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Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/223386
Imaging Efficacy of [18F]CTT1057 PET/CT in Patients with Biochemically Recurrent Prostate Cancer: Results from GuidePath-A Phase 3, Prospective Multicenter Study
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Improved diagnostic accuracy in patients with prostate cancer at first biochemical recurrence (BCR) with low prostate-specific antigen (PSA) levels is needed. This prospective study (GuidePath; NCT04838613) aimed to evaluate the imaging performance of the prostate-specific membrane antigen (PSMA)-targeted PET radiotracer [18F]CTT1057 to detect PSMA-positive lesions in patients diagnosed predominantly at first BCR. Methods: Eligible patients had a PSA of 0.2 ng/mL or greater after radical prostatectomy or an increase in PSA level of at least 2 ng/mL above nadir after radiation therapy. Patients received 370 MBq of [18F]CTT1057 and 150 MBq of [68Ga]Ga-PSMA-11 and underwent PET/CT 90 min (±30 min) and 50-100 after injection, respectively. [18F]CTT1057 images were assessed by 3 independent readers blinded to all clinical information. Coprimary endpoints were region-level correct localization rate (CLR) and patient-level positive predictive value (PPV) of [18F]CTT1057 to detect PSMA-positive lesions and were compared with a hierarchical composite truth standard (CTS). The CTS comprised 3 levels of standard-of-truth procedures (in order of priority): histopathology (CTS level 1); imaging, including at least 1 contrast-enhanced CT scan and 1 [68Ga]Ga-PSMA-11 PET/CT scan (CTS level 2); and a decrease in PSA level of 50% or greater 3 mo after radiation therapy (CTS level 3). For study success, the lower-bound 95% CI had to surpass 50% for region-level CLR and 20% for patient-level PPV for at least 2 of the 3 [18F]CTT1057 PET/CT readers. Results: Of 202 patients screened, 161 were evaluable for efficacy. Among these, 93.2% were experiencing their first BCR, 96.3% had received radical prostatectomy as initial definitive therapy, and baseline median PSA level was 0.4 ng/mL (interquartile range, 0.3-0.8 ng/mL). The imaging standard of truth was used for 159-160 patients (99%) across the 3 readers. Both coprimary endpoints were met. Region-level CLR ranged from 65.2% to 75.0% (lower-bound 95% CI, 53.4%-62.1%), and patient-level PPV ranged from 64.6% to 76.5% (lower-bound 95% CI, 51.8%-62.5%). Conclusion: [18F]CTT1057 met the predefined thresholds for region-level CLR and patient-level PPV in a clinically relevant patient cohort predominantly at first BCR with low PSA levels. [18F]CTT1057 is an accurate PSMA-targeted PET radiotracer for BCR detection.
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FANTI, Stefano, ROBLES BARBA, Javier jesus, BEHR, Spencer, MAURER, Tobias, PAREDES BARRANCO, Pilar, WALZ, Jochen, DUCH, Joan, SIMO PERDIGO, Marc, MAINTA, Ismini charis, BONNEFOY, Pierre benoit, COULANGES, Medge, TANG, Jun, SEIGNE, Christelle, WILKE, Celine, CATAFAU, Ana m., IAGARU, Andrei, AGGARWAL, Rahul. Imaging Efficacy of [18F]CTT1057 PET/CT in Patients with Biochemically Recurrent Prostate Cancer: Results from GuidePath-A Phase 3, Prospective Multicenter Study. _Journal of Nuclear Medicine_. 2025. Vol. 66, núm. 8, pàgs. 1210-1216. [consulta: 26 de novembre de 2025]. ISSN: 0161-5505. [Disponible a: https://hdl.handle.net/2445/223386]