drugset / Trial / NCT03419234

Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel

NCT03419234 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone acetate and antiandrogen therapy may fight prostate cancer by lowering and/or blocking the use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abiraterone acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill more tumor cells.

Timeline

Start
2018-04-26
Primary completion
2024-01-08
Completion
2028-04-01

Outcome

Met primary endpoint

registry analysis (superiority test); Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel) vs Arm B (Abiraterone Acetate, Prednisone); p = 0.049; Log Rank NCT03419234 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Abiraterone acetate Small molecule — Oral
Subject Cabazitaxel Other / unclassified — Intravenous
Background Prednisone Other / unclassified — Oral