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NCT05653856 · ClinicalTrials.gov registry record · Phase 2
Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer
A Phase 2 study of Metastasis From Malignant Tumor of Prostate (Disorder), sponsored by Curium US.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 9
- Study locations
NCT05653856: Completed Phase 2 study of Metastasis From Malignant Tumor of Prostate (Disorder), sponsored by Curium US.
NCT05653856 is a Phase 2 study of Metastasis From Malignant Tumor of Prostate (Disorder) that has completed, run by Curium US. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05653856, a Phase 2 study of Metastasis From Malignant Tumor of Prostate (Disorder), has completed, sponsored by Curium US.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 9
- Study locations
Study Summary
This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.
Primary Outcome
To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regio
Conditions Studied
Interventions
- DRUG 64Cu-PSMA I&T
Study Locations (9)
Missouri
- Saint Louis University - St Louis
- John J. Cochran Veterans Hospital - St Louis
- Washington University - St Louis
Nebraska
- Nebraska Cancer Specialists - Omaha
- XCancer Omaha/Urology Cancer Center - Omaha
Connecticut
- Yale University - New Haven
Illinois
- Edward Hines, Jr. VA Hospital - Hines
Maryland
- Johns Hopkins University - Baltimore
Texas
- MD Anderson - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-12-05 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 2 |
What the finished NCT05653856 record still lists
NCT05653856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Metastasis From Malignant Tumor of Prostate (Disorder) appearing as the primary indexed condition, and to 1 intervention - of which 64Cu-PSMA I&T is the first listed.
NCT05653856 lists 9 locations in 6 states (Missouri, Nebraska, Connecticut).
Frequently Asked Questions
What is clinical trial NCT05653856 about?
NCT05653856 is a clinical study titled "Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer". This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.
What is the current status of trial NCT05653856?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2022-12-05. Estimated completion is 2023-05-17.
What conditions does trial NCT05653856 study?
This clinical trial studies the following conditions: Metastasis From Malignant Tumor of Prostate (Disorder).
What interventions are being tested in trial NCT05653856?
The interventions under investigation include: 64Cu-PSMA I&T (DRUG).
Who is sponsoring clinical trial NCT05653856?
This trial is sponsored by Curium US, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05653856 being conducted?
This trial has 9 study locations across Connecticut, Illinois, Maryland, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05653856's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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