Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men

Basic Trial Information

Objectives

1. Estimate dietary heterocyclic amine (HA) exposure in African American men who use HA-forming meats and cooking methods.
2. 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.

Entry Criteria

Disease Characteristics:

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

Prior/Concurrent Therapy:

• Not specified

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

Expected Enrollment

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

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Lawrence Livermore National Laboratory at University of California

Kenneth Bogen, DrPH, MPH, MA, ScD, Principal investigator		Ph: 925-422-0902 Email: bogen@llnl.gov

U.S.A.
California
	Livermore
	Lawrence Livermore National Laboratory at University of California
		Kenneth Bogen, DrPH, MPH, MA, ScD	Ph:  925-422-0902
			Email: bogen@llnl.gov
	Oakland
	Alta Bates Summit Medical Center - Summit Campus
		Leslie Paine	Ph:  510-869-8833
			Email: painel@sutterhealth.org

Registry Information
Official Title		Prostate Cancer Screening and Dietary HA Exposure in African-Americans: Phase II
Trial Start Date		2002-03-21
Registered in ClinicalTrials.gov		NCT00354497
Date Submitted to PDQ		2006-05-10
Information Last Verified		2008-08-08
NCI Grant/Contract Number		CA55861

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