Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness

Inclusion Criteria:

Diagnosis of localized prostate cancer (PCa), based on pathological assessment from biopsy specimens
No prior or current therapy for PCa 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 prostatic specific antigen (PSA)
Health status cleared by primary MD or urologist
Eastern Cooperative Oncology Group (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 definitive treatment)
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 placebo capsules
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
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 PCa, women are not eligible for the study.