Effects of GCP on Prostate Cancer.

NCT ID: NCT00269555

Last Updated: 2010-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Genistein Combined Polysaccharide (GCP)

Intervention Type DRUG

Eligibility Criteria

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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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Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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University of California, Davis

Principal Investigators

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Robert Hackman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Ralph W deVere White, MD

Role: STUDY_DIRECTOR

University of California, Davis

Locations

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University of California, Davis

Sacramento, California, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.urology.2003.09.061.

Reference Type BACKGROUND
PMID: 14972467 (View on PubMed)

Other Identifiers

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200412146

Identifier Type: -

Identifier Source: org_study_id

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