Management of Men With PI-RADS 4-5 Lesions and Negative Biopsy

Samir S. Taneja, MD, Professor of Urologic Oncology at NYU Grossman School of Medicine, discusses how to approach a negative MRI-targeted prostate biopsy in men with PI-RADS 4 or 5 lesions, explaining both why an MRI-targeted biopsy for a high suspicion MRI might be benign and what steps to take to determine the biopsy’s accuracy. Citing the PROMIS study, he notes that MRI is not entirely accurate and has neither a perfect positive predictive value (PPV) nor a perfect negative predictive value (NPV), though PPV is better at Gleason Grade greater than or equal to 3+4. Dr. Taneja then lists factors influencing PPV of MRI/template biopsy, including the given definition of clinically significant prostate cancer (csPCa), indication for biopsy, the prevalence of disease in the sampled cohort, and biopsy technique/operator skill. He goes into depth on how the MRI-targeted biopsy technique might influence the likelihood of a false negative, noting how the PROFUS study showed that csPCa was more often found with fusion biopsy compared to visual targeting. Dr. Taneja also considers the significance of the number of cores taken, observing that while most men are diagnosed with csPCa in the first core, there is a subset that requires core 3 and 4. He synthesizes the data into a set of suggestions for a clinical approach to a negative MRI-targeted biopsy in the setting of PI-RADS 4-5 abnormality, stating that clinicians should assess how confident they should be in the biopsy, assess the accuracy of imaging, repeat imaging in 6-12 months to rule out a false positive and, if the abnormality persists, they should perform a repeat biopsy.

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