Search

Objectives: To compare the detection rates of overall prostate cancer (PCa) and clinically significant PCa (csPCa) and the median percentage of cancer per biopsy core between MRI-guided In-bore and MRI-TRUS fusion-targeted biopsy (TBx). Methods: In this retrospective study, 223 patients who underwent prostate multiparametric MRI (mpMRI) and subsequent MR-directed biopsy were included. For PCa and csPCa detection rate (DR), contingency tables were tested via the Pearson’s chi-squared to explore the variance of the outcome distribution. The percentage of cancer per biopsy core was tested with a two-tailed Mann-Withney test. Results: One hundred and seventeen and 106 patients underwent MRI-TRUS fusion or MRI In-bore TBx, respectively. 402 MRI biopsy targets were identified, of which 206 (51.2%) were biopsied with the MRI-TRUS TBx and 196 (48.8%) with the MRI In-bore TBx technique. Per-patient PCa and csPCa detection rates were 140/223 (62.8%) and 97/223 (43.5%), respectively. PCa-DR was 73/117 (62.4%) and 67/106 (63.2%) for MRI-TRUS and MRI In-Bore TBx (p = 0.9), while csPCa detection rate reached 50/117 (42.7%) and 47/106 (44.3%), respectively (p = 0.81). The median per-patient percentage of malignant tissue within biopsy cores was 50% (IQR: 27–65%) for PCa and 60% (IQR: 35–68%) for csPCa, with a statistically significant difference between the techniques. Conclusion No statistically significant difference in the detection rate of MRI In-bore and MRI-TRUS fusion TBx was found. MRI In-bore TBx showed higher per-core percentage of malignant cells. Advances in knowledge MRI In-bore biopsy might impact risk stratification and patient management considering the higher per-core percentage of malignant cells, especially for patients eligible for active surveillance or focal therapy.

Objectives: To compare the effect of different PSA density (PSAD) thresholds on the accuracy for clinically significant prostate cancer (csPCa) of the Prostate Imaging Reporting And Data System v.2.1 (PI-RADSv2.1). Methods: We retrospectively included 123 biopsy-naïve men who underwent multiparametric magnetic resonance imaging (mpMRI) and transperineal mpMRI-targeted and systematic prostate biopsy between April 2019 and October 2020. mpMRI, obtained on a 3.0T magnet with a PI-RADSv2.1-compliant protocol, was read by two radiologists (>1500/>500 mpMRI examinations). csPCa was defined as International Society of Urogenital Pathology grading group ≥2. Receiver operating characteristic analysis was used to calculate per-index lesion sensitivity, specificity, and area under the curve (AUC) of PI-RADSv.2.1 categories after adjusting for PSAD ≥0.10,≥0.15, and ≥0.20 ng/mL ml−1. Per-adjusted category cancer detection rate (CDR) was calculated, and decision analysis performed to compare PSAD-adjusted PI-RADSv.2.1 categories as a biopsy trigger. Results: csPCa prevalence was 43.9%. PSAD-adjustment increased the CDR of PI-RADSv2.1 category 4. Sensitivity/specificity/AUC were 92.6%/53.6%/0.82 for unadjusted PI-RADS, and 85.2%/72.4%/0.84, 62.9%/85.5%/0.83, and 92.4%/53.6%/0.82 when adjusting PI-RADS categories for a 0.10, 0.15, and 0.20 ng/ml ml−1 PSAD threshold, respectively. Triggering biopsy for PI-RADS four lesions and PSAD ≥0.10 ng/mL ml−1 was the strategy with greatest net benefit at 30 and 40% risk probability (0.307 and 0.271, respectively). Conclusions: PI-RADSv2.1 category four with PSAD ≥0.10 ng/mL ml−1 was the biopsy-triggering cut-off with the highest net benefit in the range of expected prevalence for csPCa. Advances in knowledge: 0.10 ng/mL ml−1 is the PSAD threshold with higher clinical utility in stratifying the risk for prostate cancer of PI-RADSv.2.1 categories.

OBJECTIVES (I) To determine Vesical Imaging-Reporting and Data System (VI-RADS) score 5 accuracy in predicting locally advanced bladder cancer (BCa), so as to potentially identify those patients who could avoid the morbidity of deep transurethral resection of bladder tumour (TURBT) in favour of histological sampling-TUR prior to radical cystectomy (RC). (II) To explore the predictive value of VI-RADS score 5 on time-to-cystectomy (TTC) outcomes. PATIENTS AND METHODS We retrospectively reviewed patients' ineligible or refusing cisplatin-based combination neoadjuvant chemotherapy who underwent multiparametric magnetic resonance imaging (mpMRI) of the bladder prior to staging TURBT followed by RC for muscle-invasive BCa. Sensitivity, specificity, positive and negative predictive values (PPV, NPV) were calculated for VI-RADS score 5 vs. score 2-4 cases to assess the accuracy of mpMRI for extravesical BCa detection (≥pT3). VI-RADS score performance was assessed by receiver operating characteristics curve analysis. A Κ statistic was calculated to estimate mpMRI and pathological diagnostic agreement. The risk of delayed TTC (i.e. time from initial BCa diagnosis of >3 months) was assessed using multivariable logistic regression model. RESULTS A total of 149 T2-T4a, cN0-M0 patients (VI-RADS score 5, n = 39 vs VI-RADS score 2-4, n = 110) were examined. VI-RADS score 5 demonstrated sensitivity, specificity, PPV and NPV, in detecting extravesical disease of 90.2% (95% confidence interval [CI] 84-94.3), 98.1% (95% CI 94-99.6), 94.9% (95% CI 89.6-97.6) and 96.4% (95% CI 91.6-98.6), respectively. The area under the curve was 94.2% (95% CI 88.7-99.7) and inter-reader agreement was excellent (Κinter 0.89). The mean (SD) TTC was 4.2 (2.3) and 2.8 (1.1) months for score 5 vs 2-4, respectively (P

Purpose of review Accurate staging of bladder cancer is essential to guide appropriate management. In this review, we discuss the principles, applications and performance of multiparametric MRI (mpMRI) and PET-computer tomography (PET-CT) for local and distant staging of bladder cancer. Recent findings Bladder mpMRI has a high diagnostic performance in local staging of bladder cancer, superior to other imaging modalities. It can accurately differentiate muscle invasive bladder cancer (MIBC) from non-MIBC (NMIBC), as well as ≤T2 from ≥T3 stages. mpMRI can be used to assess pelvic lymph nodes, although its sensitivity is relatively low. For the assessment of the upper urinary tract, CT urography is the imaging modality of choice. magnetic resonance urography is a viable alternative to CT in selected cases. Although PET-CT is accurate for nodal and distant staging of bladder cancer, there is no clear evidence on its superior diagnostic performance compared with contrast-enhanced CT. Summary mpMRI is the most accurate imaging modality for local staging of bladder cancer, capable to accurately distinguish MIBC from NMIBC. Nodal and distant staging relies primarily on contrast-enhanced CT.

Objectives We aimed to determine the interobserver reproducibility of the Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) criteria for magnetic resonance imaging in patients on active surveillance (AS) for prostate cancer (PCa) at two different academic centres. Methods The PRECISE criteria score the likelihood of clinically significant change over time. The system is a 1-to-5 scale, where 1 or 2 implies regression of a previously visible lesion, 3 denotes stability and 4 or 5 indicates radiological progression. A retrospective analysis of 80 patients (40 from each centre) on AS with a biopsy-confirmed low- or intermediate-risk PCa (i.e. ≤ Gleason 3 + 4 and prostate-specific antigen ≤ 20 ng/ml) and ≥ 2 prostate MR scans was performed. Two blinded radiologists reported all scans independently and scored the likelihood of radiological change (PRECISE score) from the second scan onwards. Cohen’s κ coefficients and percent agreement were computed. Results Agreement was substantial both at a per-patient and a per-scan level (κ = 0.71 and 0.61; percent agreement = 79% and 81%, respectively) for each PRECISE score. The agreement was superior (κ = 0.83 and 0.67; percent agreement = 90% and 91%, respectively) when the PRECISE scores were grouped according to the absence/presence of radiological progression (PRECISE 1–3 vs 4–5). Higher inter-reader agreement was observed for the scans performed at University College London (UCL) (κ = 0.81 vs 0.55 on a per-patient level and κ = 0.70 vs 0.48 on a per-scan level, respectively). The discrepancies between institutions were less evident for percent agreement (80% vs 78% and 86% vs 75%, respectively). Conclusions Expert radiologists achieved substantial reproducibility for the PRECISE scoring system, especially when data were pooled together according to the absence/presence of radiological progression (PRECISE 1–3 vs 4–5). Key Points • Inter-reader agreement between two experienced prostate radiologists using the PRECISE criteria was substantial. • The agreement was higher when the PRECISE scores were grouped according to the absence/presence of radiological progression (i.e. PRECISE 1–3 vs PRECISE 4 and 5). • Higher inter-reader agreement was observed for the scans performed at UCL, but the discrepancies between institutions were less evident for percent agreement.

