Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone

The purpose of this trial is to test if the combination of enzalutamide and metformin in patients with castration resistant prostate cancer progressing on androgen deprivation therapy is more effective compared to enzalutamide alone. The half of the patients will receive the experimental treatment combination, enzalutamide and metformin, while the other half will receive enzalutamide alone.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone (IMPROVE TRIAL): A Randomized, Open Label, Phase II Trial
Estimated Enrollment: 168
Study Start Date: June 2016
Estimated Study Completion Date: June 2026
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Enzalutamide + Metformin
- Active Comparator: Enzalutamide