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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 21 to 120 years
• Men only
• Healthy volunteers accepted
• Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Genetic Susceptibility, Environment & Prostate Cancer Risk

Conditions

Hereditary Prostate Cancer, Prostate Cancer

Being tested

DNA analysis, polymorphism analysis, laboratory biomarker analysis, medical chart review, questionnaire administration

Keywords

hereditary prostate cancer, prostate cancer

Medical subject headings

Prostate cancer, familial, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• DNA analysisGenetic

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

• polymorphism analysisGenetic

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

• laboratory biomarker analysisOther

  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 reviewOther

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

• questionnaire administrationOther

  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

• evaluation of cancer risk factorsProcedure or surgery

  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 factorsProcedure or surgery

  prostate biopsy pathology reports will be reviewed for high risk factors

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: through study completion; 1 day

2. 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.

   Measured: through study completion; 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted13 Nov 2009 (estimated)
2. Study startJul 2008
3. Primary completionDec 2012
4. Study completionDec 2012

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Hereditary Prostate CancerStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.