Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer

A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 (Leuprolide Acetate FluidCrystal® Injection Depot Once Monthly) After Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients With Prostate Cancer

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.

Inclusion Criteria:

• Men ≥40 and ≤85 years of age
• Histological or cytological proven adenocarcinoma of the prostate requiring hormone therapy
• Life expectancy over 12 months
• World Health Organisation/ The Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1 or 2
• Adequate and stable renal function
• Adequate and stable hepatic function

Exclusion Criteria:

• Evidence of brain metastasis, spinal cord compression, or urinary tract obstruction
• Serum Testosterone levels below 150 ng/dL at Screening visit
• Medical or radiological prostate cancer treatments within 2 months prior to the Screening visit
• Surgical treatment of prostate cancer within 2 weeks prior to the Screening visit
• Prior orchiectomy, hypophysectomy, or adrenalectomy
• Prior use of LHRH agonists within 12 months prior to the Screening visit and during the study