Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue

The overall goal of this project is to quantify the long-term effects of dutasteride on the architectural and nuclear features of benign prostate tissue, using state-of-the art digital image analysis techniques. The ultimate result will be a multivariable morphological "signature" that could provide a useful indicator of an individual's degree of drug response.

Study Overview

• Status: Completed
• Conditions: Benign Prostate Tissue

• Study Type: Observational
• Enrollment (Actual): 80

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

Cross-sectional comparison of biomarkers in prostate biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial

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
• subgroup: Year 2 biopsy blocks and HE slides available for Aim 4a

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Dutasteride; No PCa at Year 2 or Year 4
Placebo; No PCa at Year 2 or Year 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Architectural Features	To characterize and quantify the effects of dutasteride on histological (architectural) features of benign prostate tissue via comparison of a random sample of Year 4 biopsy specimens from the dutasteride and placebo groups.	Year 4
Morphometric features	To quantify the long-term (Year 4) effects of dutasteride on nuclear morphometric features (i.e., size, shape and texture) in benign prostatic epithelial cells. To develop and validate a multivariable morphological score based on summarization of differences between drug- and placebo-treated tissues.	Year 4
Independent changes in architecture and morphometry	To determine the degree to which drug-related changes at Year 4 in architectural and nuclear features are independent of (i.e., not explained by) changes in serum DHT, gland volume and PSA.	Year 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cytomorphology	To determine, by comparing Year 2 to Year 4 samples within individuals, whether drug-related cytomorphological changes are constant, declining or progressing.	Year 2 & Year 4

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Peter H Gann, MD, ScD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 14, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: PSA; Dutasteride; Avodart; Benign prostate; serum DHT
• Other Study ID Numbers: 2011-0646