Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments dutasteride, placebo
Sponsor University of Illinois at Chicago
Collaborator National Cancer Institute (NCI)
Start date September 2011
End date July 2017
Trial size 300 participants
Trial identifier NCT01594502, 2010-0670, R01CA155301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm
Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy.
dutasteride
0.5 mg daily
Subject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
placebo
Placebo Comparator
Subject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
dutasteride
0.5 mg daily
Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy.
placebo
Placebo Comparator
Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy.
dutasteride
0.5 mg daily
Subject assigned to placebo, prostate cancer found on Year 2 biopsy.
placebo
Placebo Comparator

Primary Outcomes

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.
time frame: Year 4

Secondary Outcomes

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

Eligibility Criteria

Male participants from 50 years up to 75 years old.

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:

Additional Information

Official title R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
Principal investigator Peter H Gann, MD, ScD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Illinois at Chicago.