Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of GCP on Prostate Cancer.

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00269555
First received: December 22, 2005
Last updated: June 25, 2010
Last verified: June 2010

December 22, 2005
June 25, 2010
May 2004
January 2006   (final data collection date for primary outcome measure)
Reduction in PSA serum levels.
Same as current
Complete list of historical versions of study NCT00269555 on ClinicalTrials.gov Archive Site
Stabilization of PSA serum levels.
Same as current
Not Provided
Not Provided
 
Effects of GCP on Prostate Cancer.
Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Prostate Cancer
Drug: Genistein Combined Polysaccharide (GCP)
Not Provided
deVere White RW, Hackman RM, Soares SE, Beckett LA, Li Y, Sun B. Effects of a genistein-rich extract on PSA levels in men with a history of prostate cancer. Urology. 2004 Feb;63(2):259-63.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
September 2006
January 2006   (final data collection date for primary outcome measure)

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.

-

Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00269555
200412146
Not Provided
Dr. Robert Hackman, University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: Robert Hackman, PhD University of California, Davis
Study Director: Ralph W deVere White, MD University of California, Davis
University of California, Davis
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP