Status:
COMPLETED
Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Benign Prostate Tissue
Eligibility:
MALE
50-75 years
Brief Summary
The overall goal of this project is to quantify the long-term effects of dutasteride on the architectural and nuclear features of benign prostate tissue, using state-of-the art digital image analysis ...
Eligibility Criteria
Inclusion
- completed REDUCE trial (Year 4 exit biopsy with blocks and HE slides available; i.e., U.S. participants only)
- 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
- subgroup: Year 2 biopsy blocks and HE slides available for Aim 4a
Exclusion
- N/A
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01473030
Start Date
November 1 2011
End Date
December 1 2018
Last Update
October 5 2020
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612