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Background and Objective: Intensification of targeted biopsy (TBx) around a magnetic resonance imaging (MRI)-visible lesion with regional biopsy (RBx) could obviate the need for systematic biopsy (SBx). We aimed to compare the detection yields of clinically significant prostate cancer (csPCa)-defined as International Society of Urological Pathology (ISUP) grade group ≥2-between TBx + RBx and the reference standard (TBx + SBx)., Methods: RBx was defined as perilesional or ipsilateral biopsy. A literature search was conducted up to September 2023 using PubMed, Embase, and Web of Science databases. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. Included studies were eligible when presenting data from SBx, TBx, and TBx + RBx cores and their detection yields. The Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) criteria were used to assess the risk of bias of the included studies., Key Findings and Limitations: Twenty-one studies were included for a meta-analysis. The overall detection yield of csPCa was not statistically different between TBx + SBX and TBx + RBx (46.1% vs 44.2%; odds ratio [OR] 1.07, 95% confidence interval [CI] 0.99-1.16, p = 0.07); similar findings were found also for ISUP grade group ≥3 prostate cancer (PCa; OR 1.06, 95% CI 0.92-1.22, p = 0.43) and in different subgroup analyses. TBx + SBx was associated with higher cancer detection of ISUP grade group 1 PCa (OR 1.16, 95% CI 1.04-1.30, p = 0.008). The main limitations include the retrospective nature of most of the selected studies, heterogeneity of RBx definition, and template., Conclusions and Clinical Implications: Our study supports the use of the TBx + RBx template in the early detection pathway for the detection of csPCa. SBx can be omitted when targeting lesions visible on MRI., Patient Summary: A prostate biopsy strategy consisting of taking biopsy in and around an magnetic resonance imaging-visible lesion reduces the risk of detecting indolent prostate cancers without affecting the detection of aggressive tumours., (Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Prostate cancer (PCa) is the most diagnosed cancer in men, with an increasing need to integrate noninvasive imaging and circulating microRNAs beyond prostate-specific antigen for screening and early detection., Objective: To validate magnetic resonance imaging (MRI) biomarkers and circulating microRNAs as triage tests for patients directed to prostate biopsy, and to test different diagnostic pathways to compare their performance on patients' outcome, in terms of unnecessary biopsy avoidance., Design, Setting, and Participants: A prospective single-center cohort study, enrolling patients with PCa suspicion who underwent MRI, MRI-directed fusion biopsy (MRDB), and circulating microRNAs, was conducted. A network-based analysis was used to identify MRI biomarkers and microRNA drivers of clinically significant PCa., Intervention: MRI, MRDB, and blood sampling., Outcome Measurements and Statistical Analysis: The decision curve analysis was exploited to assess the performance of the proposed diagnostic pathways and to quantify their benefit in terms of biopsy avoidance., Results and Limitations: Overall, 261 men were enrolled and underwent MRDB for PCa detection. A total of 178 patients represented the entire cohort: 55 (30.9%) were negative for PCa, 39 (21.9%) had grade group (GG) 1 PCa, and 84 (47.2%) had GG >1 PCa. The proposed integrated pathway, including clinical data, MRI biomarkers, and microRNAs, provided the best net benefit with a biopsy avoidance rate of about 20% at a low disease probability. The main limitation is the monocentric design in a referral center., Conclusions: The integrated pathway represents a validated model that sees MRI biomarkers and microRNAs as a prebiopsy triage of patients at a risk for clinically significant PCa. The proposed pathway showed the highest net benefit in terms of unnecessary biopsy avoidance., Patient Summary: The proposed integrated pathway for early detection of prostate cancer (PCa) allows accurate patient allocation to biopsy and patients' stratification into risk group categories, reducing overdiagnosis and overtreatment of clinically insignificant PCa., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Context: Bladder cancer prognosis and treatment are heavily dependent on accurate staging. Traditional imaging and pathologic evaluation of transurethral resection (TUR) specimens have been associated with high rates of clinical understaging at the time of radical cystectomy (RC)., Objective: We describe current components and limitations of bladder cancer staging for muscle-invasive bladder cancer (MIBC), and discuss the rationale for inclusion of novel biomarkers and imaging modalities to improve diagnostic accuracy., Evidence Acquisition: We summarize the data informing MIBC staging accuracy using a nonsystematic review of published literature and provide expert opinion on current and emerging standards in MIBC staging., Evidence Synthesis: Nearly 50% of patients undergoing RC are clinically understaged preoperatively. Components of clinical staging include TUR specimen evaluation, bimanual examination under anesthesia (EUA), and cross-sectional imaging of the chest, abdomen, and pelvis. Complete endoscopic resection of visible disease with sampling of muscularis propria is indicated. While histologic features such as tumor size, focality, variant histologic differentiation, and lymphovascular invasion have prognostic utility, insufficient evidence exists to incorporate them into current staging paradigms. For primary tumor staging, conventional computed tomography (CT) has limited accuracy in differentiating non-MIBC from MIBC. Magnetic resonance imaging (MRI) has exhibited superior pT staging accuracy with the validated Vesical Imaging Reporting and Data System. Positron emission tomography (PET)/CT does not increase clinical nodal staging accuracy beyond CT or MRI, and there exists no consensus role for the use of PET in routine clinical staging., Conclusions: In the absence of reliable biomarkers to serve as staging adjuncts, we continue to rely heavily on basic clinical staging components-TUR with accurate pathologic evaluation, EUA, and standard cross-sectional imaging modalities. MRI shows promising accuracy and interobserver reliability for primary tumor staging., Patient Summary: Effective clinical staging for muscle-invasive bladder cancer estimates local and systemic disease burden and can dictate eligibility for systemic therapy and/or radical cystectomy. Herein, we review the accuracy and limitations of current and emerging staging modalities., (Copyright © 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Imaging techniques are used to identify local recurrence of prostate cancer (PCa) for salvage therapy and to exclude metastases that should be addressed with systemic therapy. For magnetic resonance imaging (MRI), a reduction in the variability of acquisition, interpretation, and reporting is required to detect local PCa recurrence in men with biochemical relapse after local treatment with curative intent., Objective: To propose a standardised method for image acquisition and assessment of PCa local recurrence using MRI after radiation therapy (RP) and radical prostatectomy (RT)., Evidence Acquisition: Prostate Imaging for Recurrence Reporting (PI-RR) was formulated using the existing literature. An international panel of experts conducted a nonsystematic review of the literature. The PI-RR system was created via consensus through a combination of face-to-face and online discussions., Evidence Synthesis: Similar to with PI-RADS, based on the best available evidence and expert opinion, the minimum acceptable MRI parameters for detection of recurrence after radiation therapy and radical prostatectomy are set. Also, a simplified and standardised terminology and content of the reports that use five assessment categories to summarise the suspicion of local recurrence (PI-RR) are designed. PI-RR scores of 1 and 2 are assigned to lesions with a very low and low likelihood of recurrence, respectively. PI-RR 3 is assigned if the presence of recurrence is uncertain. PI-RR 4 and 5 are assigned for a high and very high likelihood of recurrence, respectively. PI-RR is intended to be used in routine clinical practice and to facilitate data collection and outcome monitoring for research., Conclusions: This paper provides a structured reporting system (PI-RR) for MRI evaluation of local recurrence of PCa after RT and RP., Patient Summary: A new method called PI-RR was developed to promote standardisation and reduce variations in the acquisition, interpretation, and reporting of magnetic resonance imaging for evaluating local recurrence of prostate cancer and guiding therapy., (Copyright © 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Context: A noninvasive multiparametric magnetic resonance imaging (MRI)-based scoring system for predicting muscle-invasive bladder cancer (MIBC), the "Vesical Imaging Reporting and Data System" (VI-RADS), was recently developed by an international multidisciplinary panel. Since then, a few studies evaluating the value of VI-RADS for predicting MIBC have been published., Objective: To review the diagnostic performance of VI-RADS for the prediction of MIBC., Evidence Acquisition: PubMed and EMBASE databases were searched up to November 10, 2019. We included diagnostic accuracy studies using VI-RADS to predict MIBC using cystectomy or transurethral resection as the reference standard. Methodological quality was evaluated with Quality Assessment