Clinical Trial 15835
Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness and Mechanism of Action between African American and Caucasian Men
The purpose of our study is to recruit and treat 260 men diagnosed with prostate cancer and scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo for a 4-6 week period to see if we can slow down the rate of prostate cancer growth. A placebo is a pill or something that looks like the medicine that is being studied but has no active medicine in it. We also want to see if taking purified isoflavones is safe and if it reduces lower urinary tract symptoms. In addition, we want to study if purified isoflavones are able to slow the progression of prostate cancer, and the mechanism of action of purified isoflavones. If the safety and the effects of purified isoflavones on slowing down the progression of prostate cancer is shown in our study, this will also be a safe way of treating men who are at high risk of prostate cancer, so that we can prevent prostate cancer in the future.
- Inclusion Criteria
- African American and Caucasian men between the ages of 30 (to be inclusive of African American men with earlier age diagnosis) and 80
- Diagnosis of localized CaP, based on pathological assessment from biopsy specimens
- No prior or current therapy for CaP or history of cancer except non-melanoma skin cancer
- Scheduled for prostatectomy between 3 - 6 weeks (+/-3 days) after start of study agent
- No known history of hepatic or renal disease (LFTs (SGOT/SGPT) > 5.0 x upper limit of normal as evidenced by impairment of baseline laboratory values, Actual creatinine clearance of >60 utilizing the Cockcroft-Gault formula (1976), which employs creatinine measurements and a patient's weight to predict the clearance. The constant is 1.23 for men.
- Omnivorous diet
- No evidence of prostatitis or urinary tract infection
- Able and willing to give written informed consent
- Currently not using or willing to discontinue any nutritional supplements that contain soy or soy isoflavones
- Not allergic to study supplements
- Not on antibiotics
- Men who do not consume more than 3 - 4 oz of soy or soy products per week
- Not taking steroid hormones or medications which have known impact on PSA
- Health status cleared by primary MD or urologist
- ECOG performance status of 0-1.
- Exclusion Criteria
- Prior history of prostate cancer; Current or prior history of other malignancies (exceptions include nonmelanoma skin cancer or other cancer with no evidence of tumor recurrence five years after definitivetreatment)
- History of renal or hepatic disease, including history of hepatitis B, C or delta as evidenced by impairment of baseline laboratory values
- Participation in any other investigational study or use of any other investigational agents within 30 days of study entry
- History of allergic reactions attributed to soy isoflavones or other compounds of similar chemical or biologic composition to Novasoy 400® or the inactive components present in the purified isoflavone and
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any psychological, familial, sociological or other concomitant condition that would not allow adequate compliance with the study protocol
- Inclusion of Women and Minorities
- Only African American (a person having origins in any of the black racial groups of Africa) and Caucasian (a person having origins in any of the original people of Europe, Middle East, or North Africa) men, as defined by the NIH, will be included in this study. Since this is an investigation targeting men with CaP, women are not eligible for the study.
Specific Aim 1: We will recruit, randomize and treat 130 AA men and 130 Caucasian men (n=260; 65/arm) diagnosed with clinically localized CaP to receive Novasoy at a dose of 40 mgs per day or placebo in the pre-surgical period prior to radical prostatectomy (minimum 4 weeks, maximum 6 weeks) and evaluate and compare the safety and compliance of the study agent between the groups as follows:
Specific Aim 2: To evaluate and compare effectiveness of the study agent in the groups described in Specific Aim 1, changes in biomarkers of CaP progression from baseline to prostatectomy will be analyzed and compared (primary: treated vs. placebo within each racial group; secondary: between two racial groups) using tissue and serum samples, as measured by changes in: (a) Modulation of serum steroid hormones (decrease in free testosterone, increase in total estradiol); (b) Biochemical and grade progression markers such as prostate specific antigen (PSA), tumor volume (TV), percent Ki-67 and Gleason Score (GS); and (c) Genetic markers such as apoptotic index.