Back to resultsHigh Risk Prostate Cancer Prevention Study
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
finasteride
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer focused on measuring prostate cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Kansas Medical Center
- Veterans Administration Medical Centenr
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Finasteride plus soy
Arm Description
Finasteride and soy
Outcomes
Primary Outcome Measures
Biomarkers will be identified to help predict future prostate cancer risks and patients likely to benefit from preventive strategies
Secondary Outcome Measures
provide a platform ongoing evaluation of novel preventive agents
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01174953
Brief Title
High Risk Prostate Cancer Prevention Study
Official Title
High Risk Prostate Cancer Prevention Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 prostate cancer. Also, the investigators intend to create a large database with health information from men who are at high risk of developing prostate cancer, along with serum and tissue samples from those patients who are willing to provide tissue and serum samples.
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 2008, prostate cancer is the second leading cause of cancer death in men. In Kansas, prostate cancer is also the most frequent cancer among men and ranked third (253 deaths in 2006) behind lung cancer (884 deaths in 2006) and colorectal cancer (273 deaths in 2006) in cancer related mortality. Despite the significant morbidity and mortality related to this disease, screening and treatment approaches remain controversial and there is significant morbidity related to the treatment of early stage disease. Preventative strategies and strategies which identify patients at highest risk are needed desperately.
The goal of this proposal 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 prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Finasteride plus soy
Arm Type
Other
Arm Description
Finasteride and soy
Intervention Type
Drug
Intervention Name(s)
finasteride
Other Intervention Name(s)
Proscar, Propecia, isolavone
Intervention Description
Finasteride 5 mg once daily
Soy 4 capsules twice daily (160 mg total)
Primary Outcome Measure Information:
Title
Biomarkers will be identified to help predict future prostate cancer risks and patients likely to benefit from preventive strategies
Time Frame
2 years from completion of enrollment
Secondary Outcome Measure Information:
Title
provide a platform ongoing evaluation of novel preventive agents
Time Frame
approximately 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Van Veldhuizen, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Veterans Administration Medical Centenr
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
12. IPD Sharing Statement
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High Risk Prostate Cancer Prevention Study
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