Text Size

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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00354497
First received: July 19, 2006
Last updated: May 9, 2009
Last verified: August 2008
History of Changes

July 19, 2006
May 9, 2009
March 2002
 
  • 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 ]
  • Dietary heterocyclic amine (HA) exposure in African American men
  • Correlation of HA exposure with prostate cancer screening results
Complete list of historical versions of study NCT00354497 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men
Prostate Cancer Screening and Dietary HA Exposure in African-Americans: Phase II

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.

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.
Interventional
Phase 2
Primary Purpose: Screening
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
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
 
 

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
Male
50 Years to 70 Years
Yes
 
United States
 
NCT00354497
CDR0000485428, LLNL-05-104
 
 
Lawrence Livermore National Laboratory at University of California
National Cancer Institute (NCI)
Principal Investigator: Kenneth T. Bogen, DrPH, MPH, MA, ScD Lawrence Livermore National Laboratory at University of California
National Cancer Institute (NCI)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP