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| Sponsor: | Kaunas University of Medicine |
|---|---|
| Information provided by: | Kaunas University of Medicine |
| ClinicalTrials.gov Identifier: | NCT00780754 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: dutasteride Procedure: prostate biopsy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate |
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: dutasteride
treatment group
|
Drug: dutasteride
0.5mg
Procedure: prostate biopsy
prostate biopsy
|
| Active Comparator: watchful waiting strategy |
Procedure: prostate biopsy
prostate biopsy
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
Contacts and Locations| Contact: Stasys Auskalnis | +37037326090 | auskalnis74@gmail.com |
| Lithuania | |
| Urology dep. of Kaunas University of Medicine | Recruiting |
| Kaunas, Lithuania, 50009 | |
| Contact: Daimantas Milonas, MD, PhD +370 37 326090 daimantasmilonas@yahoo.com | |
| Contact: Stasys Auskalnis +370 37 326090 auskalnis74@gmail.com | |
| Principal Investigator: Daimantas Milonas, assist professor | |
| Principal Investigator: | Daimantas Milonas, assist professor | Kaunas Medical University |
More Information
| Responsible Party: | Stasys Auskalnis, Kaunas University of Medicine |
| ClinicalTrials.gov Identifier: | NCT00780754 History of Changes |
| Other Study ID Numbers: | BE-2-27 |
| Study First Received: | October 26, 2008 |
| Last Updated: | October 27, 2008 |
| Health Authority: | Lithuania: Kaunas University of Medicine |
|
prostate cancer chemoprevention dutasteride |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Dutasteride 5-alpha Reductase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
