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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date † | December 22, 2005 | ||||||||
| Last Updated Date | September 7, 2006 | ||||||||
| Start Date † | May 2004 | ||||||||
| Current Primary Outcome Measures † |
Reduction in PSA serum levels. | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00269555 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
Stabilization of PSA serum levels. | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | Effects of GCP on Prostate Cancer. | ||||||||
| Official Title † | Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance. | ||||||||
| Brief Summary | Genistein Combined Polysaccharide (GCP) is derived from adding soy powder to shiitake mushrooms. This concentrated mixture is currently being sold in Japan and the United States and is thought to possibly contain properties that may be useful in treating certain types of cancer. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study | ||||||||
| Condition † | Prostate Cancer | ||||||||
| Intervention † | Drug: Genistein Combined Polysaccharide (GCP) | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | deVere White RW, Hackman RM, Soares SE, Beckett LA, Li Y, Sun B. Effects of a genistein-rich extract on PSA levels in men with a history of prostate cancer. Urology. 2004 Feb;63(2):259-63. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Active, not recruiting | ||||||||
| Enrollment † | 62 | ||||||||
| Completion Date | September 2006 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | 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. - |
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| Gender | Male | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00269555 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of California, Davis | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | University of California, Davis | ||||||||
| Verification Date | September 2006 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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