Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.

Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.

Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.

Inclusion Criteria:

• Participants must be male and have a pathological diagnosis of prostate cancer
• Pathological diagnosis of prostate cancer must be confirmed and on file with CRA prior to study entry.
• No treatment (surgery, radiation, or hormones) prior to study entry.
• PSA between 2.0 and 10.0 ng/ml.
• If PSA is >10.0, patient must have been on Active Surveillance for 12 months prior to study initiation.
• No known allergy to soy or soy products.
• The patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (OTC supplements).
• Participant has not been on any previous GCP clinical trial.
• Normal Chemistry values prior to study entry.

Exclusion Criteria:

• No pathological documentation of prostate cancer.
• Prior treatment for prostate cancer.
• PSA >10.0 ng/ml but not on Active Surveillance for 12 months.
• Allergy to soy or soy products.
• Abnormal chemistry values.