Prostate Cancer
Conditions
Keywords
prostate cancer, dutasteride
Brief summary
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.
Interventions
DRUGDutasteride
0.5 mg daily
DRUGPlacebo
Placebo Comparator
Sponsors
National Cancer Institute (NCI)
University of Illinois at Chicago
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed