Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness

Completed

• Conditions: Prostatic Neoplasm

• Registration Number: NCT03289130
• Lead Sponsor: University of South Carolina

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.

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 Timeline

• Study Start: 2004-09
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2258

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High aggressive prostate cancer	Baseline (cross-sectional study)	Gleason score\>=8, or PSA\>20ng/ml, or Gleason score\>7 and clinical stage T3-T4