Evaluation of the efficacy of green tea catechins (Categ Plus) in the chemoprevention of prostatic carcinoma in patients with high grade PIN. A randomised multicentric, double blind clinical study. - ND

Conditions: Prostatic intraepithelial neoplasia
MedDRA version: 9.1Level: LLTClassification code 10036964Term: Prostatic intraepithelial neoplasia

Registration Number: EUCTR2007-000759-32-IT

Lead Sponsor: SOFAR SPA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>2. to evaluate eventual variations in the level of the Prostate Specific Antigen after the treatment<br><br>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

Secondary Outcome Measures