Prostate Imaging Reporting and Data System 3 Category Cases at Multiparametric Magnetic Resonance for Prostate Cancer: A Systematic Review and Meta-analysis.

Context: 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.

Objective: 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.

Evidence Acquisition: 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.

Evidence Synthesis: 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.

Conclusions: 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.

Patient Summary: 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.