scholarly journals Diagnostic accuracy of the Novel 29 MHz micro-ultrasound “ExactVuTM” for the detection of clinically significant prostate cancer: A prospective single institutional study. A step forward in the diagnosis of prostate cancer

2021 ◽  
Vol 93 (2) ◽  
pp. 132-138
Author(s):  
Francesco Chessa ◽  
Riccardo Schiavina ◽  
Amelio Ercolino ◽  
Caterina Gaudiano ◽  
Davide Giusti ◽  
...  

Introduction and Objective: ExactVuTM is a real-time micro-ultrasound system which provides, according to the Prostate Risk Identification Using Micro-Ultrasound protocol (PRI-MUS), a 300% higher resolution compared to conventional transrectal ultrasound. To evaluate the performance of ExactVuTM in the detection of Clinically significant Prostate Cancer (CsPCa). Materials and methods: Patients with Prostate Cancer diagnosed at fusion biopsy were imaged with ExactVuTM. CsPCa was defined as any Gleason Score ≥ 3+4. ExactVuTM examination was considered as positive when PRI-MUS score was ≥ 3. PRI-MUS scoring system was considered as correct when the fusion biopsy was positive for CsPCa. A transrectal fusion biopsy- proven CsPCa was considered as a gold standard. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and area under the receiver operator characteristic (ROC) curve (AUC) were calculated. Results: 57 patients out of 68 (84%) had a csPCa. PRI-MUS score was correctly assessed in 68% of cases. Regarding the detection of CsPCa, ExactVuTM ’s sensitivity, specificity, PPV, and NPV was 68%, 73%, 93%, and 31%, respectively and the AUC was 0.7 (95% CI 0.5-0-8). For detecting CsPCa in the transition/ anterior zone the sensitivity, specificity, PPV, and NPV was 45%, 66%, 83% and 25% respectively ant the AUC was 0.5 (95% CI 0.2-0.9). Accounting only the CsPCa located in the peripheral zone, sensitivity, specificity, PPV, and NPV raised up to 74%, 75%, 94%, 33%, respectively with AUC 0.75 (95% CI 0.5-0-9). Conclusions: ExactVuTM provides high resolution of the prostatic peripheral zone and could represent a step forward in the detection of CsPCa as a triage tool. Further studies are needed to confirm these promising results.

Cancers ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1064 ◽  
Author(s):  
Sebastian Chakrit Bhakdi ◽  
Prapat Suriyaphol ◽  
Ponpan Thaicharoen ◽  
Sebastian Tobias Karl Grote ◽  
Chulaluk Komoltri ◽  
...  

Even though more than 350,000 men die from prostate cancer every year, broad-based screening for the disease remains a controversial topic. Guidelines demand that the only commonly accepted screening tool, prostate-specific antigen (PSA) testing, must be followed by prostate biopsy if results are elevated. Due to the procedure’s low positive predictive value (PPV), however, over 80% of biopsies are performed on healthy men or men with clinically insignificant cancer—prompting calls for new ways of vetting equivocal PSA readings prior to the procedure. Responding to the challenge, the present study investigated the diagnostic potential of tumour-associated circulating endothelial cells (tCECs), which have previously been described as a novel, blood-based biomarker for clinically significant cancers. Specifically, the objective was to determine the diagnostic accuracy of a tCEC-based blood test to detect clinically significant prostate cancer (defined as Gleason score ≥ 3 + 4) in high-risk patients. Performed in a blinded, prospective, single-centre set-up, it compared a novel tCEC index test with transrectal ultrasound-guided biopsy biopsy as a reference on a total of 170 patients and found that a tCEC add-on test will almost double the PPV of a standalone PSA test (32% vs. 17%; p = 0.0012), while retaining a negative predictive value above 90%.


2016 ◽  
Vol 88 (4) ◽  
pp. 292 ◽  
Author(s):  
Andrea B. Galosi ◽  
Guevar Maselli ◽  
Giulia Sbrollini ◽  
Gaetano Donatelli ◽  
Lorenzo Montesi ◽  
...  

