drugset / Trial / NCT03764540

Docetaxel Versus Cabazitaxel Post Abiraterone or Enzalutamide

NCT03764540

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabazitaxel Other / unclassified 25 mg/m2 Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Background Prednisone Other / unclassified 10 mg Oral