E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with first prostate biopsy with diagnosis of ASAP (Atypical Small Acinar Proliferation) or multifocal (≥2 positive samples) HGPIN (High-Grade Prostatic Intraepithelial Neoplasia) |
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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 | 10029037 |
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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 |
1.Verification of the stability of the preparation and its components in different environmental conditions in agreement with EMEA guidelines. 2.Verification of the plasmatic concentration of lycopene by a pharmacokinetic study. 3.Verification of the tolerability of the administered formulation. 4.Evaluation of the preventive efficacy of the formulation against prostate carcinoma in patients with high risk. |
|
E.2.2 | Secondary objectives of the trial |
1.Evaluation of the patient compliance. 2.Evaluation of other benefits against prostate disease. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age >45 and <75 Patients with first prostate biopsy negative for prostate carcinoma, but with multifocal HGPIN (&#8805;2 positive samples for HGPIN) or ASAP Signed informed consent Patient compliance allowing an adequate follow-up |
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E.4 | Principal exclusion criteria |
Previous or current therapy with food integrators with supposed protecting effect Previous or current therapy with inhibitor of 5 alfa reductase (finasteride, dutasteride) Neoplastic disease requiring a chemotherapy, radiotherapy or immunotherapy treatment Concomitant disease that would interfere with protocol or results |
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E.5 End points |
E.5.1 | Primary end point(s) |
The stability of the preparation. 2. The pharmacokinetic evaluation of the lycopene in order to verify the plasmatic steady state. 3. The possible adverse effects reported during the study. 4. The difference of prostate carcinoma, ASAP and HGPIN incidence on the biopsy after 6 months of treatment between treated or control patients. 5. The difference of prostate carcinoma, ASAP and HGPIN incidence on the biopsy after 12 months of treatment between patients entered in a 6 months open-label phase and patients that stopped the treatment after the first 6 months. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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
| |
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 |