E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with advanced (locally or metastatic) prostate cancer scheduled to receive an LHRH analogue as androgen deprivation therapy |
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MedDRA Classification |
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 assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24. |
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E.2.2 | Secondary objectives of the trial |
Overall patient acceptability of SC vs IM injection of Pamorelin® 11,25 mg Overall caregiver acceptability of SC vs IM injection of Pamorelin® 11,25 mg To assess the tolerability and safety of SC and IM injections of Pamorelin® 11,25 mg To assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via SC injection as compared to Pamorelin® 11,25 mg administered via standard IM injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 12
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Provision of written informed consent prior to any study related procedures. 2) Male patients aged 18 years and older 3) Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy. 4) Life expectancy of more than 9 months 5) Documented testosterone levels of ≥ 125 ng/dl measured by any laboratory or on site within the previous 6 months 6) Patient able and willing to comply with the requirements of the protocol.
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E.4 | Principal exclusion criteria |
1) Has a history of hypersensitivity to the studied drug or drugs with a similar chemical structure. 2) Was treated with any other Investigational Medicinal Product within the last 30 days before study entry. 3) Has previously received a GnRH analogue, estrogens or a steroidal anti –androgen within the last year preceding the study. 4) Concomitant anti-coagulation treatment. 5) Patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study. 6) Patient with known spinal medullar compression. 7) Has a history of, or known current, problems with alcohol abuse. 8) Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude. 9) Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy Variables: Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l) measured at week 24
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Pamorelin 11,25 IM injected |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 14 |
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 | 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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |