Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
Conditions
Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
prostate cancer, chemoprevention, dutasteride
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: dutasteride Type: Drug
Name: prostate biopsy Type: Procedure
Overall Status
Recruiting
Summary
Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. According to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization.

There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 40 Years
Gender: Male
Criteria: Inclusion Criteria:

1. Age - 40-80 years

2. HPIN on prostate biopsy specimens

3. PSA below 20ng/ml

4. No hormone therapy or radiation in pelvic region

5. No previous treatment with 5alfa reductase inhibitors

6. Signed Subject Information and Informed Subject Consent Form.

Exclusion Criteria:

1. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
Location
Urology dep. of Kaunas University of Medicine
Kaunas, Lithuania
Status: Recruiting
Contact: Daimantas Milonas, MD, PhD - +370 37 326090 - daimantasmilonas@yahoo.com
Start Date
April 2007
Completion Date
December 2010
Sponsors
Kaunas University of Medicine
Source
Kaunas University of Medicine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page