NCT00342771

An Epidemiological Study of Genetic Risk Factors for Prostate Cancer in African-American and Caucasian Males

Completed Last updated 14 August 2020

What this trial tests

trial in Prostate Cancer in 2,033 participants. Completed in 6 August 2020.

Timeline

8 November 2004

Primary endpoint
6 August 2020

6 August 2020

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,033
Start date	8 November 2004
Primary completion	6 August 2020
Estimated completion	6 August 2020
Sites	2 locations across United States

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 40 to 90, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine the association of genetic variants and gene expression patterns with the risk of prostate cancer. There will be (It will include?) genotype analysis of blood DNA from 600 patients with the disease and from 600 healthy people, and there will be a gene expression analysis of prostate tumors. Prostate cancer is a leading cause of death among men in Western countries. It is estimated that 220,000 or more new cases of the disease will occur in the United States during 2004. The disease incidence is rising. About 25% to 30% of the cancers become aggressive. The nonhereditary disease rarely occurs in men who are younger than age 40. There are large differences in incidence by geography and race. The highest rates are seen among African-American men in the United States. Also, although Caucasians have a lower rate of disease incidence and mortality in the United States, the rates among them are high compared with rates in some European countries. The reasons for such differences are not well understood, but both environmental and genetic risk factors are thought to be involved.

Patients ages 40 to 80 years who have had prostate cancer confirmed within the past 6 months, who reside in Baltimore City or adjacent metropolitan counties, and who were born in the United States may be eligible for this study. They will be recruited in collaboration with the Departments of Pathology and Urology at the University of Maryland and the Baltimore Veterans Affairs Medical Center. Those men serving as controls in this study will be identified through the Department of Motor Vehicles database and will be matched by age and race with the patients who have cancer. The study will include 600 participants with prostate cancer and 600 participants in the control group.

Trained interviewers will administer two questionnaires. The primary questionnaire will be used to assess information such as medical and cancer history, tobacco use, current medications, occupational history, family medical history, and socioeconomic status. A supplemental questionnaire will pertain to patients' exposure to risk factors for prostate cancer. It will assess the human body, diet, medical history, family medical history, and sexual history. The section on sexual history will be self-administered.

Patients will undergo collection of blood and urine for various tests. For cancer patients with prostate surgery, there will also be a collection of tissue, to be performed at the time that the prostate gland is scheduled for surgical removal. The pattern of gene expression will be analyzed in low- and high-stage tumors.

There will be no direct benefit from participating in the study, but participants will receive an incentive of up to $75 to participate in the study. No form of treatment is involved in this study. However, it is hoped that the study findings will improve researchers' understanding of prostate cancer biology with respect to the causes of the health variances between African-Americans and Caucasians.

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Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Elevated HERV-K mRNA expression in PBMC is associated with a prostate cancer diagnosis particularly in older men and smokers.
   Wallace TA, Downey RF, Seufert CJ, Schetter A, et al · · 2014 · cited 78× · PMID 24858205 · DOI 10.1093/carcin/bgu114
2. Racial disparity in prostate cancer in the African American population with actionable ideas and novel immunotherapies.
   Dovey ZS, Nair SS, Chakravarty D, Tewari AK. · · 2021 · cited 18× · PMID 33599076 · DOI 10.1002/cnr2.1340
3. Racial disparity in prostate cancer: an outlook in genetic and molecular landscape.
   Kaushal JB, Raut P, Muniyan S, Siddiqui JA, et al · · 2024 · cited 4× · PMID 38902476 · DOI 10.1007/s10555-024-10193-8