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NCT05586360 · ClinicalTrials.gov registry record · Phase 2
T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT05586360: Recruiting Phase 2 study of Prostate Cancer, sponsored by Medical University of South Carolina.
NCT05586360 is a Phase 2 study of Prostate Cancer that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 36 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05586360, a Phase 2 study of Prostate Cancer, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will evaluate whether simvastatin reduces intraprostatic immunosuppressive microenvironment through YAP-mediated T-reg dysfunction, and increases intraprostatic anti-tumor immune response in men recently diagnosed with localized prostate cancer electing to receive prostatectomy for their care. Half the men will be randomized to receive statins for 8 weeks prior to their surgery, while the other half will receive standard of care.
Primary Outcome
Number of men diagnosed with localized prostate cancer randomized to receive a statin prior to prostatectomy that have greater intra-prostatic YAP-mediated T-reg dysfunction compared to men randomized to the control group. Intra-prostatic T-reg dysfunction will be determined by the proportion of Foxp3+ T-regs with phosphorylated YAP sequestered in the cytoplasm detected by multiplex immunofluorescence and digital quantitative image analysis.
Conditions Studied
Interventions
- DRUG Simvastatin 40mg
Study Locations (2)
Georgia
- Emory University - Atlanta
South Carolina
- Hollings Cancer Center at Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2024-03-11 |
| Est. Completion | 2027-08-01 |
| Phase | Phase 2 |
What NCT05586360 shows while recruiting
NCT05586360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Simvastatin 40mg is the first listed.
NCT05586360 reports a single indexed study location in Georgia, South Carolina.
Frequently Asked Questions
What is clinical trial NCT05586360 about?
NCT05586360 is a clinical study titled "T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer". This study will evaluate whether simvastatin reduces intraprostatic immunosuppressive microenvironment through YAP-mediated T-reg dysfunction, and increases intraprostatic anti-tumor immune response in men recently diagnosed with localized prostate cancer electing to receive prostatectomy for their ...
What is the current status of trial NCT05586360?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2024-03-11. Estimated completion is 2027-08-01.
What conditions does trial NCT05586360 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT05586360?
The interventions under investigation include: Simvastatin 40mg (DRUG).
Who is sponsoring clinical trial NCT05586360?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05586360 being conducted?
This trial has 2 study locations across Georgia, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05586360's enrollment target sits among peer trials
36 544th of 735 higher than 185 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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