Clinical trial · Interventional
Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer
A Multi-Center, Open-Label, Randomized Phase 2 Study of Copper Cu 64 PSMA I&T Injection in Patients With Histologically Proven Metastatic Prostate Cancer
NCT05653856CI-TRIAL-00085055completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis From Malignant Tumor of Prostate (Disorder) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 64Cu-PSMA I&T | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic Imaging with 64Cu-PSMA-I&T
- description
- 64Cu-PSMA I\&T
- interventionNames
- Drug: 64Cu-PSMA I&T
Primary outcomes (3)
- measure
- Region-Level Correct Localization Rate (CLR)
- timeFrame
- 4 Hours
- description
- 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 regions containing at least one PET positive finding.
- measure
- Patient-Level Correct Detection Rate (CDR)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically proven prostate adenocarcinoma. 2. Prior radical prostatectomy or radiation therapy with curative intent. 3. Recurrence of disease defined as: 1. Prior Radical Prostatectomy: PSA \> 0.2 ng/mL, or 2. Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir 4. Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy. 5. Age greater than or equal to 18 years. 6. Able to understand and provide signed written informed consent. Exclusion Criteria: 1. Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level. 2. Body weight greater than 350 lb (158 kg). 3. Investigational therapy within the past 30 days. 4. Creatinine clearance (ClCr) less than 30 mL/min. 5. Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.