DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: University of Illinois at Chicago
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostate Tissue

Phase: N/A

Status: Active, not recruiting

Sponsored by: University of Illinois at Chicago

Official(s) and/or principal investigator(s):
Peter H Gann, MD, ScD, Principal Investigator, Affiliation: University of Illinois at Chicago

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.

Clinical Details

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

Study design: Observational Model: Case Control, Time Perspective: Cross-Sectional

Primary outcome:

Architectural Features

Morphometric features

Independent changes in architecture and morphometry

Secondary outcome: Changes in cytomorphology

Eligibility

Minimum age: 50 Years. Maximum age: 75 Years. Gender(s): Male.

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:

- N/A

Locations and Contacts

University of Illinois at Chicago, Chicago, Illinois 60612, United States
Additional Information

Starting date: November 2011
Last updated: April 17, 2014

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017