Clinical trial · Interventional
A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with 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)
Molecular Imaging (MI) uses tracers which emit radiation to provide clinically valuable imaging for patient with cancer. Most current MI agents utilize Fluorine 18 or Gallium 68 as the positron emitter for PET imaging. However, these isotopes have short half-lives which limit the geographic distribution range of tracers made with these isotopes. Copper 61 (61Cu) has a 3.3 hour half-life, which would allow for far greater distribution range following radiotracer production. This phase I trial will test the safety and effectiveness of a novel MI radiotracer that uses 61Cu as its positron emitting isotope and targets Prostate Specific Membrane Antigen (PSMA) for imaging prostate cancer. A successful trial will provide the ability to advance this novel 61Cu-NODAGA-PSMA radioisotope into phase II trials, as well as open a new paradigm into the production of MI radioisotopes with 61Cu.
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 |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Copper 61-PSMA PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET/CT
- description
- TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration.
- interventionNames
- Drug: Copper 61-PSMA PET/CT
Primary outcomes (1)
- measure
- Incidence of Imaging Agent-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- Up to 24 hours after administration of radiotracer
- description
- For the primary objective of safety, side effects will be monitored the day of and the day following radiotracer administration.
Secondary outcomes (2)
- measure
- Dosimetry
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy proven prostate adenocarcinoma 2. Age ≥ 18 years 3. ECOG 0 or 1 4. At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment 5. Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL/minute. Exclusion Criteria: 1. Known allergy/hypersensitivity to PSMA-targeted imaging agents 2. Other active malignancy, other than the known prostate cancer
References
Publications (2)
- BACKGROUNDBasaco Bernabeu T, Mansi R, Del Pozzo L, Zanger S, Gaonkar RH, McDougall L, De Rose F, Jaafar-Thiel L, Herz M, Eiber M, Ulaner GA, Weber WA, Fani M. 61Cu-PSMA-Targeted PET for Prostate Cancer: From Radiotracer Development to First-in-Human Imaging. J Nucl Med. 2024 Sep 3;65(9):1427-1434. doi: 10.2967/jnumed.123.267126. PMID 39025646
- DERIVEDUlaner GA, Bassett JC, Reddy R, Thomsen B, Reynolds D, Jerjian KJ, Wolfe R, Benjamin DJ, Fani M, O'Donoghue J, Baier M, Schubert N, Pais B, De Rose F, Jaafar L. 61Cu-NODAGA Prostate-specific Membrane Antigen Imaging and Therapy for Prostate Cancer: Phase 1 Trial of a New Class of 61Cu-labeled PET Radiotracers. Radiology. 2025 Dec;317(3):e251151. doi: 10.1148/radiol.251151. PMID 41363974