Clinical trial · Expanded Access
Clinical Use of 68Ga PSMA-11 PET/CT in Diagnosing, Staging and Restaging Prostate Cancer
Clinical Use of 68Ga Prostate Specific Membrane Antigen-11 Positron Emission Tomography With Computed Tomography in Diagnosing, Staging and Restaging Prostate Cancer
- 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)
The purpose of this protocol is to provide 68Ga Prostate Specific Membrane Antigen-11 (68Ga PSMA-11) for clinical use in the diagnosis, staging and restaging of prostate cancer using Positron Emission Tomography with Computed Tomography (PET/CT) prior to its full local Federal Drug Administration (FDA) approval. Extensive research has shown that 68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care usually used in staging and restaging prostate cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
| Prostate Cancer Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-11 | Drug | — | UNRESOLVED |
| Positron Emission Tomography/Computed Tomography | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * One of the following: 1. Patients with suspected recurrence based on elevated serum prostate specific antigen (PSA) level. 2. Patients with suspected metastasis who are candidates for initial definitive therapy. 3. Patients with metastatic prostate cancer, for whom Lutetium-177 vipivotide tetraxetan PSMA-directed therapy is indicated. * Patients must be able to lie still for approximately 20 - 40 minutes for the PET/CT scans. * Patients must be deemed medically stable by their treating physician. * Patients must have the ability and willingness to sign a written informed consent. Exclusion Criteria: * Patients must not weigh more than the maximum weight limit for the PET/CT scanner table (\> 225 kilograms or 500 pounds). * Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11. * Patients must not be claustrophobic.
References
Publications (0)
Data not yet available