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OBJECTIVES To assess upgrading rates in patients on active surveillance (AS) for prostate cancer (PCa) after serial multiparametric magnetic resonance imaging (mpMRI). METHODS We conducted a retrospective analysis of 558 patients. Five different criteria for mpMRI progression were used: 1) a Prostate Imaging Reporting and Data System (PI-RADS) score increase; 2) a lesion size increase; 3) an extraprostatic extension score increase; 4) overall mpMRI progression; and 5) the number of criteria met for mpMRI progression (0 vs 1 vs 2-3). In addition, two definitions of PCa upgrading were evaluated: 1) International Society of Urological Pathology Grade Group (ISUP GG) ≥2 with >10% of pattern 4 and 2) ISUP GG ≥ 3. Estimated annual percent changes methodology was used to show the temporal trends of mpMRI progression criteria. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of mpMRI progression criteria were also analysed. Multivariable logistic regression models tested PCa upgrading rates. RESULTS Lower rates over time for all mpMRI progression criteria were observed. The NPV of serial mpMRI scans ranged from 90.5% to 93.5% (ISUP GG≥2 with >10% of pattern 4 PCa upgrading) and from 98% to 99% (ISUP GG≥3 PCa upgrading), depending on the criteria used for mpMRI progression. A prostate-specific antigen density (PSAD) threshold of 0.15 ng/mL/mL was used to substratify those patients who would be able to skip a prostate biopsy. In multivariable logistic regression models assessing PCa upgrading rates, all five mpMRI progression criteria achieved independent predictor status. CONCLUSION During AS, approximately 27% of patients experience mpMRI progression at first repeat MRI. However, the rates of mpMRI progression decrease over time at subsequent mpMRI scans. Patients with stable mpMRI findings and with PSAD

Viral respiratory infections are one of the main causes of hospitalization in children. Even if mortality rate is low, 2% to 3% of the hospitalized children need mechanical ventilation. Risk factors for admission to the pediatric intensive care unit (PICU) are well known, while few studies have described risk factors for invasive ventilator support and prolonged hospitalization.A retrospective study including all patients aged between 2 and 18 months with a confirmed viral respiratory infection, requiring admission to PICU from September to March between 2015 and 2019, was conducted at Bambino Gesù Children's Hospital in Rome, Italy.One hundred ninety patients were enrolled, with a median age of 2.7 months; 32.1% had at least one comorbidity, mainly prematurity. The most frequent isolated viruses were RSV-B, rhinovirus, and RSV-A; 38.4% needed mechanical ventilation. This subgroup of patients had lower median birth weight compared with patients not requiring mechanical ventilation (2800 g vs. 3180 g, p = 0.02); moreover, comorbidities were present in 43.8% of intubated patients and in 24.8% of patients treated with non-invasive ventilation (p = 0.006). Viral coinfection did not result to be a risk factor for mechanical support, while virus-bacteria coinfection was significantly associated with mechanical ventilation (p 0.001). Similar risk factors were identified for prolonged hospitalization.Early identification of patients who could have a sudden respiratory deterioration and need of mechanical ventilation is crucial to reduce complications due to orotracheal intubation and prolonged hospitalization in PICU. Further studies are needed to define high-risk group of patients and to design targeted interventions.

Objectives: To evaluate the effects of two different levels of positive end-expiratory pressure (PEEP) during helmet continuous positive airway pressure (HCPAP) support on the intubation rate in infants with bronchiolitis admitted to pediatric intensive care units (PICUs). Design: Multicentric prospective, randomized, open clinical trial. Setting: Four tertiary PICUs in Italy. Participants: Infants admitted to PICUs due to severe bronchiolitis and requiring respiratory support. Interventions: The enrolled patients were randomly assigned one of two PEEP levels for HCPAP support: high (P10 group: 10 cmH O) or low (P5 group: 5 cmH O). Measurements and Main Results: In total, 64 patients were randomly assigned to the P10 group, and 60 to the P5 group. The intubation rate was 9/60 (15%) and 9/64 (14%) in P5 and P10 groups (OR 0.94, 95% CI 0.36-2.46, p=0.99). Of the patients in the P5 group, 47 (78%) were escalated to a PEEP level of 10 cmH O. PEEP level was not associated to intubation rate (OR 0.69, 95% CI 0.19 to 2.40, p=0.57), after adjustment for age, gestational age, high flow nasal cannula application, bronchiolitis severity score and pediatric index of mortality 3. No cases of pneumothorax were observed in this study. Conclusions: In this trial on infants with severe bronchiolitis, a PEEP level of 10 cm H O during HCPAP in comparison to an initial level of 5 cm H O did not show to prevent intubation. These results are not conclusive due to the premature stopping.

