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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: December 1, 2015
Last verified: December 2015
  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 2017
Estimated Primary Completion Date: December 2016 (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   (Adult, Senior)
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: December 1, 2015
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
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016