NCT03764540

Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide

Randomized Phase II Study of Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide Progression

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, national, randomized, open label study, comparing the efficacy of cabazitaxel at 25 mg/m² plus prednisone (Arm A) over docetaxel at 75mg/m2 plus prednisone (Arm B) after enzalutamide at 160 mg once daily or abiraterone acetate at 1000 mg once daily plus prednisone in chemotherapy-naïve patients with mCRPC who have progressed on abiraterone acetate or enzalutamide. Each patient will be treated until disease progression, unacceptable toxicity, or patient's refusal of further study treatment. All eligible patients will be randomly assigned to either arm A or B in a 1:1 proportion.

Conditions

• Metastatic Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-12-05
• Last updated: 2025-04-13

Locations

1 site across 1 country: Canada