Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men
NCT ID: NCT00354497
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
800 participants
INTERVENTIONAL
2002-03-31
Brief Summary
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PURPOSE: This phase II trial is studying prostate cancer screening and dietary heterocyclic amines in African American men.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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SCREENING
Interventions
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physiologic testing
study of socioeconomic and demographic variables
evaluation of cancer risk factors
mutation carrier screening
study of high risk factors
Eligibility Criteria
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Inclusion Criteria
* 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
50 Years
70 Years
MALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Lawrence Livermore National Laboratory at University of California
OTHER
Principal Investigators
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Kenneth T. Bogen, DrPH, MPH, MA, ScD
Role: PRINCIPAL_INVESTIGATOR
Lawrence Livermore National Laboratory at University of California
Locations
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Lawrence Livermore National Laboratory at University of California
Livermore, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Countries
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Facility Contacts
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Kenneth T. Bogen, DrPH, MPH, MA, ScD
Role: primary
Leslie J. Paine
Role: primary
Other Identifiers
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LLNL-05-104
Identifier Type: -
Identifier Source: secondary_id
CDR0000485428
Identifier Type: -
Identifier Source: org_study_id