The USFDA has recently approved the first radiohybrid positron emission tomography (PET) imaging agent, flotufolastat F 18, for prostate cancer. It targets prostate-specific membrane antigen (PSMA) in prostate cancer patients with suspected metastasis or recurrence with increased serum prostate-specific antigen (PSA) levels. The approval of flotufolastat F 18 is based on data from two Phase 3 trials – LIGHTHOUSE and SPOTLIGHT – which evaluated the safety and diagnostic performance of flotufolastat F 18.
Data from LIGHTHOUSE and SPOTLIGHT trial The LIGHTHOUSE study results demonstrated high specificity of flotufolastat F 18 for detecting pelvic lymph nodes compared to histopathology in patients with PSMA-positive lesions before radical prostatectomy. The SPOTLIGHT study results showed high detection rates (% positive PET scans) with flotufolastat F 18, even at low PSA levels in patients…
