Survey of Prostate Cancer in Accra, Ghana

Prostate Cancer Clinical Trial

Official title:

Survey of Prostate Cancer in Accra, Ghana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339534
• Other study ID #: 999902240
• Secondary ID: 02-C-N240
• Status: Completed
• Start date: June 26, 2002
• Est. completion date: May 15, 2020

Study information

• Verified date: May 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study, conducted at Korle-Bu Hospital in Accra, Ghana, will help elucidate the roles of lifestyle and genetic factors in prostate cancer risk. There is a strong variation in risk of prostate cancer throughout the world. The rates of the disease among African Americans are some of the world s highest. In the United States, the incidence of prostate cancer is 70 percent higher in African Americans than in white Americans and the death rate in African Americans is almost double that of white Americans. The reasons for this excessive risk are unknown, but both genetic and lifestyle factors have been suggested.

Because Africans and African Americans share similar genetic ancestry but have vastly different lifestyles, a better understanding of the rates and risk factor profiles for prostate cancer among Africans will provide important clues to what causes the disease. This study will try to assess the incidence of prostate cancer in the West African nation of Ghana. The study has two components:

• Clinical survey The methods of diagnosis at Korle-Bu will be evaluated and the incidence of prostate cancer over a 5-year period will be estimated.

• Screening and detection survey A survey of 1,000 men between 50 and 74 years of age will estimate the prevalence of both asymptomatic and undiagnosed symptomatic prostate cancer in the Accra population.

The clinical survey will use data from the cancer logbook and medical records at Korle-Bu Hospital and the Ghanaian National Census to derive an estimate of prostate cancer incidence within Accra. The estimate will be low, since it will be based only on men diagnosed or treated at Korle-Bu and will not include men with asymptomatic disease, men diagnosed elsewhere, or men without access to medical care. The screening and detection survey will assess the presence of asymptomatic and unrecognized symptomatic prostate cancer using PSA testing and digital rectal examination in a random sample of 1,000 men in the general population of Accra. This will provide a high estimate of disease prevalence. The two estimates will provide an approximation of the true incidence rate of the disease in Accra.

Comparison of these data with similar data from community surveys of African Americans will provide insight into reasons for the excess risk of prostate cancer in African Americans.

Description:

OBJECTIVE: The key aim of this study is to assess the burden of prostate cancer in Ghana and to evaluate how the impact of prostate cancer among West Africans compares with that among African Americans, whose reported incidence rates are among the highest in the world. West Africans and African Americans share genetic ancestry but have very different lifestyles and environmental exposures. The study aim will be achieved by establishing lower and upper bounds on the true incidence of prostate cancer in the capital city of Accra. The secondary aim of the study is to establish epidemiological, biochemical, and genetic profiles of West Africans for comparisons with African Americans to provide etiologic clues for prostate cancer. DESIGN: The study will consist of two components: 1. a clinical survey, a. divided into a five-year retrospective, and b. a 3-year prospective phase, and 2. a population screening survey.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1758
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 125 Years

Eligibility

• INCLUSION CRITERIA:

The 1,000 Accra residents selected for screening will include 300 men 50-59, 400 men 60-69, and 300 men 70-74 years of age.

EXCLUSION CRITERIA:

Men who do not meet the age requirements will be excluded from the study.

In addition, men who have a history of prostate cancer for which they have received treatment will also be excluded (men with untreated prostate cancer will be included).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Ghana	University of Ghana Medical-Korle Bu Teaching Hospital	Accra

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate cancer	Prostate cancer (case-control observational/epidemiologic study)	At recruitment: case-control study