Leuprolide Acetate 3.75 mg Depot to Treat Prostate Cancer

Inclusion Criteria:

• Males >/= 18 years of age, with histologically proven carcinoma of the prostate, whomight benefit from medical androgen deprivation therapy

• Life expectancy of at least 1 year

• World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performancestatus of 0, 1, or 2

• Adequate renal function at screening as defined by serum creatinine </= 1.6 times theULN (upper limit of normal) for the clinical laboratory

• Adequate and stable hepatic function as defined by bilirubin </= 1.5 times the ULN andtransaminases (i.e. SGOT, SGPT) </= 2.5 times the ULN for the clinical laboratory atscreening

• Ability to comprehend the full nature and purpose of the study, including possiblerisks and side effects; ability to co-operate with the Investigator and to comply withthe requirements of the entire study

• Signed written informed consent prior to inclusion in the study

Exclusion Criteria:

• Evidence of brain metastases, in the opinion of the Investigator, taking into accountmedical history, clinical observations and symptoms

• Evidence of spinal cord compression, in the opinion of the Investigator, taking intoaccount medical history, clinical observations and symptoms

• Evidence of severe urinary tract obstruction with threatening urinary retention, inthe opinion of the Investigator, taking into account medical history, clinicalobservations and symptoms

• Excruciating, severe pain from extensive osseous deposits, in the opinion of theInvestigator, taking into account medical history, clinical observations and symptoms

• Testosterone levels < 1.5 ng/mL at screening, locally determined at the laboratory ofeach clinical site

• Previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g. antibodytherapies, tumor-vaccines), biological response modifiers (e.g. cytokines) within 3months of baseline

• Previous hormonal therapy for treatment of prostate cancer, such as luteinisinghormone-releasing hormone (LHRH) analogues (e.g. Lupron®, Zoladex®, etc.) [no wash-outallowed]

• Previous treatment with androgen receptor (AR) blockers, such as Casodex®, Fugerel®,Megace®, Androcur® (no wash-out allowed)

• Previous orchiectomy, adrenalectomy or hypophysectomy

• Previous prostatic surgery (e.g. radical prostatectomy, transurethral resection of theprostate [TUR-P]) within 2 weeks of baseline

• Previous local therapy to the primary tumor with a curative attempt other than surgery (external beam radiotherapy, brachytherapy, thermotherapy, cryotherapy) within 2 weeksof baseline

• Any investigational drug within 5 half-lives of its physiological action or 3 months (whichever is longer) before baseline

• Administration of 5-alpha-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 3 months before baseline

• Over-the-counter (OTC) or alternative medical therapies which have an estrogenic oranti-androgenic effect (i.e., PC-SPES, saw palmetto, Glycyrrhiza®, Urinozinc®,dehydroepiandrosterone [DHEA]) within the 3 months before baseline

• Hematological parameters (RBC, total and differential WBC count, platelet count,hemoglobin, hematocrit) outside 20% of the upper or lower limits of normal (ULN, LLN)for the clinical laboratory at screening

• Co-existent malignancy, according to the Investigator's opinion

• Uncontrolled congestive heart failure, myocardial infarction or a coronary vascularprocedure (e.g. balloon angioplasty, coronary artery bypass graft) or significantsymptomatic cardiovascular disease(s) within 6 months before baseline; restinguncontrolled hypertension: (>/= 160/100 mmHg) or symptomatic hypotension within 3months before baseline

• Venous thrombosis within 6 months of baseline

• Insulin-dependent diabetes mellitus

• History of drug and/or alcohol abuse within 6 months of baseline

• Serious concomitant illness(es) or disease(s) [e.g., hematological, renal, hepatic,respiratory, endocrine, psychiatric] that may interfere with, or put patients atadditional risk for, their ability to receive the treatment outlined in the protocol

• Patients receiving anticoagulants who have prothrombin and partial thromboplastintimes outside of the normal range for the laboratory assays; patients who are onanticoagulation or antiplatelet medications (e.g. dipyridamole, ticlopidine, warfarinderivatives) who are not receiving a stable dose for 3 months before baseline;patients who are receiving warfarin-derivative anticoagulants who do not have anInternational Normalized Ratio (INR) in the therapeutic range for the clinicalindication for which the anticoagulant has been prescribed.

• Blood donations/losses within 2 months of baseline, apart from previous prostaticsurgery patients (see earlier exclusion [9]; please note that these patients shouldnot be included in the pharmacokinetic [PK] group)

• Known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or anyexcipients of the study formulation

• History of the following prior to the study:

• immunization (within 4 weeks of baseline);

• flu shots (within 2 weeks of baseline);

• anaphylaxis;

• skin disease which would interfere with injection site evaluation;

• dermatographism will be documented at screening and followed up while ontreatment.