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PCaP: Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness

Sponsor
University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT03289130
Collaborator
United States Department of Defense (U.S. Fed), University of North Carolina, Chapel Hill (Other), Louisiana State University Health Sciences Center in New Orleans (Other)
2,258
Enrollment
59
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The North Carolina-Louisiana Prostate Cancer Project is a population-based case-only study of over 2,000 men newly diagnosed with prostate cancer designed to address racial differences in prostate cancer aggressiveness and survival through a comprehensive evaluation of social, individual, and tumor level influences on prostate cancer aggressiveness. Project 3 specifically aims to examine nutritional modulation of prostate cancer aggressiveness using dietary assessment and biomarker-based data on dietary factors.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A total of 2,258 (1,130 African Americans and 1128 European Americans) men newly diagnosed with prostate cancer in North Carolina and Louisiana were enrolled into the study between 2004 and 2009. Participants signed informed consent and were interviewed by a trained nurse who collected information on demographics, occupation, family history, health status, health care, prostate cancer diagnosis and screening history, medication use, anthropometrics, lifestyle factors (e.g., physical activity, smoking), and diet and supplement use. Research subjects were asked to recall their diet in the year prior to prostate cancer diagnosis via a modified version of the National Cancer Institute Diet History Questionnaire. Vitamin and supplement use in the year prior to prostate cancer diagnosis was assessed via a validated questionnaire, and current use was assessed by bottle label inventory. Blood, urine, and adipose tissue samples were collected.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2258 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    The North Carolina-Louisiana Prostate Cancer Project, Project 3 Ancillary Study
    Actual Study Start Date :
    Sep 1, 2004
    Actual Primary Completion Date :
    Aug 1, 2009
    Actual Study Completion Date :
    Aug 1, 2009

    Outcome Measures

    Primary Outcome Measures

    1. High aggressive prostate cancer [Baseline (cross-sectional study)]

      Gleason score>=8, or PSA>20ng/ml, or Gleason score>7 and clinical stage T3-T4

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 79 Years
    Sexes Eligible for Study:
    Male
    Inclusion Criteria:

    • first diagnosis of histologically confirmed adenocarcinoma of the prostate

    • 40-79 years old at diagnosis,

    • can complete the study interview in English,

    • do not live in an institution (nursing home),

    • are not cognitively impaired or in a severely debilitated physical state,

    • are not under the influence of alcohol, severely medicated, or apparently psychotic at the time of the interview.

    • must self-identify as at least part African American/Black or Caucasian American/White/European American.

    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of South Carolina
    • United States Department of Defense
    • University of North Carolina, Chapel Hill
    • Louisiana State University Health Sciences Center in New Orleans

    Investigators

    • Principal Investigator: Susan E Steck, University of South Carolina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Susan Steck, Associate Professor, University of South Carolina
    ClinicalTrials.gov Identifier:
    NCT03289130
    Other Study ID Numbers:
    • DAMD-11-1-0568
    First Posted:
    Sep 20, 2017
    Last Update Posted:
    Apr 17, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Apr 17, 2019