E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced and/or metatstatic prostate cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 assess the duration of action of two different initial “loading” dose regimens of Teverelix LA in terms of suppression of testosterone to below castrate level (0.5 ng/ml) in patients with prostate cancer |
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E.2.2 | Secondary objectives of the trial |
-To assess the pharmacodynamics of Teverelix in terms of ability to suppress and maintain plasma testosterone levels below castration level (<0.5 ng/ml) until (after week 3), 2 consecutive, increasing T levels above castration level, with the latter one above 2ng/ml have been recorded. -To assess the effects on Luteinising Hormone (LH) -To assess the effects on Prostate Specific Antigen (PSA) -To assess the safety of Teverelix LA in terms of local tolerability and systemic tolerability (adverse events and changes in laboratory parameters) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologically proven adenocarcinoma of the prostate • Suitable androgen deprivation therapy (advanced prostate cancer i.e. with local invasion and/or metastasis) • Signed, written informed consent |
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E.4 | Principal exclusion criteria |
• Liver or renal function tests (ASAT/SGOT, ALAT/SGPT), total bilirubin, creatinine) exceeding twice the upper limit of the normal range, unless the elevation is attributed to hepatic metastasis • Screening QTc interval of ≥ 430 msec • Any contraindication to the use of Teverelix LA • Life expectancy of less than 1 year • Baseline Testosterone value below 2.31 ng/ml • Bilateral orchidectomy • Pre-existing hormone therapy or planned concomitant use of androgen deprivation therapy with any agent other than the investigational drug • Neurological, psychiatric disease, drug or alcohol abuse which could interfere with the subject’s proper compliance • Evidence of concurrent malignancy • Exposure to another investigational agent within the last month • Lack of ability or willingness to give informed consent • Anticipated non-availability for study visits/procedures |
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E.5 End points |
E.5.1 | Primary end point(s) |
Duration of castration (ie T < 0.5 ng/ml) Escape from castration is defined as, after week 3, two consecutive increasing T levels above castration level, have been recorded, with the latter one above 2ng/ml. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | Yes |
E.7.1.3.1 | Other trial type description |
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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 | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
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 | No |
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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |