prostate cancer MedDRA version: 6.0 Level: LLT Classification code 10007113
Conditions
Interventions
Product Name: Leuprolide acetate
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: leuprolide acetate or leuprorelin
CAS Number: 74381-53-6
Other descriptive n
Sponsors
GP-Pharm s.a.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Males at least 18 years of age or above, with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy; life expectancy of at least 1 year; World Health Organization/Eastern Cooperative or Group (WHO/ECOG) performance status of 0, 1, or 2; adequate renal function at screening as defined by serum creatinine less than or equal to 1.6 times the ULN (upper limit of normal) for the clinical laboratory; adequate and stable hepatic function as defined by bilirubin less than or equal to 1.5 times the ULN and transaminases (i.e. SGOT, SGPT) less than or equal to 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Evidence of brain metastases, spinal cord compression, evidence of severe urinary tract obstruction with threatening urinary retention and 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; 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 LHRH analogues (e.g. Lupron®, Zoladex®); previous treatment with AR-receptor blockers, such as Casodex®, Fugerel®, Megace®, Androcur®; previous orchiectomy, adrenalectomy or hypophysectomy; previous prostatic surgery (e.g. radical prostatectomy, 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, of baseline; administration of 5-a-reductase inhibitors (Proscar®, Avodart®, Propecia®) within 3 months of baseline; OTC or alternative medical therapies which have an estrogenic or anti-androgenic effect within the 3 months of 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; uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure or significant symptomatic cardiovascular disease(s) within 6 months of baseline; resting uncontrolled hypertension or symptomatic hypotension within 3 months of 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); 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 (please note that these patients should not be included in the PK group); known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any excipients of the study formulation; history of 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of the study treatment in reducing plasma testosterone below castration levels;Secondary Objective: Determination of serum LH, FSH and PSA concentrations; World Health Organization/Eastern Cooperative or Group (WHO/ECOG) performance status, bone pain, urinary symptoms and urinary pain after administration. Evaluation of the safety of the new formulation based on: adverse events, local tolerability, vital signs, ECGs and clinical laboratory parameters. Determination of plasma leuprolide levels (only 12 subjects - PK group in a predefined clinical site);Primary end point(s): To determine: 1. The proportion of patients achieving castration levels of plasma testosterone (defined as <0.5 ng/mL) 4 weeks after the 1st administration; 2. The proportion of patients maintaining castration levels of plasma testosterone from week 4 to study end; 3. The proportion of patients showing acute rises in plasma testosterone levels upon repeated dosing (the so-called “acute-on-chronic” phenomenon). | — |
Countries
Austria, Czech Republic, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed