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

University of Illinois

Status: Completed

Conditions: Benign Prostate Tissue

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01473030

2011-0646

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Dutasteride

Description:

No PCa at Year 2 or Year 4

Placebo

Description:

No PCa at Year 2 or Year 4