Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594502
• Other study ID #: 2010-0670
• Secondary ID: R01CA155301
• Status: Completed
• Start date: September 2011
• Est. completion date: July 2016

Study information

• Verified date: October 2020
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: July 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Dutasteride
0.5 mg daily
• Placebo
Placebo Comparator

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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