Evaluation of chemopreventive effect of a galenic preparation, comparable to a food integrator, composed by seleniomethionine, lycopene and polyphenols (green tea epigallocatechingallate and catechins) in patients with high risk of prostate carcinoma: a randomized phase II study - ND
- Conditions
- Patients with first prostate biopsy with diagnosis of ASAP (Atypical Small Acinar Proliferation) or multifocal (&#88052 positive samples) HGPIN (High-Grade Prostatic Intraepithelial Neoplasia)MedDRA version: 9.1Level: LLTClassification code 10029037
- Registration Number
- EUCTR2009-014548-13-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Age >45 and <75
Patients with first prostate biopsy negative for prostate carcinoma, but with multifocal HGPIN (≥2 positive samples for HGPIN) or ASAP
Signed informed consent
Patient compliance allowing an adequate follow-up
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method