E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Male patients with carcinoma of the prostate aged 18 years and more and suitable for hormonal manipulation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
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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 demonstrate that the new Novosis Leuprorelin 10.72 mg implant is therapeutically non inferior to the reference product Trenantone®
Primary variable: Area under the curve (AUC) of the testosterone levels on Days 28, 42, 56, 70, 84 |
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E.2.2 | Secondary objectives of the trial |
- Testosterone levels on days 0, 14, 28, 42, 56, 70, 84 - percentage of patients who have reached castration level of testosterone (2 nmol/l)at the end of the study (Day 84) - the plasma levels of leuprorelin and LH/FSH (Days 0, 14, 28, 42, 56, 70, 84), - number of non-responders,
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Males aged 18 years or older • Histologically confirmed diagnosis of carcinoma of the prostate suitable for hormonal manipulation including patients with rising PSA after having undergone surgery or radiotherapy with curative intention • Life expectancy of at least six months • The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form • The patient is able to understand and follow instructions and is able to participate in the study for the entire period • Patients must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures.
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E.4 | Principal exclusion criteria |
• Hypersensitivity to Trenantone® or to other GnRH analogues • Treatment with a drug modifying testosterone level or function is prohibited. To these belong e.g. flutamide, spironolactone, domperidone, cimetidine, amitriptyline, methyldopa, minoxidil, and finasteride • Treatment and/or pretreatment with other GnRH analogues • Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion • Cancer disease within the last 10 years except prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin • Patients with clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or any infectious disorder or any other condition including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator • Mental incapacity or language barriers precluding adequate understanding or co-operation • Patients who have received an investigational drug within the last 12 weeks preceding Visit 1 • Previous participation in this study
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary variable: Area under the curve (AUC) of the testosterone levels on Days 28, 42, 56, 70, 84 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |