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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 120

Inclusion Criteria

1. Males 61619; 18 years of age, with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy; 2. life expectancy of at least 1 year; 3. World Health Organization/Eastern Cooperative or Group WHO/ECOG performance status of 0, 1, or 2; 4. adequate renal function at screening as defined by serum creatinine 61603; 1.6 times the ULN upper limit of normal for the clinical laboratory; 5. adequate and stable hepatic function as defined by bilirubin 61603; 1.5 times the ULN and transaminases i.e. SGOT, SGPT 61603; 2.5 times the ULN for the clinical laboratory at screening; 6. 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; 7. 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

1. Evidence of brain metastases, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms 2. evidence of spinal cord compression, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms 3. 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 4. excruciating, severe pain from extensive osseous deposits, in the opinion of the Investigator, taking into account medical history, clinical observations and symptoms 5. testosterone levels 61500; 1.5 ng/mL at screening, locally determined at the laboratory of each clinical site; 6. previous cancer systemic therapy such as chemotherapy, immunotherapy, biological response modifiers within 3 months of baseline; 7. previous hormonal therapy for treatment of prostate cancer, such as LHRH analogues no wash-out allowed ; 8. previous treatment with AR-receptor blockers, such as Casodex, Fugerel, Megace, Androcur no wash-out allowed ; 9. previous orchiectomy, adrenalectomy or hypophysectomy 10. previous prostatic surgery e.g. radical prostatectomy, transurethral resection of the prostate within 2 weeks of baseline; 11. 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; 12. any investigational drug within 5 half-lives of its physiological action or 3 months, whichever is longer, before baseline rationale to prevent adverse effects of another drug being attributed to study drug and to prevent potential interactions ; 13. administration of 5-alpha-reductase inhibitors within 3 months before baseline; 14. over-the-counter OTC or alternative medical therapies which have an estrogenic or anti-androgenic effect within the 3 months before baseline; 15. hematological parameters outside 20 of the upper or lower limits of normal for the clinical laboratory at screening; 16. co-existent malignancy, according to the Investigator s opinion; 17. uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure or significant symptomatic cardiovascular disease s within 6 months before baseline; resting uncontrolled hypertension or symptomatic hypotension within 3 months before baseline; 18. venous thrombosis within 6 months of baseline; 19. insulin-dependent diabetes mellitus; 20. history of drug and/or alcohol abuse within 6 months of baseline; 21. serious concomitant illness es or disease s that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol; 22. 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 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; 23. blood donations/losses within 2 months of baseline, apart from previous prostatic surgery patients; 24. known hypersensitivity to GnRH, GnRH agonist, including any LHRH

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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