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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dutasteride | No PCa at Year 2 or Year 4 | ||
| Placebo | No PCa at Year 2 or Year 4 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Year 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Year 2 & Year 4 |
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Inclusion Criteria:
Exclusion Criteria:
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Cross-sectional comparison of biomarkers in prostate biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial
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| Name | Affiliation | Role |
|---|---|---|
| Peter H Gann, MD, ScD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
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Biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial