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Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00354497
First received: July 19, 2006
Last updated: May 9, 2009
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Other: physiologic testing
Other: study of socioeconomic and demographic variables
Procedure: evaluation of cancer risk factors
Procedure: mutation carrier screening
Procedure: study of high risk factors
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Prostate Cancer Screening and Dietary HA Exposure in African-Americans: Phase II

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Dietary heterocyclic amine (HA) exposure in African American men [ Designated as safety issue: No ]
  • Correlation of HA exposure with prostate cancer screening results [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: March 2002
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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354497

Locations
United States, California
Lawrence Livermore National Laboratory at University of California Recruiting
Livermore, California, United States, 94550
Contact: Kenneth T. Bogen, DrPH, MPH, MA, ScD     925-422-0902     bogen@llnl.gov    
Alta Bates Summit Medical Center - Summit Campus Recruiting
Oakland, California, United States, 94609
Contact: Leslie J. Paine     510-869-8833     painel@sutterhealth.org    
Sponsors and Collaborators
Lawrence Livermore National Laboratory at University of California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kenneth T. Bogen, DrPH, MPH, MA, ScD Lawrence Livermore National Laboratory at University of California
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00354497     History of Changes
Other Study ID Numbers: CDR0000485428, LLNL-05-104
Study First Received: July 19, 2006
Last Updated: May 9, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013