Utility of 18 F-Flotufolastat Positron Emission Tomography/Computed Tomography Imaging in High-Risk Prostate Cancer in a Real-World Setting

INTRODUCTION: F-rhPSMA-7.3) in men with newly diagnosed high-risk prostate cancer (PCa) and negative conventional imaging. The primary end point was the rate of clinical upstaging and its effect on subsequent management. METHODS: F-flotufolastat. The results were interpreted by board-certified nuclear medicine physicians trained in PSMA imaging. RESULTS: F-flotufolastat identified extraprostatic disease in 36 of 110 patients (32.7%). Among them, 15 of 36 (41.7%) had isolated regional lymph node (N1) involvement, while 21 of 36 (58.3%) demonstrated distant metastatic (M1) disease. Of the patients who were upstaged, 34 of 36 patients (94.4%) had a change in their treatment plan. The most common treatment intensification included the addition of an androgen receptor inhibitor and expanded radiotherapy fields (50.0%). Furthermore, 34.3% received up-front chemotherapy alongside an androgen receptor inhibitor and radiation. A minority (8.6%) proceeded with radical prostatectomy as a first step of a multimodality approach. CONCLUSIONS: F-flotufolastat led to clinical upstaging in nearly one-third of men with high-risk PCa and negative conventional imaging, resulting in significant treatment change in most patients. These findings support the integration of PSMA-targeted imaging into initial staging pathways for men with high-risk PCa.