E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the efficacy and safety of a new leuprolide acetate formulation in patients with prostate cancer |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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 analogues, or any excipients of the study formulation; 25. history of the following prior to the study a immunization within 4 weeks of baseline ; b flu shots within 2 weeks of baseline ; c anaphylaxis; d skin disease which would interfere with injection site evaluation; |
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E.5 End points |
E.5.1 | 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 from week 4 to study end. Evaluation of the safety of the new formulation based on AEs, local tolerability, vital signs, ECGs and clinical laboratory parameters. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |