A Phase 2 Trial of 61Cu-NU101 PET/CT Compared Against Current Standard-of-care 18F-piflufolastat (Pylarify®) PET/CT.

Summary

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.

Timeline

Start

2026-08-01

Primary completion

2028-08-01

Completion

2028-10-01

Publications

• Background Roberts 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.
• Background Ulaner 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.
• Background van 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.
• Background Chatalic 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.
• Background Lawhn-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.
• Background Yilmaz 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.
• Background Komek H, Can C, Yilmaz U, Altindag S. Prognostic value of 68 Ga PSMA I&T PET/CT SUV parameters on survival outcome in advanced prostat cancer. Ann Nucl Med. 2018 Oct;32(8):542-552. doi: 10.1007/s12149-018-1277-5. Epub 2018 Jul 13.
• Background Cytawa W, Seitz AK, Kircher S, Fukushima K, Tran-Gia J, Schirbel A, Bandurski T, Lass P, Krebs M, Polom W, Matuszewski M, Wester HJ, Buck AK, Kubler H, Lapa C. 68Ga-PSMA I&T PET/CT for primary staging of prostate cancer. Eur J Nucl Med Mol Imaging. 2020 Jan;47(1):168-177. doi: 10.1007/s00259-019-04524-z. Epub 2019 Sep 16.
• Background Follacchio GA, De Feo MS, De Vincentis G, Monteleone F, Liberatore M. Radiopharmaceuticals Labelled with Copper Radionuclides: Clinical Results in Human Beings. Curr Radiopharm. 2018;11(1):22-33. doi: 10.2174/1874471011666171211161851.
• Background Amanuel FK. Nuclear model prediction for production of medical 22Na, 51Cr, 60Co, 61Cu, 64Cu, 65Zn, 67, 68Ga, 88Y and 99Mo radionuclides: Comparison of experimental and theoretical data. Appl Radiat Isot. 2021 Jun;172:109674. doi: 10.1016/j.apradiso.2021.109674. Epub 2021 Mar 3.
• Background Ulaner GA, Thomsen B, Bassett J, Torrey R, Cox C, Lin K, Patel T, Techasith T, Mauguen A, Rowe SP, Lindenberg L, Mena E, Choyke P, Yoshida J. 18F-DCFPyL PET/CT for Initially Diagnosed and Biochemically Recurrent Prostate Cancer: Prospective Trial with Pathologic Confirmation. Radiology. 2022 Nov;305(2):419-428. doi: 10.1148/radiol.220218. Epub 2022 Jul 19.
• Background Jadvar H, Calais J, Fanti S, Feng F, Greene KL, Gulley JL, Hofman M, Koontz BF, Lin DW, Morris MJ, Rowe SP, Royce TJ, Salami S, Savir-Baruch B, Srinivas S, Hope TA. Appropriate Use Criteria for Prostate-Specific Membrane Antigen PET Imaging. J Nucl Med. 2022 Jan;63(1):59-68. doi: 10.2967/jnumed.121.263262. Epub 2021 Sep 30. No abstract available.
• Background Morris MJ, Rowe SP, Gorin MA, Saperstein L, Pouliot F, Josephson D, Wong JYC, Pantel AR, Cho SY, Gage KL, Piert M, Iagaru A, Pollard JH, Wong V, Jensen J, Lin T, Stambler N, Carroll PR, Siegel BA; CONDOR Study Group. Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study. Clin Cancer Res. 2021 Jul 1;27(13):3674-3682. doi: 10.1158/1078-0432.CCR-20-4573. Epub 2021 Feb 23.
• Background Pienta KJ, Gorin MA, Rowe SP, Carroll PR, Pouliot F, Probst S, Saperstein L, Preston MA, Alva AS, Patnaik A, Durack JC, Stambler N, Lin T, Jensen J, Wong V, Siegel BA, Morris MJ. A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY). J Urol. 2021 Jul;206(1):52-61. doi: 10.1097/JU.0000000000001698. Epub 2021 Feb 26.
• Background Hope TA, Eiber M, Armstrong WR, Juarez R, Murthy V, Lawhn-Heath C, Behr SC, Zhang L, Barbato F, Ceci F, Farolfi A, Schwarzenbock SM, Unterrainer M, Zacho HD, Nguyen HG, Cooperberg MR, Carroll PR, Reiter RE, Holden S, Herrmann K, Zhu S, Fendler WP, Czernin J, Calais J. Diagnostic Accuracy of 68Ga-PSMA-11 PET for Pelvic Nodal Metastasis Detection Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection: A Multicenter Prospective Phase 3 Imaging Trial. JAMA Oncol. 2021 Nov 1;7(11):1635-1642. doi: 10.1001/jamaoncol.2021.3771.
• Background Fendler WP, Calais J, Eiber M, Flavell RR, Mishoe A, Feng FY, Nguyen HG, Reiter RE, Rettig MB, Okamoto S, Emmett L, Zacho HD, Ilhan H, Wetter A, Rischpler C, Schoder H, Burger IA, Gartmann J, Smith R, Small EJ, Slavik R, Carroll PR, Herrmann K, Czernin J, Hope TA. Assessment of 68Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer: A Prospective Single-Arm Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):856-863. doi: 10.1001/jamaoncol.2019.0096.
• Background FDA Approves Pluvicto/Locametz for Metastatic Castration-Resistant Prostate Cancer. J Nucl Med. 2022 May;63(5):13N. No abstract available.
• Background Keam SJ. Piflufolastat F 18: Diagnostic First Approval. Mol Diagn Ther. 2021 Sep;25(5):647-656. doi: 10.1007/s40291-021-00548-0. Epub 2021 Jul 22.
• Background Wahl RL, Chareonthaitawee P, Clarke B, Drzezga A, Lindenberg L, Rahmim A, Thackeray J, Ulaner GA, Weber W, Zukotynski K, Sunderland J. Mars Shot for Nuclear Medicine, Molecular Imaging, and Molecularly Targeted Radiopharmaceutical Therapy. J Nucl Med. 2021 Jan;62(1):6-14. doi: 10.2967/jnumed.120.253450.
• Background Evans JD, Jethwa KR, Ost P, Williams S, Kwon ED, Lowe VJ, Davis BJ. Prostate cancer-specific PET radiotracers: A review on the clinical utility in recurrent disease. Pract Radiat Oncol. 2018 Jan-Feb;8(1):28-39. doi: 10.1016/j.prro.2017.07.011. Epub 2017 Jul 20.

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