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Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer. Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer. Clinical research trials and Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer. medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer.. Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer. Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer. clinical trial. Participants frequently obtain the most expert healthcare available for their Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer. condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer.  Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer.
Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer.
For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: 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.
Details: 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 metastatses, 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 didnÂ’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.
Eligibility:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: US male veterans with early stage prostate cancer.
Total Enrollment: 1000
Location and Contact Information:
Richmond (McGuire) VAMC *Recruiting*
Richmond, Virginia, 23249
United States
Recruiting Michael Godschalk 804-675-5088
Washington D.C. VAMC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8179
Kansas City VAMC *Recruiting*
Kansas City, Missouri, 64128
United States
Recruiting Peter VanVeldhuizen 816-861-4700
Long Beach VAHCS *Recruiting*
Long Beach, California, 90822
United States
Recruiting Padmini Iyer 562-826-5748
Tampa (James A Haley) VAMC *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Raul Salup 813-972-7579
Syracuse VAMC *Terminated*
Syracuse, New York, 13210
United States
Terminated
Houston VAMC *Recruiting*
Houston, Texas, 77030
United States
Recruiting Terry Hayes 713-794-7368
St. Louis VAMC (John Cochran Division) *Recruiting*
St. Louis, Missouri, 63106
United States
Recruiting Melvin Blanchard 314-652-4100
Southern Arizona VAHCS *Recruiting*
Tucson, Arizona, 85723
United States
Recruiting Maria Bishop 520-792-1450
Huntington VA Medical Center *Recruiting*
Huntington, West Virginia, 25704
United States
Recruiting Sandra Prunty 304-429-6775
Pittsburgh VAMC *Recruiting*
Pittsburgh, Pennsylvania, 15240
United States
Recruiting Thomas Hakala 412-688-6209
Northport VAMC *Recruiting*
Northport, New York, 11768
United States
Recruiting Mohammad Zarrabi 631-261-4400
Additional Information:
Study ID Numbers: 719B;
Study Start Date: January 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00011349
Other Prostate Cancer Studies:
1. Phase I/II Study of IV Estramustine Combined with Taxol in Patients with Hormone Refractory Adenocarcinoma of the Prostate
2. Selenium and Vitamin E in Preventing Prostate Cancer
3. YM598 in patients with rising PSA after initial therapy for localized prostate cancer
4. Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer
5. Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia
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Evaluate risk factors which predict the transformation of early stage to clinically aggressive prostate cancer.
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