Clinical trial NCT01013129: Studying Genes, Environment, and Prostate Cancer Risk in Patients With or Without Prostate Cancer
Official title: Genetic Susceptibility, Environment & Prostate Cancer Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Prostate Cancer
Prostate Cancer
Keywords: hereditary prostate cancer
prostate cancer
Lead sponsor: Portland VA Medical Center
Sponsor class: FED
First posted: 2009-11-13
Enrollment: 748
Sex: MALE
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Association between variation in genes involved in reactive oxygen species detoxification, oxidative stress response, and prostate cancer risk
timeFrame: through study completion; 1 day
measure: Association between blood fatty acids and prostate cancer risk
timeFrame: through study completion; 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Veterans Affairs Medical Center - Portland
state: Oregon
Study officials:
affiliation: Portland VA Medical Center
name: Jackilen Shannon, PhD
role: PRINCIPAL_INVESTIGATOR
References: