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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 14, 2011

Last Updated Date

January 15, 2013

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01473030 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

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

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

Condition ^ICMJE

Benign Prostate Tissue

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Dutasteride
No PCa at Year 2 or Year 4
Placebo
No PCa at Year 2 or Year 4

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

August 2016

Estimated Primary Completion Date

August 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Gender

Male

Ages

50 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01473030

Other Study ID Numbers ^ICMJE

2011-0646

Has Data Monitoring Committee

Responsible Party

Peter Gann, University of Illinois

Study Sponsor ^ICMJE

University of Illinois

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Peter H Gann, MD, ScD

University of Illinois

Information Provided By

University of Illinois

Verification Date

January 2013

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

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