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GCP in localized prostate cancer on active surveillance
NCT00584532Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2003
- Primary completion
- Dec 2005
- Sponsor
- University of California, Davis
- Modality
- Botanical Extract
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 3, randomised, double-blind trial in prostate cancer (PCa) comparing Placebo with GCP (2 arms). Primary endpoint: Decrease in PSA levels at 6 months. Started Nov 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo capsules daily
GCP
Genistein Combined Polysaccharide 5g daily
03
Who it enrols
Male patients with a pathological diagnosis of prostate cancer on active surveillance, with PSA between 2.0 and 10.0 ng/ml (or >10 if on surveillance for 12 months), and no prior treatment (surgery, radiation, hormones).
04
Endpoints
Primary
Decrease in PSA levels
Secondary
PSA Doubling Time
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