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Objectives To assess the accuracy of Koelis fusion biopsy for the detection of prostate cancer and clinically significant prostate cancer in the everyday practice. Methods We retrospectively enrolled 2115 patients from 15 institutions in four European countries undergoing transrectal Koelis fusion biopsy from 2010 to 2017. A variable number of target (usually 2–4) and random cores (usually 10–14) were carried out, depending on the clinical case and institution habits. The overall and clinically significant prostate cancer detection rates were assessed, evaluating the diagnostic role of additional random biopsies. The cancer detection rate was correlated to multiparametric magnetic resonance imaging features and clinical variables. Results The mean number of targeted and random cores taken were 3.9 (standard deviation 2.1) and 10.5 (standard deviation 5.0), respectively. The cancer detection rate of Koelis biopsies was 58% for all cancers and 43% for clinically significant prostate cancer. The performance of additional, random cores improved the cancer detection rate of 13% for all cancers (P < 0.001) and 9% for clinically significant prostate cancer (P < 0.001). Prostate cancer was detected in 31%, 66% and 89% of patients with lesions scored as Prostate Imaging Reporting and Data System 3, 4 and 5, respectively. Clinical stage and Prostate Imaging Reporting and Data System score were predictors of prostate cancer detection in multivariate analyses. Prostate‐specific antigen was associated with prostate cancer detection only for clinically significant prostate cancer. Conclusions Koelis fusion biopsy offers a good cancer detection rate, which is increased in patients with a high Prostate Imaging Reporting and Data System score and clinical stage. The performance of additional, random cores seems unavoidable for correct sampling. In our experience, the Prostate Imaging Reporting and Data System score and clinical stage are predictors of prostate cancer and clinically significant prostate cancer detection; prostate‐specific antigen is associated only with clinically significant prostate cancer detection, and a higher number of biopsy cores are not associated with a higher cancer detection rate.

Our overall detection rate was 45.5% and 37.8% in Group A (patients with previous negative biopsy and persistent suspicion of PCA) and in Group B (biopsy naïve patients) respectively; clinical significant PCA detection rate was respectively 40% and 35.7%. These results are similar to current literature and promising for the future. We believe that using platforms of co-registered MRI/US fusion biopsy can potentially improve risk stratification and reduces understaging, undergrading and the need for repeat biopsies in biopsy naïve patients (using a stereotactic first mapping) and in patients with previous negative biopsy and persistent suspicion of PCA ( using a second MRI/US fusion biopsy).

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Aim: The upgrading or staging in men with prostate cancer (PCA) undergoing active surveillance (AS), defined as Gleason score (GS) ≥ 3+4 or more than 2 area with cancer, was investigated in our experience using the software-based fusion biopsy (FB). Methods: We selected from our database, composed of 620 biopsies, only men on AS according to criteria of John Hopkins Protocol (T1c, < 3 positive cores, GS = 3+3 = 6). Monitoring consisted of PSA measurement every 3 months, a clinical examination every 6 months, confirmatory FB within 6 months and then annual FB in all men. The suspicious MRI lesions were scored according to the Prostate Imaging Reporting and Data System (PI-RADS) classification version 2. FB were performed with a transrectal elastic free-hand fusion platform. The overall and clinically significant cancer detection rate was reported. Secondary, the diagnostic role of systematic biopsies was evaluated. Results: We selected 56 patients on AS with mean age 67.4 years, mean PSA 6.7 ng/ml and at least one follow-up MRI-US fusion biopsy (10 had 2 or 3 follow-up biopsies). Lesions detected by MRI were: PIRADS-2 in 5, PIRADS-3 in 28, PIRADS-4 in 18 pts and PIRADS-5 in 5 patients. In each MRI lesion, FB with 2.1 ± 1.1 cores were taken with a mean total cores of 13 ± 2.4 including the systematic cores. The overall cancer detection rate was 71% (40/56): 62% (25/40) in target core and 28% (15/40) in systematic core. The overall significant cancer detection rate was 46% (26/56): 69% (18/26) in target vs 31% (8/26) in random cores. Conclusions: The incidence of clinical significant cancer was 46% in men starting active surveillance, but it was more than doubled using MRI/US Target Biopsy 69% (18/26) rather than random cores (31%, 8/26). However, 1/3 of disease upgrades would have been missed if only the targeted biopsies were performed. Based on our experience, MRI/US fusion target biopsy must be associated to systematic biopsies to improve detection of significant cancer, reducing the risks of misclassification.