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Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Peter Gann, University of Illinois
ClinicalTrials.gov Identifier:
NCT01594502
First received: April 17, 2012
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Prostate Cancer
 Drug: Dutasteride
Drug: Placebo

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

Resource links provided by NLM:

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

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Multivariable treatment-response score between subjects who develop PCa while on dutasteride and those who do not. [ Time Frame: Year 4 ] [ Designated as safety issue: No ]
  • Magnitude of association between nuclear phenotype in benign biopsies, and subsequent risk of PCa in untreated men at elevated risk. [ Time Frame: Year 4 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders 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:

  • N/A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594502

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois
National Cancer Institute (NCI)
Investigators
Principal Investigator: Peter H Gann, MD, ScD University of Illinois
  More Information

No publications provided

Responsible Party: Peter Gann, Professor and Director, Division of Pathology Research, University of Illinois
ClinicalTrials.gov Identifier: NCT01594502     History of Changes
Other Study ID Numbers: 2010-0670, R01CA155301
Study First Received: April 17, 2012
Last Updated: May 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois:
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013