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

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ClinicalTrials.gov Identifier: NCT01473030
Recruitment Status : Active, not recruiting
First Posted : November 17, 2011
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Peter Gann, University of Illinois at Chicago

Brief Summary:
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 or disease
Benign Prostate Tissue

Study Type : Observational
Actual Enrollment : 80 participants
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
Study Start Date : November 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.


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


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes 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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Peter Gann, 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