Initial clinical and pathological diagnostic workup of urinary bladder cancer is based on cystoscopy, transurethral resection of suspicious lesions, and computed tomography when indicated. Accurate staging is necessary for further therapeutic decision-making. This review summarizes the current status of multiparametric magnetic resonance imaging (mpMRI) and the vesical imaging-reporting and data system (VI-RADS) classification. MpMRI may improve the accuracy of assessment of local tumor invasion compared to conventional imaging alone. VI-RADS standardizes reporting of MRI staging and classifies the likelihood of muscle-invasive bladder cancer into five categories. Preliminary data suggest low interobserver variability. However, prospective multicenter studies are necessary to validate the VI-RADS classification. Progress in functional, molecular, and hybrid imaging may further improve the accuracy of clinical tumor and nodal staging for bladder cancer.

The MRI of the prostate is the gold standard for the detection of clinically significant prostate cancer (csPCa). Nonetheless, MRI still misses around 11% of clinically significant disease. The aim was to comprehensively integrate tissue and circulating microRNA profiling, MRI biomarkers and clinical data to implement PCa early detection. In this prospective cohort study, 76 biopsy naïve patients underwent MRI and MRI directed biopsy. A sentinel sample of 15 patients was selected for a pilot molecular analysis. Weighted gene coexpression network analysis was applied to identify the microRNAs drivers of csPCa. MicroRNA–target gene interaction maps were constructed, and enrichment analysis performed. The ANOVA on ranks test and ROC analysis were performed for statistics. Disease status was associated with the underexpression of the miRNA profiled, a correlation was found with ADC (r = −0.51, p = 0.02) and normalized ADC values (r = −0.64, p = 0.002). The overexpression of miRNAs from plasma was associated with csPCa (r = 0.72, p = 0.02), and with PI-RADS assessment score (r = 0.73, p = 0.02), a linear correlation was found with biomarkers of diffusion and perfusion. Among the 800 profiled microRNA, eleven were identified as correlating with PCa, among which miR-548a-3p, miR-138-5p and miR-520d-3p were confirmed using the RT-qPCR approach on an additional cohort of ten subjects. ROC analysis showed an accuracy of &gt, 90%. Provided an additional validation set of the identified miRNAs on a larger cohort, we propose a diagnostic paradigm shift that sees molecular data and MRI biomarkers as the prebiopsy triage of patients at risk for PCa. This approach will allow for accurate patient allocation to biopsy, and for stratification into risk group categories, reducing overdiagnosis and overtreatment.

Purpose The aim of the study was to prospectively evaluate the agreement between chest magnetic resonance imaging (MRI) and computed tomography (CT) and to assess the diagnostic performance of chest MRI relative to that of CT during the follow-up of patients recovered from coronavirus disease 2019. Materials and methods Fifty-two patients underwent both follow-up chest CT and MRI scans, evaluated for ground-glass opacities (GGOs), consolidation, interlobular septal thickening, fibrosis, pleural indentation, vessel enlargement, bronchiolar ectasia, and changes compared to prior CT scans. DWI/ADC was evaluated for signal abnormalities suspicious for inflammation. Agreement between CT and MRI was assessed with Cohen’s k and weighted k. Measures of diagnostic accuracy of MRI were calculated. Results The agreement between CT and MRI was almost perfect for consolidation (k = 1.00) and change from prior CT (k = 0.857); substantial for predominant pattern (k = 0.764) and interlobular septal thickening (k = 0.734); and poor for GGOs (k = 0.339), fibrosis (k = 0.224), pleural indentation (k = 0.231), and vessel enlargement (k = 0.339). Meanwhile, the sensitivity of MRI was high for GGOs (1.00), interlobular septal thickening (1.00), and consolidation (1.00) but poor for fibrotic changes (0.18), pleural indentation (0.23), and vessel enlargement (0.50) and the specificity was overall high. DWI was positive in 46.0% of cases. Conclusions The agreement between MRI and CT was overall good. MRI was very sensitive for GGOs, consolidation and interlobular septal thickening and overall specific for most findings. DWI could be a reputable imaging biomarker of inflammatory activity.

Background Multiparametric MRI (mpMRI) is the "state of the art" management tool for patients with suspicion of prostate cancer (PCa). The role of non-contrast MRI is investigated to move toward a more personalized, less invasive, and highly cost-effective PCa diagnostic workup. Objective To perform a non-systematic review of the existing literature to highlight strength and flaws of performing non-contrast MRI, and to provide a critical overview of the international scientific production on the topic. Materials and methods Online databases (Medline, PubMed, and Web of Science) were searched for original articles, systematic review and meta-analysis, and expert opinion papers. Results Several investigations have shown comparable diagnostic accuracy of biparametric (bpMRI) and mpMRI for the detection of PCa. The advantage of abandoning contrast-enhanced sequences improves operational logistics, lowering costs, acquisition time, and side effects. The main limitations of bpMRI are that most studies comparing non-contrast with contrast MRI come from centers with high expertise that might not be reproducible in the general community setting; besides, reduced protocols might be insufficient for estimation of the intra- and extra-prostatic extension and regional disease. The mentioned observations suggest that low-quality mpMRI for the general population might represent the main shortage to overcome. Discussion Non-contrast MRI future trends are likely represented by PCa screening and the application of artificial intelligence (AI) tools. PCa screening is still a controversial topic; bpMRI has become one of the most promising diagnostic applications, as it is a more sensitive test for PCa early detection, compared to serum PSA level test. Also, AI applications and radiomic have been the object of several studies investigating PCa detection using bpMRI, showing encouraging results. Conclusion Today, the accessibility to MRI for early detection of PCa is a priority. Results from prospective, multicenter, multireader, and paired validation studies are needed to provide evidence supporting its role in the clinical practice.

The Vesical Imaging-Reporting and Data System (VI-RADS) has been introduced to provide preoperative bladder cancer staging and has proved to be reliable in assessing the presence of muscle invasion in the pre-TURBT (trans-urethral resection of bladder tumor). We aimed to assess through a systematic review and meta-analysis the inter-reader variability of VI-RADS criteria for discriminating non-muscle vs. muscle invasive bladder cancer (NMIBC, MIBC). PubMed, Web of Science, Cochrane, and Embase were searched up until 30 July 2020. The Quality Appraisal of Diagnostic Reliability (QAREL) checklist was utilized to assess the quality of included studies and a pooled measure of inter-rater reliability (Cohen&rsquo, s Kappa [&kappa, ] and/or Intraclass correlation coefficients (ICCs)) was calculated. Further sensitivity analysis, subgroup analysis, and meta-regression were conducted to investigate the contribution of moderators to heterogeneity. In total, eight studies between 2018 and 2020, which evaluated a total of 1016 patients via 21 interpreting genitourinary (GU) radiologists, met inclusion criteria and were critically examined. No study was considered to be significantly flawed with publication bias. The pooled weighted mean &kappa, estimate was 0.83 (95%CI: 0.78&ndash, 0.88). Heterogeneity was present among the studies (Q = 185.92, d.f. = 7, p &lt, 0.001, I2 = 92.7%). Meta-regression analyses showed that the relative % of MIBC diagnosis and cumulative reader&rsquo, s experience to influence the estimated outcome (Coeff: 0.019, SE: 0.007, p= 0.003 and 0.036, SE: 0.009, p = 0.001). In the present study, we confirm excellent pooled inter-reader agreement of VI-RADS to discriminate NMIBC from MIBC underlying the importance that standardization and reproducibility of VI-RADS may confer to multiparametric magnetic resonance (mpMRI) for preoperative BCa staging.

