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A Study of Grape Seed Extract in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising PSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03087903
Recruitment Status : Active, not recruiting
First Posted : March 23, 2017
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: Grape Seed Extract Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent has been obtained.
  2. Adults > or = 18 years of age.
  3. Histologically confirmed prostate adenocarcinoma.
  4. Evidence of rising PSA, on 2 separate occasions, at least one week apart. Baseline PSA must be ≥ 0.2 ng/mL at the time of screening. Radiographic evidence of disease is not allowed.
  5. Patients must have sufficient PSA time points prior to enrollment (a minimum of 3 PSA levels within a six month period) to calculate a baseline PSA doubling time.
  6. Patients must not be on active LHRH agonist/antagonist therapy and must have testosterone level > 50 ng/dL.
  7. Patients must not be on active anti-androgen therapy or 5-alpha reductase inhibitors. Patients on stable dose of 5-alpha reductase inhibitors for benign prostatic hypertrophy for at least 12 months may continue. They must withdraw from the study if this is stopped while on study.
  8. Patients who are candidates for local salvage therapy must have had this option pursued or discussed; and the patient must have either declined salvage therapy or was deemed not to be a candidate for salvage therapy.
  9. Patients who have PSA recurrence after local salvage therapy may participate in this study.
  10. Patients with hormone sensitive disease who received prior androgen deprivation therapy as part of primary/salvage local treatment or patients receiving intermittent androgen deprivation therapy will be allowed to participate.
  11. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  12. Adequate hematologic function (absolute neutrophil count [ANC]≥1,500 cells/µL; hemoglobin ≥9 g/dL, platelets ≥75,000/µL).
  13. Adequate renal function (serum creatinine ≤ 2X the upper limit of normal (ULN)
  14. Adequate hepatic function (total bilirubin ≤ 2 x upper limit of normal [ULN], alanine aminotransferase [ALT]≤ 3xULN, aspartate aminotransferase [AST]≤3 x ULN).
  15. Patients can continue taking what they are taking at the time they start on the study, but agree not to start any new (over the counter) herbal supplement on regular basis during study duration.
  16. Prior chemotherapy for prostate cancer (upfront, adjuvant, etc.) is allowed as long as it was not given for hormone-refractory disease.

Exclusion Criteria:

  1. Patients who are on active surveillance for untreated localized disease may not participate in this study.
  2. Inability to swallow gelatin capsules, or any medical condition that interferes with normal gastrointestinal absorption.
  3. Major surgery, radiation, or treatment with any other investigational drug within 2 weeks of study treatment.
  4. Documented hypersensitivity reaction to any product with GSE (see complete list in Appendix 1).
  5. Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
  6. Symptomatic prostate cancer as determined by cancer-related pain requiring narcotic pain medication.
  7. History of another cancer is exclusionary unless it is believed to be likely cured or is unlikely to be fatal in the next 3 years (e.g. squamous cell carcinoma, superficial bladder cancer, chronic lymphocytic leukemia, etc).
  8. Very fast PSA doubling time of less than 4 weeks, if the absolute PSA is > 2 ng/mL.
  9. Known allergy/intolerance to soy, phosphatidycholine or any other constituents of grape seed extract.

Information from the National Library of Medicine

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


Locations
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United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Paul Maroni, MD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03087903    
Other Study ID Numbers: 16-0607.cc
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Prostate Specific Antigen (PSA)
Non-Metastatic Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Grape Seed Extract
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs