This study is an open-label, multi-center study in which a minimum of 165 patients will receive one (1) of three (3) lots of Oakwood Laboratories' Leuprolide Acetate for Injectable Suspension 22.5 mg for two cycles. A subset of patients (minimum of 12) will be assigned to each lot (A, B or C) and will have additional blood sampling to characterize leuprolide release kinetics for each dose administered.
The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer.