Effects of a Genistein Concentrated Polysaccharide (GCP) for Prostate Cancer on Active Surveillance. (GCP)
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|ClinicalTrials.gov Identifier: NCT00584532|
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : January 2, 2008
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Placebo Drug: GCP - Genistein Combined Polysaccharide||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of a Genistein Concentrated Polysaccharide (GCP) on Patients With a Diagnosis of Prostate Cancer on Active Surveillance.|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2007|
Placebo Comparator: A
A=Placebo ARM of Study
10 Placebo Capsules taken orally every day.
Other Name: Placebo capsules (contain cellulose only)
Active Comparator: B
B=GCP Capsules. Ten 500 mg capsules per day for a total of 5 grams a day.
Drug: GCP - Genistein Combined Polysaccharide
Ten 500 mg capsules given orally per day. Total of 5 grams per day per patient.
- Decrease in PSA levels in men on GCP [ Time Frame: 6 Months ]
- Increased PSA Doubling Time (PSADT)in men on GCP. [ Time Frame: 6 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584532
|Principal Investigator:||Robert Hackman, MD||University of California, Davis - Dept. of Nutrition|