The FDA has approved Pylarify TruVu (piflufolastat F 18), a new PET imaging agent that helps detect prostate cancer that has spread or returned. Pylarify TruVu targets the Prostate-Specific Membrane Antigen (PSMA) on cancer cells, making them visible on a PET/CT scan.
The approval covers two groups of men: those with high-risk prostate cancer before surgery or radiation, and those who have rising PSA levels after prior treatment to locate recurrence. Clinical trials, including OSPREY and CONDOR, showed Pylarify TruVu is much more accurate than standard imaging. It has nearly 98% specificity, meaning doctors can trust that a detected lesion is truly cancer, which helps avoid unnecessary surgeries or target treatment precisely.
Overall, Pylarify TruVu provides a detailed “map” of prostate cancer spread, offering nearly triple the reliability of traditional imaging for detecting lymph node involvement and improving treatment planning.