In-bore Biopsy Research Articles

Editorial Comment to "Can the Briganti 2019 nomogram be modified to predict lymph node metastasis risk in patients with prostate cancer detected with in-bore biopsy?"

Editorial Comment to "Can the Briganti 2019 nomogram be modified to predict lymph node metastasis risk in patients with prostate cancer detected with in-bore biopsy?"

Can the Briganti 2019 nomogram be modified to predict lymph node metastasis risk in patients with prostate cancer detected with in-bore biopsy?

We aimed to modify the Briganti 2019 nomogram and to test whether it is valid for patients who were diagnosed with prostate cancer through in-bore prostate biopsies. Data for 204 patients with positive multiparametric prostate MRI and prostate cancer identified either by mpMRI-cognitive/software fusion or in-bore biopsy and who underwent robot-assisted radical prostatectomy and extended pelvic lymph node dissection between 2012 and 2023 were retrospectively analyzed. The Briganti 2019 nomogram was applied to the mpMRI-cognitive/software fusion biopsy group (142 patients) in the original form, and then, two modifications were tested for the targeted component. Original and modified scores were compared. These modifications were adapted for the in-bore biopsy group (62 patients). The final histopathologic stage was regarded as the gold standard. Nodal metastases were identified in 18/142 (12.6%) of mpMRI-cognitive/software fusion biopsy patients and 8/62 (12.9%) of the in-bore biopsy patients. In the mpMRI-cognitive/software fusion biopsy group, tumor size/core size (%) of targeted biopsy cores and positive core percentage on systematic biopsy were significant parameters for lymph node metastasis based on univariate logistic regression analyses (p < 0.05). With the modifications of these parameters for the in-bore biopsy group, V1 modification of the Briganti 2019 nomogram provided 100% sensitivity and 31.5% specificity (AUC:0.627), while V2 modification provided 75% sensitivity and 46.3% specificity (AUC:0.645). Briganti 2019 nomogram may be modified by utilizing tumor size/core size (%) for targeted biopsy cores instead of positive core percentage on systematic biopsy or by not taking both parameters into consideration to detect node metastasis risk of patients diagnosed with in-bore biopsies.

Targeted biopsy of the prostate.

Diagnostic multiparametric MRI of the prostate has steadily evolved over the last three decades and can now reliably depict the dominant tumor in most men with prostate cancer. In response, several methods of targeted biopsy to direct tissue sampling of suspected tumor foci seen at multiparametric MRI have been developed and successfully tested in recent years, including software-assisted MRI-ultrasound (US) fusion biopsy and direct MRI-guided in-bore biopsy. These advances are leading to a sea change in the approach to prostate cancer diagnosis, with the traditional approach of blind systematic biopsy increasingly being replaced by MRI directed targeted biopsy. This review aims to describe the current status of targeted biopsy, with an emphasis on the relative accuracy of different techniques. The results of several critical large multicenter trials are presented, while unanswered questions that require more research are highlighted.

MRI-guided in-bore biopsy of the prostate – defining the optimal number of cores needed

BackgroundNumerous studies have shown that magnetic resonance imaging (MRI)-targeted biopsy approaches are superior to traditional systematic transrectal ultrasound guided biopsy (TRUS-Bx). The optimal number of biopsy cores to be obtained per lesion identified on multiparametric MRI (mpMRI) images, however, remains a matter of debate. The aim of this study was to evaluate the incremental value of additional biopsy cores in an MRI-targeted “in-bore”-biopsy (MRI-Bx) setting.Patients and methodsTwo hundred and forty-five patients, who underwent MRI-Bx between June 2014 and September 2021, were included in this retrospective single-center analysis. All lesions were biopsied with at least five biopsy cores and cumulative detection rates for any cancer (PCa) as well as detection rates of clinically significant cancers (csPCa) were calculated for each sequentially labeled biopsy core. The cumulative per-core detection rates are presented as whole numbers and as proportion of the maximum detection rate reached, when all biopsy cores were considered. CsPCa was defined as Gleason Score (GS) ≥ 7 (3 + 4).ResultsOne hundred and thirty-two of 245 Patients (53.9%) were diagnosed with prostate cancer and csPCa was found in 64 (26.1%) patients. The first biopsy core revealed csPCa/ PCa in 76.6% (49/64)/ 81.8% (108/132) of cases. The second, third and fourth core found csPCa/ PCa not detected by previous cores in 10.9% (7/64)/ 8.3% (11/132), 7.8% (5/64)/ 5.3% (7/132) and 3.1% (2/64)/ 3% (4/132) of cases, respectively. Obtaining one or more cores beyond the fourth biopsy core resulted in an increase in detection rate of 1.6% (1/64)/ 1.5% (2/132).ConclusionWe found that obtaining five cores per lesion maximized detection rates. If, however, future research should establish a clear link between the incidence of serious complications and the number of biopsy cores obtained, a three-core biopsy might suffice as our results suggest that about 95% of all csPCa are detected by the first three cores.

Natural history of histologically benign PIRADS 4-5 lesions in multiparametric MRI: Real-life experience in an academic center.

The follow-up findings of patients who underwent prostate biopsy for prostate image reporting and data system (PIRADS) 4 or 5 multiparametric magnetic resonance imaging (mpMRI) findings and had benign histology were retrospectively reviewed. There were 190 biopsy-naive patients. Patients with at least 12 months of follow-up between 2012 and 2023 were evaluated. All MRIs were interpreted by two very experienced uroradiologists. Of the patients, 125 had either cognitive or software fusion MR-targeted biopsies with 4 + 8/10 cores. The remaining 65 patients had in-bore biopsies with 4-5 cores. Prostate-specific antigen (PSA) levels below 4 ng/mL were defined as PSA regression following biopsy. PIRADS 1-3 lesions on new MRI images were classified as MRI regression. Median patient age and PSA were 62 (39-82) years and six (0.4-33) ng/mL, respectively, at the initial work-up. During a median follow-up period of 44 months, 37 (19.4%) patients were lost to follow-up. Of the remaining 153 patients, 82 (53.6%) had persistently high PSA. Among them, 72 (87.8%) had repeat mpMRI within 6-24 months which showed regressive findings (PIRADS 1-3) in 53 patients (73.6%) and PIRADS 4-5 index lesion persistence in 19 cases (26.4%). The latter group was recommended to have rebiopsy. Of these 19 patients, 16 underwent MRI-targeted rebiopsy. Prostate cancer was diagnosed in six (37.5%) patients and of these four (25%) were clinically significant (>Grade Group 1). Totally, clinically significant prostate cancer was detected in 4/153 (2.6%) patients followed up. Patients should be warned against the relative relaxing effect of a negative biopsy after identification of PIRADS 4-5 index lesion. While PSA decrease was observed in many patients during follow-up, persistent MRI findings were present in nearly a quarter of patients with persistently high PSA. A rebiopsy is warranted in these patients, with significant prostate cancer diagnosed in a quarter of patients with rebiopsy.

MRI in-bore biopsy following MRI/US fusion-guided biopsy in patients with persistent suspicion of clinically significant prostate cancer

PurposePatients with suspicion of clinically significant prostate cancer (csPC) on multiparametric prostate MRI (mpMRI) but negative or inconclusive MRI/US fusion-guided biopsy (FB) can be challenging in clinical practice. To assess the utility of MRI in-bore biopsy (IB) in patients with discordant imaging and histopathological findings after FB. MethodsConsecutive patients with Prostate Imaging Reporting and Data System (PI-RADS) category 4 or 5 on mpMRI at 3T after FB without histologically confirmed csPC who underwent IB between 01/2014 and 05/2022, were retrospectively included. The primary objective was to assess the detection rate of csPC. Secondary objectives were to analyze clinical parameters, MRI parameters, and lesion localization. ResultsIn the final cohort of 51 patients, the IB resulted in an overall detection rate of 71% for PC and 47% for csPC. Furthermore, in 55% of cases with initial low-grade PC, the Gleason score was upgraded after IB. CsPC was often detected apical and/or anterior. The detection rate for PC was 58% in PI-RADS category 4 and 94% in PI-RADS category 5 (csPC 39% and 61%, respectively). Patients with csPC had statistically significant smaller prostate volumes, a higher PI-RADS category, a higher prostate-specific antigen density (PSAD), and were older. ConclusionsFor a relevant proportion of patients with PI-RADS category 4 or 5 and negative or inconclusive findings on previous FB, but with persistent suspicion of csPC, a subsequent IB verified the presence of csPC. Therefore, IB can be a backup in cases of uncertainty.

