Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaunas University of Medicine
• Treatments: Dutasteride

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.