A Study of Grape Seed Extract in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising PSA
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|ClinicalTrials.gov Identifier: NCT03087903|
Recruitment Status : Active, not recruiting
First Posted : March 23, 2017
Last Update Posted : January 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: Grape Seed Extract||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||January 9, 2018|
|Actual Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 2021|
Experimental: 150 mg of Grape Seed Extract (GSE)
150 mg of GSE twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation.
Dietary Supplement: Grape Seed Extract
Patients will take 150 mg of Grape Seed Extract (GSE) product by mouth twice daily (in the form of 75 mg capsule of Leucoselect Phytosome preparation). Total oral dosage is 300 mg of 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.
Other Name: Leucoselect Phytosome
- The number of patients with PSA response [ Time Frame: 6 weeks and 3, 6, 9, and 12 months ]PSA response will be defined as an increase in prostate specific antigen (PSA) doubling time (PSADT) of 30% (PSADT is the length of time it takes for a PSA to double based on an exponential growth pattern). Patients must have a PSA level of ≥ 0.2 at study entry and should have at least three prior PSA values with dates from which to calculate a PSA doubling time.
- The rate of change of the PSA over time (PSA velocity) for each patient [ Time Frame: 6 weeks and 3, 6, 9, and 12 months ]PSA velocity will be calculated as a change from the first PSA reading, standardized as PSA change per month. PSA Response will be defined as increase in PSADT of 30% (PSADT is the length of time it takes for a PSA to double based on an exponential growth pattern). Biomarkers will be defined as proinflammatory cytokines, lipid and comprehensive metabolic panel in patient serum samples as well as, gut microbiome (measured by by high-throughput16S sequencing), plasma and stool metabolomics (after short and long-term consumption of GSE), and the effects of diet on gut microbiome.
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): NCT03087903
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|Poudre Valley Hospital|
|Fort Collins, Colorado, United States, 80524|
|Principal Investigator:||Paul Maroni, MD||University of Colorado, Denver|