NCT01013129

Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer

Genetic Susceptibility, Environment & Prostate Cancer Risk

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 748 (actual)
• Sponsor: Portland VA Medical Center · Federal
• Sex: Male
• Age: 21 Years – 120 Years
• Healthy volunteers: Accepted

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 research project is studying genes, environment, and prostate cancer risk in patients with or without prostate cancer.

Detailed description

OBJECTIVES: * To determine the association between variation in genes involved in ROS detoxification, oxidative stress response, and prostate cancer risk. * To determine the association between fatty acid levels 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. Medical records of probands are reviewed for demographics, history and course of disease, and clinical laboratory test results. All probands completed 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 was 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 750 participants will be accrued for this study.

Conditions

• Hereditary Prostate Cancer
• Prostate Cancer

Interventions

Type	Name	Description
GENETIC	DNA analysis	saliva samples will be collected from men (probands) who join the study.
GENETIC	polymorphism analysis	we will genotype DNA samples (buccal) from all probands and conduct a traditional case-control analysis
OTHER	laboratory biomarker analysis	10ml blood specimen will be obtained and processed (on probands locally-consented and/or those who have an appointment at the VA in Portland, Oregon) to allow for analyses of erythrocyte fatty acids and future nutrient and DNA analyses
OTHER	medical chart review	PSA results, prostate biopsy pathology reports and clinician notes related to the biopsy are reviewed for final data analysis
OTHER	questionnaire administration	probands are asked to complete questionnaires on 1) family history of cancer, 2) diet history over the past year, 3) employment environment and risk factors and/or 4) changes to diet, medications since enrollment in originating case control study
PROCEDURE	evaluation of cancer risk factors	pathology reports will be reviewed for probands whose prostate biopsies reveal cancer; these factors will be evaluated for cancer risk factors
PROCEDURE	study of high risk factors	prostate biopsy pathology reports will be reviewed for high risk factors

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-11-13
• Last updated: 2021-11-11

Locations

1 site across 1 country: United States