Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness (PCaP)

April 15, 2019 updated by: Susan Steck, University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

2258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Principal Investigator: Susan E Steck, University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2004

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 18, 2017

First Posted (ACTUAL)

September 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAMD-11-1-0568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data may be requested from PCaP through a centralized data request process.

IPD Sharing Time Frame

Data are currently available indefinitely.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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