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

NCT03087903 | Completed DMC

• 1 other identifier: 16-0607.cc
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

Prostate Specific Antigen (PSA); Non-Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The rate of change of the PSA over time (PSA velocity) for each patient

  6 weeks and 3, 6, 9, and 12 months

Study Arms (1)

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.

Dietary Supplement: Grape Seed Extract

Interventions

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.

Also known as: Leucoselect Phytosome

150 mg of Grape Seed Extract (GSE)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent has been obtained.
• Adults \> or = 18 years of age.
• Histologically confirmed prostate adenocarcinoma.
• 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.
• 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.
• Patients must not be on active LHRH agonist/antagonist therapy and must have testosterone level \> 50 ng/dL.
• 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.
• 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.
• Patients who have PSA recurrence after local salvage therapy may participate in this study.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Adequate hematologic function (absolute neutrophil count \[ANC\]≥1,500 cells/µL; hemoglobin ≥9 g/dL, platelets ≥75,000/µL).
• Adequate renal function (serum creatinine ≤ 2X the upper limit of normal (ULN)
• Adequate hepatic function (total bilirubin ≤ 2 x upper limit of normal \[ULN\], alanine aminotransferase \[ALT\]≤ 3xULN, aspartate aminotransferase \[AST\]≤3 x ULN).
• 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.

You may not qualify if:

• Patients who are on active surveillance for untreated localized disease may not participate in this study.
• Inability to swallow gelatin capsules, or any medical condition that interferes with normal gastrointestinal absorption.
• Major surgery, radiation, or treatment with any other investigational drug within 2 weeks of study treatment.
• Documented hypersensitivity reaction to any product with GSE (see complete list in Appendix 1).
• Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
• Symptomatic prostate cancer as determined by cancer-related pain requiring narcotic pain medication.
• Very fast PSA doubling time of less than 4 weeks, if the absolute PSA is \> 2 ng/mL.
• Known allergy/intolerance to soy, phosphatidycholine or any other constituents of grape seed extract.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cancer League of Colorado: collaborator

Study Sites (2)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Grape Seed Extract; leucoselect phytosome

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• Paul Maroni, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 23, 2017
• Study Start: January 18, 2018
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)