R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Placebo Year 2 no PCa, Year 4 PCa
Subject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
干预措施: Placebo (Drug)
Dutasteride Year 2 no PCa, Year 4 PCa
Subject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
干预措施: Dutasteride (Drug)
Placebo, Year 2 and 4 no PCa
Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy.
干预措施: Placebo (Drug)
Dutasteride Year 2 PCa
Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy.
干预措施: Dutasteride (Drug)
Dutasteride, Year 2 and 4 no PCa
Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy.
干预措施: Dutasteride (Drug)
Placebo, Year 2 PCa
Subject assigned to placebo, prostate cancer found on Year 2 biopsy.
干预措施: Placebo (Drug)
结局指标
主要结局
Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue.
时间窗: Year 4
次要结局
- 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)
研究者
Peter Gann
Professor and Director, Division of Pathology Research
University of Illinois at Chicago