Prostatic intraepithelial neoplasia MedDRA version: 9.1 Level: LLT Classification code 10036964 Term: Prostatic intraepithelial neoplasia
Conditions
Interventions
Product Name: CATEG PLUS
Pharmaceutical Form: Capsule, hard
Current Sponsor code: CATEG PLUS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical for
Sponsors
SOFAR SPA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. age > 45 years 2. patients with High grade PIN diagnosed by biopsy. it is possible to refer to a previous biopsy (not before 6 months) 3. no clinic evidence of prostate cancer 4.written consent 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
Exclusion criteria
Exclusion criteria: 1. patients taking 5-alfa reduttase drugd (finasteride, dutasteride) 2. patients with other malignances 3. diseases of kidney and liver, cardiovascular and haematological disease, pulmonary or neurological, gastroenterologic or endocrine diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the green tea catechins'efficacy, in particular of EGCG in the prevention of the prostate carcinoma in patienta with High grade PIN lesions;Secondary Objective: 1. To evaluate EGCG plasmatic levels by cinetic analysis. these test will be conducted only in the group of patients in the main centre 2. to evaluate eventual variations in the level of the Prostate Specific Antigen after the treatment 3.To investigate the proliferation activity and cellular death by immunoistochemistry;Primary end point(s): patients with prostatic carcinoma at 6 months of treatment have to drop out | — |
Countries
Italy
Outcome results
None listed