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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:
Information provided by (Responsible Party):
Peter Gann, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01594502
First received: April 17, 2012
Last updated: April 17, 2014
Last verified: April 2014
  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:


Further study details as provided by University of Illinois at Chicago:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 at Chicago
Investigators
Principal Investigator: Peter H Gann, MD, ScD University of Illinois at Chicago
  More Information

No publications provided

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
Study First Received: April 17, 2012
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 20, 2014