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Objectives: The aims of this study are to develop and validate a clinical decision support system based on demographics, prostate-specific antigen (PSA), microRNA (miRNA), and MRI for the detection of prostate cancer (PCa) and clinical significant (cs) PCa, and to assess if this system performs better compared to MRI alone., Methods: This retrospective, multicenter, observational study included 222 patients (mean age 66, range 46-75 years) who underwent prostate MRI, miRNA (let-7a-5p and miR-103a-3p) assessment, and biopsy. Monoparametric and multiparametric models including age, PSA, miRNA, and MRI outcome were trained on 65% of the data and then validated on the remaining 35% to predict both PCa (any Gleason grade [GG]) and csPCa (GG ≥ 2 vs GG = 1/negative). Accuracy, sensitivity, specificity, positive and negative predictive value (NPV), and area under the receiver operating characteristic curve were calculated., Results: MRI outcome was the best predictor in the monoparametric model for both detection of PCa, with sensitivity of 90% (95%CI 73-98%) and NPV of 93% (95%CI 82-98%), and for csPCa identification, with sensitivity of 91% (95%CI 72-99%) and NPV of 95% (95%CI 84-99%). Sensitivity and NPV of PSA + miRNA for the detection of csPCa were not statistically different from the other models including MRI alone., Conclusion: MRI stand-alone yielded the best prediction models for both PCa and csPCa detection in biopsy-naïve patients. The use of miRNAs let-7a-5p and miR-103a-3p did not improve classification performances compared to MRI stand-alone results., Clinical Relevance Statement: The use of miRNA (let-7a-5p and miR-103a-3p), PSA, and MRI in a clinical decision support system (CDSS) does not improve MRI stand-alone performance in the detection of PCa and csPCa., Key Points: • Clinical decision support systems including MRI improve the detection of both prostate cancer and clinically significant prostate cancer with respect to PSA test and/or microRNA. • The use of miRNAs let-7a-5p and miR-103a-3p did not significantly improve MRI stand-alone performance. • Results of this study were in line with previous works on MRI and microRNA., (© 2024. The Author(s).)

Background: The knowledge of tumor location and extension can allow a modulated radical prostatectomy in order to minimize positive surgical margins and reduce functional morbidity after surgery in patients with prostate cancer (PCa). Multiparametric (mp) magnetic resonance imaging (MRI) could allow the assessment of tumor extension and of its relationship with external structures. Aim of this study is to propose a new radiological Wheeler (rW) staging system applied to mp-MRI, based on the pathologic staging system (pW) for the local assessment of PCa., Methods: This retrospective single-center multi-reader study included consecutive patients with PCa and preoperative mp-MRI, who underwent non-nerve sparing radical prostatectomy. Three radiologists reported on all examinations and classified each selected lesion according to imaging criteria following rW. Whole-mount histological sections were used as the reference standard. An experienced pathologist classified the extent of prostatic capsular invasion of each PCa according to the pW. Each histological section was scanned for comparison with mp-MRI findings. The rate of PCa correctly classified by radiologists using the pW was assessed. To evaluate the accuracy of mp-MRI in the discrimination between T2 and T3 PCa, the AUC was computed., Results: One-hundred and five patients with a total of 195 PCa foci were included in the study. 130/195 tumors with a clear overlap between mp-MRI and surgical specimens were selected. The sensitivity of the most experienced reader was lower than that of the other two readers (48.6% vs. 68.6% and 62.9%, P>0.09) while specificity and PPV were higher (95.8% vs. 79.0% and 57.9%, P<0.001; 81.0% vs. 54.6% and 35.5%, P<0.041; respectively). The AUC values for the most and the intermediate experienced readers in the detection of extracapsular extension were in the range 0.72-0.74., Conclusions: The rW staging system has low accuracy in predicting each single pW class, while accuracy was over 80% for experienced readers in the identification of organ-confined (T2 stage class) tumors and non-organ confined cases (T3 stage class).

