Trial Design and oversight
METASTATIC DISEASE
We present a randomized, prospective, double-blind, placebo-controlled phase II trial evaluating the efficacy of empiric glycemic control with metformin in castrated men with advanced PC (NCT:01620593). The trial was designed to enroll a total of 94 men with advanced metastatic PC and men with PC who were candidates for castration therapy despite no evidence of definite metastatic disease including patient with biochemical failure for up to a year. Patients were randomly assigned at a 1:1 ratio to receive either metformin (500 mg TID PO) or placebo.The randomization phase involved enrollment of patients who had undergone screening for eligibility criteria and had pathologically proven metastatic PC (