Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

Study Overview
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Brief Summary
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The goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.

Official Title
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R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Dutasteride
* Drug: Placebo


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 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 Year 2 PCa<br>Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy. | Drug: Dutasteride<br>* 0.5 mg daily<br>|
| Placebo Year 2 no PCa, Year 4 PCa<br>Subject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy. | Drug: Placebo<br>* Placebo Comparator<br>|
| Dutasteride Year 2 no PCa, Year 4 PCa<br>Subject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy. | Drug: Dutasteride<br>* 0.5 mg daily<br>|
| Placebo, Year 2 and 4 no PCa<br>Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy. | Drug: Placebo<br>* Placebo Comparator<br>|
| Dutasteride, Year 2 and 4 no PCa<br>Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy. | Drug: Dutasteride<br>* 0.5 mg daily<br>|
| Placebo, Year 2 PCa<br>Subject assigned to placebo, prostate cancer found on Year 2 biopsy. | Drug: Placebo<br>* Placebo Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue. |  | Year 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multivariable treatment-response score between subjects who develop PCa while on dutasteride and those who do not. |  | Year 4 | 
| Magnitude of association between nuclear phenotype in benign biopsies, and subsequent risk of PCa in untreated men at elevated risk. |  | Year 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, dutasteride