Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men

Prostate Cancer Screening and Dietary HA Exposure in African-Americans: Phase II

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00354497

Enrollment

800

Registered

2006-07-20

Start date

2002-03-31

Completion date

Unknown

Last updated

2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer

Brief summary

RATIONALE: Screening may help doctors find prostate cancer sooner, when it may be easier to treat. The amount of heterocyclic amines in the diet may affect prostate cancer screening results and the risk of prostate cancer. PURPOSE: This phase II trial is studying prostate cancer screening and dietary heterocyclic amines in African American men.

Detailed description

OBJECTIVES: * Estimate dietary heterocyclic amine (HA) exposure in African American men who use HA-forming meats and cooking methods. * Correlate dietary HA exposure with prostate-specific antigen and digital rectal exam screening results (i.e., higher HA exposure with increased abnormality in prostate cancer screening results) in these participants. OUTLINE: This is a prospective study. Participants complete a routine medical questionnaire and undergo a detailed dietary interview that focuses on meat consumption, cooking preferences, and other factors that may be associated with prostate cancer risk. Participants then undergo a digital rectal exam (DRE) and blood collection for prostate-specific antigen (PSA) testing (total PSA and % free PSA). Results of PSA testing and DRE, including follow-up instructions (if needed), are sent to the participant 3-4 weeks later. Blood samples are also examined by phenotypic assays for UV-damage induced nucleotide excision-repair capacity. PROJECTED ACCRUAL: A total of 800 participants will be accrued for this study.

Interventions

OTHERphysiologic testing

OTHERstudy of socioeconomic and demographic variables

PROCEDUREevaluation of cancer risk factors

PROCEDUREmutation carrier screening

PROCEDUREstudy of high risk factors

Study design

Primary purpose

SCREENING

Eligibility

Sex/Gender

MALE

Age

50 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

DISEASE CHARACTERISTICS: * African American male * No previous diagnosis of prostate cancer * Desires prostate cancer screening as a routine preventative medical service PATIENT CHARACTERISTICS: * Lives in or near Oakland, California * Speaks English * No medical or other disability (e.g., blindness, psychological dysfunction, or amputation) that would preclude study participation PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

Measure	Time frame
Dietary heterocyclic amine (HA) exposure in African American men	—
Correlation of HA exposure with prostate cancer screening results	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026