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OpenTrials
Completed

NCT Number: NCT01473030

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.

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Key information

Conditions

Benign Prostate Tissue

Age range

50 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • GlaxoSmithKline

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2011
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.