Status:
COMPLETED
Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
Lead Sponsor:
Kaunas University of Medicine
Conditions:
Prostate Cancer
Eligibility:
MALE
40-80 years
Phase:
PHASE3
Brief 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 w...
Eligibility Criteria
Inclusion
- Age - 40-80 years
- HPIN on prostate biopsy specimens
- PSA below 20ng/ml
- No hormone therapy or radiation in pelvic region
- No previous treatment with 5alfa reductase inhibitors
- Signed Subject Information and Informed Subject Consent Form.
Exclusion
- 1\. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00780754
Start Date
April 1 2007
End Date
December 1 2010
Last Update
March 6 2018
Active Locations (1)
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1
Urology dep. of Kaunas University of Medicine
Kaunas, Lithuania, 50009