Effects of GCP on Prostate Cancer.

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Genistein Combined Polysaccharide (GCP)

Drug

Primary outcomes

Reduction in PSA serum levels.

Secondary outcomes

Stabilization of PSA serum levels.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Dec 23, 2005
Registry last updated: Jun 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed