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

Genetic Susceptibility, Environment & Prostate Cancer Risk

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01013129
Enrollment
748
Registered
2009-11-13
Start date
2008-07-31
Completion date
2012-12-31
Last updated
2021-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Prostate Cancer, Prostate Cancer

Keywords

hereditary prostate cancer, prostate cancer

Brief 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.

Interventions

GENETICDNA analysis

saliva samples will be collected from men (probands) who join the study.

GENETICpolymorphism analysis

we will genotype DNA samples (buccal) from all probands and conduct a traditional case-control analysis

OTHERlaboratory 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

OTHERmedical chart review

PSA results, prostate biopsy pathology reports and clinician notes related to the biopsy are reviewed for final data analysis

OTHERquestionnaire 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

PROCEDUREevaluation 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

PROCEDUREstudy of high risk factors

prostate biopsy pathology reports will be reviewed for high risk factors

Sponsors

Portland VA Medical Center
Lead SponsorFED

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
21 Years to 120 Years
Healthy volunteers
Yes

Inclusion criteria

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) * 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

Design outcomes

Primary

MeasureTime frameDescription
Association between variation in genes involved in reactive oxygen species detoxification, oxidative stress response, and prostate cancer riskthrough study completion; 1 dayUsing saliva samples, we conducted analysis on probands' oxidative stress pathway genes and whether these were associated with prostate cancer risk.
Association between blood fatty acids and prostate cancer riskthrough study completion; 1 dayUsing blood samples, we conducted analysis on probands' fatty acid level and whether these were associated with prostate cancer risk.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026