Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer

The purpose of this study is to look at the efficacy and safety of leuprolide acetate in patients with prostate cancer.

Other assessments include evaluation of main leuprolide PK parameters in 12 subjects after administration of 3 doses. Study Design: This will be a multi-center, open-label, fixed investigation of six monthly dosages of leuprolide acetate 3.75 mg administered to patients with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy. A total of 120 male patients will receive a single, i.m. injection of leuprolide acetate 3.75 mg initially on study day 0 (after baseline assessment) and then monthly (i.e. every 28 days) for five months. 12 of the patients will also have plasma leuprolide levels measured for PK analysis during the first 3 injection periods (PK group). These patients will belong to pre-defined study sites.