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Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide

NCT03764540 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-04-13

No results posted yet for this study

Summary

Prostate cancer (PCa) is the most frequently diagnosed cancer in Canadian men. While the majority of PCa is slow growing and responds well to first line treatment, a proportion of cases (10%) progress to metastatic form resulting in more than 4 000 deaths annually in Canada and 250 000 worldwide. Currently, first line treatment for PCa includes surgery, radiation and androgen deprivation therapy (ADT). A rapid evolution in the understanding of disease biology, combined with approvals of new therapies including immunotherapy, novel chemotherapy, hormonal agents and a bone calcium matrix-targeted radionuclide, along with further drugs in development, have made treatment decisions for metastatic castration-resistant prostate cancer (mCRPC) increasingly complex and challenging.

This is a Phase II Study of Cabazitaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). The current study is designed to determine if cabazitaxel will improve progression free survival (PFS) or overall survival (OS).

This study will enroll patients with mCRPC, who have been previously treated and progressed under docetaxel or abiraterone regimen.

Patients must meet the study eligibility criteria and must be competent to give informed consent.

Conditions

Interventions

DRUG

Cabazitaxel plus prednisone

Cabazitaxel 25 mg/m² intravenously on day 1 of each cycle, plus prednisone 10 mg orally given daily. A cycle is defined as a 3-weeks period for a maximum of 10 cycles.

DRUG

Docetaxel plus prednisone

Docetaxel 75 mg/m² intravenously on day 1 of each cycle, plus prednisone 10 mg orally given daily. A cycle is defined as a 3-weeks period for a maximum of 10 cycles.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • fred Saad, MD · CHUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03764540 on ClinicalTrials.gov