Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men - Full Text View

Sponsors and Collaborators:	Lawrence Livermore National Laboratory at University of California 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	Procedure: evaluation of cancer risk factors Procedure: mutation carrier screening Procedure: physiologic testing Procedure: study of high risk factors Procedure: study of socioeconomic and demographic variables	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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

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
Alta Bates Summit Medical Center - Summit Campus	Recruiting
Oakland, California, United States, 94609
Contact: Leslie J. Paine 510-869-8833 painel@sutterhealth.org
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

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

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

Study ID Numbers:	CDR0000485428, LLNL-05-104
Study First Received:	July 19, 2006
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00354497
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009