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| Name | Class |
|---|---|
| Cancer League of Colorado | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150 mg of Grape Seed Extract (GSE) | Experimental | 150 mg of GSE twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grape Seed Extract | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with PSA response | 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. | 6 weeks and 3, 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of change of the PSA over time (PSA velocity) for each patient | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Maroni, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States | ||
| Poudre Valley Hospital |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D056604 | Grape Seed Extract |
| C000624588 | leucoselect phytosome |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
|
| 6 weeks and 3, 6, 9, and 12 months |
| Fort Collins |
| Colorado |
| 80524 |
| United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004364 |
| Pharmaceutical Preparations |