number 056001
Ghent, Belgium
Investigational Site Number 056005
Leuven, Belgium
Investigational Site Number 203005
Brno, Czechia
Start Date
November 9, 2015
Primary Completion Date
March 27, 2019
Completion Date
March 15, 2021
Last Updated
May 27, 2022
255
ACTUAL participants
cabazitaxel XRP6258
DRUG
enzalutamide
DRUG
abiraterone acetate
DRUG
prednisone
DRUG
Lead Sponsor
Sanofi
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06242119