Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Placebo; Drug: Dutasteride

• Registration Number: NCT01594502
• Lead Sponsor: University of Illinois at Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-09
• Primary Completion: 2015-11
• Study Completion: 2016-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-09
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 139

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo, Year 2 PCa	Placebo	Subject assigned to placebo, prostate cancer found on Year 2 biopsy.
Dutasteride, Year 2 and 4 no PCa	Dutasteride	Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy.
Placebo Year 2 no PCa, Year 4 PCa	Placebo	Subject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
Placebo, Year 2 and 4 no PCa	Placebo	Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy.
Dutasteride Year 2 no PCa, Year 4 PCa	Dutasteride	Subject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
Dutasteride Year 2 PCa	Dutasteride	Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States