Clinical trial · Interventional
A Phase 2 Trial of 61Cu-NU101 PET/CT Compared Against Current Standard-of-care 18F-piflufolastat (Pylarify®) PET/CT.
A Two Center Phase 2 Trial of 61Cu-noDAGa-PSMA I&T (61Cu-NU101) for Patients With Prostate Cancer
NCT07635524CI-TRIAL-00114145not yet recruitingPhase 2ClinicalTrials.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)
The purpose of this research is to test whether a new investigational Molecular Imaging (MI) agent called 61Cu-NU101 is equal to or better than a currently used MI agent, Pylarify, for the detection of prostate cancer metastases. 34 participants with biopsy-proven prostate cancer and cancer seen on a Pylarify PET scan will be enrolled in this study. The investigational 61Cu-NU101 PET/CT will be perfromed. If there is a difference between the standard Pylarify exam and the investigational 61Cu-NU101 exam, a biopsy of one lesion that is different between the two exams may be performed.
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cu-NU101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cu-NU101
- description
- Subjects will receive a single dose of 61Cu-NU101, administered as a slow intravenous bolus over 10 seconds, with a dosage of 148 MBq (4 mCi) +/-10% , followed by PET/CT imaging 1 hour (+/- 10 minutes) and 4 hours (+/- 30 minutes) post radiotracer administration. There are no specific restrictions that should apply when administering 61Cu-NU101. There will be optional 5-minute dynamic scans at tracer administration and 20- and 40-minutes post injection.
- interventionNames
- Drug: Cu-NU101
Primary outcomes (1)
- measure
- Sensitivity of imaging with 61Cu- NU101,
- timeFrame
- 4 hours post-administration
- description
- Demonstrate the sensitivity of imaging with 61Cu- NU101, as compared to a currently standard of care PSMA-targeted imaging agent, 18F-piflufolastat.
Secondary outcomes (1)
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 2 4 .Oligometastatic disease (1-5 radiotracer avid disease sites) on 18F- piflufolastat PET/CT within 30 days of trial recruitment Exclusion Criteria: 1. Known allergy/hypersensitivity to PSMA-targeted imaging agents 2. Other active malignancy, other than the known prostate cancer
References
Publications (20)
- BACKGROUNDRoberts MJ, Maurer T, Perera M, Eiber M, Hope TA, Ost P, Siva S, Hofman MS, Murphy DG, Emmett L, Fendler WP. Using PSMA imaging for prognostication in localized and advanced prostate cancer. Nat Rev Urol. 2023 Jan;20(1):23-47. doi: 10.1038/s41585-022-00670-6. Epub 2022 Dec 6. PMID 36473945
- BACKGROUNDUlaner 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
- BACKGROUNDvan der Gaag S, Bartelink IH, Vis AN, Burchell GL, Oprea-Lager DE, Hendrikse H. Pharmacological Optimization of PSMA-Based Radioligand Therapy. Biomedicines. 2022 Nov 23;10(12):3020. doi: 10.3390/biomedicines10123020. PMID 36551776
- BACKGROUNDChatalic KL, Heskamp S, Konijnenberg M, Molkenboer-Kuenen JD, Franssen GM, Clahsen-van Groningen MC, Schottelius M, Wester HJ, van Weerden WM, Boerman OC, de Jong M. Towards Personalized Treatment of Prostate Cancer: PSMA I&T, a Promising Prostate-Specific Membrane Antigen-Targeted Theranostic Agent. Theranostics. 2016 Apr 12;6(6):849-61. doi: 10.7150/thno.14744. eCollection 2016. PMID 27162555
- BACKGROUNDLawhn-Heath C, Salavati A, Behr SC, Rowe SP, Calais J, Fendler WP, Eiber M, Emmett L, Hofman MS, Hope TA. Prostate-specific Membrane Antigen PET in Prostate Cancer. Radiology. 2021 May;299(2):248-260. doi: 10.1148/radiol.2021202771. Epub 2021 Mar 30. PMID 33787338
- BACKGROUNDYilmaz U, Komek H, Can C, Altindag S. The role of (68Ga)PSMA I&T in biochemical recurrence after radical prostatectomy: detection rate and the correlation between the level of PSA, Gleason score, and the SUVmax. Ann Nucl Med. 2019 Aug;33(8):545-553. doi: 10.1007/s12149-019-01360-x. Epub 2019 May 8.