This study aimed to identify predictors of positive biopsy outcomes in patients with a PI-RADS 3 lesion on MRI, a category deemed equivocal for clinically significant prostate cancer (csPCa), to help reduce unnecessary biopsies. Using a database of MRI-US fusion biopsies performed between December 2013 and November 2022, researchers focused on patients with a maximum PI-RADS score of 3, selecting only the most recent biopsy for those with multiple procedures. In the cohort of 417 patients, 47% of biopsies were benign, while 33% indicated Grade Group 1 (GGG1) cancer and 20% showed Grade Group 2 or higher (GGG2+). Key factors such as prostate volume on MRI, PSA density (PSAD), and biopsy status (categorized as biopsy-naïve, active surveillance, or prior negative biopsy) were significantly associated with cancer risk (all p < .001).
Multivariable analysis revealed that PSAD, active surveillance status, and biopsy-naïve status increased the likelihood of detecting any prostate cancer. Specifically, each 0.1-unit increase in PSAD raised the odds of finding prostate cancer by 2.196 times, while active surveillance and biopsy-naïve statuses increased cancer detection odds by 6.849 and 2.005 times, respectively. For detecting GGG2+ cancers, both PSAD and active surveillance status were significant predictors. PSAD’s negative predictive value (NPV) for GGG2+ disease was especially notable at 89%, with a threshold of 0.125, while active surveillance and biopsy-naïve statuses had NPVs of 85% and 77%, respectively. Age and abnormal digital rectal exam (DRE) findings were not significant predictors in either analysis.
In conclusion, PSAD and biopsy history are valuable predictors for guiding biopsy decisions in patients with PI-RADS 3 lesions, potentially reducing unnecessary procedures. This research was funded by the Yale Department of Urology.