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Muscadine Plus (MPX) In Men With Prostate Cancer

NCT03535675 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-05-22

Study results available
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Summary

This research is being done to determine if men with rising PSA after initial therapy for localized prostate cancer who display the Alanine/Alanine SOD2 genotype of MnSOD and supplement their diet with MPX have greater decrease in PSA slope following treatment compared to men that do not supplement with MPX.

Conditions

  • Adenocarcinoma of the Prostate

Interventions

DRUG

Muscadine Plus

Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.

DRUG

Placebos

The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.

Sponsors & Collaborators

  • Greater Washington Community Foundation

    collaborator UNKNOWN

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Channing Paller, M.D · SKCCC at Johns Hopkins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2022-07-06
Completion
2022-11-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03535675 on ClinicalTrials.gov