Impact of piflufolastat F18 imaging on disease management for prostate cancer patients: Observations from the PYLARIFY Registry study.

339 Background: PSMA-PET imaging is widely accepted as preferred to conventional imaging (CT, MRI, SPECT) for the management of patients with prostate cancer (PCa). PSMA-PET imaging has demonstrated the ability to more accurately stage patients with PCa. Such information is critical to physicians when determining an appropriate disease management plan for their patients. The long-term impact of PSMA-PET imaging on PCa management in real-world clinical settings has yet to be fully established. In this real-world observational registry study preliminary data on change in management following PSMA-PET imaging were evaluated. Methods: The PYLARIFY Registry (NCT 05712473), conducted under SoNaR, a Cardinal Health Specialty Networks Registry, is a 5-year prospective, multicenter, United States based observational study that follows patients receiving PSMA-PET with piflufolastat F18 imaging as part of their routine PCa management. The registry includes newly diagnosed treatment-naïve patients (Cohort 1) and patients with biochemical recurrence (BCR) (Cohort 2). To evaluate the impact of PSMA-PET with piflufolastat F18 on clinical decision-making, physician-reported treatment plans before and after imaging were assessed. Disease management for the first 325 enrolled patients was characterized and the overall impact of piflufolastat F18 imaging results on changes in management was quantified by calculating the Jaccard Index for both patient cohorts. Treating physicians also rated the confidence in their management plan following piflufolastat F18 imaging. Results: Among the 161 patients in the newly diagnosed cohort, the Jaccard Index was 0.437, indicating a 56.3% variation between pre-imaging and post-imaging treatment plans. Similarly for the 164 patients in the BCR cohort, the Jaccard Index was 0.430 reflecting a 57.0% variation in disease management strategies before and after imaging. These findings are comparable to the 63% change in planned management observed within a BCR cohort in the CONDOR clinical study. Overall, physicians reported increased confidence in their disease management plans for 97.8% of patients following piflufolastat F18 imaging. Conclusions: Present findings support the clinical utility of piflufolastat F18 in guiding real-world clinical decision-making in both newly diagnosed and BCR prostate cancer patients. The observed changes in treatment plans demonstrate a substantial shift in management strategies following PSMA-PET imaging. Our findings are consistent with those of a clinical trial and further underscore the clinical value that piflufolastat F18 provides to physicians and patients in a real-world setting.