CompletedNot Applicable

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

United States41 participantsStarted 2018-01-18

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexMALE

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. 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).
✕. Very fast PSA doubling time of less than 4 weeks, if the absolute PSA is \> 2 ng/mL.

What they're measuring

The number of patients with PSA response

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

Trial details

NCT IDNCT03087903

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-29

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