Clinical trial NCT00128531 (phase 3, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: leuprolide acetate
SMILES: CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O
Eligibility criteria:

        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 </= 1.6 times the
             ULN (upper limit of normal) for the clinical laboratory

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