Trial Information
Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
Outcome Time Frame:
6, 12, 24, and 36 months
Safety Issue:
Yes
Principal Investigator
Daimantas Milonas, assist professor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Kaunas Medical University
Authority:
Lithuania: Kaunas University of Medicine
Study ID:
BE-2-27
NCT ID:
NCT00780754
Start Date:
April 2007
Completion Date:
December 2010
Related Keywords:
- Prostate Cancer
- prostate cancer
- chemoprevention
- dutasteride
- Neoplasms
- Prostatic Neoplasms