Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness

NCT03289130 | Completed

• 1 other identifier: DAMD-11-1-0568
• Study Type: observational
• Target: 2,258
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• High aggressive prostate cancer

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

  Baseline (cross-sectional study)

Eligibility Criteria

• Age: 40 Years - 79 Years
• Gender Eligibility Details: Only males were enrolled (prostate cancer only occurs in males).
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents of North Carolina and Louisiana with a first diagnosis of prostate cancer.

You may qualify if:

• first diagnosis of histologically confirmed adenocarcinoma of the prostate
• 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.

Sponsors & Collaborators

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

Related Publications (2)

• 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.

  PMID: 16676364 BACKGROUND

• 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.

  PMID: 29722851 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, urine, adipose tissue, DNA extracted from whole blood, frozen tissue

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Susan E Steck

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: September 1, 2004
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data are currently available indefinitely.