Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness

Prostatic Neoplasm Clinical Trial

— PCaP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289130
• Other study ID #: DAMD-11-1-0568
• Status: Completed
• Start date: September 2004
• Est. completion date: August 2009

Study information

• Verified date: April 2019
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2258
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Gender: Male
• Age group: 40 Years to 79 Years

Eligibility

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:

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High aggressive prostate cancer	Gleason score>=8, or PSA>20ng/ml, or Gleason score>7 and clinical stage T3-T4	Baseline (cross-sectional study)