Prostate Cancer Screening and Dietary Heterocyclic Amines in African American Men

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00354497
• Other study ID #: CDR0000485428
• Secondary ID: LLNL-05-104
• Status: Recruiting
• Phase: Phase 2
• First received: July 19, 2006
• Last updated: September 19, 2013
• Start date: March 2002

Study information

• Verified date: August 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• physiologic testing

• study of socioeconomic and demographic variables

Procedure:
• evaluation of cancer risk factors

• mutation carrier screening

• study of high risk factors

Locations

Country	Name	City	State
United States	Lawrence Livermore National Laboratory at University of California	Livermore	California
United States	Alta Bates Summit Medical Center - Summit Campus	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Lawrence Livermore National Laboratory at University of California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary heterocyclic amine (HA) exposure in African American men			No
Primary	Correlation of HA exposure with prostate cancer screening results			No