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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
GCP - Genistein Combined Polysaccharide
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Localized, Prostate, Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    A

    B

    Arm Description

    A=Placebo ARM of Study

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

    Outcomes

    Primary Outcome Measures

    Decrease in PSA levels in men on GCP

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 22, 2007
    Last Updated
    December 22, 2007
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00584532
    Brief Title
    Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.
    Acronym
    GCP
    Official Title
    Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2003 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Localized, Prostate, Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Placebo Comparator
    Arm Description
    A=Placebo ARM of Study
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Placebo capsules (contain cellulose only)
    Intervention Description
    10 Placebo Capsules taken orally every day.
    Intervention Type
    Drug
    Intervention Name(s)
    GCP - Genistein Combined Polysaccharide
    Intervention Description
    Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.
    Primary Outcome Measure Information:
    Title
    Decrease in PSA levels in men on GCP
    Time Frame
    6 Months
    Secondary Outcome Measure Information:
    Title
    Increased PSA Doubling Time (PSADT)in men on GCP.
    Time Frame
    6 Months

    10. Eligibility

    Sex
    Male
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Hackman, MD
    Organizational Affiliation
    University of California, Davis - Dept. of Nutrition
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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