Trial Information

Prevalence of Human Papillomavirus in Men Living in the Northern Plains

Prostate cancer is a major health problem among American Indian men. Recent studies indicate
marked prostate cancer disparity among American Indian men in South Dakota compared to the
Caucasian population in United States (1.86 times higher mortality due to prostate cancer).
In terms of incidence and mortality American Indian men are suffering from prostate cancer
at a rate similar to African-American men. While there has been a concentrated effort to
reduce prostate cancer mortality in the African American population; no efforts have been
initiated to improve upon the prostate cancer disparity in the American Indian population.
According to the researchers, this is the first prostate cancer study which is focused on
American Indian men. This study is aimed to determine why prostate cancer is so highly
prevalent in American Indian men. Recent studies have suggested a link between HPV infection
and prostate cancer and a recent study from the group demonstrated very high incidence of
HPV infection in American Indian women, suggesting that American Indian men are equally
exposed to HPV infection due to the sexually transmitted nature of the disease.
Additionally, smoking is a known risk factor for prostate cancer and the American Indian
population has a high incidence of smoking. Taken together, the high rates of HPV infection
and smoking have prompted us to determine the association of HPV infection with prostate
cancer in American Indian men. Information gained from this proposal will lead to advanced
understanding of the role of HPV infection and smoking in the pathogenesis of prostate
cancer. This study will also determine if HPV infection is a risk factor for the development
of prostate cancer in American Indian men.

The potential study participant will be identified while at a routine physician visit and
asked if he would like to participate in a research study. If yes, the questions for
eligibility will be asked. If eligible, a clinic nurse will explain the details of the
study to the potential participant and the participant will be allowed to consent or to
decline. If consent is obtained, the participant will answer the epidemiology questionnaire
in a private interview with a clinic nurse. The participant will allow the participating
physician to take samples from his genital area using 3 moistened Dacron swabs (similar to
Q-tips) while in a private examination room. The 3 areas are: 1) the glans of the penis, 2)
the shaft of the penis and 3) the scrotum. This process will not be invasive or painful and
will take less than 2 minutes. The study participant has ended his role in the study at
this time and will not be contacted further. After the samples are collected, each swab
will be placed into a pre-labeled container and stored at -20C (freezer temperature). The
samples, consents and questionnaire will be batch shipped to the laboratory. At the
laboratory, the sample will be processed for DNA/RNA analysis (PCR based technology) which
will determine the presence or absence of HPV DNA as well as determine the type of HPV
present (high or low risk genotypes). This information will be used to determine the
prevalence of HPV infection in men living in South Dakota.

The investigators expect to learn the prevalence of HPV infection in South Dakotan men.
This information is important because of the connection between HPV infection and the
development of cancer. HPV is well known for its role in cervical cancer and cancers of the
head and neck. There is a growing body of literature suggesting that HPV infection may also
play a role in the development of other cancers, including prostate cancer. American Indian
men suffer from prostate cancer at a greater frequency and severity than Caucasian men;
therefore, the investigators have specifically included this group of men in the sample.
The HPV prevalency data will be used in combination with laboratory experiments and
examination of prostate cancer tissues to examine the association between HPV and prostate
cancer.