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Early Stage Prostate Cancer Cohort

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00011349
First Posted: February 19, 2001
Last Update Posted: April 15, 2013
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.
Information provided by (Responsible Party):
VA Office of Research and Development
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CSP #719B - Prospective Cohort of Early Stage Prostate Cancer

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

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

Enrollment: 1116
Study Start Date: January 2001
Study Completion Date: January 2010
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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.
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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 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
Investigators
Study Chair: Michael J. Gaziano, MD MOH VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00011349     History of Changes
Other Study ID Numbers: 719B
First Submitted: February 15, 2001
First Posted: February 19, 2001
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
Neoplasms
Genital Diseases, Male
Prostatic Diseases