Background: An approach based on multiparametric magnetic resonance imaging (mpMRI) might increase the detection rate (DR) of clinically significant prostate cancer (csPCa)., Objective: To compare an mpMRI-based pathway with the standard approach for the detection of prostate cancer (PCa) and csPCa., Design, Setting, and Participants: Between November 2014 and April 2016, 212 biopsy-naïve patients with suspected PCa (prostate specific antigen level ≤15 ng/ml and negative digital rectal examination results) were included in this randomized clinical trial. Patients were randomized into a prebiopsy mpMRI group (arm A, n=107) or a standard biopsy (SB) group (arm B, n=105)., Intervention: In arm A, patients with mpMRI evidence of lesions suspected for PCa underwent mpMRI/transrectal ultrasound fusion software-guided targeted biopsy (TB) (n=81). The remaining patients in arm A (n=26) with negative mpMRI results and patients in arm B underwent 12-core SB., Outcomes Measurements and Statistical Analysis: The primary end point was comparison of the DR of PCa and csPCa between the two arms of the study; the secondary end point was comparison of the DR between TB and SB., Results and Limitations: The overall DRs were higher in arm A versus arm B for PCa (50.5% vs 29.5%, respectively; p=0.002) and csPCa (43.9% vs 18.1%, respectively; p<0.001). Concerning the biopsy approach, that is, TB in arm A, SB in arm A, and SB in arm B, the overall DRs were significantly different for PCa (60.5% vs 19.2% vs 29.5%, respectively; p<0.001) and for csPCa (56.8% vs 3.8% vs 18.1%, respectively; p<0.001). The reproducibility of the study could have been affected by the single-center nature., Conclusions: A diagnostic pathway based on mpMRI had a higher DR than the standard pathway in both PCa and csPCa., Patient Summary: In this randomized trial, a pathway for the diagnosis of prostate cancer based on multiparametric magnetic resonance imaging (mpMRI) was compared with the standard pathway based on random biopsy. The mpMRI-based pathway had better performance than the standard pathway., (Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objective: To determine the association among prostate cancer gene 3 (PCA3) score, Prostate Imaging Reporting and Data System (PI-RADS) grade and Gleason score, in a cohort of patients with elevated prostate-specific antigen (PSA), undergoing magnetic resonance imaging/ultrasonography fusion software-based targeted prostate biopsy (TBx) after a previous negative randomised 'standard' biopsy (SBx)., Patients and Methods: In all, 282 patients who underwent TBx after previous negative SBx and a PCA3 urine assay, were enrolled. The associations between PCA3 score/PI-RADS and PCA3 score/Gleason score were investigated by K-means clustering, a receiver operating characteristic analysis and binary logistic regression., Results: The PCA3 score difference for the negative vs positive TBx cohorts was highly statistically significant. A 1-unit increase in the PCA3 score was associated to a 2.4% increased risk of having a positive TBx result. A PCA3 score of >80 and a PI-RADS grade of ≥4 were independent predictors of a positive TBx. The association between the PCA3 score and PI-RADS grade was statistically significant (the median PCA3 score for PI-RADS grade groups 3, 4, and 5 was 58, 104, and 146, respectively; P = 0.006). A similar pattern was detected for the relationship between the PCA3 score and Gleason score; an increasing PCA3 score was associated with a worsening Gleason score (median PCA3 score equal to 62, 105, 132, 153, 203, and 322 for Gleason Score 3+4, 4+3, 4+4, 4+5, 5+4, and 5+5, respectively; P < 0.001)., Conclusion: TBx improved PCA3 score diagnostic and prognostic performance for prostate cancer. The PCA3 score was directly associated both with biopsy Gleason score and PI-RADS grade: notably, in the 'indeterminate' PI-RADS grade 3 subgroup., (© 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.)

Objective: To assess the performance capabilities of multiparametric magnetic resonance imaging (mpMRI), the prostate health index (PHI) and prostate cancer antigen 3 (PCA3) in predicting the presence of pathologically confirmed significant prostate cancer (PCSPCa), according to the European Randomized Study of Screening Prostate Cancer definition, in a single cohort of patients who underwent radical prostatectomy (RP) but who were eligible for active surveillance (AS)., Materials and Methods: An observational retrospective study was performed in 120 patients with prostate cancer (PCa), treated with robot-assisted RP but eligible for AS according to Prostate Cancer Research International: Active Surveillance criteria. Blood and urine specimens were collected before initial prostate biopsy for PHI and PCA3 measurements, respectively. In addition, all patients underwent mpMRI, preoperatively and 6-8 weeks after biopsy, with a 1.5T scanner using a four-to-five-channel phase array coil combined with an endorectal coin. mpMRI images were assessed and diagrams showing the prostate sextants were used to designate regions of abnormality within the prostate. Prostate findings were assigned to one of five categories according to Prostate Imaging-Reporting and Data System guidelines (PI-RADS) and considered positive for PCa if final PI-RADS score was >3 and negative if ≤3., Results: Pathologically confirmed reclassification was observed in 55 patients (45.8%). mpMRI showed good specificity and negative predictive value (0.61 and 0.73, respectively) for excluding PCSPCa compared with the PHI and PCA3. On multivariate analyses and after 1 000 bootstrapping resampling, the inclusion of both mpMRI and the PHI significantly increased the accuracy of the base model in predicting PCSPCa. For the prediction of PCSPCa, in particular, the base model had an area under the curve (AUC) of 0.71 which significantly increased by 4% with the addition of the PHI (AUC = 0.75; P < 0.01) and by 7% with the addition of mpMRI (AUC = 0.78; P < 0.01). Decision-curve analysis showed that the multivariable model with mpMRI had the highest net benefit., Conclusion: In a single cohort of patients who underwent RP but who were eligible for AS, mpMRI and, to a lesser extent, the PHI, had an important role in discriminating the presence of PCSPCa; both measures could therefore be useful in the selection and monitoring of patients undergoing AS., (© 2015 The Authors BJU International © 2015 BJU International Published by John Wiley & Sons Ltd.)

Objectives: To evaluate the role of multiparametric magnetic resonance imaging in improving the predictive accuracy of the Prostate Cancer Research International: Active Surveillance and Epstein criteria for active surveillance in prostate cancer., Methods: A retrospective study was carried out with 126 prostate cancer patients treated with robot-assisted radical prostatectomy, but eligible for active surveillance according to the Prostate Cancer Research International: Active Surveillance criteria; 63 patients were also eligible according to the Epstein criteria. All patients underwent preoperative multiparametric magnetic resonance imaging, after at least 6 weeks from biopsy. The images from the multiparametric magnetic resonance imaging were assessed, and diagrams showing prostate sextants were used to designate regions of abnormalities within the prostate. Findings in the prostate were assigned to one of five categories according the Prostate Imaging-Reporting and Data System guidelines (v1.0), and considered positive for prostate cancer if the final Prostate Imaging-Reporting and Data System guidelines were >3 and negative if ≤3. Multivariate logistic regression analysis was carried out to evaluate the gain in accuracy of the Prostate Cancer Research International: Active Surveillance and Epstein criteria when added to multiparametric magnetic resonance imaging. Decision curve analysis was carried out to identify the net benefit of each model., Results: The inclusion of multiparametric magnetic resonance imaging to the Epstein criteria and the Prostate Cancer Research International: Active Surveillance multivariate model significantly increased their accuracy in predicting pathologically-confirmed insignificant prostate cancer by 7% and 5%, respectively. At the decision curve analysis evaluation, the model including the Prostate Cancer Research International: Active Surveillance criteria and multiparametric magnetic resonance imaging improved the clinical risk prediction over the other models., Conclusions: The present findings suggest that multiparametric magnetic resonance imaging is able to increase the predictive accuracy of Prostate Cancer Research International: Active Surveillance and Epstein criteria to identify prostate cancer patients eligible for active surveillance., (© 2016 The Japanese Urological Association.)

Purpose: To assess the use of the new Focal-One® HIFU platform in salvage setting to evaluate the occurrence of postoperative complications. Methods: Patients who underwent salvage HIFU (sHIFU) with Focal-One® platform were enrolled prospectively (Candiolo cancer institute—FPO IRCCS; registry number: 258/2018). Perioperative and postoperative outcomes (in terms of oncological and functional ones) were recorded during the first year of follow-up. In particular postoperative complications were classified according to Clavien–Dindo system. Results: 20 patients were enrolled. No grade 3 complications were recorded. Referring to grade 2 complications, eight patients reported urgency after 3 months of follow-up, and in 4 cases, a low urinary tract infection occurred. Evaluating the impact of sHIFU on patients' sexual potency, micturition and quality of life, no significant deterioration was recorded during the follow-up as proven using the ANOVA analysis for repeated measurements. Only two patient had a biochemical failure after 12 months of follow-up. Conclusions: The real-time intraoperative guidance with Focal-One® platform, allows a continuous monitoring and tailoring of the treatment, with a minimization of the adverse events even in a salvage setting. [ABSTRACT FROM AUTHOR]

Objectives: To present the functional and oncological outcomes after ≥1 year of follow‐up, following an experience of >1000 robot‐assisted radical prostatectomies (RARPs) with our standardised total anatomical reconstruction (TAR) technique. To evaluate which factors influence postoperative continence recovery in order to obtain a nomogram to predict the risk of postoperative urinary incontinence (UI). Patients and Methods: The enrolment phase began in June 2013 and ended in May 2017. Patients were prospectively included in the study with the following inclusion criteria: (i) localised prostate cancer (clinical stages cT1–3, cN0, cM0); (ii) indication for RP; and (iii) preoperative multiparametric prostate magnetic resonance imaging. All patients underwent RARP with the TAR technique done at the end of the demolitive phase. The continence rates were assessed at 24 h, and 1, 4, 12, 24 and 48 weeks after catheter removal. Patients were defined as continent if they answered 'zero pad' or 'one safety pad' per day. A logistic regression model was used to evaluate the potential impact of some pre‐ and intraoperative factors on postoperative urinary continence recovery. Model discrimination was assessed using an area under (AUC) the receiver operating characteristic (ROC) curve. A nomogram to predict the risk of postoperative UI after RARP with the TAR technique was generated based on the logistic model. Results: In all, 1008 patients were enrolled in our study. At 24 h, and 1, 4, 12, 24 and 48 weeks after catheter removal, 621 (61.61%), 594 (58.93%), 803 (79.66%), 912 (90.48%), 950 (94.25%) and 956 (94.84%) patients were continent, respectively. In the logistic regression model, the variables analysed had a higher impact on continence recovery at 4 and 12 weeks. At 4 weeks, the postoperative odds of urinary continence recovery increased with the absence of diabetes [odds ratio (OR) 2.76, 95% confidence interval (CI) 1.41–5.41] and D'Amico low vs high risk (OR 2.01, 95% CI 1.01–3.99). At 12 weeks, urinary continence increased with the absence of diabetes (OR 3.01, 95% CI 1.23–7.35), D'Amico low vs high risk (OR 4.04, 95% CI 1.56–10.47), and D'Amico intermediate vs high risk (OR 3.33, 95% CI 1.66–6.70). ROC curves were drawn and an AUC value of 61.9% (95% CI 57.49–66.36) at 4 weeks and 63.8% (95% CI 58.03–69.65) at 12 weeks were computed. Based on these parameters, two nomograms (at 4 and 12 weeks postoperatively) were generated. Conclusion: The TAR technique conferred excellent results in the early recovery of urinary continence. Two nomograms were created, to predict preoperatively the postoperative odds of urinary continence recovery at 4 and 12 weeks after RARP by integrating the presence of diabetes and D'Amico risk classification. [ABSTRACT FROM AUTHOR]

Purpose We evaluated the minimum core number for better index tumor detection to determine the best core site as well as biopsy Gleason score heterogeneity in the same index lesion. The aim was to optimize the highest Gleason score detection. Materials and Methods A total of 327 patients with negative digital rectal examination underwent magnetic resonance imaging/transrectal ultrasound fusion targeted biopsy for elevated/rising prostate specific antigen and/or 1 or more detectable lesions on multiparametric magnetic resonance imaging after a previous negative standard biopsy. Depending on the diameter of each index lesion (8 or less, or greater than 8 mm) 4 or 6 cores, respectively, were taken according to a well determined sequence. Results Of the patients 166 (50.7%) had prostate cancer, including 79 (47.6%) with an 8 mm or less index lesion and 87 (52.4%) with a greater than 8 mm index lesion. Of patients with an index tumor 8 mm or less 7 (8.9%) had 1, 31 (39.2%) had 2, 27 (34.2%) had 3 and 14 (17.7%) had 4 positive cores. Similarly, of patients with a lesion greater than 8 mm 8 (9.2%) had 1, 30 (34.5%) had 2, 13 (14.9%) had 3, 14 (16.1%) had 4, 12 (13.8%) had 5 and 10 (11.5%) had 6 positive cores. The major prevalence of positive cores was observed in the center of the target. Gleason score heterogeneity was found in 12.6% of those with an 8 mm or less target vs 26.4% with a target greater than 8 mm. In the center of the target there was a slight prevalence of Gleason pattern 4 or greater, or a lesser pattern. Conclusions Approaching magnetic resonance imaging/transrectal ultrasound fusion targeted biopsy with a single core might be inadequate. Rather, taking 2 cores in the center of the index lesion may provide more accurate cancer detection and optimize the chances of finding the highest Gleason pattern. [ABSTRACT FROM AUTHOR]

The article discusses the benefits of multi-parametric magnetic resonance imaging (mpMRI) in detecting the clinical manifestation for prostate cancer. However, mpMRI is expensive, labor-intensive and time-consuming reporting, and is not feasible for screening purposes in men at risk of prostate cancer. The authors believe that both prostatectomy and fusion biopsy remain preferable in evaluating diagnostic accuracy of prostate cancer biomarkers.