Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

Completed · Has a placebo group

Conditions studied: Prostate Cancer

In brief

The goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.

Key facts

Study ID

NCT01594502

Run by

University of Illinois at Chicago

People needed

139

Starts

2011-09-01

Expected to finish

2016-07-01

Last updated by the study team

2020-10-12

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

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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