Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue

Completed

Conditions studied: Benign Prostate Tissue

In brief

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.

Key facts

Study ID

NCT01473030

Run by

University of Illinois at Chicago

People needed

80

Starts

2011-11-01

Expected to finish

2018-12-01

Last updated by the study team

2020-10-05

Who can join

Age: 50 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• N/A

Where it is running

• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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