Patients with first prostate biopsy with diagnosis of ASAP (Atypical Small Acinar Proliferation) or multifocal (&
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
Other descriptive name: SELENIUM, CATECHINES, LYCOPENE
Concentration type: equal
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the pla
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Age >45 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1.Evaluation of the patient compliance. 2.Evaluation of other benefits against prostate disease.;Main Objective: 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.;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. | — |
Countries
Italy
Outcome results
None listed