← Back to Search

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
Select...
My prostate cancer was confirmed through a tissue examination.
Select...
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.
Select...
I am not on hormone therapy for cancer and my testosterone is above 50 ng/dL.
Select...
I am able to care for myself and perform daily activities.
Select...
My blood counts meet the required levels for treatment.
Select...
My liver tests are within the required range.
Select...
I am 18 years old or older.
Select...
My kidney function is within the normal range.

Timeline

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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,427 Total Patients Enrolled
13 Trials studying Prostate Cancer
2,985 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
~4 spots leftby Jan 2025