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.
Study Type
OBSERVATIONAL
Enrollment
80
University of Illinois at Chicago
Chicago, Illinois, United States
Architectural Features
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.
Time frame: Year 4
Morphometric features
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.
Time frame: Year 4
Independent changes in architecture and morphometry
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.
Time frame: Year 4
Changes in cytomorphology
To determine, by comparing Year 2 to Year 4 samples within individuals, whether drug-related cytomorphological changes are constant, declining or progressing.
Time frame: Year 2 & Year 4
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