Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
NCT ID: NCT00780754
Last Updated: 2018-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2007-04-30
2010-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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dutasteride
treatment group
dutasteride
0.5mg
prostate biopsy
prostate biopsy
watchful waiting strategy
prostate biopsy
prostate biopsy
Interventions
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dutasteride
0.5mg
prostate biopsy
prostate biopsy
Eligibility Criteria
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Inclusion Criteria
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
40 Years
80 Years
MALE
No
Sponsors
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Kaunas University of Medicine
OTHER
Responsible Party
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Stasys Auskalnis
doctor
Principal Investigators
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Daimantas Milonas, assist professor
Role: PRINCIPAL_INVESTIGATOR
Kaunas Medical University
Locations
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Urology dep. of Kaunas University of Medicine
Kaunas, , Lithuania
Countries
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Other Identifiers
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BE-2-27
Identifier Type: -
Identifier Source: org_study_id
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