Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

October 9, 2020 updated by: Peter Gann, University of Illinois at Chicago

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: Year 4
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.
Time Frame: Year 4
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
Year 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-0670
  • R01CA155301 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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