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

NCT00584532 | Completed Phase 2 DMC

• 1 other identifier: 281609
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Localized; Prostate; Cancer

Outcome Measures

Primary Outcomes (1)

• Decrease in PSA levels in men on GCP

  6 Months

Secondary Outcomes (1)

• Increased PSA Doubling Time (PSADT)in men on GCP.

  6 Months

Study Arms (2)

A

PLACEBO COMPARATOR

A=Placebo ARM of Study

Drug: Placebo

B

ACTIVE COMPARATOR

B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.

Drug: GCP - Genistein Combined Polysaccharide

Interventions

Placebo DRUG

10 Placebo Capsules taken orally every day.

Also known as: Placebo capsules (contain cellulose only)

A

GCP - Genistein Combined Polysaccharide DRUG

Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.

B

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

genistein combined polysaccharide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Robert Hackman, MD

  University of California, Davis - Dept. of Nutrition

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: January 2, 2008
• Study Start: November 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2007
• Last Updated: November 24, 2023

Record last verified: 2007-12