We describe our experience in prostate biopsy using a new standardized cognitive fusion techniques, that we call “cognitive zonal fusion biopsy”. This new technique is based on two operative options: the first based on target biopsies, the Cognitive Target Biopsy (CTB) if the same target was detected with transrectal ultrasound (TRUS) and multiparametric magnetic resonance (mpMRI); the second based on saturation biopsies, the Zonal Saturation Biopsy (ZSB) on anatomical zone/s containing the region of interest if the same target was not evident with TRUS and MRI. We evaluated results of our technique compared to standard biopsy in order to identify clinically relevant prostate cancer. Methods: This is a single-center prospective study conducted in 58 pts: 25 biopsy-naïve, 25 with previous negative biopsy and in 8 with cancer in active surveillance. Based on mpMRI and transrectal ultrasonography (TRUS), all patients were scheduled for standard 12-core TRUS-guided biopsy. If mpMRI was suggestive or positive (PI-RADS 3, 4 or 5): patients underwent additional targeted 2 to 6 cores using cognitive zonal fusion technique. Results: 31/58 (53.4%) patients had a cancer. Our technique detected 80.6% (25 of 31) with clinically significant prostate cancer, leading to detection of insignificant cancer in 20%. Using standard mapping in MR negative areas we found 5 clinically significant cancer and 4 not significant cancers. MRI cancer detection rate was 18/31 (58.1%), and 9/18 (50%) in high grade tumors. Therefore MRI missed 50% of high grade cancers. The mean number of cores taken with cognitive zonal fusion biopsy was 6.1 (2-17), in addition biopsy sampling was done outside the ROI areas. Overall 15.4 cores (12-22) were taken. Cancer amount in Zonal Biopsy was larger than 7.3 mm (1-54.5) in comparison with 5.2 mm (1-23.5) in standard mapping. Largest percentage of cancer involvement with cognitive zonal fusion technique was detected in 19.4% vs 15.9%. Conclusions: Cognitive Zonal Saturation Biopsies should be used to reduce operator variability of cognitive fusion biopsy in addition to standard biopsy. Cognitive zonal biopsy based on mpMRI findings identifies clinically relevant prostate in 80%, has larger cancer extension in fusion biopsies than in random biopsies, and reduce the number of cores if compared to saturation biopsy.


2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 51-51
Author(s):  
Michele Fascelli ◽  
Rachael Sussman ◽  
Thomas P Frye ◽  
Arvin Koruthu George ◽  
Steven Abboud ◽  
...  

51 Background: Multiparametric MRI (mpMRI) has been shown to improve clinically significant prostate cancer (CaP) detection. Targeted biopsy using MRI/transrectal ultrasonography (TRUS) fusion is a novel diagnostic tool. The negative predictive value (NPV) of an MRI/TRUS fusion targeted biopsy of a suspicious lesion on mpMRI was determined. Methods: 30 of 181 men who underwent prostatectomy from 2008-2014 were retrospectively identified and had at least one lesion on mpMRI negative for cancer on MRI/TRUS fusion biopsy. Whole mount pathology specimens, gold standard for CaP detection, were aligned with MRI to assess true histopathology of all identified targets. Lesions negative for CaP on biopsy and not identified as cancer on pathology were considered true negatives (TN). Lesions biopsied negative but later found to possess foci of CaP on whole mount were considered false negatives (FN). Calculations of NPV were then made per biopsy year, MRI suspicion score, and lesion size on MRI. Results: 48 lesions of a total 81 identified on mpMRI were reported negative for CaP in the 30 patients who underwent fusion biopsy. Of these, 37 lesions were found to be truly negative on histopathology, while 11 lesions had CaP foci on whole mount specimen. Overall NPV was 77% (37/48). The NPV increased over time (Table 1), and was as high as 85.7% most recently. Conclusions: This series demonstrated a NPV of 77% for targeted MRI/TRUS fusion biopsy of lesions seen on mpMRI. The increasing NPV trend noted over time may have further applications to assess the learning curve for this diagnostic method. Not surprisingly, NPV is higher for low and moderately suspicious lesions than for highly suspicious lesions. This data may help physicians interpret the clinical implications of a negative fusion biopsy. [Table: see text]


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Madhuri Monique Rudolph ◽  
Alexander Daniel Jacques Baur ◽  
Hannes Cash ◽  
Matthias Haas ◽  
Samy Mahjoub ◽  
...  

