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

Kaunas University of Medicine200 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Prostate Cancer

Interventions

dutasterideDRUG

0.5mg

prostate biopsyPROCEDURE

prostate biopsy

Eligibility

Sex: MALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Urology dep. of Kaunas University of Medicine

Kaunas, Lithuania

Outcomes

Primary Outcomes

rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN

Time frame: 6, 12, 24, and 36 months

Secondary Outcomes

effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).

Time frame: 6, 12, 24, and 36 months

Data from ClinicalTrials.gov

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