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Muscadine Plus for Prostate Cancer

Phase 3

Waitlist Available

Led By Channing Paller, M.D

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether men with a particular gene type who take a dietary supplement have a greater decrease in PSA levels than men who do not take the supplement.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Prostate Specific Antigen (PSA) Response

Secondary outcome measures

PSA Doubling Time

PSA Objective Response Rate

PSA Progression

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Each treatment cycle consists of once daily oral dosing of 4000 mg placebos, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of placebo and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.

Group II: Muscadine PlusExperimental Treatment1 Intervention

Each treatment cycle consists of once daily oral dosing of 4000 mg Muscadine Plus, every day throughout each 12 week (84 day) cycle. Patients may continue to receive additional cycles of study drug and will be followed every three months with standard visits with their physician until completion of 48 weeks of study treatment, disease progression, or until they wish to discontinue the drug.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebos

2019

Completed Phase 4

~2030

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Greater Washington Community FoundationUNKNOWN

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

557 Previous Clinical Trials

32,841 Total Patients Enrolled

57 Trials studying Prostate Cancer

3,348 Patients Enrolled for Prostate Cancer

Channing Paller, M.DPrincipal InvestigatorSKCCC at Johns Hopkins

Frequently Asked Questions

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

Does this study accept patients who are senior citizens?

"The age limit for participants in this study are between 18-99 years old."

Answered by AI

Does Muscadine Plus have the FDA's official seal of approval?

"There is both pre-existing data supporting the efficacy of Muscadine Plus and numerous rounds of safety testing, so it received a score of 3."

Answered by AI

Is this study being conducted at different hospitals in North America?

"There are 11 clinical trial sites running this study, with locations in Baltimore, Chicago, Boston and other cities. Trial participants should select the location nearest them to limit travel requirements."

Answered by AI

If a patient wanted to participate in this research, would they be able to at this time?

"Unfortunately, this particular clinical trial is not presently looking for candidates. Although the last update was on 8/15/2022, it appears as if recruiting efforts concluded prior. There are 796 other trials that might be a better fit and are currently enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Muscadine Plus (MPX) In Men With Prostate Cancer

2018. "Muscadine Plus (MPX) In Men With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03535675.