Trial Information
R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
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
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Cross-Sectional
Outcome Measure:
Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue.
Outcome Time Frame:
Year 4
Safety Issue:
No
Principal Investigator
Peter H Gann, MD, ScD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Illinois
Authority:
United States: Institutional Review Board
Study ID:
2010-0670
NCT ID:
NCT01594502
Start Date:
September 2011
Completion Date:
July 2021
Related Keywords:
- Prostate Cancer
- prostate cancer
- dutasteride
- Prostatic Neoplasms
Name | Location |
University of Illinois at Chicago |
Chicago, Illinois 60612 |