Enzalutamide and Mifepristone in Treating Patients With Metastatic Hormone Resistant Prostate Cancer

Summary

This partially randomized phase I/II trial studies the side effects and best dose of enzalutamide and mifepristone when given together and to see how well they work in treating patients with metastatic hormone resistant prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide and mifepristone, may lessen the amount of androgens made by the body. It is not yet known whether enzalutamide is more effective with or without mifepristone in treating patients with prostate cancer.

Timeline

Start

2013-12-13

Primary completion

2019-06-10

Completion

2020-08-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Treatment (Enzalutamide) vs Treatment (Enzalutamide, Mifepristone); p = 0.83; Log Rank NCT02012296 ↗

Drugs

Indications