The role of conventional imaging and piflufolastat F18 in newly diagnosed and recurrent prostate cancer patients: Preliminary observations from the PYLARIFY Registry.

41 Background: Next generation imaging modalities for the diagnosis and characterization of prostate cancer have seen increased utilization in the past several years. PSMA-PET imaging has seen particular promise as a more accurate modality compared to conventional (CT, skeletal scintigraphy and PET) imaging. Use of PSMA imaging can significantly improve how prostate cancer is staged and thus enhance the clinicians’ confidence in therapeutic decision making. Methods: The PYLARIFY Registry (NCT 05712473), conducted under SoNaR, a Specialty Networks Registry, is a US-based multi-center prospective 5 year observational study following patients receiving standard of care piflufolastat F18 imaging as part of their prostate cancer management. The registry includes newly diagnosed patients who have not yet initiated any treatment (Cohort 1) and patients with biochemical recurrence (Cohort 2). Demographics, all baseline imaging procedures and the frequency of each type of imaging for the first 100 enrolled patients were analyzed. We also explored time-to-PSMA for newly diagnosed patients who received conventional imaging as part of their staging assessment. The clinician confidence ratings that the piflufolastat F18 imaging had on treatment decision making were also evaluated. Results: The first 100 patients had a mean age of 71.0 (SD 9.1) and 80% had a Gleason Grade group of 2 or higher. At least 1 conventional imaging procedure prior to the piflufolastat F18 PET scan was performed on 10% of patients in Cohort 1 and 77% in Cohort 2. For Cohort 1 patients, piflufolastat F18 scans were preceded by a total of 4 imaging procedures, with an average of 1 conventional imaging procedure per patient prior to their piflufolastat F18 scan. Cohort 2 patients had a total of 95 imaging procedures with an average of 1.58 conventional imaging procedures per patient prior to their piflufolastat F18 scan. The 3 most utilized conventional imaging modalities in both cohorts of patients that received conventional imaging prior to piflufolastat F18 scans were CT (80%), and skeletal scintigraphy (72%) and PET (26%). The median difference in diagnostic journey length between Cohort 1 newly diagnosed patients having conventional imaging and those having only piflufolastat F18 was 28 additional days. Across both cohorts, clinicians rated improvement in treatment planning confidence following 96% of piflufolastat F18 scans. Conclusions: Piflufolastat F18 provides a high degree of confidence for prostate cancer patient management. A growing number of patients are being managed with piflufolastat F18 scans only. Many patients however still undergo lengthy and resource-intensive conventional imaging procedures prior to their piflufolastat F18 scan.