Effects of GCP on Prostate Cancer.
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|ClinicalTrials.gov Identifier: NCT00269555|
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : June 29, 2010
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Genistein Combined Polysaccharide (GCP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||62 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||September 2006|
- Reduction in PSA serum levels.
- Stabilization of PSA serum levels.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
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).
No pathological documentation of prostate cancer.
Allergy to soy or soy products
Prior history of treatment for prostate cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269555
|United States, California|
|University of California, Davis|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Robert Hackman, PhD||University of California, Davis|
|Study Director:||Ralph W deVere White, MD||University of California, Davis|
|Responsible Party:||Dr. Robert Hackman, University of California, Davis|
|Other Study ID Numbers:||
|First Posted:||December 23, 2005 Key Record Dates|
|Last Update Posted:||June 29, 2010|
|Last Verified:||June 2010|
Prostate Specific Antigen
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases
Physiological Effects of Drugs
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists