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Polyphenol

Grape Seed Extract for Prostate Cancer If instead, Alzheimer's disease was indeed meant to be included as well, please provide clarification so I can give you an accurate trial name

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will test a grape seed extract supplement to see if it is effective in treating Alzheimer's disease. Patients will take the supplement twice a day and be evaluated every few months for up to a year.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The number of patients with PSA response

Secondary outcome measures

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

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

~90

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,542 Total Patients Enrolled

13 Trials studying Prostate Cancer

2,987 Patients Enrolled for Prostate Cancer

Paul Maroni, MDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Grape Seed Extract (Polyphenol) Clinical Trial Eligibility Overview. Trial Name: NCT03087903 — N/A

Prostate Cancer Research Study Groups: 150 mg of Grape Seed Extract (GSE)

Prostate Cancer Clinical Trial 2023: Grape Seed Extract Highlights & Side Effects. Trial Name: NCT03087903 — N/A

Grape Seed Extract (Polyphenol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03087903 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still the possibility to enroll participants in this research endeavor?

"Correct. Information available on clinicaltrials.gov suggests that this medical study is actively recruiting patients, having been first posted on September 1st 2018 and last updated August 22nd 2022. Approximately 20 individuals need to be recruited from 2 separate facilities."

Answered by AI

Is this trial open to individuals older than 40 years of age?

"This medical experiment is targeting individuals aged 18 to 99."

Answered by AI

What are the criteria for determining eligibility in this clinical trial?

"In order to be considered for this research, individuals must meet two criteria: they should have prostate cancer and fall in the age range of 18-99. This trial is looking for 20 participants."

Answered by AI

To what extent is this experiment being conducted with participants?

"Affirmative. Information available on clinicaltrials.gov reveals that the research project, which was first posted 9th of January 2018, is actively recruiting participants. The study requires 20 patients to be recruited from two separate sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "A Study of Grape Seed Extract in Asymptomatic Non-Metastatic Prostate Cancer Patients With Rising PSA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03087903.

All > Metastatic Prostate Cancer