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

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584532
First received: December 22, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

December 22, 2007
December 22, 2007
November 2003
December 2005   (final data collection date for primary outcome measure)
Decrease in PSA levels in men on GCP [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Increased PSA Doubling Time (PSADT)in men on GCP. [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Placebo
    10 Placebo Capsules taken orally every day.
    Other Name: Placebo capsules (contain cellulose only)
  • Drug: GCP - Genistein Combined Polysaccharide
    Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.
  • Placebo Comparator: A
    A=Placebo ARM of Study
    Intervention: Drug: Placebo
  • Active Comparator: B
    B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.
    Intervention: Drug: GCP - Genistein Combined Polysaccharide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
December 2007
December 2005   (final data collection date for primary outcome measure)

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.
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00584532
200412146-5
Yes
Robert Hackman, PhD, University of California, Davis - Department of Nutrition
University of California, Davis
Not Provided
Principal Investigator: Robert Hackman, MD University of California, Davis - Dept. of Nutrition
University of California, Davis
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP