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NCT05381103 · ClinicalTrials.gov registry record · Phase 2
PSMA-PET to Guide Prostatectomy
A Phase 2 study of Prostate Cancer, sponsored by Five Eleven Pharma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 288
- Enrollment target
- 1
- Study location
NCT05381103: Recruiting Phase 2 study of Prostate Cancer, sponsored by Five Eleven Pharma.
NCT05381103 is a Phase 2 study of Prostate Cancer that is actively recruiting participants, run by Five Eleven Pharma. The registered enrollment target is 288 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05381103, a Phase 2 study of Prostate Cancer, is actively recruiting participants, sponsored by Five Eleven Pharma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 288 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.
Primary Outcome
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST PSMA-PET and SOC MRI
- DIAGNOSTIC_TEST SOC MRI
Study Locations (1)
Indiana
- Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 2 |
What NCT05381103 shows while recruiting
NCT05381103 is an interventional study that assigns participants to a tested intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which PSMA-PET and SOC MRI is the first listed.
NCT05381103 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05381103 about?
NCT05381103 is a clinical study titled "PSMA-PET to Guide Prostatectomy". In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluate...
What is the current status of trial NCT05381103?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 288 participants. The study started on 2021-10-01. Estimated completion is 2028-12-01.
What conditions does trial NCT05381103 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT05381103?
The interventions under investigation include: PSMA-PET and SOC MRI (DIAGNOSTIC_TEST), SOC MRI (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05381103?
This trial is sponsored by Five Eleven Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05381103 being conducted?
This trial has 1 study location across Indiana. 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 NCT05381103's enrollment target sits among peer trials
288 171st of 735 higher than 565 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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