Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
N/A
N/A
N/A
N/A
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
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.
-
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Reduction in PSA serum levels.
Principal Investigator
Robert Hackman, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Davis
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
200412146
NCT ID:
NCT00269555
Start Date:
May 2004
Completion Date:
September 2006
Related Keywords:
- Prostate Cancer
- Prostate
- Cancer
- Prostate Specific Antigen
- C04.588.945.440.770
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of California, Davis | Sacramento, California 95818 |