Abstract The purpose of this study is to compare diagnostic performance of Prostate Imaging Reporting and Data System (PI-RADS) version (v) 2.1 and 2.0 for detection of Gleason Score (GS) ≥ 7 prostate cancer on MRI. Three experienced radiologists provided PI-RADS v2.0 scores and at least 12 months later v2.1 scores on lesions in 333 prostate MRI examinations acquired between 2012 and 2015. Diagnostic performance was assessed retrospectively by using MRI/transrectal ultrasound fusion biopsy and 10-core systematic biopsy as the reference. From a total of 359 lesions, GS ≥ 7 tumor was present in 135 lesions (37.60%). Area under the ROC curve (AUC) revealed slightly lower values for peripheral zone (PZ) and transition zone (TZ) scoring in v2.1, but these differences did not reach statistical significance. A significant number of score 2 lesions in the TZ were downgraded to score 1 in v2.1 showing 0% GS ≥ 7 tumor (0/11). The newly introduced diffusion-weighted imaging (DWI) upgrading rule in v2.1 was applied in 6 lesions from a total of 143 TZ lesions (4.2%). In summary, PI-RADS v2.1 showed no statistically significant differences in overall diagnostic performance of TZ and PZ scoring compared to v2.0. Downgraded BPH nodules showed favorable cancer frequencies. The new DWI upgrading rule for TZ lesions was applied in only few cases.


2019 ◽  
pp. 100-108
Author(s):  
A. V. Vasilev ◽  
A. V. Mishchenko ◽  
R. A. Kadyrleev ◽  
A. S. Petrova ◽  
A. K. Nosov ◽  
...  

Purpose. To evaluate the effectiveness of prostate cancer detection with method of cognitive mpMRI/TRUS fusion biopsy using strain sonoelastography.Materials and methods. Cognitive transrectal fusion biopsy of prostate was performed in 32 patients. According to the data of a preliminary conducted mpMRI, 33 foci suspicious of prostate cancer were included (PIRADSv2 = 3–5). Before the biopsy, all patients underwent ultrasound planning using compression sonoelastography.Results. The overall sensitivity was 76% for the targeted biopsy, and 49% for systematic biopsy. The number of biopsy specimens with a clinically significant Gleason grade in the targeted biopsy group was 85% of all columns with cancer specimens, in the systematic biopsy group this number was 68%. On average, the Gleason grade after targeted biopsy was 7.5 ± 0.9, and it was 7.2 ± 0.9 in the columns after systematic biopsy. On average, the percentage of tumor in the columns after targeted biopsy was 72% ± 29% and it was 55% ± 35% in the columns after systematic biopsy. The false positive for mpMRI was 15%. The overall sensitivity for the strain sonoelastography was 69% in this study, clinically significant cancer was detected in 71% of all columns with cancer specimens. False positive for elastography was observed in 18% of cases.Conclusion. Comparing with systematic biopsy, cognitive mpMRI / TRUS fusion biopsy can improve the detection rate of clinically significant prostate cancer and reduce the number of detected cases of clinically insignificant cancer. In cases of a total or subtotal tumor lesion in the peripheral zone detected on mpMRI, it is possible to take fewer columns for morphological verification of the tumor. The use of compression sonoelastography as an additional parameter of navigation in cognitive mpMRI/TRUS fusion biopsy can be considered as a promising way to increase the detection rate of clinically significant prostate cancer.


2021 ◽  
pp. 20210509
Author(s):  
Chau Hung Lee ◽  
Balamurugan Vellayappan ◽  
Cher Heng Tan

