NCT02485691

Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
DRUG	cabazitaxel XRP6258	Pharmaceutical form: solution Route of administration: intravenous
DRUG	enzalutamide	Pharmaceutical form: capsule Route of administration: oral
DRUG	abiraterone acetate	Pharmaceutical form: tablet Route of administration: oral
DRUG	prednisone	Pharmaceutical form: tablet Route of administration: oral

Timeline

• Start date: 2015-11-09
• Primary completion: 2019-03-27
• Completion: 2021-03-15
• First posted: 2015-06-30
• Last updated: 2022-05-27
• Results posted: 2022-02-14

Locations

65 sites across 13 countries: Austria, Belgium, Czechia, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Spain, United Kingdom