Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Placebo; Drug: GCP - Genistein Combined Polysaccharide

• Registration Number: NCT00584532
• Lead Sponsor: University of California, Davis

Brief Summary

Genistein Combined Polysaccharide (GCP) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2005-12
• Status Verified: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2007-12-22
• Study First Submitted QC: 2007-12-22
• Study First Posted: 2008-01-02
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

• Participants must be male and have a pathological diagnosis of prostate cancer
• Pathological diagnosis of prostate cancer must be confirmed and on file with CRA prior to study entry.
• No treatment (surgery, radiation, or hormones) prior to study entry.
• 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).
• Participant has not been on any previous GCP clinical trial.
• Normal Chemistry values prior to study entry.

Exclusion Criteria

• No pathological documentation of prostate cancer.
• Prior treatment for prostate cancer.
• PSA >10.0 ng/ml but not on Active Surveillance for 12 months.
• Allergy to soy or soy products.
• Abnormal chemistry values.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Placebo	A=Placebo ARM of Study
B	GCP - Genistein Combined Polysaccharide	B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.

Primary Outcome Measures

Name	Time	Method
Decrease in PSA levels in men on GCP	6 Months

Secondary Outcome Measures

Name	Time	Method
Increased PSA Doubling Time (PSADT)in men on GCP.	6 Months