New Clinical Trial: Risk Factors in African American Men

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: cancer prevention intervention  Procedure: evaluation of cancer risk factors  Procedure: mutation carrier screening  Procedure: screening intervention  Procedure: study of high risk factors  Procedure: study of physiologic variables  Procedure: study of socioeconomic and demographic variables	Phase II

Further study details as provided by National Cancer Institute (NCI):

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.

Ages Eligible for Study:  50 Years   -   70 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00354497

California
      Alta Bates Summit Medical Center - Summit Campus, Oakland,  California,  94609,  United States; Recruiting
      Lawrence Livermore National Laboratory at University of California, Livermore,  California,  94550,  United States; Recruiting

Study chairs or principal investigators

Kenneth T. Bogen, DrPH, MPH, MA,  Principal Investigator,  Lawrence Livermore National Laboratory at University of California   

Study ID Numbers:  CDR0000485428; LLNL-05-104
Last Updated:  July 19, 2006
Record first received:  July 19, 2006
ClinicalTrials.gov Identifier:  NCT00354497
Health Authority: United States: Federal Government