Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness

NCT ID: NCT03289130

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2258 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2009-08-31

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.

Conditions

Prostatic Neoplasm

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

-

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Susan Steck

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan E Steck

Role: PRINCIPAL_INVESTIGATOR

University of South Carolina

References

Schroeder JC, Bensen JT, Su LJ, Mishel M, Ivanova A, Smith GJ, Godley PA, Fontham ET, Mohler JL. The North Carolina-Louisiana Prostate Cancer Project (PCaP): methods and design of a multidisciplinary population-based cohort study of racial differences in prostate cancer outcomes. Prostate. 2006 Aug 1;66(11):1162-76. doi: 10.1002/pros.20449.

Reference Type: BACKGROUND

PMID: 16676364 (View on PubMed)

Steck SE, Omofuma OO, Su LJ, Maise AA, Woloszynska-Read A, Johnson CS, Zhang H, Bensen JT, Fontham ETH, Mohler JL, Arab L. Calcium, magnesium, and whole-milk intakes and high-aggressive prostate cancer in the North Carolina-Louisiana Prostate Cancer Project (PCaP). Am J Clin Nutr. 2018 May 1;107(5):799-807. doi: 10.1093/ajcn/nqy037.

Reference Type: DERIVED

PMID: 29722851 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

View Document

Other Identifiers

DAMD-11-1-0568

Identifier Type: -

Identifier Source: org_study_id