Early Stage Prostate Cancer Cohort

This study is ongoing, but not recruiting participants.

First Received: February 15, 2001 Last Updated: October 5, 2009 History of Changes

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00011349

Purpose

Environmental factors such as diet and cigarette smoking may play a role in predicting the progression of early stage prostate cancer to advance disease. The goal of this project is to establish an observational cohort of patients with early stage prostate cancer who elect not to undergo radical prostatectomy or radiation therapy to evaluate risk factors which predict the transformation of early stage to clinically aggressive disease.

Condition
Prostate Cancer

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	CSP #719B - Prospective Cohort of Early Stage Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

The primary endpoint of the study will be prostate cancer mortality. [ Time Frame: approximately once a year ] [ Designated as safety issue: No ]

Enrollment:	1116
Study Start Date:	January 2001
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

Show Detailed Description

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

We propose to establish an observational cohort of 1000 US male veterans from 10-12 VAMC with early stage prostate cancer with no known distant metastases.

Criteria

Inclusion Criteria:

US male veterans with early stage prostate cancer.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011349

Locations

United States, Arizona
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
United States, California
VA Medical Center, Long Beach
Long Beach, California, United States, 90822
United States, District of Columbia
VA Medical Center, DC
Washington, District of Columbia, United States, 20422
United States, Florida
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States, 33612
United States, Massachusetts
VA Boston Health Care System
Brockton, Massachusetts, United States, 02401
United States, Missouri
VA Medical Center, Kansas City MO
Kansas City, Missouri, United States, 64128
VA Medical Center, St Louis
St Louis, Missouri, United States, 63106
United States, New York
VA Medical Center, Northport
Northport, New York, United States, 11768
VA Medical Center, Syracuse
Syracuse, New York, United States, 13210
United States, Pennsylvania
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, West Virginia
VA Medical Center, Huntington
Huntington, West Virginia, United States, 25704

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Study Chair:

Michael J. Gaziano, MD MOH

VA Boston Health Care System

More Information

No publications provided

Responsible Party:	Department of Veterans Affairs ( Gaziano, Michael - Study Chair )
Study ID Numbers:	719B
Study First Received:	February 15, 2001
Last Updated:	October 5, 2009
ClinicalTrials.gov Identifier:	NCT00011349 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Prostate Cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009