Effects of GCP on Prostate Cancer.
Effects of a Genistein Combined Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started May 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedJune 29, 2010
June 1, 2010
1.7 years
December 22, 2005
June 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in PSA serum levels.
Secondary Outcomes (1)
Stabilization of PSA serum levels.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- No pathological documentation of prostate cancer.
- Allergy to soy or soy products
- Prior history of treatment for prostate cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Davis
Sacramento, California, 95817, United States
Related Publications (1)
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. doi: 10.1016/j.urology.2003.09.061.
PMID: 14972467BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Hackman, PhD
University of California, Davis
- STUDY DIRECTOR
Ralph W deVere White, MD
University of California, Davis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 23, 2005
Study Start
May 1, 2004
Primary Completion
January 1, 2006
Study Completion
September 1, 2006
Last Updated
June 29, 2010
Record last verified: 2010-06