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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Treatments: Genistein

Criteria

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.