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

Prostate Cancer Clinical Trial

Official title:

Genetic Susceptibility, Environment & Prostate Cancer Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013129
• Other study ID #: CDR0000648179
• Secondary ID: VAMC-OR-M1736CPC
• Status: Completed
• Start date: July 2008
• Est. completion date: December 2012

Study information

• Verified date: November 2021
• Source: Portland VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Hereditary Prostate Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• DNA analysis
saliva samples will be collected from men (probands) who join the study.
• 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
• medical chart review
PSA results, prostate biopsy pathology reports and clinician notes related to the biopsy are reviewed for final data analysis
• 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
• study of high risk factors
prostate biopsy pathology reports will be reviewed for high risk factors

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center - Portland	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Portland VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between variation in genes involved in reactive oxygen species detoxification, oxidative stress response, and prostate cancer risk	Using saliva samples, we conducted analysis on probands' oxidative stress pathway genes and whether these were associated with prostate cancer risk.	through study completion; 1 day
Primary	Association between blood fatty acids and prostate cancer risk	Using blood samples, we conducted analysis on probands' fatty acid level and whether these were associated with prostate cancer risk.	through study completion; 1 day