Trial Information

Genetic Susceptibility, Environment & Prostate Cancer Risk

OBJECTIVES:

- To evaluate the evidence of familial aggregation for prostate cancer and identify a
homogenous subgroup of families with elevated likelihood of aggressive disease ("high
familial risk") using a family case-control design.

- To determine if genetic variation in selected genes involved in reactive oxygen species
(ROS) detoxification (e.g., glutathione and superoxide dismutase genes) and the
oxidative stress response (e.g., NFE2) are independently or jointly associated with
greater mitochondrial DNA damage and increased prostate cancer risk.

- To determine if dietary intake of ω-3 fatty acids alters the risk of prostate cancer.

- To determine the association between variation in genes involved in ROS detoxification,
oxidative stress response, and prostate cancer risk.

OUTLINE: Probands undergo blood and saliva sample collection for fatty acid, DNA, and
polymorphism analyses. Archived blood and tissue samples from probands who previously
participated in Dr. Shannon's Diet and Prostate Cancer Risk study are also analyzed.
First-degree relatives (FDRs) of probands found to be part of a homogenous high-risk
subgroup undergo saliva sample collection for DNA analyses.

Medical records of probands are reviewed for demographics, history and course of disease,
and clinical laboratory test results.

All probands and their FDRs complete the "Genetic Risk Easy Assessment Tool Family History
of Cancer" and "Diet History and Environmental Risk Factor" questionnaires at baseline. If
a proband previously participated on our Diet and Prostate Cancer Risk study, he is asked to
complete the "Changes in Diet, Prescriptions, Supplementals and Herbal Remedies"
questionnaire in addition to the "Genetic Risk Easy Assessment Tool Family History of
Cancer" questionnaire at baseline for this study.

PROJECTED ACCRUAL: A total of 2,250 participants (750 probands and 1,500 first-degree
relatives) will be accrued for this study.