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

Study Overview
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Brief Summary
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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.

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

Conditions
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Benign Prostate Tissue

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dutasteride<br>No PCa at Year 2 or Year 4 | |
| Placebo<br>No PCa at Year 2 or Year 4 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign prostate, serum DHT, Dutasteride, PSA, Avodart