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

First Received on July 19, 2006. Last Updated on May 9, 2009 History of Changes

Sponsor:	Lawrence Livermore National Laboratory at University of California
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00354497

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 II

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:

MedlinePlus related topics: Cancer Prostate Cancer

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 February 09, 2012