Status:
COMPLETED
High Risk Prostate Cancer Prevention Study
Lead Sponsor:
University of Kansas
Conditions:
Prostate Cancer
Eligibility:
MALE
55-95 years
Phase:
NA
Brief Summary
The purpose of this study is to study the molecular effects of the chemopreventative agent, finasteride, in combination with dietary soy supplementation in patients at high risk for the development of...
Detailed Description
Over 180,000 new cases of prostate cancer are diagnosed in the United States each year, making prostate cancer the most frequently diagnosed cancer in men. With an estimated 28,660 deaths occurring in...
Eligibility Criteria
Inclusion
- Based on the PSA, DRE and Family history of prostate cancer patients will be risk stratified using Prostate Cancer Risk Calculator. Must have at least 25% chance of prostate cancer development as assessed by the prostate cancer risk calculator.
- During time of study period, patients must agree not to take any new vitamin supplementation, soy or herbal supplement.
- Must not be receiving concurrent chemotherapy, radiation or hormonal therapy.
- No history of prior allergy and intolerability to soy-based products.
- Must not have been taking any soy supplementation, soy isoflavones or finasteride within 90 days prior to study enrollment.
- Must be able to safely be on study supplements for period of at least four months.
- All patients must have been informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- All patients must be willing to undergo prestudy and follow-up assessment, including prostate biopsies.
Exclusion
- Patients diagnosed with prostate cancer on initial biopsy
- Patients with any active malignancy
- Receiving any concurrent chemotherapy, hormonal therapy or radiation
- Patient not compliant with treatment for at least 4 months
- Patients with history of deep vein thrombosis, myocardial infarction, coronary artery disease,and cerebrovascular accident in the last 6 months will also be excluded.
- Patients on active anticoagulation will be excluded.
- Patients with liver function tests more than 2 levels of upper limit of normal
- Patients who develop more than grade 2 toxicity will also be removed from the study
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01174953
Start Date
July 1 2010
End Date
March 1 2013
Last Update
January 1 2014
Active Locations (2)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Veterans Administration Medical Centenr
Kansas City, Missouri, United States, 64128