Early Stage Prostate Cancer Cohort
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00011349
First received: February 15, 2001
Last updated: April 11, 2013
Last verified: April 2013
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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 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 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Group 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:
- 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
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 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
Investigators
| Study Chair: | Michael J. Gaziano, MD MOH | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA |
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00011349 History of Changes |
| Other Study ID Numbers: | 719B |
| Study First Received: | February 15, 2001 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Prostate Cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 13, 2013