Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
Information source: University of Illinois at Chicago
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostate Tissue
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Illinois at Chicago Official(s) and/or principal investigator(s): Peter H Gann, MD, ScD, Principal Investigator, Affiliation: University of Illinois at Chicago
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 techniques. The ultimate result will be a multivariable morphological
"signature" that could provide a useful indicator of an individual's degree of drug
response.
Clinical Details
Official title: Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
Study design: Observational Model: Case Control, Time Perspective: Cross-Sectional
Primary outcome: Architectural FeaturesMorphometric features Independent changes in architecture and morphometry
Secondary outcome: Changes in cytomorphology
Eligibility
Minimum age: 50 Years.
Maximum age: 75 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- N/A
Locations and Contacts
University of Illinois at Chicago, Chicago, Illinois 60612, United States
Additional Information
Starting date: November 2011
Last updated: April 17, 2014
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