Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men

September 19, 2013 updated by: Lawrence Livermore National Laboratory at University of California

Prostate Cancer Screening and Dietary HA Exposure in African-Americans: Phase II

RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to treat. The amount of heterocyclic amines in the diet may affect prostate cancer screening results and the risk of prostate cancer.

PURPOSE: This phase II trial is studying prostate cancer screening and dietary heterocyclic amines in African American men.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Estimate dietary heterocyclic amine (HA) exposure in African American men who use HA-forming meats and cooking methods.
  • Correlate dietary HA exposure with prostate-specific antigen and digital rectal exam screening results (i.e., higher HA exposure with increased abnormality in prostate cancer screening results) in these participants.

OUTLINE: This is a prospective study.

Participants complete a routine medical questionnaire and undergo a detailed dietary interview that focuses on meat consumption, cooking preferences, and other factors that may be associated with prostate cancer risk. Participants then undergo a digital rectal exam (DRE) and blood collection for prostate-specific antigen (PSA) testing (total PSA and % free PSA). Results of PSA testing and DRE, including follow-up instructions (if needed), are sent to the participant 3-4 weeks later.

Blood samples are also examined by phenotypic assays for UV-damage induced nucleotide excision-repair capacity.

PROJECTED ACCRUAL: A total of 800 participants will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Livermore, California, United States, 94550
        • Recruiting
        • Lawrence Livermore National Laboratory at University of California
        • Contact:
          • Kenneth T. Bogen, DrPH, MPH, MA, ScD
          • Phone Number: 925-422-0902
          • Email: bogen@llnl.gov
      • Oakland, California, United States, 94609
        • Recruiting
        • Alta Bates Summit Medical Center - Summit Campus
        • Contact:

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

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • African American male
  • No previous diagnosis of prostate cancer
  • Desires prostate cancer screening as a routine preventative medical service

PATIENT CHARACTERISTICS:

  • Lives in or near Oakland, California
  • Speaks English
  • No medical or other disability (e.g., blindness, psychological dysfunction, or amputation) that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • Not specified

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

  • Primary Purpose: Screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Dietary heterocyclic amine (HA) exposure in African American men
Correlation of HA exposure with prostate cancer screening results

Collaborators and Investigators

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

Sponsor

Lawrence Livermore National Laboratory at University of California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kenneth T. Bogen, DrPH, MPH, MA, ScD, Lawrence Livermore National Laboratory at University of California

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

March 1, 2002

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 20, 2006

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000485428
  • LLNL-05-104

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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