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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:
ClinicalTrials.gov Identifier:
NCT01473030
First Posted: November 17, 2011
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Peter Gann, University of Illinois at Chicago
November 14, 2011
November 17, 2011
November 6, 2017
November 2011
December 2017   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01473030 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
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.
Not Provided
Observational
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Not Provided
Biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial
Probability Sample
Cross-sectional comparison of biomarkers in prostate biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial
Benign Prostate Tissue
Not Provided
  • Dutasteride
    No PCa at Year 2 or Year 4
  • Placebo
    No PCa at Year 2 or Year 4
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2018
December 2017   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: Male
50 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01473030
2011-0646
No
Not Provided
Not Provided
Peter Gann, University of Illinois at Chicago
University of Illinois at Chicago
GlaxoSmithKline
Principal Investigator: Peter H Gann, MD, ScD University of Illinois at Chicago
University of Illinois at Chicago
November 2017