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

Prostate Cancer Clinical Trial

— GCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584532
• Other study ID #: 281609
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2003
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2007
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Placebo
10 Placebo Capsules taken orally every day.
• GCP - Genistein Combined Polysaccharide
Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in PSA levels in men on GCP		6 Months
Secondary	Increased PSA Doubling Time (PSADT)in men on GCP.		6 Months