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

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Prostate Cancer

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The primary endpoint of the study will be prostate cancer mortality.

Outcome Time Frame:

approximately once a year

Safety Issue:


Principal Investigator

Michael J. Gaziano, MD MOH

Investigator Role:

Study Chair

Investigator Affiliation:

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA


United States: Federal Government

Study ID:




Start Date:

January 2001

Completion Date:

January 2010

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms



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