Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer and Their First-Degree Relatives

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedBiomarker/Laboratory analysis, Genetics, Natural history/EpidemiologyClosed21 and overOtherCDR0000648179
VAMC-OR-M1736, CPC-07129-L, M1736, NCT01013129

Trial Description


RATIONALE: Gathering information about genetic and environmental factors may help doctors learn more about a person's risk for developing prostate cancer.

PURPOSE: This clinical trial is studying genes, environment, and prostate cancer risk in patients with or without prostate cancer and their first-degree relatives.

Further Study Information


  • 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.

Eligibility Criteria


  • Meets 1 of the following criteria:
  • Prior diagnosis of prostate cancer or negative prostate biopsy AND previously participated in Dr. Shannon's Diet and Prostate Cancer Risk study and consented to future studies (proband)
  • Referred to the Portland VA Medical Center urology clinic for a prostate biopsy (proband)
  • First-degree relative (e.g., sibling, parent, or offspring) of a proband
  • Introduced to this study by a proband OR found to be related to a proband who is part of a homogenous high-risk subgroup after completion of the family history of cancer analysis


  • See Disease Characteristics


  • See Disease Characteristics

Trial Contact Information

Trial Lead Organizations/Sponsors

Veterans Affairs Medical Center - Portland

    Jackilen Shannon, Principal Investigator

    Link to the current record.
    NLM Identifier NCT01013129 processed this data on October 17, 2013

    Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to