Piflufolastat F18 Imaging Is Associated With High Clinician Confidence in Prostate Cancer Management

Prostate-specific membrane antigen (PSMA) imaging with piflufolastat F18 influenced treatment decision-making and was associated with high clinician confidence in prostate cancer management, according to findings from the observational PYLARIFY registry (NCT05712473) evaluating the imaging modality in patients with newly diagnosed prostate cancer or prostate cancer with biochemical recurrence (BCR). These findings were presented by Neal D. Shore, MD, FACS, and colleagues at the 2025 Genitourinary Cancers Symposium.

Findings presented demonstrated that among newly diagnosed patients (cohort 1; n = 40), 30% had an increase in treatment intensity following piflufolastat F18 imaging, 55% had no change, and 15% experienced a decrease in treatment intensity. Among patients with BCR (cohort 2; n = 60), 57% had an increase in treatment intensity after imaging, 27% had no change, and 17% had a reduction in treatment intensity.

Additionally, clinician confidence in treatment planning following piflufolastat F18 imaging was high across both cohorts. Among surveyed clinicians, 53% strongly agreed that the imaging modality improved confidence in treatment recommendations for both cohorts 1 and 2. Among both groups, 43% of clinicians said they agreed that the imaging gave them confidence in their treatment decision. Only a small fraction of clinicians (5% in cohort 1 and 3% in cohort 2) reported a neutral stance, and no clinicians disagreed or strongly disagreed.

"Clinicians indicate that piflufolastat F18 provides a high degree of confidence for disease management decisions for [patients with] prostate cancer patients," Shore and colleagues wrote in a poster presentation of the data. “Many [patients with] newly-diagnosed prostate cancer are being managed with piflufolastat F18 scans only. Some patients still undergo lengthy and resource-intensive conventional imaging procedures prior to their piflufolastat F18 scan.”

Shore is the medical director for the Carolina Urologic Research Center in Myrtle Beach, South Carolina.

PYLARIFY Registry Design

The PYLARIFY Registry is a multicenter, prospective, 5-year observational study conducted in the United States under SoNaR, a specialty networks registry. The study followed patients receiving standard-of-care piflufolastat F18 imaging as part of their prostate cancer management.

“Use of PSMA imaging can significantly improve how prostate cancer is staged and thus enhance the clinician’s confidence in therapeutic decision-making,” study authors wrote. “[The objective of this study was] to assess the real-world clinical utility of PYLARIFY PSMA PET through the evaluation of long-term outcomes for prostate cancer patients who are eligible for a PSMA PET scan.”

In accordance with the study protocol, patients were stratified into two cohorts: cohort 1 included newly diagnosed patients who had not yet received treatment, and cohort 2 included patients with BCR.

Investigators evaluated baseline demographics, imaging procedures, and imaging frequency for the first 100 patients enrolled. Additionally, time-to-PSMA imaging was assessed in newly diagnosed patients who underwent conventional imaging as part of their staging assessment. A clinician-directed survey was also conducted to assess physician confidence in piflufolastat F18 imaging.

Baseline Patient Demographics

Regarding baseline characteristics, the median age was 70.7 years (standard deviation [SD], 9.1) in cohort 1 and 71.3 years (SD, 9.3) in cohort 2. The proportion of patients classified as having a high Gleason risk score (≥8) at diagnosis was 35% in cohort 1 and 26% in cohort 2. However, a higher proportion of patients in both cohorts had intermediate to high Gleason scores (cohort 1, 90%; cohort 2; 74%). Medicare coverage was reported in 68% of newly diagnosed patients and 55% of patients with BCR.

At the time of diagnosis, 98% of newly diagnosed patients had nonmetastatic hormone-sensitive prostate cancer compared with 95% of patients in the BCR cohort. Transportation barriers were reported in 83% of newly diagnosed patients and 70% of those with BCR. Additionally, 38% of newly diagnosed patients and 32% of patients with BCR were identified as current or former smokers.

Regarding imaging history, 10% of newly diagnosed patients had undergone at least 1 conventional imaging procedure before receiving piflufolastat F18 compared with 77% of patients with BCR. The average number of conventional imaging procedures per patient was 1.0 in the newly diagnosed cohort and 1.58 in the BCR cohort. The most common conventional imaging modalities across both cohorts were CT scan (80%), skeletal scintigraphy (72%), and PET scan (26%).

Reference

Shore N, O'Donnell L, Willson B, et al. The role of conventional imaging and piflufolastat F18 in newly diagnosed and recurrent prostate cancer patients: preliminary observations from the PYLARIFY registry. J Clin Oncol. 2025;43(suppl 5);41. doi:10.1200/JCO.2025.43.5_suppl.41