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


N/A
N/A
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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.

-

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Reduction in PSA serum levels.

Principal Investigator

Robert Hackman, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

200412146

NCT ID:

NCT00269555

Start Date:

May 2004

Completion Date:

September 2006

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Cancer
  • Prostate Specific Antigen
  • C04.588.945.440.770
  • Prostatic Neoplasms

Name

Location

University of California, DavisSacramento, California  95818