Phase II Clinical Trial of Purified Isoflavones in Prostate Cancer: Comparing Safety, Effectiveness
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Purified isoflavones; Methyl cellulose blend
Intervention description: Soy-based isoflavone concentrate with methyl cellulose blend filler - Take 2 capsules daily; Placebo - Take 2 capsules daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 71.0
Sex: Male
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of our study is to recruit and treat 96 men diagnosed with prostate cancer and
      scheduled for a prostatectomy with a capsule form of either purified isoflavones or placebo
      for a 3-6 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.
    

Eligibility criteria:

        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.