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

NCT00780754 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-03-06

No results posted yet for this study

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).

Conditions

Interventions

DRUG

dutasteride

0.5mg

PROCEDURE

prostate biopsy

prostate biopsy

Sponsors & Collaborators

  • Kaunas University of Medicine

    lead OTHER

Principal Investigators

  • Daimantas Milonas, assist professor · Kaunas Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Lithuania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00780754 on ClinicalTrials.gov