An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      This study will examine the association of genetic variants and gene expression patterns with
      the risk of prostate cancer. There will be (It will include?) genotype analysis of blood DNA
      from 600 patients with the disease and from 600 healthy people, and there will be a gene
      expression analysis of prostate tumors. Prostate cancer is a leading cause of death among men
      in Western countries. It is estimated that 220,000 or more new cases of the disease will
      occur in the United States during 2004. The disease incidence is rising. About 25% to 30% of
      the cancers become aggressive. The nonhereditary disease rarely occurs in men who are younger
      than age 40. There are large differences in incidence by geography and race. The highest
      rates are seen among African-American men in the United States. Also, although Caucasians
      have a lower rate of disease incidence and mortality in the United States, the rates among
      them are high compared with rates in some European countries. The reasons for such
      differences are not well understood, but both environmental and genetic risk factors are
      thought to be involved.

      Patients ages 40 to 80 years who have had prostate cancer confirmed within the past 6 months,
      who reside in Baltimore City or adjacent metropolitan counties, and who were born in the
      United States may be eligible for this study. They will be recruited in collaboration with
      the Departments of Pathology and Urology at the University of Maryland and the Baltimore
      Veterans Affairs Medical Center. Those men serving as controls in this study will be
      identified through the Department of Motor Vehicles database and will be matched by age and
      race with the patients who have cancer. The study will include 600 participants with prostate
      cancer and 600 participants in the control group.

      Trained interviewers will administer two questionnaires. The primary questionnaire will be
      used to assess information such as medical and cancer history, tobacco use, current
      medications, occupational history, family medical history, and socioeconomic status. A
      supplemental questionnaire will pertain to patients' exposure to risk factors for prostate
      cancer. It will assess the human body, diet, medical history, family medical history, and
      sexual history. The section on sexual history will be self-administered.

      Patients will undergo collection of blood and urine for various tests. For cancer patients
      with prostate surgery, there will also be a collection of tissue, to be performed at the time
      that the prostate gland is scheduled for surgical removal. The pattern of gene expression
      will be analyzed in low- and high-stage tumors.

      There will be no direct benefit from participating in the study, but participants will
      receive an incentive of up to $75 to participate in the study. No form of treatment is
      involved in this study. However, it is hoped that the study findings will improve
      researchers' understanding of prostate cancer biology with respect to the causes of the
      health variances between African-Americans and Caucasians.

      ...
    

Detailed description: 
      We are conducting an epidemiological prostate cancer case-control study in Baltimore,
      Maryland. Participants will be African American and Caucasian males who reside in Baltimore
      city and surrounding areas. The study is ongoing and will recruit 1000 prostate cancer cases
      and 1000 population-based controls. The cases are recruited at two Baltimore hospitals, the
      Veterans Affairs Medical Center and the University of Maryland Center. Cases will have
      pathologically confirmed prostate cancer. The population-based controls are identified
      through the Maryland Department of Motor Vehicle Database, and are frequency-matched by age
      and race to cases. Enrollment of controls started concurrently with case accrual. The first
      12 months of the study constituted a pilot study, during which we evaluated the recruitment
      procedures. The study involves the administration of two questionnaires and collection of
      blood from all study subjects. The two questionnaires consist of a main questionnaire and a
      supplemental questionnaire. The questionnaires evaluate family cancer history, tobacco use,
      medication, occupational history, socioeconomic status and risk factors for prostate cancer.
      Fresh-frozen tumor specimens will be obtained from cancer patients if available. The study is
      supported by an epidemiological infrastructure that has been developed by our resource
      contractor at the University of Maryland for a lung cancer case-control study. This lung
      cancer study is ongoing, and the controls that are recruited for the prostate cancer study
      are joint controls with the lung cancer study. Hence, population-based male controls
      recruited by our contractor have double eligibility for the concurrent lung and prostate
      cancer studies. To achieve an age and race matching of cases and controls in the prostate
      study, we will over-sample male controls in the lung study.

      We will test the primary hypothesis that genes and environmental exposures, including
      infections and medical history, and interactions between those exposures and genetic factors
      modify prostate cancer susceptibility. As the secondary goal, we will study gene expression
      profiles of prostate tumors to identify changes in tumor biology that are associated with
      exposure to genetic and environmental risk factors. It is a focus of this research to
      identify mechanisms in tumor biology that may cause the aggressive nature of prostate cancer
      in African American men.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study is a case-control study with a clinical and a community component. Participants
        are African- American and Caucasian males who resided in Baltimore city and surrounding
        areas. The cases were recruited at two Baltimore hospitals, the Veterans Affairs Medical
        Center and the University of Maryland Medical Center. Cases had pathologically confirmed
        prostate cancer. The population-based controls were identified through the Maryland
        Department of Motor Vehicle database.@@@@@@
      
Keywords: Tobacco Use; Tumor Biology; Biomarker; Risk Factor; Health Disparity