Accurate staging of bladder cancer (BC) is critical, with local tumor staging directly influencing management decisions and affecting prognosis. However, clinical staging based on clinical examination, including cystoscopy and transurethral resection of bladder tumor (TURBT), often understages patients compared to final pathology at radical cystectomy and lymph node (LN) dissection, mainly due to underestimation of the depth of local invasion and the presence of LN metastasis. MRI has now become established as the modality of choice for the local staging of BC and can be additionally utilized for the assessment of regional LN involvement and tumor spread to the pelvic bones and upper urinary tract (UUT). The recent development of the Vesical Imaging-Reporting and Data System (VI-RADS) recommendations has led to further improvements in bladder MRI, enabling standardization of image acquisition and reporting. Multiparametric magnetic resonance imaging (mpMRI) incorporating morphological and functional imaging has been proven to further improve the accuracy of primary and recurrent tumor detection and local staging, and has shown promise in predicting tumor aggressiveness and monitoring response to therapy. These sequences can also be utilized to perform radiomics, which has shown encouraging initial results in predicting BC grade and local stage. In this article, the current state of evidence supporting MRI in local, regional, and distant staging in patients with BC is reviewed. LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY STAGE: 2 J. Magn. Reson. Imaging 2020;52:649-667.

Up to date, screening for prostate cancer (PCa) remains one of the most appealing but also a very controversial topics in the urological community. PCa is the second most common cancer in men worldwide and it is universally acknowledged as a complex disease, with a multi-factorial etiology. The pathway of PCa diagnosis has changed dramatically in the last few years, with the multiparametric magnetic resonance (mpMRI) playing a starring role with the introduction of the “MRI Pathway”. In this scenario the basic tenet of network medicine (NM) that sees the disease as perturbation of a network of interconnected molecules and pathways, seems to fit perfectly with the challenges that PCa early detection must face to advance towards a more reliable technique. Integration of tests on body fluids, tissue samples, grading/staging classification, physiological parameters, MR multiparametric imaging and molecular profiling technologies must be integrated in a broader vision of “disease” and its complexity with a focus on early signs. PCa screening research can greatly benefit from NM vision since it provides a sound interpretation of data and a common language, facilitating exchange of ideas between clinicians and data analysts for exploring new research pathways in a rational, highly reliable, and reproducible way.

Purpose The PRECISE score estimates the likelihood of radiological progression in patients on active surveillance (AS) for prostate cancer (PCa) with serial multiparametric magnetic resonance imaging (mpMRI). A PRECISE score of 1 or 2 denotes radiological regression, PRECISE 3 indicates stability and PRECISE 4 or 5 implies progression. We evaluated the inter-reader reproducibility of different apparent diffusion coefficient (ADC) calculations and their relationship to the PRECISE score. Material and methods Baseline and follow-up scans (on the same MR systems) of 30 patients with visible lesions from two different institutions (University College London and Sapienza University of Rome) were analysed by two radiologists (one from each site). The PRECISE score was initially assessed in consensus. At least six weeks later, to reduce the likelihood of being influenced by the consensus PRECISE reading, each radiologist independently calculated ADC for the following: lesion, non-cancerous tissue and urine in the bladder. Normalised ADC ratios were calculated with respect to normal prostatic tissue (npADC) and urine. Spearman's correlation (ρ), intraclass correlation coefficients (ICC), differences in ADC and ROC curves were computed. Results Interobserver reproducibility was very good (ρ > 0.8; ICC > 0.90). Lesion ADC (0.91 vs 0.73 × 10−3 mm2/s; p=0.025) and npADC ratio (0.68 vs 0.53; p=0.012) at follow-up mpMRI were different between patients with radiological regression or stability vs progression. Cut-offs of 0.77 × 10−3 mm2/s (lesion ADC) and 0.59 (npADC ratio) could differentiate the two groups (area under the curve: 0.74 and 0.77, respectively). Conclusion The ADC, npADC ratio and the PRECISE score should be recorded for MRI-based AS.

Background Vesical Imaging Reporting and Data System (VI-RADS) score is adopted to provide preoperative bladder cancer (BCa) staging. Repeated transurethral resection of bladder tumor (Re-TURBT) is recommended in most of high-risk non–muscle-invasive bladder cancers (HR-NMIBCs) due to possibility of persistent/understaged disease after initial TURBT. No diagnostic tools able to improve patient’s stratification for such recommendation exist. Objective To (1) prospectively validate VI-RADS for discriminating between NMIBC and muscle-invasive bladder cancer (MIBC) at TURBT, and (2) evaluate the accuracy of VI-RADS for identifying HR-NMIBC patients who could avoid Re-TURBT and detecting those at higher risk for understaging after TURBT. Design, setting, and participants Patients with BCa suspicion were offered multiparametric magnetic resonance imaging (mpMRI) before TURBT. According to VI-RADS, a cutoff of ≥3 to define MIBC was assumed. TURBT reports were compared with preoperative VI-RADS scores to assess accuracy of mpMRI for discriminating between NMIBC and MIBC. HR-NMIBC Re-TURBT reports were compared with preoperatively recorded VI-RADS scores to assess mpMRI accuracy in predicting Re-TURBT outcomes. Intervention Multiparametric MRI of the bladder before TURBT. Outcome measurements and statistical analysis Sensitivity, specificity, positive (PPV) and negative (NPV) predictive values were calculated for mpMRI performance in patients undergoing TURBT and for HR-NMIBC patients candidate for Re-TURBT. Performance of mpMRI was assessed by receiver operating characteristic curve analysis. Ƙ statistics was used to estimate inter- and intrareader variability. Results and limitations A total of 231 patients were enrolled. Multiparametric MRI showed sensitivity, specificity, PPV, and NPV for discriminating NMIBC from MIBC at initial TURBT of 91.9% (95% confidence interval [CI]: 82.2–97.3), 91.1% (95% CI: 85.8–94.9), 77.5% (95% CI: 65.8–86.7), and 97.1% (95% CI: 93.3–99.1), respectively. The area under the curve (AUC) was 0.94 (95% CI: 0.91–0.97). Among HR-NMIBC patients (n = 114), mpMRI before TURBT showed sensitivity, specificity, PPV, and NPV of 85% (95% CI: 62.1–96.8), 93.6% (95% CI: 86.6–97.6), 74.5% (95% CI: 52.4–90.1), and 96.6% (95% CI: 90.5–99.3) respectively, to identify patients with MIBC at Re-TURBT. The AUC was 0.93 (95% CI: 0.87–0.97). Conclusions VI-RADS is accurate for discriminating between NMIBC and MIBC. Within HR-NMIBC cases, VI-RADS could, in future, improve the selection of patients who are candidate for Re-TURBT. Patient summary We investigated the accuracy of Vesical Imaging Reporting and Data System (VI-RADS) score to asses bladder cancer staging before transurethral resection of bladder tumors, and we explored the performance of VI-RADS score as a future preoperative predictive tool for the selection of high-risk non–muscle-invasive bladder cancer patients who are candidate for undergoing early repeated transurethral resection of the primary tumor site.

Bladder cancer (BCa) is among the ten most frequent cancers globally. It is the tumor with the highest lifetime treatment-associated costs, and among the tumors with the heaviest impacts on postoperative quality of life. The purpose of this article is to review the current applications and future perspectives of the Vesical Imaging Reporting and Data System (VI-RADS). VI-RADS is a newly developed scoring system aimed at standardization of MRI acquisition, interpretation, and reporting for BCa. An insight will be given on the BCa natural history, current MRI applications for local BCa staging with assessment of muscle invasiveness, and clinical implications of the score for disease management. Future applications include risk stratification of nonmuscle invasive BCa, surveillance, and prediction and monitoring of therapy response. LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY STAGE: 2.

