What is the mechanism of action of this treatment?

Common treatments for prostate cancer include surgery, radiation therapy, hormone therapy, chemotherapy, and emerging treatments like antioxidants. Antioxidants, such as Grape Seed Extract (GSE), work by neutralizing free radicals, thereby reducing oxidative stress and potentially slowing cancer progression. This is particularly relevant for prostate cancer patients as oxidative stress is implicated in cancer development and progression. By mitigating oxidative damage, antioxidants may help in managing prostate cancer, especially in cases where traditional treatments are not suitable or as complementary therapies to enhance overall treatment efficacy.

What side effects are associated with this type of intervention?

Common treatments for prostate cancer include surgery, radiation therapy, hormone therapy, and chemotherapy. Antioxidant treatments similar to Grape Seed Extract, such as pomegranate juice and vitamin E, have been studied for their potential benefits. Pomegranate juice has shown some promise in prolonging PSA doubling time, but further testing is needed. Vitamin E, while generally safe, has not shown consistent benefits in cancer prevention and may increase all-cause mortality at high doses. Side effects of these antioxidant treatments are generally mild but can include gastrointestinal issues and, in rare cases, more serious conditions like cholestatic hepatitis when combined with other ingredients.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer include a variety of drugs and therapies. Abiraterone, often combined with prednisone, is used for advanced prostate cancer and works by inhibiting androgen production. While grape seed extract is being studied for its antioxidant effects, there are no FDA-approved prostate cancer treatments specifically categorized as antioxidants. Most approved treatments focus on hormone therapy, chemotherapy, and targeted therapies rather than antioxidant mechanisms.

What other types of research exist?

Promising alternatives to Grape Seed Extract for prostate cancer patients include: 1) Saw Palmetto, which has shown effects on urodynamic parameters and voiding symptoms in men with lower urinary tract symptoms. 2) Red Wine Polyphenols, which contain antioxidants that inhibit prostate cancer development. 3) Omega-3 Fatty Acids, which have protective effects against various forms of cancer. 4) Vitamin E, which has been studied for its neuroprotective effects and potential benefits in cancer care. Patients should discuss these options with their healthcare provider to determine the best course of action.

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Polyphenol

Grape Seed Extract for Prostate Cancer

N/A

Waitlist Available

Led By Paul Maroni, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Patients who are on active surveillance for untreated localized disease may not participate in this study

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial involves patients taking a grape seed extract supplement to help manage their prostate health. The supplement is believed to protect cells and reduce inflammation. Patients' PSA levels will be monitored to assess the effectiveness of the treatment.

Who is the study for?

This trial is for adults over 18 with prostate cancer who've seen a rise in PSA after local therapy, not on active hormone therapies, and have declined or aren't candidates for salvage therapy. They must be able to swallow capsules, have no severe allergies to GSE products, and not be on surveillance for untreated localized disease.

What is being tested?

The study tests the effects of Grape Seed Extract (GSE) taken orally at 150 mg twice daily. Participants will take GSE for up to one year with evaluations every six weeks initially and then every three months.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions to supplements such as digestive issues or allergic responses in those sensitive to grape seed extract components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer was confirmed through a tissue examination.

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My PSA levels have increased on two tests done a week apart, with a baseline of at least 0.2 ng/mL, and I have no visible cancer on scans.

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I am not on hormone therapy for cancer and my testosterone is above 50 ng/dL.

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I am able to care for myself and perform daily activities.

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My blood counts meet the required levels for treatment.

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My liver tests are within the required range.

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I am 18 years old or older.

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My kidney function is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not just being watched for my untreated localized disease.

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My PSA levels are rising very quickly.

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I cannot swallow pills or have a condition affecting my stomach's ability to absorb medicine.

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I need strong painkillers for my prostate cancer pain.

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I haven't had major surgery, radiation, or experimental drugs in the last 2 weeks.

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I have a chronic HIV or hepatitis infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks and 3, 6, 9, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks and 3, 6, 9, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of patients with PSA response

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 150 mg of Grape Seed Extract (GSE)Experimental Treatment1 Intervention

150 mg of GSE twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Grape Seed Extract

2008

Completed Phase 1

~110

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include surgery, radiation therapy, hormone therapy, chemotherapy, and emerging treatments like antioxidants. Antioxidants, such as Grape Seed Extract (GSE), work by neutralizing free radicals, thereby reducing oxidative stress and potentially slowing cancer progression. This is particularly relevant for prostate cancer patients as oxidative stress is implicated in cancer development and progression. By mitigating oxidative damage, antioxidants may help in managing prostate cancer, especially in cases where traditional treatments are not suitable or as complementary therapies to enhance overall treatment efficacy.

Establishing the infrastructure to conduct comparative effectiveness research toward the elimination of disparities: a community-based participatory research framework.Specialty supplements and prostate cancer risk in the VITamins and Lifestyle (VITAL) cohort.Phase II study of pomegranate juice for men with rising prostate-specific antigen following surgery or radiation for prostate cancer.