drugset / Trial / NCT00780754

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

NCT00780754

Phase 3 Completed 200 enrolled Kaunas University of Medicine
RandomizedParallel-groupOpen-labelPrevention

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).

Timeline

Start
2007-04
Primary completion
2010-12
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Dutasteride Small molecule 0.5 mg

Indications