Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance. (NCT00584532) | Clinical Trial Compass
CompletedPhase 2/3
Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.
66 participantsStarted 2003-11
Plain-language summary
Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.
Who can participate
SexMALE
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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.