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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Peter Gann, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01473030
First received: November 14, 2011
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition
Benign Prostate Tissue

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Architectural Features [ Time Frame: Year 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Changes in cytomorphology [ Time Frame: Year 2 & Year 4 ] [ Designated as safety issue: No ]
    To determine, by comparing Year 2 to Year 4 samples within individuals, whether drug-related cytomorphological changes are constant, declining or progressing.


Biospecimen Description:

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


Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dutasteride
No PCa at Year 2 or Year 4
Placebo
No PCa at Year 2 or Year 4

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473030

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
GlaxoSmithKline
Investigators
Principal Investigator: Peter H Gann, MD, ScD University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: Peter Gann, Professor and Director, Division of Pathology Research, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01473030     History of Changes
Other Study ID Numbers: 2011-0646
Study First Received: November 14, 2011
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Benign prostate
serum DHT
Dutasteride
PSA
Avodart

Additional relevant MeSH terms:
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014