Trials / Completed
CompletedNCT00780754
Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Kaunas University of Medicine · Academic / Other
- Sex
- Male
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | dutasteride | 0.5mg |
| PROCEDURE | prostate biopsy | prostate biopsy |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2008-10-28
- Last updated
- 2018-03-06
Locations
1 site across 1 country: Lithuania
Source: ClinicalTrials.gov record NCT00780754. Inclusion in this directory is not an endorsement.