of Diagnostic Accuracy Studies-2. Sensitivity and specificity were pooled and plotted using hierarchical summary receiver operating characteristics (HSROC) modeling. Meta-regression analyses were done to explore heterogeneity., Evidence Synthesis: Six studies (1770 patients) were included. Pooled sensitivity and specificity were 0.83 (95% confidence interval [CI] 0.70-0.90) and 0.90 (95% CI 0.83-0.95), and the area under the HSROC curve was 0.94 (95% CI 0.91-0.95). Heterogeneity was present among the studies (Q = 29.442, p <  0.01; I 2  = 87.93%, and 90.99% for sensitivity and specificity). Meta-regression analyses showed that the number of patients (>205 vs ≤205), magnetic field strength (3 vs 1.5 T), T2-weighted image slice thickness (3 vs 4 mm), and VI-RADS cutoff score (≥3 vs ≥4) were significant factors affecting heterogeneity (p ≤  0.03)., Conclusions: VI-RADS shows good sensitivity and specificity for determining MIBC. Technical factors associated with MRI acquisition and cutoff scores need to be taken into consideration as they may affect performance., Patient Summary: A recently established noninvasive magnetic resonance imaging-based scoring system shows good diagnostic performance in detecting muscle-invasive bladder cancer., (Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Context: There is a lack of comprehensive data regarding the factors that influence the diagnostic accuracy of multiparametric magnetic resonance imaging (mpMRI) to detect and localize clinically significant prostate cancer (csPCa)., Objective: To systematically review the current literature assessing the factors influencing the variability of mpMRI performance in csPCa diagnosis., Evidence Acquisition: A computerized bibliographic search of Medline/PubMed database was performed for all studies assessing magnetic field strength, use of an endorectal coil, assessment system used by radiologists and inter-reader variability, experience of radiologists and urologists, use of a contrast agent, and use of computer-aided diagnosis (CAD) tools in relation to mpMRI diagnostic accuracy., Evidence Synthesis: A total of 77 articles were included. Both radiologists' reading experience and urologists'/radiologists' biopsy experience were the main factors that influenced diagnostic accuracy. Therefore, it is mandatory to indicate the experience of the interpreting radiologists and biopsy-performing urologists to support the reliability of the findings. The most recent Prostate Imaging Reporting and Data System (PI-RADS) guidelines are recommended for use as the main assessment system for csPCa, given the simplified and standardized approach as well as its particular added value for less experienced radiologists. Biparametric MRI had similar accuracy to mpMRI; however, biparametric MRI performed better with experienced readers. The limited data available suggest that the combination of CAD and radiologist readings may influence diagnostic accuracy positively., Conclusions: Multiple factors affect the accuracy of mpMRI and MRI-targeted biopsy to detect and localize csPCa. The high heterogeneity across the studies underlines the need to define the experience of radiologists and urologists, implement quality control, and adhere to the most recent PI-RADS assessment guidelines. Further research is needed to clarify which factors impact the accuracy of the MRI pathway and how., Patient Summary: We systematically reported the factors influencing the accuracy of multiparametric magnetic resonance imaging (mpMRI) in detecting clinically significant prostate cancer (csPCa). These factors are significantly related to each other, with the experience of the radiologists being the dominating factor. In order to deliver the benefits of mpMRI to diagnose csPCa, it is necessary to develop expertise for both radiologists and urologists, implement quality control, and adhere to the most recent Prostate Imaging Reporting and Data System assessment guidelines., (Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Context: In patients treated for prostate cancer, a rising serum prostate-specific antigen (PSA) level is a first sign of relapse, but imaging is needed to determine the localization of the recurrence, which may be local, in lymph nodes, and/or metastatic. With the increasing success rate of earlier salvage therapy, the diagnosis has become pertinent when the recurrent PSA level is still very low., Objective: To systematically review the literature on the role of the existing imaging techniques in patients with early recurrent prostate cancer., Evidence Acquisition: A systematic literature search across the MEDLINE and EMBASE databases was conducted in February 2018, searching for original studies reporting on imaging in a (sub)group of patients with recurrent PSA levels not higher than 5ng/ml. This systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. The methodological quality of the studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool., Evidence Synthesis: A total of 98 studies were included in this systematic review, reporting on the role of transrectal ultrasonography (TRUS), computed tomography (CT), bone scintigraphy (BS), single-photon emission CT, multiparametric magnetic resonance imaging (mpMRI), whole-body MRI (wbMRI), and positron emission tomography (PET)-CT/MRI using 18F fluoro-deoxy-glucose, 11C choline, 18F (fluoro)(methyl)choline, 11C acetate, 18F FACBC (fluciclovine) and prostate-specific membrane antigen (PSMA)-based tracers. CT and BS were not sufficiently sensitive in the early recurrence setting. For the detection of local recurrence, TRUS or mpMRI can be used; however, at the lowest PSA levels, few data were available, only after radical prostatectomy, showing a wide range of positivity. TRUS or mpMRI need to be combined with (PET)-CT to assess distant disease, but new techniques such as wbMRI, PET-MRI, or PET-CT allow for an all-in-one approach. At recurrent PSA levels <0.5ng/ml, detection rates up to 31.3% were reported using 11 C choline PET-CT and up to 65.0% using 68 Ga PSMA-11 PET-CT. At recurrent PSA levels <0.2ng/ml, detection rates of 68 Ga PSMA-11 PET-CT ranged from 11.3% to as high as 58.3%., Conclusions: Detection rates of different imaging techniques depend on the PSA level at the time of imaging. Recent advanced imaging techniques may detect the localization of the recurrence, even when the PSA levels are still very low., Patient Summary: In patients treated for prostate cancer, a rising serum prostate-specific antigen (PSA) level is a sign of recurrence of the disease. Advanced imaging techniques may demonstrate the localization of the recurrence, even when the PSA levels are still very low., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Transrectal ultrasound-guided biopsy (TRUS-Bx) is recommended by the European Urology Association (EAU) as the first diagnostic modality for men at risk of prostate cancer (PCa). Current EAU guidelines reserve the use of multiparametric MRI to target or guide any repeat biopsy (mpMRI-Bx). It remains uncertain if TRUS-Bx is effective as a first strategy in terms of costs, diagnostic performance, time to diagnosis, and triage for individualised therapy., Objective: To determine the diagnostic and treatment costs and the effectiveness of pathways incorporating mpMRI-Bx compared to TRUS-Bx in men at high risk of PCa., Design, Setting, and Participants: A cost and time analysis was performed using data from a randomised single-centre study of 1140 patients (prostate-specific antigen >4ng/ml) divided into two groups: 570 patients underwent an initial TRUS-Bx and 570 underwent 3-T mpMRI-Bx., Outcome Measurements and Statistical Analysis: Budget analyses were used to compare the diagnostic strategies using reimbursement data from the Italian National Health Security system. Analyses of reimbursable diagnostic and treatment costs were undertaken separately. Histologic outcomes, pathway diagnostic accuracy, therapy choices, and time to diagnosis were compared., Results and Limitations: The cumulative diagnosis costs were 14.6% greater for the mpMRI-Bx pathway than for the TRUS strategy, and 5.2-6.0% higher for therapy. Diagnostic costs were €228 946 for mpMRI-Bx and €199 750 for TRUS-Bx, and the corresponding therapy costs were €1 912 000 and €1 802 800. The mpMRI-Bx strategy was highly effective in excluding clinically significant disease (Gleason ≥7; sensitivity and negative predictive value both 100%, 95% confidence interval 98-100%). The time to diagnosis was significantly shorter for the mpMRI-Bx (median 4.0 mo interquartile range [IQR] 3-6) than for the TRUS-Bx strategy (median 6 mo, IQR 4-12; p<0.001). Limitations include the lack of data on costs associated with treatment-related complications and follow-up data., Conclusions: The mpMRI-Bx strategy is effective for diagnosing patients with a clinical suspicion of PCa and provides more accurate diagnosis, with combined diagnosis and therapy costs only moderately higher than for the standard strategy., Patient Summary: It is a matter of debate whether a diagnostic pathway that incorporates multiparametric magnetic resonance imaging (MRI) as the first-line test before performing any type of biopsy in men suspected of having prostate cancer (PCa) is cost-effective. Our analysis of the costs for men suspected of harbouring PCa revealed higher diagnostic costs for the MRI approach, with the benefits of greater diagnostic accuracy. Moreover, the combined diagnostic and treatment costs are only modestly higher whenever the same treatment for all patients is considered., (Copyright © 2018 European Association of Urology. All rights reserved.)