Introduction: To compare surgical, oncologic, functional outcomes and complication rate between intracorporeal neobladder (ICNB) and extracorporeal neobladder (ECNB) orthotopic ileal neobladder of robot-assisted radical cystectomy (RARC) in patients with nonmetastatic bladder carcinoma (BC). Materials and Methods: From 2014 to 2019, we prospectively collected and retrospectively analyzed 101 patients with nonmetastatic BC treated with RARC and ortothopic neobladder. Chi-squared test estimated differences in proportions of functional and oncologic outcomes. Multivariable logistic regression models (MLRMs) focused on overall, early (30 days from discharge) in ICNB vs ECNB. Results: Of all patients, 57 (56.4%) ICNB and 44 (43.6%) ECNB patients were identified. At least one complication occurred in 75.4% vs 72.7% in ICNB vs ECNB, respectively (p = 0.9). In MLRMs, focusing on complication rate, there was no statistically significant difference between ICNB vs ECNB for overall (p = 0.8), early (p = 0.6), and late complications (p = 0.8). No statistically significant differences were recorded for tumor relapse rate, cancer-specific and other cause mortality. No positive surgical margins were recorded in both groups. Daytime and nighttime continence recovery were 89.4% vs 87.1% (p = 1.0) and 63.8% vs 51.6% (p = 1.0) for ICNB vs ECNB. Potency recovery was 59.1% vs 54.3% (p = 0.5) for ICNB vs ECNB. Conclusions: No statistically significant differences in complication rate (overall, early, or late) were identified, when ICNB and ECNB were compared. Similarly, no statistically significant difference was found in oncologic and functional outcomes.

BACKGROUND To test clinically significant prostate cancer (csPCa) rates during follow-up in biopsy naive patients that underwent two different diagnostic pathways: (1) SB GROUP (n = 354): systematic random biopsies (SB) vs. (2) TB GROUP (n = 264): multiparametric magnetic resonance imaging (mpMRI) and only targeted biopsies (TB) of PI-RADS ≥ 3 lesions. Patients with PI-RADS ≤ 2 score avoided prostate biopsies. METHODS Retrospective single centre study of 618 biopsy naive patients (2015-2018). Two different definitions of csPCa were used: (1) csPCa ISUP GG ≥ 2 (ISUP grade group [GG] ≥ 2) and (2) csPCa ISUP GG ≥ 3. Kaplan-Meier plots and univariable Cox regression models tested rates over time of csPCa ISUP GG ≥ 2 and caPCa ISUP GG ≥ 3 in SB GROUP vs. TB GROUP. RESULTS At initial biopsy, TB achieved higher rates of csPCa ISUP GG ≥ 2 (35.3 vs. 18.9%; p

OBJECTIVE To evaluate the clinical and pathological implications of Prostate Cancer (PCa) patients with a Prostate Imaging - Reporting and Data System (PI-RADS) 3 lesion at multi parametric magnetic resonance imaging (mpMRI). METHODS We included 356 patients with a PI-RADS score 3 lesion at mpMRI who underwent prostate biopsy for a suspect of PCa at a single tertiary high-volume centre between 2013 and 2016.We developed Uni- (UVA) and multi variable (MVA) logistic regression analyses assessing the predictors of three endpoints: 1) diagnosis of PCa, 2) active surveillance (AS) criteria and 3) clinically significant (CS) PCa at final pathology. RESULTS PCa was diagnosed in 285 patients (80%), out of these 154 (56%) were eligible for AS according to Prostate Cancer Research International Active Surveillance (PRIAS) criteria. Over the 228 (64%) patients who underwent surgery, 93 (40.8%) had a CS disease at final pathology. Hundred and ninety-three (84.6%) had a pT2 disease and 35 (15.4%) had a pT3 disease. The size of the main lesion, age, PSA and prostate volume efficiently predicted PCa at MVA (all p

Sexual disorders following retroperitoneal pelvic lymph node dissection (RPLND) for testis tumor can affect the quality of life of patients. The aim of the current study was to investigate several different andrological outcomes, which may be influenced by robot-assisted (RA) RPLND. From January 2012 to March 2020, 32 patients underwent RA-RPLND for stage I nonseminomatous testis cancer or postchemotherapy (PC) residual mass. Modified unilateral RPLND nerve-sparing template was always used. Major variables of interest were erectile dysfunction (ED), premature ejaculation (PE), dry ejaculation (DE), or orgasm alteration. Finally, fertility as well as the fecundation process (sexual intercourse or medically assisted procreation [MAP]) was investigated. Ten patients (31.3%) presented an andrological disorder of any type after RA-RPLND. Hypospermia was present in 4 (12.5%) patients, DE (International Index of Erectile Function-5 [IIEF-5]lt;25) in 3 (9.4%) patients, and ED in 3 (9.4%) patients. No PE or orgasmic alterations were described. Similar median age at surgery, body mass index (BMI), number of nodes removed, scholar status, and preoperative risk factor rates were identified between groups. Of all these 10 patients, 6 (60.0%) were treated at the beginning of our robotic experience (2012-2016). Of all 32 patients, 5 (15.6%) attempted to have a child after RA-RPLND. All of these 5 patients have successfully fathered children, but 2 (40.0%) required a MAP. In conclusion, a nonnegligible number of andrological complications occurred after RA-RPLND, mainly represented by ejaculation disorders, but ED occurrence and overall sexual satisfaction deficit should be definitely considered. No negative impact on fertility was described after RA-RPLND.

Children are prone to bloodstream infections (BSIs), the rapid and accurate diagnosis of which is an unmet clinical need. The T2MR technology is a direct molecular assay for identification of BSI pathogens, which can help to overcome the limits of blood culture (BC) such as diagnostic accuracy, blood volumes required, and turnaround time. We analyzed results obtained with the T2Bacteria (648) and T2Candida (106) panels in pediatric patients of the Bambino Gesù Children’s Hospital between May 2018 and September 2020 in order to evaluate the performance of the T2Dx instrument with respect to BC. T2Bacteria and T2Candida panels showed 84.2% and 100% sensitivity with 85.9% and 94.1% specificity, respectively. The sensitivity and specificity of the T2Bacteria panel increased to 94.9% and 98.7%, respectively, when BC was negative but other laboratory data supported the molecular result. T2Bacteria sensitivity was 100% with blood volumes

The paper highlitghts the role played by comics in stimulating formative and cultural literacy processes held in contemporary world. After having devoted time to the Italian situation, it highlights the potential and the limits comics met on an educational basis, as it is necessary to use them critically and on a reasonable basis. After the First World War, comics were spread extensively for war propaganda aims. Afterwards, the Great War has consolidated its presence in essays and volumes, as several comics about it were published, almost of all for its anniversary.

Background: We compared multimodality treatment (MMT, defined as robot-assisted radical prostatectomy (RARP) with androgen deprivation therapy (ADT), with or without adjuvant radiotherapy (RT)) vs. ADT alone in oligometastatic prostate cancer (OPC) patients. Methods: From 2010 to 2018, we identified 74 patients affected by cM1a-b OPC (≤5 metastases). Kaplan–Meier (KM) plots depicted cancer-specific mortality (CSM), disease progression, metastatic castration-resistant PC (mCRPC), and time to second-line systemic therapy rates. Multivariable Cox regression models (MCRMs) focused on disease progression and mCRPC. Results: Forty (54.0%) MMT and thirty-four (46.0%) ADT patients were identified. On KM plots, higher CSM (5.9 vs. 37.1%; p = 0.02), mCRPC (24.0 vs. 62.5%; p < 0.01), and second-line systemic therapy (33.3 vs. 62.5%; p < 0.01) rates were recorded in the ADT group. No statistically significant difference was recorded for disease progression. ForMCRMs adjusted for the metastatic site and PSA, a higher mCRPC rate was recorded in the ADT group. No statistically significant difference was recorded for disease progression. Treatment-related adverse events occurred in 5 (12.5%) MMT vs. 15 (44.1%) ADT patients (p < 0.01). Conclusions: MMT was associated with lower CSM, mCRPC, and second-line therapy rates. A lower rate of treatment-related adverse events was recorded for the MMT group.

BackgroundThe technological complexity and heterogeneity of intensive care ventilator models currently available on the market together with the heterogeneity in pediatric patients (0 to 18 years old), make the choice of the best machine for pediatric healthcare setting crucial.This paper is aimed at addressing all the critical aspects linked to the implementation of intensive care ventilators in a pediatric setting, highlighting the most relevant technical features and describing the methodology to conduct health technology assessment (HTA) for supporting the decision-making process.Four ventilators models were included in the assessment process. A decision-making support tool (DoHTA method) based on Analytic Hierarchy Process, was applied. 28 Key Performance Indicators (KPIs) were identified, defining the safety, clinical effectiveness, organizational, technical, and economic aspects. The Performance scores of each ventilator have been measured with respect to KPIs integrated with the total cost of ownership (TCO) analysis, leading to a final rank of the four possible technological solutions. ResultsThe final technologies’ performance scores reflected a deliver valued, contextualized, and shared outputs, detecting the most performant technological solution for the specific hospital context. HTA results had informed and supported the pediatric hospital decision-making process. ConclusionsThis study, identifying and discussing the pros and cons of innovative features of ventilators and all the evaluation criteria and aspects to be taken into account during the evaluation process, can be considered as a valuable proof of evidence as well as a reliable and transferable method for conducting a decision making process in a hospital context.

Our aim was to review clinical outcome and patient satisfaction after cataract surgery to obtain spectacle independence following multifocal intraocular lens (IOL) implantation. A prospective case-series study was designed to evaluate the safety and efficacy of the Hanita FullRange pseudophakic multifocal intraocular lens in patients with programmed cataract surgery, performed between October 2017 and May 2018, with follow-up after 12 months. Manifest refraction spherical equivalent (SE), SE refractive accuracy, uncorrected distance (UDVA), intermediate (UIVA) and near visual acuity (UNVA) and a binocular defocus curve were evaluated. In addition, a short “satisfaction questionnaire” was developed. Surgeries were performed without viscoelastic substance. The corneal endothelial cell density (ECD), central corneal thickness (CCT) and intraocular pressure (IOP) were also evaluated. A total of 480 eyes of 240 patients with mean ± standard deviation (SD) of age of 75 ± 6.12 years were included. The mean ± standard deviation (SD) of preoperative SE was 2.0 ± 2.18 D (range; -5.50 to 4.75) which decreased to -0.04 ± 0.28 D (range; -0.75 to 0.625) 12 months after surgery. Regarding SE refractive accuracy 82.9 % of eyes obtained SE values between -0.5 and 0.5 D. There was no loss of lines of vision and 98.3% of patients achieved UDVA between 20/20 and 20/25. The UNVA (binocular) obtained was J1 for 72.5% and J2 for 27.5% of patients. Regarding defocus curve, 0.04 logMAR for -3.0 D, 0.09 logMAR for -1.5 D and 0.03 logMAR for 0 D was achieved. The mean CCT was increased by 6.62 ± 2.79 micrometer (1.24%), the mean ECD was decreased by 226.08 ± 11.63 cell/mm2 (9.00 %) and the IOP remained stable one year after surgery. In response to the satisfaction questionnaire, 92% of patients stated that they had obtained spectacle independence. Finally, spectacle independence was achieved in most of the cases, with a high level of patient satisfaction one year after implantation of a FullRange IOL. No complications were detected. We concluded that the refractive efficacy of FullRange multifocal IOL was proved in majority of cases. A large follow up period is necessary in future studies to confirm the results.

Objectives To evaluate whether low PI-RADS v2 assessment categories are effective at excluding extraprostatic extension (EPE) of prostate cancer (≥pT3a PCa). Methods The local institutional ethics committee approved this retrospective analysis of 301 consecutive PCa patients. Patients were classified as low- or intermediate/high-risk based on clinical parameters and underwent pre-surgical multiparametric magnetic resonance imaging. A PI-RADS v2 assessment category and ESUR EPE score were assigned for each lesion by two readers working in consensus. Histopathologic analysis of the whole-mount radical prostatectomy specimen was the reference standard. Univariate and multivariate analyses were performed to evaluate the association of PI-RADS v2 assessment category with final histology ≥pT3a PCa. Results For a PI-RADS v2 assessment category threshold of 3, the overall performance for ruling out (sensitivity, negative predictive value, negative likelihood ratio) ≥pT3a PCa was 99%/98%/0.04 and was similar in both the low-risk (96%/97%/0.12; N = 137) and the intermediate/high-risk groups (100%/100%/0.0; N = 164). In univariate analysis, all clinical and tumor characteristics except age were significantly associated with ≥pT3a PCa. In multivariate analysis, PI-RADS v2 assessment categories ≤ 3 had a protective effect relative to categories 4 and 5. The inclusion of ESUR EPE score improved the AUC of ≥pT3a PCa prediction (from 0.73 to 0.86, p = 0.04 in the overall cohort). The impact of PI-RADS v2 assessment category is reflected in a nomogram derived on the basis of our cohort. Conclusions In our cohort, low PI-RADS v2 assessment categories of 3 or less confidently ruled out the presence of ≥pT3a PCa irrespective of clinical risk group. Key Points • Our analysis of 301 mp-MRI and RARP specimens showed that the addition of PI-RADS v2 assessment categories to clinical parameters improves the exclusion of ≥pT3a (extraprostatic) prostate cancer. • PI-RADS v2 assessment categories of 1 to 3 are useful for excluding ≥pT3a prostate cancer with a NPV of 98%; such patients can be considered as candidates for less invasive approaches. • The ability to exclude ≥pT3a prostate cancer may improve confidence in choosing nerve-sparing surgery or in avoiding pelvic nodal dissections, and similarly for patients undergoing radiotherapy, in adopting short-course adjuvant hormonal therapy or foregoing prophylactic nodal irradiation. Electronic supplementary material The online version of this article (10.1007/s00330-019-06092-0) contains supplementary material, which is available to authorized users.

Purpose To report long-term oncological outcomes after penile-sparing surgery (PSS) for superficial (Ta-Tis) or initially invasive (T1) penile cancer patients. Methods We retrospectively analysed 85 patients with Ta/Tis/T1cN0cM0 penile cancer (1996-2018). All patients underwent PSS: circumcision, excision or laser ablation. First, Kaplan-Meier plots and multivariable Cox regression models tested tumor recurrence rates (any local/regional/metastatic). Second, Kaplan-Meier plots depicted progression-free survival ( ≥ T2 or N1-3 or M1 disease). Results Median (IQR) follow-up time was 64 (48–95) months. Overall, 48 (56%) patients experienced tumor recurrence. Median (IQR) time to tumor recurrence was 34 (7–52) months. Higher recurrence rates were observed for Tis (65%) and T1 (64%), compared to Ta (40%), but these differences were not significant on multivariable Cox regression analyses (HR:2.0 with 95% CI [0.9–5.1] and HR:2.2 with 95% CI [0.9–5.9], respectively). Moreover, higher recurrence rates were observed for G2-3 tumors (74%), compared to G1 (57%), but these differences were not significant on multivariable Cox regression analyses (HR:1.6; 95% CI [0.8-3.2]). During follow-up, 15 (17.5%) vs. 18 (21.2%) vs. 10 (11.5%) patients underwent 1 vs. 2 vs. ≥ 3 PSS. Moreover, 26 (30.6%) and 4 (4.7%) men were treated with glansectomy and partial/total penile amputation due to local progression, tumor size or patient preference. Additionally, 24 (28%) men underwent invasive nodal staging. Last, 22 (25.9%) patients experienced disease progression. Median (IQR) time to disease progression was 51 (31–82) months. Conclusion Patients treated with PSS for newly diagnosed superficial or initially invasive squamous cell carcinoma of the penis should be informed about the non-negligible risk of tumor recurrence and disease progression over time. In consequence, strict follow-up protocols are needed.

Background: circulating levels of lymphocytes, platelets and neutrophils have been identified as factors related to unfavorable clinical outcome for many solid tumors. The aim of this cohort study is to evaluate and validate the use of the Prostatic Systemic Inflammatory Markers (PSIM) score in predicting and improving the detection of clinically significant prostate cancer (csPCa) in men undergoing robotic radical prostatectomy for low-risk prostate cancer who met the inclusion criteria for active surveillance. Methods: we reviewed the medical records of 260 patients who fulfilled the inclusion criteria for active surveillance. We performed a head-to-head comparison between the histological findings of specimens after radical prostatectomy (RP) and prostate biopsies. The PSIM score was calculated on the basis of positivity according to cutoffs (neutrophil-to-lymphocyte ratio (NLR) 2.0, platelets-to-lymphocyte ratio (PLR) 118 and monocyte-to-lymphocyte-ratio (MLR) 5.0), with 1 point assigned for each value exceeding the specified threshold and then summed, yielding a final score ranging from 0 to 3. Results: median NLR was 2.07, median PLR was 114.83, median MLR was 3.69. Conclusion: we found a significantly increase in the rate of pathological International Society of Urological Pathology (ISUP) ≥ 2 with the increase of PSIM. At the multivariate logistic regression analysis adjusted for age, prostate specific antigen (PSA), PSA density, prostate volume and PSIM, the latter was found the sole independent prognostic variable influencing probability of adverse pathology.

Purpose: To develop a novel risk tool that allows the prediction of lymph node invasion (LNI) among patients with prostate cancer (PCa) treated with robot-assisted radical prostatectomy (RARP) and extended pelvic lymph node dissection (ePLND). Methods: We retrospectively identified 742 patients treated with RARP + ePLND at a single center between 2012 and 2018. All patients underwent multiparametric magnetic resonance imaging (mpMRI) and were diagnosed with targeted biopsies. First, the nomogram published by Briganti et al. was validated in our cohort. Second, three novel multivariable logistic regression models predicting LNI were developed: (1) a complete model fitted with PSA, ISUP grade groups, percentage of positive cores (PCP), extracapsular extension (ECE), and Prostate Imaging Reporting and Data System (PI-RADS) score; (2) a simplified model where ECE score was not included (model 1); and (3) a simplified model where PI-RADS score was not included (model 2). The predictive accuracy of the models was assessed with the receiver operating characteristic-derived area under the curve (AUC). Calibration plots and decision curve analyses were used. Results: Overall, 149 patients (20%) had LNI. In multivariable logistic regression models, PSA (OR: 1.03; P= 0.001), ISUP grade groups (OR: 1.33; P= 0.001), PCP (OR: 1.01; P= 0.01), and ECE score (ECE 4 vs. 3 OR: 2.99; ECE 5 vs. 3 OR: 6.97; P< 0.001) were associated with higher rates of LNI. The AUC of the Briganti et al. model was 74%. Conversely, the AUC of model 1 vs. model 2 vs. complete model was, respectively, 78% vs. 81% vs. 81%. Simplified model 1 (ECE score only) was then chosen as the best performing model. A nomogram to calculate the individual probability of LNI, based on model 1 was created. Setting our cut-off at 5% we missed only 2.6% of LNI patients. Conclusions: We developed a novel nomogram that combines PSA, ISUP grade groups, PCP, and mpMRI-derived ECE score to predict the probability of LNI at final pathology in RARP candidates. The application of a nomogram derived cut-off of 5% allows to avoid a consistent number of ePLND procedures, missing only 2.6% of LNI patients. External validation of our model is needed.

To test clinically significant prostate cancer (csPCa) rates during follow-up in biopsy naïve patients that underwent two different diagnostic pathways: (1) SB GROUP (n = 354): systematic random biopsies (SB) vs. (2) TB GROUP (n = 264): multiparametric magnetic resonance imaging (mpMRI) and only targeted biopsies (TB) of PI-RADS ≥ 3 lesions. Patients with PI-RADS ≤ 2 score avoided prostate biopsies.Retrospective single centre study of 618 biopsy naive patients (2015-2018). Two different definitions of csPCa were used: (1) csPCa ISUP GG ≥ 2 (ISUP grade group [GG] ≥ 2) and (2) csPCa ISUP GG ≥ 3. Kaplan-Meier plots and univariable Cox regression models tested rates over time of csPCa ISUP GG ≥ 2 and caPCa ISUP GG ≥ 3 in SB GROUP vs. TB GROUP.At initial biopsy, TB achieved higher rates of csPCa ISUP GG ≥ 2 (35.3 vs. 18.9%; p 0.001) and csPCa ISUP GG ≥ 3 (12.6 vs. 6.2%; p = 0.04), relative to SB. After a median time follow-up of 36 months, the rates of csPCa ISUP GG ≥ 2 (6.1 vs. 4.4%; p = 0.6) and csPCa ISUP GG ≥ 3 (3.3 vs. 1.1%; p = 0.2) were similar in SB GROUP vs. TB GROUP. Moreover, in TB GROUP patients that avoided prostate biopsies because of negative baseline mpMRI (n = 145), only 4.1% exhibited csPCa ISUP GG ≥ 2 during follow-up. Moreover, none of these patients (PI-RADS ≤ 2) had csPCa ISUP GG ≥ 3.In biopsy naïve setting, a diagnostic pathway including pre-biopsy mpMRI and TB of only PCa suspicious lesions is not associated with higher rates of csPCa during follow-up, relative to a diagnostic pathway of SB. Moreover, patients with negative baseline mpMRI could safely avoid prostate biopsies and could be followed with repeated PSA testing, since only a small proportion of them would harbor csPCa.