Objectives: To perform a systematic review and meta-analysis comparing diagnostic performance and inter reader agreement between PI-RADS v. 2.1 and PI-RADS v. 2 in the detection of clinically significant prostate cancer (csPCa). Methods: A systematic review was performed, searching the major biomedical databases (Medline, Embase, Scopus), using the keywords “PIRADS 2.1” or “PI RADS 2.1” or “PI-RADS 2.1”. Studies reporting on head-to-head diagnostic comparison between PI-RADS v. 2.1 and v. 2 were included. Pooled sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were compared between PI-RADS v. 2.1 and v. 2. Summary receiver operator characteristic graphs were plotted. Analysis was performed for whole gland, and pre-planned subgroup analysis was performed by tumour location (whole gland vs transition zone (TZ)), high b-value DWI (b-value ≥1400 s/mm2), and reader experience (<5 years vs ≥5 years with prostate MRI interpretation). Inter-reader agreement and pooled rates of csPCa for PI-RADS 1–3 lesions were compared between PI-RADS v. 2.1 and v. 2. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies tool v. 2 (QUADAS-2). Results: Eight studies (1836 patients, 1921 lesions) were included. Pooled specificity for PI-RADS v. 2.1 was significantly lower than PI-RADS v. 2 for whole gland (0.62 vs 0.66, p = 0.02). Pooled sensitivities, PPVs and NPVs were not significantly different (p = 0.17, 0.31, 0.41). Pooled specificity for PI-RADS v. 2.1 was significantly lower than PI-RADS v. 2 for TZ only (0.67 vs 0.72, p = 0.01). Pooled sensitivities, PPVs and NPVs were not significantly different (p = 0.06, 0.36, 0.17). Amongst studies utilising diffusion-weighted imaging with highest b-value of ≥1400 s/mm2, pooled sensitivities, specificities, PPVs and NPVs were not significantly different (p = 0.52, 0.4, 0.5, 0.47). There were no significant differences in pooled sensitivities, specificities, PPVs and NPVs between PI-RADS v. 2.1 and PI-RADS v. 2 for less-experienced readers (p = 0.65, 0.37, 0.65, 0.81) and for more experienced readers (p = 0.57, 0.90, 0.91, 0.65). For PI-RADS v. 2.1 alone, there were no significant differences in pooled sensitivity, specificity, PPV and NPV between less and more experienced readers (p = 0.38, 0.70, 1, 0.48). Inter-reader agreement was moderate to substantial for both PI-RADS v. 2.1 and v. 2. There were no significant differences between pooled csPCa rates between PI-RADS v. 2.1 and v. 2 for PI-RADS 1–2 lesions (6.6% vs  7.3%, p = 0.53), or PI-RADS 3 lesions (24.1% vs  26.8%, p = 0.28). Conclusions: Diagnostic performance and inter-reader agreement for PI-RADS v. 2.1 is comparable to PI-RADS v. 2, however the significantly lower specificity of PI-RADS v. 2.1 may result in increased number of unnecessary biopsies. Advances in knowledge: 1. Compared to PI-RADS v. 2, PI-RADS v. 2.1 has a non-significantly higher sensitivity but a significantly lower specificity for detection of clinically significant prostate cancer. 2. PI-RADS v. 2.1 could potentially result in considerable increase in number of negative targeted biopsy rates for PI-RADS 3 lesions, which could have been potentially avoided.


2020 ◽  
Vol 30 (11) ◽  
pp. 6042-6051 ◽  
Author(s):  
T. Ullrich ◽  
C. Arsov ◽  
M. Quentin ◽  
F. Mones ◽  
A. C. Westphalen ◽  
...  

Abstract Objectives To assess the ability of multiparametric MRI (mp-MRI) of the prostate to exclude prostate cancer (PCa) progression during monitoring patients on active surveillance (AS). Methods One hundred forty-seven consecutive patients on AS with mp-MRI (T2WI, DWI, DCE-MRI) at 3T were initially enrolled. Fifty-five received follow-up mp-MRI after a minimum interval of 12 months and subsequent targeted MR/US fusion-guided biopsy (FUS-GB) plus concurrent systematic transrectal ultrasound-guided (TRUS-GB) biopsy as reference standard. Primary endpoint was the negative predictive value (NPV) of the follow-up mp-MRI to exclude histopathologic tumor progression using PRECISE recommendations. Secondary endpoints were the positive predictive value (PPV), sensitivity, specificity, Gleason score (GS) upgrades, and comparison of biopsy method. Results Of 55 patients, 29 (53%) had a GS upgrade on re-biopsy. All 29 patients showed a tumor progression on follow-up mp-MRI. Fifteen of 55 patients (27%) displayed signs of tumor progression, but had stable GS on re-biopsy. None of the 11 patients (20%) without signs of progression on follow-up mp-MRI had a GS upgrade on re-biopsy. The NPV was 100%, PPV was 66%, sensitivity was 100%, and specificity 42%. FUS-GB resulted in GS upgrade significantly more often (n = 28; 51%) compared with TRUS-GB (n = 12; 22%; p < 0.001). Conclusions (Follow-up) Mp-MRI can reliably exclude PCa progression in patients on AS. Standard serial re-biopsies might be waived if follow-up mp-MRIs are stable. Over 60% of patients with signs of tumor progression on mp-MRI during AS had a GS upgrade on re-biopsy. Targeted re-biopsies should be performed if cancer progression or higher-grade PCa is suspected on mp-MRI. Key Points • None of the patients with unsuspicious mp-MRI had a GS upgrade in re-biopsy and mp-MRI might replace serial biopsies in these cases • More than 60% of patients with mp-MRI signs of tumor progression had subsequent Gleason score (GS) upgrades • Targeted re-biopsies should be performed in case of higher GS cancer suspicion on mp-MRI


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