Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance.
NCT ID: NCT00584532
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
66 participants
INTERVENTIONAL
2003-11-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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A
A=Placebo ARM of Study
Placebo
10 Placebo Capsules taken orally every day.
B
B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.
GCP - Genistein Combined Polysaccharide
Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.
Interventions
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Placebo
10 Placebo Capsules taken orally every day.
GCP - Genistein Combined Polysaccharide
Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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University of California, Davis - Department of Nutrition
Principal Investigators
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Robert Hackman, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis - Dept. of Nutrition
Other Identifiers
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281609
Identifier Type: -
Identifier Source: org_study_id