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Completed

NCT Number: NCT03289130

Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. High aggressive prostate cancer

    Time frame: Baseline (cross-sectional study)

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

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

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

Registry information

Official study title

The North Carolina-Louisiana Prostate Cancer Project, Project 3 Ancillary Study

Acronym: PCaP

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2017
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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