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

December 22, 2007 updated by: University of California, Davis

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A
A=Placebo ARM of Study
Drug: Placebo
10 Placebo Capsules taken orally every day.
Other Names:
  • Placebo capsules (contain cellulose only)
Active Comparator: B
B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.
Drug: GCP - Genistein Combined Polysaccharide
Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in PSA levels in men on GCP
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Increased PSA Doubling Time (PSADT)in men on GCP.
Time Frame: 6 Months
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Robert Hackman, MD, University of California, Davis - Dept. of Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 22, 2007

First Submitted That Met QC Criteria

December 22, 2007

First Posted (Estimate)

January 2, 2008

Study Record Updates

Last Update Posted (Estimate)

January 2, 2008

Last Update Submitted That Met QC Criteria

December 22, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200412146-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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