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Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03289130
Acronym
PCaP
Enrollment
2258
Registered
2017-09-20
Start date
2004-09-30
Completion date
2009-08-31
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasm

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
40 Years to 79 Years

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

\-

Design outcomes

Primary

MeasureTime frameDescription
High aggressive prostate cancerBaseline (cross-sectional study)Gleason score\>=8, or PSA\>20ng/ml, or Gleason score\>7 and clinical stage T3-T4

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026