An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males
An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males
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.

 ...
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.
-  ELIGIBILITY CRITERIA

 CASE SUBJECT SELECTION

 We will recruit incident cases of pathologically confirmed PCa at all stages of the disease
 that are age 40 to 90 years. Treatment can be surgery or therapy. The following check list
 will be used to verify eligibility of a case subject.

 ELIGIBILITY CHECK LIST - PROSTATE CANCER CASES

 CRITERIA (ALL MUST BE CHECKED):

 -  Has been diagnosed with prostate cancer within the last two years

 -  Pathological diagnosis of prostate cancer made at the local hospital pathology
 department

 -  Resides in Baltimore City or contiguous metropolitan counties, Anne Arundel and Prince
 George s counties, Eastern Shore, western and northern Maryland, or adjacent counties
 in Pennsylvania, Delaware, Virginia, or the Washington Metropolitan area

 -  Has a residential working phone within his home

 -  Born in the United States

 -  Of African-American or Caucasian descent, and age 40 to 90 years

 -  A non-objection statement by the physician from the hospital where the patient was
 identified, or listed as the treating physician by the tumor registry or surgical
 pathology report, to contact the patient

 -  Is not currently residing in an institution, such as a prison, nursing home, or
 shelter

 -  Is not a severely ill patient in the intensive care unit

 -  Speaks English well enough to be interviewed

 -  Is able to give informed consent

 -  Is physically and mentally capable of performing the interview

 -  Has never been interviewed as a control for this study

 -  Subject provides informed consent and signs form.

 Unwilling Unavailable

 SELECTION OF POPULATION-BASED CONTROLS

 Population-based controls will be identified through the Department of Motor Vehicles
 (DMV), and matched on age (5-year intervals), gender and race to cases. Recruitment of
 controls will start concurrently with case accrual, using the age and race frequency
 distribution of cancer patients in previous years, but recruitment objectives can be
 re-assessed to ensure a frequency-matched study. We will exclude controls that do not have
 a listed home phone number. The following check list will be used to verify eligibility of
 a control subject.

 ELIGIBILITY CHECK LIST - POPULATION-BASED CONTROLS

 CRITERIA (ALL MUST BE CHECKED):

 -  Resides in Baltimore City or contiguous metropolitan counties, Anne Arundel and Prince
 George s counties, Eastern Shore, western and northern Maryland, or adjacent counties
 in Pennsylvania, Delaware, Virginia, or the Washington Metropolitan area

 -  Has a residential working phone within his home

 -  Born in the United States

 -  Of African-American or Caucasian descent, and age 40 to 90 years

 -  Does not have a personal history of cancer other than basal and non-melanomic skin
 cancer

 -  Have never had radiation therapy or chemotherapy

 Is not currently residing in an institution, such as a prison, nursing home, or shelter

 -  Speaks English well enough to be interviewed

 -  Is able to give informed consent

 -  Is physically and mentally capable of performing the interview

 -  Has never been interviewed as a control for the study

 -  Subject provides informed consent and signs form.

 Unwilling Unavailable