MedTrace Logo

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

NCT02485691 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2022-05-27

Study results available
· View outcomes & findings →

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.

Conditions

  • Prostate Cancer Metastatic

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-09
Primary Completion
2019-03-27
Completion
2021-03-15

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Greece
  • Iceland
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02485691 on ClinicalTrials.gov