Efficacy and Safety of a New Leuprolide Acetate 3.75 mg Depot Formulation, GP-Pharm S.A., When Given as Palliative Treatment to Prostate Cancer Patients

Inclusion Criteria:

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

- Life expectancy of at least 1 year

- World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance
status of 0, 1, or 2

- Adequate renal function at screening as defined by serum creatinine ULN (upper limit of normal) for the clinical laboratory

- Adequate and stable hepatic function as defined by bilirubin and transaminases (i.e. SGOT, SGPT) at screening

- Ability to comprehend the full nature and purpose of the study, including possible
risks and side effects; ability to co-operate with the Investigator and to comply
with the 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 account
medical history, clinical observations and symptoms

- Evidence of spinal cord compression, in the opinion of the Investigator, taking into
account medical history, clinical observations and symptoms

- Evidence of severe urinary tract obstruction with threatening urinary retention, in
the opinion of the Investigator, taking into account medical history, clinical
observations and symptoms

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

- Testosterone levels < 1.5 ng/mL at screening, locally determined at the laboratory
of each clinical site

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

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

- 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
the prostate [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 weeks of 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 or
anti-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 vascular
procedure (e.g. balloon angioplasty, coronary artery bypass graft) or significant
symptomatic cardiovascular disease(s) within 6 months before baseline; resting
uncontrolled hypertension: (>/= 160/100 mmHg) or symptomatic hypotension within 3
months 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 at
additional risk for, their ability to receive the treatment outlined in the protocol

- Patients receiving anticoagulants who have prothrombin and partial thromboplastin
times outside of the normal range for the laboratory assays; patients who are on
anticoagulation or antiplatelet medications (e.g. dipyridamole, ticlopidine, warfarin
derivatives) who are not receiving a stable dose for 3 months before baseline;
patients who are receiving warfarin-derivative anticoagulants who do not have an
International Normalized Ratio (INR) in the therapeutic range for the clinical
indication for which the anticoagulant has been prescribed.

- Blood donations/losses within 2 months of baseline, apart from previous prostatic
surgery patients (see earlier exclusion [9]; please note that these patients should
not be included in the pharmacokinetic [PK] group)

- Known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any
excipients 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 on
treatment.