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


Phase 2/Phase 3
N/A
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Effects of a Genistein Concentrated 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

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Decrease in PSA levels in men on GCP

Outcome Time Frame:

6 Months

Safety Issue:

No

Principal Investigator

Robert Hackman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis - Dept. of Nutrition

Authority:

United States: Institutional Review Board

Study ID:

200412146-5

NCT ID:

NCT00584532

Start Date:

November 2003

Completion Date:

December 2007

Related Keywords:

  • Prostate Cancer
  • Localized
  • Prostate
  • Cancer
  • Prostatic Neoplasms

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