Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Dutasteride Year 2 PCa Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy. |
Drug: Dutasteride
0.5 mg daily
|
| 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. |
Drug: Placebo
Placebo Comparator
|
| 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. |
Drug: Dutasteride
0.5 mg daily
|
| Placebo, Year 2 and 4 no PCa Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy. |
Drug: Placebo
Placebo Comparator
|
| Dutasteride, Year 2 and 4 no PCa Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy. |
Drug: Dutasteride
0.5 mg daily
|
| Placebo, Year 2 PCa Subject assigned to placebo, prostate cancer found on Year 2 biopsy. |
Drug: Placebo
Placebo Comparator
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Peter H Gann, MD, ScD, University of Illinois at Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2010-0670
- R01CA155301