Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Peter Gann, University of Illinois at Chicago
First received: November 14, 2011
Last updated: December 1, 2015
Last verified: December 2015
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.
||Observational Model: Case Control
Time Perspective: Cross-Sectional
||Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
Primary Outcome Measures:
- Architectural Features [ Time Frame: Year 4 ] [ Designated as safety issue: No ]
To characterize and quantify the effects of dutasteride on histological (architectural) features of benign prostate tissue via comparison of a random sample of Year 4 biopsy specimens from the dutasteride and placebo groups.
- Morphometric features [ Time Frame: Year 4 ] [ Designated as safety issue: No ]
To quantify the long-term (Year 4) effects of dutasteride on nuclear morphometric features (i.e., size, shape and texture) in benign prostatic epithelial cells.
To develop and validate a multivariable morphological score based on summarization of differences between drug- and placebo-treated tissues.
- Independent changes in architecture and morphometry [ Time Frame: Year 4 ] [ Designated as safety issue: No ]
To determine the degree to which drug-related changes at Year 4 in architectural and nuclear features are independent of (i.e., not explained by) changes in serum DHT, gland volume and PSA.
Secondary Outcome Measures:
- Changes in cytomorphology [ Time Frame: Year 2 & Year 4 ] [ Designated as safety issue: No ]
To determine, by comparing Year 2 to Year 4 samples within individuals, whether drug-related cytomorphological changes are constant, declining or progressing.
Biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2016 (Final data collection date for primary outcome measure)
No PCa at Year 2 or Year 4
No PCa at Year 2 or Year 4
|Ages Eligible for Study:
||50 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Cross-sectional comparison of biomarkers in prostate biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01473030
|University of Illinois at Chicago
|Chicago, Illinois, United States, 60612 |
University of Illinois at Chicago
||Peter H Gann, MD, ScD
||University of Illinois at Chicago
||Peter Gann, Professor and Director, Division of Pathology Research, University of Illinois at Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 14, 2011
||December 1, 2015
||United States: Institutional Review Board
Keywords provided by University of Illinois at Chicago:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2016
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs