The 2019 European Association of Urology guidelines recommend multiparametric magnetic resonance imaging (mpMRI) for biopsy-naïve patients with clinical suspicion of prostate cancer (PC) and avoiding biopsy in patients with negative mpMRI and low clinical suspicion. However, consensus on the optimal definition of low clinical suspicion is lacking. We evaluated 266 biopsy-naïve patients who underwent mpMRI, the 4Kscore test, and prostate biopsy to define the best strategy to avoid unnecessary testing and biopsies. The European Randomized Study of Screening for Prostate Cancer risk calculator (ERSPC-RC) and prostate-specific antigen density (PSAd) were also considered. For men with Prostate Imaging-Reporting and Data System v2.0 (PI-RADS) 1-2 lesions, the highest negative predictive value was observed for those with low or intermediate 4Kscore risk (96.9% and 97.1%), PSAd <0.10ng/ml/cm3 (98.7%), and ERSPC-RC <2% (98.7%). For men with PI-RADS 3-5 lesions the lowest positive predictive value was observed for those with low 4Kscore risk (0%), PSAd <0.10ng/ml/cm3 (13.2%), and ERSPC-RC <2% (12.3%). The best biopsy strategy was an initial 4Kscore followed by mpMRI if the 4Kscore was>7.5% and a subsequent biopsy if the mpMRI was positive (PI-RADS 3-5) or the 4Kscore was ≥18%. This would result in missing 2.7% (2/74) of clinically significant PCs (csPCs) and avoiding 34.2% of biopsies. Initial mpMRI followed by biopsy for negative mpMRI (PI-RADS 1-2) if the 4Kscore was ≥18% or PSAd was ≥0.10ng/ml/cm3 resulted in a similar percentage of csPC missed (2.7% [2/74] and 1.3% [1/74]) but slightly fewer biopsies avoided (25.2% and 28.1%). Physicians should consider clinical risk screening tools when ordering and interpreting mpMRI results to avoid unnecessary testing and diagnostic errors. PATIENT SUMMARY: Performing the 4Kscore test in conjunction with multiparametric magnetic resonance imaging for men with a clinical suspicion of prostate cancer may help to reduce unnecessary biopsies.

European urology oncology. 2019 Sep 20 [Epub ahead of print]

Ugo Giovanni Falagario, Alberto Martini, Ethan Wajswol, Patrick-Julien Treacy, Parita Ratnani, Ivan Jambor, Harry Anastos, Sara Lewis, Kenneth Haines, Luigi Cormio, Giuseppe Carrieri, Ardeshir R Rastinehad, Peter Wiklund, Ash Tewari

Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy. Electronic address: ., Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Radiology, University of Turku, Turku, Finland., Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, NY, USA., Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy.

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