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Brief Title: A Study of Grape Seed Extract in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising PSA
Official Title: A Phase 2 Study of Grape Seed Extract (GSE) Product in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)
Study ID: NCT03087903
Brief Summary: Patients will take 150 mg of GSE product by mouth twice daily and will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year.
Detailed Description: Patients will take 150 mg of GSE product by mouth twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation; total oral dosage is 300 mg GSE per day for one year. Patients will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. PSA measurements will be obtained at these scheduled visits and patients must not have a doubling of their PSA (compared to baseline) by 3 months in order to continue on study. Patients who meet criteria to continue on study will be treated until disease progression or for one year (whichever comes first).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
University of Colorado Cancer Center, Aurora, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Name: Paul Maroni, MD
Affiliation: University of Colorado, Denver
Role: PRINCIPAL_INVESTIGATOR