Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

NCT01594502 | Completed

• 2 other identifiers: 2010-0670R01CA155301
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; dutasteride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (6)

Dutasteride Year 2 PCa

Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy.

Drug: Dutasteride

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

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

Placebo, Year 2 and 4 no PCa

Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy.

Drug: Placebo

Dutasteride, Year 2 and 4 no PCa

Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy.

Drug: Dutasteride

Placebo, Year 2 PCa

Subject assigned to placebo, prostate cancer found on Year 2 biopsy.

Drug: Placebo

Interventions

Dutasteride DRUG

0.5 mg daily

Dutasteride Year 2 PCa; Dutasteride Year 2 no PCa, Year 4 PCa; Dutasteride, Year 2 and 4 no PCa

Placebo DRUG

Placebo Comparator

Placebo Year 2 no PCa, Year 4 PCa; Placebo, Year 2 PCa; Placebo, Year 2 and 4 no PCa

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Probability Sample

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Peter H Gann, MD, ScD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Division of Pathology Research

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: May 9, 2012
• Study Start: September 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: July 1, 2016
• Last Updated: October 12, 2020

Record last verified: 2020-10

Locations

US (1)