Study of Diagnostic Performance of [18F]CTT1057 in BCR

Summary

The current study aimed at evaluating the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of Prostate specific membrane antigen (PSMA) positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard. Approximately 190 participants were to be enrolled to ensure at least 152 participants were evaluable (i.e. have both an evaluable \[18F\]CTT1057 Positron emission tomography/Computed Tomography (PET/CT) scan imaging and at least one evaluable Composite Truth Standard (CTS) assessment and had not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures, which were required for the calculation of the co-primary endpoints.

Timeline

Start

2021-09-30

Primary completion

2023-11-23

Completion

2023-11-23

Publications

• Fanti S, Robles Barba JJ, Behr S, Maurer T, Paredes P, Walz J, Duch J, Perdigo MS, Mainta IC, Bonnefoy PB, Coulanges M, Tang J, Seigne C, Wilke C, Catafau AM, Iagaru A, Aggarwal R. Imaging Efficacy of [18F]CTT1057 PET/CT in Patients with Biochemically Recurrent Prostate Cancer: Results from GuidePath-A Phase 3, Prospective Multicenter Study. J Nucl Med. 2025 Aug 1;66(8):1210-1216. doi: 10.2967/jnumed.124.269266.

Drugs

Indications