Effects of GCP on Prostate Cancer. - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00269555

Purpose

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.

Condition	Intervention
Prostate Cancer	Drug: Genistein Combined Polysaccharide (GCP)

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Genistein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

Reduction in PSA serum levels.

Secondary Outcome Measures:

Stabilization of PSA serum levels.

Estimated Enrollment:	62
Study Start Date:	May 2004
Estimated Study Completion Date:	September 2006

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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).

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Exclusion Criteria:

No pathological documentation of prostate cancer.

Allergy to soy or soy products

Prior history of treatment for prostate cancer.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269555

Locations

United States, California
University of California, Davis
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:	Robert Hackman, PhD	University of California, Davis
Study Director:	Ralph W deVere White, MD	University of California, Davis

More Information

Publications:

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.

Study ID Numbers:	200412146
Study First Received:	December 22, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00269555
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of California, Davis:

Prostate
Cancer
Prostate Specific Antigen
C04.588.945.440.770

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Genistein

Additional relevant MeSH terms:

Anticarcinogenic Agents
Estrogens
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Protein Kinase Inhibitors

Hormones
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Estrogens, Non-Steroidal
Therapeutic Uses
Phytoestrogens

ClinicalTrials.gov processed this record on January 15, 2009