The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.

The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma. This study will also evaluate the pharmacokinetic profile of the 45 mg formulation and assess the safety of this formulation.

Inclusion Criteria:

• Histological diagnosis of prostate cancer
• Need for androgen deprivation treatment for 1 year
• Serum testosterone level ≥ 150 ng/dL
• Life expectancy of at least 18 months
• ECOG Performance status grades 0,1 or 2

Exclusion Criteria:

• Hypersensitivity to leuprolide acetate or polylactic acid
• History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
• History of hypogonadism