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Effects of GCP on Prostate Cancer.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00269555
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : June 29, 2010
Sponsor:
Information provided by:
University of California, Davis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Genistein Combined Polysaccharide (GCP) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Genistein

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Reduction in PSA serum levels.

Secondary Outcome Measures :
  1. Stabilization of PSA serum levels.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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).

-

Exclusion Criteria:

No pathological documentation of prostate cancer.

Allergy to soy or soy products

Prior history of treatment for prostate cancer.

-

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
University of California, Davis
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Robert Hackman, PhD University of California, Davis
Study Director: Ralph W deVere White, MD University of California, Davis
More Information
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Publications:

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Responsible Party: Dr. Robert Hackman, University of California, Davis
ClinicalTrials.gov Identifier: NCT00269555    
Other Study ID Numbers: 200412146
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: June 29, 2010
Last Verified: June 2010
Keywords provided by University of California, Davis:
Prostate
Cancer
Prostate Specific Antigen
C04.588.945.440.770
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Genistein
Anticarcinogenic Agents
 Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists