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Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00354497
First Posted: July 20, 2006
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  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 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 Phase 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Dietary heterocyclic amine (HA) exposure in African American men
  • Correlation of HA exposure with prostate cancer screening results

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354497


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

ClinicalTrials.gov Identifier: NCT00354497     History of Changes
Other Study ID Numbers: CDR0000485428
LLNL-05-104
First Submitted: July 19, 2006
First Posted: July 20, 2006
Last Update Posted: September 20, 2013
Last Verified: August 2008

Keywords provided by National Cancer Institute (NCI):
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases