Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men

Phase 2

• Conditions: Prostate Cancer

• Registration Number: NCT00354497
• Lead Sponsor: Lawrence Livermore National Laboratory at University of California

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.

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 Timeline

• Study Start: 2002-03
• Study First Submitted: 2006-07-19
• Study First Submitted QC: 2006-07-19
• Study First Posted: 2006-07-20
• Status Verified: 2008-08
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

Alta Bates Summit Medical Center - Summit Campus; 🇺🇸 Oakland, California, United States

Lawrence Livermore National Laboratory at University of California; 🇺🇸 Livermore, California, United States