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Trial record 79 of 119 for:    DUTASTERIDE

Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01594502
Recruitment Status : Active, not recruiting
First Posted : May 9, 2012
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Peter Gann, University of Illinois at Chicago

Tracking Information
First Submitted Date April 17, 2012
First Posted Date May 9, 2012
Last Update Posted Date April 19, 2019
Study Start Date September 2011
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2012)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 7, 2012)
  • Multivariable treatment-response score between subjects who develop PCa while on dutasteride and those who do not. [ Time Frame: Year 4 ]
  • Magnitude of association between nuclear phenotype in benign biopsies, and subsequent risk of PCa in untreated men at elevated risk. [ Time Frame: Year 4 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
Official Title R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Biopsy tissue (Year 2 and Year 4) already collected in REDUCE trial
Sampling Method Probability Sample
Study Population Probability Sample
Condition Prostate Cancer
Intervention
  • Drug: Dutasteride
    0.5 mg daily
  • Drug: Placebo
    Placebo Comparator
Study Groups/Cohorts
  • Dutasteride Year 2 PCa
    Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy.
    Intervention: Drug: Dutasteride
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Dutasteride
  • Placebo, Year 2 and 4 no PCa
    Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy.
    Intervention: Drug: Placebo
  • Dutasteride, Year 2 and 4 no PCa
    Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy.
    Intervention: Drug: Dutasteride
  • Placebo, Year 2 PCa
    Subject assigned to placebo, prostate cancer found on Year 2 biopsy.
    Intervention: Drug: Placebo
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 Active, not recruiting
Estimated Enrollment
 (submitted: May 7, 2012)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01594502
Other Study ID Numbers 2010-0670
R01CA155301 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Peter Gann, University of Illinois at Chicago
Study Sponsor University of Illinois at Chicago
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Peter H Gann, MD, ScD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date April 2019