Status:
COMPLETED
The Specific Role of Isoflavones in Reducing Prostate Cancer Risk
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Cognis
Conditions:
Prostate Cancer
Eligibility:
MALE
50-80 years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to determine if giving men with early stage (Grade 1-2) prostate cancer dietary supplement from soybeans called isoflavones, will change their blood hormone level...
Detailed Description
To prevent biasing the outcome of the study, this is a double-blind study design, where both the trialists and the participants are blinded to the specific nature of the product (isoflavones and place...
Eligibility Criteria
Inclusion
- Males, between the ages of 50 and 80
- Diagnosed with grade 1-2 prostate cancer (Gleason Score 2 to 6) Note: patients with a Gleason primary pattern 4 (4+1 or 4+2) are not eligible.
- No prior or current therapy for prostate cancer
- No other history of cancer except non-melanoma skin cancer
- No known history of hepatic and/or renal disease
- No evidence of prostatitis or urinary tract infection (men being treated with antibiotics may be enrolled 30 days after completion of therapy given that they still meet all other eligibility criteria)
- No antibiotic use within 30 days of registration
- Close to ideal body weight(Body Mass Index no greater than 32 Kg/m²)
- Omnivorous diet
- Able and willing to give written consent
Exclusion
- Less than 50 years or over 80 years of age
- Prostate cancer beyond grade 2 (Gleason Score greater than 6)
- Gleason primary pattern 4 (4+1 or 4+2)
- Prior or planned treatment for prostate cancer of any stage
- Prior history of other cancer except non-melanoma skin cancer
- Current use of nutritional supplements, including modular supplements of other agents with antioxidant properties e.g. retinoids, beta-carotene, and isoflavones
- Allergy to study agent
- Known history of hepatic or renal disease
- Body Mass Index greater than 32 Kg/m²
- Vegetarian/vegan diet
- Diet high in soy products (men who routinely consume a diet high in soy products may be enrolled 30 days after eliminating soy product from the diet)
- Prostatitis or urinary tract infection
- Treatment with antibiotics within 30 days of registration
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00617617
Start Date
February 1 2002
End Date
May 1 2007
Last Update
September 24 2012
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612