NCT00354497

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_2 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
Last Updated

September 20, 2013

Status Verified

August 1, 2008

First QC Date

July 19, 2006

Last Update Submit

September 19, 2013

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (2)

  • Dietary heterocyclic amine (HA) exposure in African American men

  • Correlation of HA exposure with prostate cancer screening results

Interventions

physiologic testingOTHER
study of socioeconomic and demographic variablesOTHER
evaluation of cancer risk factorsPROCEDURE
mutation carrier screeningPROCEDURE
study of high risk factorsPROCEDURE

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Lawrence Livermore National Laboratory at University of California

Livermore, California, 94550, United States

RECRUITING

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, 94609, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Kenneth T. Bogen, DrPH, MPH, MA, ScD

    Lawrence Livermore National Laboratory at University of California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
SCREENING
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 20, 2006

Study Start

March 1, 2002

Last Updated

September 20, 2013

Record last verified: 2008-08

Locations

US(2)