The Specific Role of Isoflavones in Reducing Prostate Cancer Risk
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

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 levels. Isoflavones are substances found in a high concentration in soybeans that are
      converted in the intestines to hormone-like compounds which are similar to estrogen. They are
      also thought to have cancer fighting properties. Clinical trials suggest that isoflavones can
      increase certain sex hormones, which results in the slower production of prostate cancer
      cells. This study will determine if adding isoflavones (supplied as Prevastein HC®) 80 mg/day
      in a pill form can change your risk factors that cause early stage prostate cancer to
      progress to more advanced disease.
    

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 placebo). Participants in both groups will be discouraged from increasing
      their intake of dietary isoflavones in the form of tofu, soy beans, soy milk, etc. In
      addition, the intervention does not include active counseling on dietary modification and
      supplementation of any one group. Monthly appointments will be made for all participants for
      data collection and toxicity assessment.

      Schema:

      This is a controlled, randomized, double blinded clinical trial, having one experimental and
      one control group (n - 75/arm). Participants in the experimental group will consume an
      isoflavones supplement in the form of Prevastein HC®, which will deliver 80 mgs (40 mg/dose)
      biologically active isoflavones and those in the control group will receive an identical
      placebo. The isoflavones supplement and the placebo tablets will be manufactured and packaged
      by Cognis Corporation.

        1. Isoflavones will be supplied at no charge by Cognis Corporation, LaGrange, Illinois as
           Prevastein HC®. Each Prevastein HC® tablet delivers 20 mg biologically active
           isoflavones, which is available for absorption. Participants will consume 2 tablets
           twice daily (with meals) in addition to their usual diet.

        2. Placebo will be supplied at no charge by Cognis Corporation, LaGrange, Illinois as an
           indistinguishable tablet. Participants will consume 2 tablets twice daily (with meals)
           in addition to their usual diet.

        3. A standardized multivitamin will be supplied at no charge.
    

Intervention name(s): Prevastein HC®; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Experimental Group - Participants in the experimental group will consume an isoflavones supplement in the form of Prevastein HC®, which will deliver 80 mgs (40 mg/dose) biologically active isoflavones.; Control Group - Control Group participants will receive an identical placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: isoflavones; soy