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

Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - 99
Start Date:January 9, 2018
End Date:December 2019
Contact:Sarah Ballard

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A Phase 2 Study of Grape Seed Extract (GSE) Product in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising Prostate Specific Antigen (PSA)

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).

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

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

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.
We found this trial at
Aurora, Colorado 80045
Principal Investigator: Paul Maroni, MD
Phone: 720-848-8879
Aurora, CO
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
Principal Investigator: Steven Schuster, MD
Phone: 970-493-6337
Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
Fort Collins, CO
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