Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.
Phase 2
Completed
- Conditions
- Prostate Cancer
- Interventions
- Drug: PlaceboDrug: GCP - Genistein Combined Polysaccharide
- Registration Number
- NCT00584532
- Lead Sponsor
- University of California, Davis
- Brief Summary
Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 66
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A Placebo A=Placebo ARM of Study B GCP - Genistein Combined Polysaccharide B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.
- Primary Outcome Measures
Name Time Method Decrease in PSA levels in men on GCP 6 Months
- Secondary Outcome Measures
Name Time Method Increased PSA Doubling Time (PSADT)in men on GCP. 6 Months