OBJECTIVE. The purpose of this article is to review the natural history and management of bladder cancer, with insight into MRI applications for the assessment of muscle invasiveness of bladder cancer using the newly developed Vesical Imaging Reporting and Data System (VI-RADS) score. CONCLUSION. Multiparametric MRI and the VI-RADS score have been consistently validated across several different institutions as appropriate tools for local staging of bladder cancer and have been proven to contribute to the diagnostic workup and management of urinary bladder cancer.

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 >4 ng/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 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.

The aim of this study was to validate the role of MR/Ultrasound Fusion-Guided Targeted Biopsy as a first diagnostic modality in subjects with clinical suspicion of prostate cancer (PCa).108 men (age range 46-78 years) with clinical suspicion for PCa (PSA 4 ng/mL) underwent multiparametric MRI of the prostate (mpMRI) and, when suspicious lesion were found (according to the PIRADSv2 scoring system), targeted biopsy was performed. All patients without significant alteration patterns at mpMRI have been referred for follow-up at 1 year.91/108 patients showed on the mpMRI highly suspicious lesions (PIRADS 4 and 5); the remaining 17/108 patients revealed no significant alteration consistent with PCa (PIRADS 3). Among the first group of patients, 58/91 proved to be positive for PCa on the pathology report: 24 patients had a Gleason Score (GS) 6 (3 + 3); 18 patients GS 7 of which 7 (3 + 4) and 11 (4 + 3); 14 patients GS 8 (4 + 4); two patients GS 9 (5 + 4); 33 proved to be negative. Overall cancer detection rate (CDR) was 63%. However, the CDR rises significantly, up to 77%, after the 53 initial consecutive biopsies that were performed (p 0,05) and thus identified as part of the learning curve. Patients of the second group (17/108) have been followed with serial PSA assessments, clinical reevaluation, and follow-up mpMRI.Performing exclusively targeted MR/Ultrasound Fusion-Guided biopsies for the diagnosis of PCa in patients with suspicious PSA levels ( 4 ng/mL) increases the detection rate of clinically significant cancer, changing both the therapeutic options and the prognosis.

To validate a novel consensus method, called target-in-target, combining human analysis of mpMRI with automated CAD system analysis, with the aim to increasing the prostate cancer detection rate of targeted biopsies. A cohort of 420 patients was enrolled and 253 patients were rolled out, due to exclusion criteria. 167 patients, underwent diagnostic 3T MpMRI. Two expert radiologists evaluated the exams adopting PI-RADSv2 and CAD system. When a CAD target overlapped with a radiologic one, we performed the biopsy in the overlapping area which we defined as target-in-target. Targeted TRUS-MRI fusion biopsy was performed in 63 patients with a total of 212 targets. The MRI data of all targets were quantitatively analyzed, and diagnostic findings were compared to pathologist’s biopsy reports. CAD system diagnostic performance exhibited sensitivity and specificity scores of 55.2% and 74.1% [AUC = 0.63 (0.54 ÷ 0.71)] , respectively. Human readers achieved an AUC value, in ROC analysis, of 0.71 (0.63 ÷ 0.79). The target-in-target method provided a detection rate per targeted biopsy core of 81.8 % vs. a detection rate per targeted biopsy core of 68.6 % for pure PI-RADS based on target definitions. The higher per-core detection rate of the target-in-target approach was achieved irrespective of the presence of technical flaws and artifacts. A novel consensus method combining human reader evaluation with automated CAD system analysis of mpMRI to define prostate biopsy targets was shown to improve the detection rate per biopsy core of TRUS-MRI fusion biopsies. Results suggest that the combination of CAD system analysis and human reader evaluation is a winning strategy to improve targeted biopsy efficiency.

In the original publication of the article, the first and last names of the second author were interchanged.