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
ClinicalTrials.gov Identifier:
NCT01473030
First received: November 14, 2011
Last updated: January 15, 2013
Last verified: January 2013

November 14, 2011
January 15, 2013
November 2011
August 2015   (final data collection date for primary outcome measure)
  • 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.
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 ] [ 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.
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
August 2016
August 2015   (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:

  • N/A
Male
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01473030
2011-0646
No
Peter Gann, University of Illinois
University of Illinois at Chicago
GlaxoSmithKline
Principal Investigator: Peter H Gann, MD, ScD University of Illinois at Chicago
University of Illinois at Chicago
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP