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NCT03535675 · ClinicalTrials.gov registry record · Phase 3
Muscadine Plus (MPX) In Men With Prostate Cancer
A Phase 3 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Terminated
- Registry status
- Phase 3
- Development phase
- 59
- Enrollment target
NCT03535675: Clinical Trial Phase 3 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03535675 is a Phase 3 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 59 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03535675, a Phase 3 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 59 participants
- Enrollment target
Study 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.
Primary Outcome
To determine if men who display the Alanine/Alanine superoxide dismutase 2 (SOD2) genotype of MnSOD and supplement their diet with MPX have greater changes in PSA slope following treatment compared to men that do not supplement with MPX. PSA response will be measured as the change of serum PSA in ng/mL/month, on-study PSA slope for each patient with comparisons between treatment arms adjusted for pre-study PSA slope; on-study PSA slope was calculated from PSA values taken at baseline,12, 24, 36
Interventions
- DRUG Placebos
- DRUG Muscadine Plus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2018-10-30 |
| Est. Completion | 2022-11-03 |
| Phase | Phase 3 |
Why NCT03535675 stopped before completion
NCT03535675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03535675 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03535675 about?
NCT03535675 is a clinical study titled "Muscadine Plus (MPX) In Men With Prostate Cancer". 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 ...
What is the current status of trial NCT03535675?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 59 participants. The study started on 2018-10-30. Estimated completion is 2022-11-03.
What interventions are being tested in trial NCT03535675?
The interventions under investigation include: Placebos (DRUG), Muscadine Plus (DRUG).
Who is sponsoring clinical trial NCT03535675?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03535675's enrollment target sits among peer trials
59 1824th of 2000 higher than 176 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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