Summary

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• Pylarify (piflufolastat F 18) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, and for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
• This summary is based on the review of one randomized controlled trial(s). 3. [¹⁸F]DCFPyL demonstrated a higher overall detection rate (58%) compared to [¹⁸F]fluoromethylcholine (40%) in patients with first prostate cancer biochemical recurrence (BCR), with significant differences observed across PSA subgroups (e.g., 88% vs. 68% for PSA > 2.0 ng/mL). ^[1]
• Patient management was altered in 44% of cases with [¹⁸F]DCFPyL PET/CT, compared to 29% with [¹⁸F]fluoromethylcholine, highlighting a greater impact on clinical decisions.
• No drug-related or serious adverse events were observed for either [¹⁸F]DCFPyL or [¹⁸F]fluoromethylcholine.
• The studies did not note any significant safety concerns or adverse effects specific to particular population types or subgroups.
• The study population consisted of men with first biochemical recurrence (BCR) of prostate cancer, divided into those who had undergone radical prostatectomy (73%, median PSA = 0.46 ng/mL) and those who had received radiation therapy (27%, median PSA = 4.23 ng/mL). [¹⁸F]DCFPyL demonstrated significantly higher effectiveness compared to [¹⁸F]fluoromethylcholine in these subgroups, with a more notable impact on patient management, irrespective of the type of prior curative therapy.