Prostate Cancer
Conditions
Keywords
Prostate, Cancer, Prostate Specific Antigen, C04.588.945.440.770
Brief summary
Genistein Combined Polysaccharide (GCP) is derived from adding soy powder to shiitake mushrooms. This concentrated mixture is currently being sold in Japan and the United States and is thought to possibly contain properties that may be useful in treating certain types of cancer.
Interventions
DRUGGenistein Combined Polysaccharide (GCP)
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
Participants must be male and have a pathological diagnosis of prostate cancer. No treatment (surgery \[RRP\], radiation, or hormones) prior to study entry. The patient has decided, after consultation with his own doctor, to have no treatment intervention (surgery \[RRP\], radiation, or hormones) for the next six months. 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). \-
Exclusion criteria
No pathological documentation of prostate cancer. Allergy to soy or soy products Prior history of treatment for prostate cancer. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in PSA serum levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Stabilization of PSA serum levels. | — |
Countries
United States
Outcome results
None listed