Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer
Status:
Terminated
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
Summary
This is a prospective randomized phase II clinical trial where patients who are receiving
enzalutamide in the pre-chemotherapy space are randomized upon objective progression
(radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same
combination plus enzalutamide.
The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel
in patients who failed or progressed while on enzalutamide would increase progression-free
survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients
alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL)
using validated scales.