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Clinical Trials/NCT00269555
NCT00269555CompletedNot Applicable

Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.

University of California, Davis2 sites in 1 country62 target enrollmentStarted: May 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
2
Primary Endpoint
Reduction in PSA serum levels.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Sex
Male
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Reduction in PSA serum levels.

Secondary Outcomes

  • Stabilization of PSA serum levels.

Investigators

Sponsor Class
Other

Study Sites (2)

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