Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
NCT ID: NCT01594502
Last Updated: 2020-10-12
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
139 participants
OBSERVATIONAL
2011-09-30
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Dutasteride Year 2 PCa
Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy.
Dutasteride
0.5 mg daily
Placebo Year 2 no PCa, Year 4 PCa
Subject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
Placebo
Placebo Comparator
Dutasteride Year 2 no PCa, Year 4 PCa
Subject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
Dutasteride
0.5 mg daily
Placebo, Year 2 and 4 no PCa
Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy.
Placebo
Placebo Comparator
Dutasteride, Year 2 and 4 no PCa
Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy.
Dutasteride
0.5 mg daily
Placebo, Year 2 PCa
Subject assigned to placebo, prostate cancer found on Year 2 biopsy.
Placebo
Placebo Comparator
Interventions
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Dutasteride
0.5 mg daily
Placebo
Placebo Comparator
Eligibility Criteria
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Inclusion Criteria
* compliant with assigned treatment based on either: (dutasteride group) at least 3 post-baseline serum DHT levels ≥ 50% lower than baseline, or (placebo group) at least 3 post-baseline serum DHT levels with none showing ≥ 50% decrease from baseline
Exclusion Criteria
50 Years
75 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Illinois at Chicago
OTHER
Responsible Party
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Peter Gann
Professor and Director, Division of Pathology Research
Principal Investigators
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Peter H Gann, MD, ScD
Role: PRINCIPAL_INVESTIGATOR
University of Illinois at Chicago
Locations
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University of Illinois at Chicago
Chicago, Illinois, United States
Countries
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Other Identifiers
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2010-0670
Identifier Type: -
Identifier Source: org_study_id
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