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
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.

Resource links provided by NLM:


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
Study Completion Date: September 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  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).

-

Exclusion Criteria:

No pathological documentation of prostate cancer.

Allergy to soy or soy products

Prior history of treatment for prostate cancer.

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Dr. Robert Hackman, University of California, Davis
ClinicalTrials.gov Identifier: NCT00269555     History of Changes
Other Study ID Numbers: 200412146
Study First Received: December 22, 2005
Last Updated: June 25, 2010
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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Genistein
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014