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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 2018

Arms, Groups and Cohorts

  • Dutasteride
    • No PCa at Year 2 or Year 4
  • Placebo
    • No PCa at Year 2 or Year 4

Clinical Trial Outcome Measures

Primary Measures

  • Architectural Features
    • Time Frame: Year 4
    • 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.
  • Morphometric features
    • Time Frame: Year 4
    • 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.
  • Independent changes in architecture and morphometry
    • Time Frame: Year 4
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 50 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Illinois at Chicago
  • Collaborator
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Principal Investigator: Peter Gann, Professor and Director, Division of Pathology Research – University of Illinois at Chicago
  • Overall Official(s)
    • Peter H Gann, MD, ScD, Principal Investigator, University of Illinois at Chicago

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