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Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

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ClinicalTrials.gov Identifier: NCT01594502
Recruitment Status : Active, not recruiting
First Posted : May 9, 2012
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Peter Gann, University of Illinois at Chicago

Brief Summary:
The goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.

Condition or disease Intervention/treatment
Prostate Cancer Drug: Dutasteride Drug: Placebo

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
Study Start Date : September 2011
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride
U.S. FDA Resources

Group/Cohort Intervention/treatment
Dutasteride Year 2 PCa
Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy.
Drug: Dutasteride
0.5 mg daily
Placebo Year 2 no PCa, Year 4 PCa
Subject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
Drug: Placebo
Placebo Comparator
Dutasteride Year 2 no PCa, Year 4 PCa
Subject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy.
Drug: Dutasteride
0.5 mg daily
Placebo, Year 2 and 4 no PCa
Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy.
Drug: Placebo
Placebo Comparator
Dutasteride, Year 2 and 4 no PCa
Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy.
Drug: Dutasteride
0.5 mg daily
Placebo, Year 2 PCa
Subject assigned to placebo, prostate cancer found on Year 2 biopsy.
Drug: Placebo
Placebo Comparator



Primary Outcome Measures :
  1. Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue. [ Time Frame: Year 4 ]

Secondary Outcome Measures :
  1. Multivariable treatment-response score between subjects who develop PCa while on dutasteride and those who do not. [ Time Frame: Year 4 ]
  2. Magnitude of association between nuclear phenotype in benign biopsies, and subsequent risk of PCa in untreated men at elevated risk. [ Time Frame: Year 4 ]

Biospecimen Retention:   Samples Without DNA
Biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Probability Sample
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

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): NCT01594502


Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Cancer Institute (NCI)
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: NCT01594502     History of Changes
Other Study ID Numbers: 2010-0670
R01CA155301 ( U.S. NIH Grant/Contract )
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Peter Gann, University of Illinois at Chicago:
prostate cancer
dutasteride

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
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