This trial is active, not recruiting.

Condition benign prostate tissue
Sponsor University of Illinois at Chicago
Collaborator GlaxoSmithKline
Start date November 2011
End date December 2016
Trial size 80 participants
Trial identifier NCT01473030, 2011-0646


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
No PCa at Year 2 or Year 4
No PCa at Year 2 or Year 4

Primary Outcomes

Architectural Features
time frame: Year 4
Morphometric features
time frame: Year 4
Independent changes in architecture and morphometry
time frame: Year 4

Secondary Outcomes

Changes in cytomorphology
time frame: Year 2 & Year 4

Eligibility Criteria

Male participants from 50 years up to 75 years old.

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:

Additional Information

Official title Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
Principal investigator Peter H Gann, MD, ScD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Illinois at Chicago.