Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Placebo; Drug: Dutasteride

• Study Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Probability Sample

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Peter H Gann, MD, ScD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 9, 2012

Study Record Updates

• Last Update Posted (Actual): October 12, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: prostate cancer; dutasteride
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; 5-alpha Reductase Inhibitors; Dutasteride
• Other Study ID Numbers: 2010-0670; R01CA155301 (U.S. NIH Grant/Contract)