Clinical trial NCT03289130: Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness
Official title: The North Carolina-Louisiana Prostate Cancer Project, Project 3 Ancillary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasm
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: University of North Carolina, Chapel Hill
name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2017-09-20
Enrollment: 2258
Sex: MALE
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of North Carolina and Louisiana with a first diagnosis of prostate cancer.

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.

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:

-

Primary outcomes:
measure: High aggressive prostate cancer
timeFrame: Baseline (cross-sectional study)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of South Carolina
name: Susan E Steck
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.