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Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00354497
Recruitment Status : Unknown
Verified August 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : July 20, 2006
Last Update Posted : September 20, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment 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

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Primary Purpose: Screening
Official Title: Prostate Cancer Screening and Dietary HA Exposure in African-Americans: Phase II
Study Start Date : March 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Dietary heterocyclic amine (HA) exposure in African American men
  2. Correlation of HA exposure with prostate cancer screening results

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes


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


  • 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


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00354497

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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   
Alta Bates Summit Medical Center - Summit Campus Recruiting
Oakland, California, United States, 94609
Contact: Leslie J. Paine    510-869-8833   
Sponsors and Collaborators
Lawrence Livermore National Laboratory at University of California
National Cancer Institute (NCI)
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Principal Investigator: Kenneth T. Bogen, DrPH, MPH, MA, ScD Lawrence Livermore National Laboratory at University of California
Layout table for additonal information Identifier: NCT00354497    
Other Study ID Numbers: CDR0000485428
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: August 2008
Keywords provided by National Cancer Institute (NCI):
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases