Early Stage Prostate Cancer Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00011349
Recruitment Status : Completed
First Posted : February 19, 2001
Last Update Posted : April 15, 2013
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease
Prostate Cancer

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 1116 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CSP #719B - Prospective Cohort of Early Stage Prostate Cancer
Study Start Date : January 2001
Actual Primary Completion Date : June 2006
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group 1

Primary Outcome Measures :
  1. The primary endpoint of the study will be prostate cancer mortality. [ Time Frame: approximately once a year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.

Inclusion Criteria:

  • US male veterans with early stage prostate cancer.

Exclusion Criteria:

  • Men will be excluded if they have prior history of other cancer within the last 5 years (with the exception of non-melanoma skin cancer) or other major illness that would preclude long-term participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00011349

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 Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
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
VA Office of Research and Development
Study Chair: Michael J. Gaziano, MD MOH VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications of Results:
Responsible Party: VA Office of Research and Development Identifier: NCT00011349     History of Changes
Other Study ID Numbers: 719B
First Posted: February 19, 2001    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: April 2013

Keywords provided by VA Office of Research and Development:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases