Trial Information

Prostate Cancer Case-Control Study: Black Versus White: VA Versus Private Sector

Primary Objectives: To explore racial differences in potential risk factors for developing
prostate cancer in the VA population and to compare and contrast the results of this study
with that of an ongoing NCI-funded study in North Carolina.

Secondary Objectives: To investigate familial aggregation of prostate cancer in blacks and
whites. To determine whether screening behavior differs in men diagnosed with early stage
prostate cancer versus those with later stage disease as well as to determine if screening
behavior differences exist between blacks and whites.

Primary Outcomes: The primary outcomes are pesticide, occupational and chemical exposure,
and dietary history. Other major endpoints include: 1) familial aggregation of prostate
cancer; 2) weight, weight history, and weight cycling; 3) subject's knowledge, attitudes,
and behaviors about prostate cancer; and 4) treatment choices.

Intervention: N/A

Study Abstract: Prostate cancer is the most commonly diagnosed cancer in American men. Among
African Americans the incidence and mortality from prostate cancer is even greater. Although
incidence rates in the Southern United States tend to be only slightly higher than that of
the nation, a clear discrepancy exists between national mortality rates and those in the
Southeastern United States. Notably high rates, particularly among African Americans are
observed and in North Carolina the prostate cancer mortality rate among African Americans is
the highest of any state in the nation. In spite of these statistics, very little is known
about racially based differences in the etiology of this disease.

This study hypothesizes that racial differences in the incidence and mortality of prostate
cancer may be a result of multiple factors including those that are socioeconomic,
environmental, dietary and genetic. This research will provide insight into
gene-environmental interactions that initiate and promote prostatic neoplasia as well as
address whether there are differences in patterns of care which impact morbidity and
survival. The results of this study will also be compared to findings in non-veterans that
are being generated through an NCI-funded sister study of these issues under the direction
of co-investigator, Dr. JoEllen Schildkraut of Duke University.

Subjects are identified from pathology reports extracted from VISTA. It has been determined
that pathology reports alone are not a sufficient source of identifying cases because not
all patients coming to VA for treatment have diagnostic pathology completed at the Durham
VA. Therefore, we have added additional protocols for subject identification such as
reviewing radiation/oncology clinic records for those subjects referred for radiation
treatment. To-date, 78 cases and 66 controls have been enrolled in the study. To increase
accrual rates, in-home visits have been used when necessary, and the Richmond, VA and
Asheville, NC VAMCs have been added as participating study sites. Due to patient accrual
problems and project staffing changes, the Durham ERIC has granted this study a six-month,
no-cost extension through 7/31/2001.