The Prostate Imaging Reporting and Data System (PI-RADS) 3 score represents a “grey zone” that need to be further investigated to solve the issue of whether to biopsy these equivocal cases or not.

To critically analyze the current evidence on PI-RADS 3 cases. We evaluated the prevalence of PI-RADS 3 cases in the literature and detection rate of prostate cancer (PC) and clinically significant PC (csPC) at biopsy with regard to factors determining these rates.

We searched in the Medline and Cochrane Library database from the literature from January 2009 to January 2019, following the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) guidelines.

A total of 28 studies were included in our analysis (total number of PI-RADS 3 cases: 1759, range 20-187). The prevalence of PI-RADS 3 cases reported in available studies was 17.3% (range 6.4-45.7%). The PC detection rate was 36% (95% confidence interval [CI] 33.8-37.4; range 10.3-55.8%), whereas that of csPC was 18.5% (95% CI 16.6-20.3; range 3.4-46.5%). Detection rates of PC and csPC were found to be similar in men who underwent a target biopsy versus those with a systematic biopsy (23.5% vs 23.9% and 11.4% vs 12.3%, respectively) and lower than the rates achieved with the combined strategy (36.9% and 19.6%, respectively). A prostate-specific antigen density (PSAD) of ≥0.15ng/ml/ml may represent an index to decide whether to submit a PI-RADS 3 case to biopsy.

In most investigations, PI-RADS 3 cases were not evaluated separately. A PI-RADS 3 lesion remains an equivocal lesion. Evaluation of clinical predictive factors in terms of csPC risk is a main aspect of helping clinicians in the biopsy decision process.

Management of Prostate Imaging Reporting and Data System 3 cases remains an unmet need, and the detection rate of clinically significant prostate cancer (csPC) among this population varies widely. Performing a combined target plus a systematic biopsy yields the highest detection of csPC. A prostate-specific antigen density of lower than 0.15ng/ml/ml may select patients for a follow-up strategy.

European urology focus. 2019 Jul 03 [Epub ahead of print]

Martina Maggi, Valeria Panebianco, Augusto Mosca, Stefano Salciccia, Alessandro Gentilucci, Giovanni Di Pierro, Gian Maria Busetto, Giovanni Barchetti, Riccardo Campa, Isabella Sperduti, Francesco Del Giudice, Alessandro Sciarra

Department of Urology, Sapienza Rome University, Policlinico Umberto I, Rome, Italy. Electronic address: ., Department of Radiology, Sapienza Rome University, Policlinico Umberto I, Rome, Italy., Department of Urology, Frascati Hospital, Rome, Italy., Department of Urology, Sapienza Rome University, Policlinico Umberto I, Rome, Italy., Biostatistical Unit, IRCCS, Regina Elena National Cancer Institute, Rome, Italy.

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