Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Phase 4 Completed 62 enrolled Blue Earth Diagnostics Aixial Group · collab

NaSingle-groupOpen-labelDiagnostic

Summary

Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy

Timeline

Start: 2024-12-04
Primary completion: 2025-08-29
Completion: 2025-08-29

Outcome

Met primary endpoint

registry analysis (superiority test); Piflufolastat (18F) PET vs Flotufolastat (18F) PET; p <0.001; NCT06604442 ↗

Publications

Nordquist LT, Andrews JR, Kuo PH, Gartrell BA, Josephson D, Purysko AS, Saltzstein DR, Pathak RA, Shore N, Sykes J, Penny R, Davis P, Helfand BT. An intra-patient contemporaneous comparison of 18F-piflufolastat and 18F-flotufolastat urinary radioactivity and pelvic region detection rates in men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy. Eur J Nucl Med Mol Imaging. 2026 May;53(6):3529-3541. doi: 10.1007/s00259-025-07732-y. Epub 2026 Feb 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	18F-DCFPyL	Diagnostic / imaging agent	9 mbq	—
Subject	Flotufolastat F 18	Diagnostic / imaging agent	8 mbq	—