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CompletedNCT03289130PCaPUpdated Apr 17, 2019

Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness

An observational study in Prostatic Neoplasm, sponsored by University of South Carolina. Completed. Open to male participants aged 40 Years to 79 Years. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by University of South Carolina · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
2,258
Ages
40 Years to 79 Years
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

  • Prostatic Neoplasm

Browse trials for

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Who can participate

Ages eligible
40 Years to 79 Years
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

-

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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
2,258 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. High aggressive prostate cancer

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

    Time frame: Baseline (cross-sectional study)

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 16676364 ↗
  • 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. PubMed 29722851 ↗

Individual participant data

Plan to share: Yes — Deidentified data may be requested from PCaP through a centralized data request process.

Supporting information: Study protocol

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Registry details

Key details

Study ID
NCT03289130
Lead sponsor
University of South Carolina
Collaborators
United States Department of Defense, University of North Carolina, Chapel Hill, Louisiana State University Health Sciences Center in New Orleans
Responsible party
Susan Steck (Associate Professor, University of South Carolina) — Principal investigator
First posted
Sep 20, 2017
Start date
Sep 2004
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Apr 17, 2019

Study contacts

Susan E Steck
principal investigator · University of South Carolina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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