Overview

This trial is active, not recruiting.

Conditions hereditary prostate cancer, prostate cancer
Treatments dna analysis, polymorphism analysis, laboratory biomarker analysis, medical chart review, questionnaire administration, evaluation of cancer risk factors, study of high risk factors
Sponsor Portland VA Medical Center
Start date July 2008
End date December 2012
Trial size 2250 participants
Trial identifier NCT01013129, CDR0000648179, CPC-07129-L, VAMC-OR-M1736

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
Degree of familial aggregation for prostate cancer
time frame: 4th quarter - 2012
Association between genetic variations, mitochondrial DNA damage, and prostate cancer risk
time frame: 4th quarter - 2012
Association between dietary intake of ω-3 fatty acids and prostate cancer risk
time frame: 4th quarter - 2012
Association between variation in genes involved in reactive oxygen species detoxification, oxidative stress response, and prostate cancer risk
time frame: 4th quarter - 2012

Eligibility Criteria

Male participants at least 21 years old.

DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: - See Disease Characteristics PRIOR CONCURRENT THERAPY: - See Disease Characteristics

Additional Information

Official title Genetic Susceptibility, Environment & Prostate Cancer Risk
Principal investigator Jackilen Shannon, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by Portland VA Medical Center.