Early Stage Prostate Cancer Cohort

April 11, 2013 updated by: US Department of Veterans Affairs

CSP #719B - Prospective Cohort of Early Stage Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Primary Objective: Evaluate risk factors which predict the transformation of early stage to clinically aggressive disease.

Intervention: None

Study Abstract: 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.

A total of 1,000 US male veterans with early stage prostate cancer will be recruited to participate in the study. In order to maximize African-American participation, VA medical centers that serve large minority populations will be utilized for recruitment. Eligible participants must have an early stage prostate cancer diagnosis (T0-T2) with no known involved lymph nodes or metastases, and no prior history of cancer (with the exception of nonmelanoma skin cancer) or other major illness that would preclude long term participation. Individuals willing to participate will be administered a lifestyle questionnaire and a dietary assessment. The lifestyle survey ascertains baseline demographics, mode of cancer diagnosis, medical history, smoking, family history of prostate cancer, alcohol use, level of physical activity, and other potential risk factors for prostate cancer progression. Nutritional parameters will be measured through a self-administered, semi-quantitative food frequency questionnaire. A blood specimen will also be collected for genetic and biochemical research. Participants will be followed annually with additional lifestyle and dietary questionnaires.

Both surveys are currently being tested through a pilot project in a population of prostate cancer survivors to assess the feasibility of collecting diet and lifestyle data in veterans and to refine the study methods and recruitment strategies (the current versions of the surveys are included).

A pilot study is being conducted to test different survey types and mailing techniques. The results from the pilot project will help improve the survey methodology and refine the survey research tools to accurately assess dietary and lifestyle factors. Lifestyle surveys have been created to ascertain baseline demographics and potential risk factors for prostate cancer survival and progression. Two versions have been generated to test participant response to varying survey lengths (a short form vs. a long form). The initial mailing of the lifestyle and dietary surveys was directed to 836 veterans diagnosed with prostate cancer in the Boston VA Healthcare Network (ICD-9 code in patient treatment files). Surveys were sent to 132 African-American veterans, 342 white veterans, and 362 veterans with no known race. An Access database has been developed to track survey response and blood collection sites have been established in VA health facilities in the Boston area. A phone tracking system has been established to answer participants questions about the survey. A total of 251 (30%) of the veterans completed the surveys and 72% agreed to provide blood samples. The response rate was 11% for African-Americans, 28% for whites, and 27% for unknown race. Follow-up mailings are currently being sent to veterans who didn't respond to the initial survey request. A telephone survey is being designed to target African-American non-responders to improve survey response in this cohort.

Prostate cancer is the most commonly diagnosed cancer in men and the second most common cause of cancer deaths among men in the United States. Counseling patients with early stage disease about treatment options is extremely difficult since the relative benefit of different approaches is not known. The evidence to date indicates that there is no clear benefit with invasive intervention over watchful waiting. In addition, little is known about risk factors which predict the transformation of early stage prostate cancer to clinically aggressive disease. This is of particular concern in the VA since more than a third of all veterans are over age 65. The ability to differentiate individuals with early stage prostate cancer from those with disease that will become clinically aggressive would have enormous benefits. It would help allay the anxiety of those with indolent disease and potentially reduce the morbidity and mortality of those with disease likely to become clinically aggressive.

Study Type

Observational

Enrollment (Actual)

1116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System, Tucson
    • California
      • Long Beach, California, United States, 90822
        • VA Medical Center, Long Beach
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • VA Medical Center, DC
    • Florida
      • Tampa, Florida, United States, 33612
        • James A. Haley Veterans Hospital, Tampa
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • VA Medical Center, Jamaica Plain Campus
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • VA Medical Center, Kansas City MO
      • St Louis, Missouri, United States, 63106
        • VA Medical Center, St Louis
    • New York
      • Northport, New York, United States, 11768
        • VA Medical Center, Northport
      • Syracuse, New York, United States, 13210
        • VA Medical Center, Syracuse
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Health Care System
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center (152)
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Hunter Holmes McGuire VA Medical Center
    • West Virginia
      • Huntington, West Virginia, United States, 25704
        • VA Medical Center, Huntington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint of the study will be prostate cancer mortality.
Time Frame: approximately once a year
approximately once a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Study Chair: Michael J. Gaziano, MD MOH, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 15, 2001

First Submitted That Met QC Criteria

February 16, 2001

First Posted (Estimate)

February 19, 2001

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 719B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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