Early Stage Prostate Cancer Cohort - Full Text View

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

MedlinePlus related topics:

Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort

Official Title:	Study #719B - Prospective Cohort of Early Stage Prostate Cancer

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

The primary endpoint of the study will be prostate cancer mortality. [ Designated as safety issue: No ]

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

Groups/Cohorts

1

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Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Responsible Party:	Department of Veterans Affairs ( Gaziano, Michael - Study Chair )
Study ID Numbers:	719B
First Received:	February 15, 2001
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00011349
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Prostate Cancer

Study placed in the following topic categories:

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on October 10, 2008

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