Prostate Cancer
Conditions
Keywords
Localized, Prostate, Cancer
Brief summary
Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.
Interventions
DRUGPlacebo
10 Placebo Capsules taken orally every day.
DRUGGCP - Genistein Combined Polysaccharide
Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in PSA levels in men on GCP | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Increased PSA Doubling Time (PSADT)in men on GCP. | 6 Months |
Outcome results
None listed