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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jackilen Shannon, Portland VA Medical Center
ClinicalTrials.gov Identifier:
NCT01013129
First received: November 11, 2009
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Hereditary Prostate Cancer
Prostate Cancer
Genetic: DNA analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: medical chart review
Other: questionnaire administration
Procedure: evaluation of cancer risk factors
Procedure: study of high risk factors

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic Susceptibility, Environment & Prostate Cancer Risk

Resource links provided by NLM:


Further study details as provided by Portland VA Medical Center:

Primary Outcome Measures:
  • Degree of familial aggregation for prostate cancer [ Time Frame: 4th quarter - 2012 ] [ Designated as safety issue: No ]
  • Association between genetic variations, mitochondrial DNA damage, and prostate cancer risk [ Time Frame: 4th quarter - 2012 ] [ Designated as safety issue: No ]
  • Association between dietary intake of ω-3 fatty acids and prostate cancer risk [ Time Frame: 4th quarter - 2012 ] [ Designated as safety issue: No ]
  • Association between variation in genes involved in reactive oxygen species detoxification, oxidative stress response, and prostate cancer risk [ Time Frame: 4th quarter - 2012 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

10ml blood specimen drawn from probands consented in person at the Portland VA; saliva samples from all consented probands; saliva samples from first degree relatives


Estimated Enrollment: 2250
Study Start Date: July 2008
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: DNA analysis
    saliva samples will be collected from men (probands) who join the study as well as from first degree relatives 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
Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Recontacting previously recruited Diet and Prostate Cancer Risk study participants; cases and biopsy negative controls
  2. Prospective recruitment of men referred for a prostate biopsy to the Portland VA urology clinic
  3. Men from the public sector who learn about our study and would like to participate
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)
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013129

Locations
United States, Oregon
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Portland VA Medical Center
Investigators
Principal Investigator: Jackilen Shannon, PhD Department of Veterans Affairs
  More Information

Additional Information:
No publications provided

Responsible Party: Jackilen Shannon, Staff Scientist, Portland VA Medical Center
ClinicalTrials.gov Identifier: NCT01013129     History of Changes
Other Study ID Numbers: CDR0000648179, VAMC-OR-M1736, CPC-07129-L
Study First Received: November 11, 2009
Last Updated: February 21, 2013
Health Authority: United States: Federal Government

Keywords provided by Portland VA Medical Center:
hereditary prostate cancer
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014