Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
physiologic testing
study of socioeconomic and demographic variables
evaluation of cancer risk factors
mutation carrier screening
study of high risk factors
Sponsored by
About this trial
This is an interventional screening trial for Prostate Cancer focused on measuring prostate cancer
Eligibility 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
Sites / Locations
- Lawrence Livermore National Laboratory at University of CaliforniaRecruiting
- Alta Bates Summit Medical Center - Summit CampusRecruiting
Outcomes
Primary Outcome Measures
Dietary heterocyclic amine (HA) exposure in African American men
Correlation of HA exposure with prostate cancer screening results
Secondary Outcome Measures
Full Information
NCT ID
NCT00354497
First Posted
July 19, 2006
Last Updated
September 19, 2013
Sponsor
Lawrence Livermore National Laboratory at University of California
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00354497
Brief Title
Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men
Official Title
Prostate Cancer Screening and Dietary HA Exposure in African-Americans: Phase II
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Lawrence Livermore National Laboratory at University of California
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
physiologic testing
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Intervention Type
Procedure
Intervention Name(s)
evaluation of cancer risk factors
Intervention Type
Procedure
Intervention Name(s)
mutation carrier screening
Intervention Type
Procedure
Intervention Name(s)
study of high risk factors
Primary Outcome Measure Information:
Title
Dietary heterocyclic amine (HA) exposure in African American men
Title
Correlation of HA exposure with prostate cancer screening results
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth T. Bogen, DrPH, MPH, MA, ScD
Organizational Affiliation
Lawrence Livermore National Laboratory at University of California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lawrence Livermore National Laboratory at University of California
City
Livermore
State/Province
California
ZIP/Postal Code
94550
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth T. Bogen, DrPH, MPH, MA, ScD
Phone
925-422-0902
Email
bogen@llnl.gov
Facility Name
Alta Bates Summit Medical Center - Summit Campus
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie J. Paine
Phone
510-869-8833
Email
painel@sutterhealth.org
12. IPD Sharing Statement
Learn more about this trial
Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men
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