Early experience in avoiding biopsies for biopsy-naive men with clinical suspicion of prostate cancer but non-suspicious biparametric magnetic resonance imaging results and prostate-specific antigen density < 0.15 ng/mL(2): A 2-year follow-up study

Background: Only limited data have been published on the diagnostic accuracy of combining biparametric (bp) magnetic resonance imaging (MRI) and prostate-specific antigen density (PSAd) to rule out biopsies. Purpose: The purpose is to assess the 2-year risk of being diagnosed with sPCa following the strategy of avoiding immediate biopsies in men with non-suspicious bp MRIs and a PSAd <0.15 ng/mL(2). Material and Methods: Two hundred biopsy-naive men with clinical suspicion of PCa underwent a pre-biopsy bp MRI from March to July 2019. Of these, 109 men had a Prostate Imaging Reporting and Data System (PI-RADS) score of 1-3 including 77 men with calculated PSAd <0.15 ng/mL(2). As a result, no biopsies were performed in these 77 men, who were clinically followed up for at least 2 years and re-examined in case of rising suspicion of sPCa. The remaining 32 men with a calculated PSAd >= 0.15 ng/mL(2) underwent systematic biopsies and targeted biopsies of any PI-RADS 3 lesion. Results: One of the 77 men (1.3%) had an sPCa diagnosed within 2 years of follow-up. All men were referred back to their general practitioner within 1 year and 9% (7/77) were re-referred to the urology department during follow-up. Among these men, 43% (3/7) continued to have PSA levels that were above their individual thresholds at confirmatory testing and underwent secondary MRI scans. Conclusions: No biopsies for men with bpMRI results exhibiting maximum PI-RADS 3 and with a PSAd <0.15 ng/mL(2) resulted in a 2-year risk of being diagnosed with sPCa of 1.3%.