Summary

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• Piflufolastat F 18 (Pylarify) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen positive lesions in men with prostate cancer who are candidates for initial definitive therapy or have suspected recurrence based on elevated serum PSA levels.
• The study compares the effectiveness and safety of Pylarify to another PET/CT tracer, fluoromethylcholine.
• In terms of effectiveness, the detection rate was significantly higher for Pylarify than for fluoromethylcholine (58% vs 40%), encompassing a broad PSA range. For instance, the detection rate for PSA levels >2.0 ng/ml was 88% versus 68%, respectively.
• Regarding the impact on patient management, changes post-PET/CT scans occurred in more cases with Pylarify compared to fluoromethylcholine (44% against 29%), suggesting its clinical utility not only in detection but also in influencing treatment pathways.
• From a safety perspective, no drug-related or serious adverse events were reported during the study, indicating that Piflufolastat F 18 has an excellent safety profile, making it a safe option for patients undergoing PET/CT scans.
• The study specifically enrolled participants experiencing their first biochemical recurrence after radical prostatectomy or radiation therapy, providing insight into this particular subgroup within the broader population suffering from prostate cancer.