Machine learning prediction of Gleason grade group upgrade between in-bore biopsy and radical prostatectomy pathology

This study aimed to enhance the accuracy of Gleason grade group (GG) upgrade prediction in prostate cancer (PCa) patients who underwent MRI-guided in-bore biopsy (MRGB) and radical prostatectomy (RP) through a combined analysis of prebiopsy and MRGB clinical data. A retrospective analysis of 95 patients with prostate cancer diagnosed by MRGB was conducted where all patients had undergone RP. Among the patients, 64.2% had consistent GG results between in-bore biopsies and RP, whereas 28.4% had upgraded and 7.4% had downgraded results. GG1 biopsy results, lower biopsy core count, and fewer positive cores were correlated with upgrades in the entire patient group. In patients with GG>1\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\hbox {GG}>1$$\\end{document}, larger tumor sizes and fewer biopsy cores were associated with upgrades. By integrating MRGB data with prebiopsy clinical data, machine learning (ML) models achieved 85.6% accuracy in predicting upgrades, surpassing the 64.2% baseline from MRGB alone. ML analysis also highlighted the value of the minimum apparent diffusion coefficient (ADCmin\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\hbox {ADC}_{\ ext{min}}$$\\end{document}) for GG>1\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\hbox {GG}>1$$\\end{document} patients. Incorporation of MRGB results with tumor size, ADCmin\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\hbox {ADC}_{\ ext{min}}$$\\end{document} value, number of biopsy cores, positive core count, and Gleason grade can be useful to predict GG upgrade at final pathology and guide patient selection for active surveillance.

Prototype Description and Ex Vivo Evaluation of a System for Combined Endorectal Magnetic Resonance Imaging and In-Bore Biopsy of the Prostate.

We describe early ex vivo proof-of-concept testing of a novel system composed of a disposable endorectal coil and converging multichannel needle guide with a reusable clamp stand, embedded electronics, and baseplate to allow for endorectal magnetic resonance (MR) imaging and in-bore MRI-targeted biopsy of the prostate as a single integrated procedure. Using prostate phantoms imaged with standard T 2 -weighted sequences in a Siemens 3T Prisma MR scanner, we measured the signal-to-noise ratio in successive 1-cm distances from the novel coil and from a commercially available inflatable balloon coil and measured the lateral and longitudinal deviation of the tip of a deployed MR compatible needle from the intended target point. Signal-to-noise ratio obtained with the novel system was significantly better than the inflatable balloon coil at each of five 1-cm intervals, with a mean improvement of 78% ( P < 0.05). In a representative sampling of 15 guidance channels, the mean lateral deviation for MR imaging-guided needle positioning was 1.7 mm and the mean longitudinal deviation was 2.0 mm. Our ex vivo results suggest that our novel system provides significantly improved signal-to-noise ratio when compared with an inflatable balloon coil and is capable of accurate MRI-guided needle deployment.

A Phase II Prospective Blinded Trial of Magnetic Resonance Imaging and In-Bore Biopsy in Active Surveillance for Prostate Cancer

To demonstrate the added benefit of multiparametric (mp)MRI risk stratification during active surveillance. This prospective, single-arm, nonrandomized study included 82 men with low-risk prostate cancer (PCa). We compared two biopsy strategies in parallel. The first biopsy strategy was an in-bore and transrectal ultrasound (TRUS) biopsy in men with suspicious mpMRI findings. The second was a TRUS biopsy in all 82 men, blinded to the results of the previously performed mpMRI. We identified 27/82 men with suspicious mpMRI. Of those 27 men, we detected 8/27 with csPCa on biopsy, and we identified two men with in-bore biopsy exclusively, three men with TRUS biopsy exclusively, and three men with both biopsy strategies. Of the 55/82 men with nonsuspicious mpMRI (who only received TRUS biopsies), two men had csPCa. TRUS biopsy of the entire cohort of 82 men would have led to the correct diagnosis of 80% men with csPCa, requiring all 82 men to receive biopsies (csPCa in 10% of the 82 biopsies). Conducting in-bore biopsies plus TRUS biopsies in men with suspicious mpMRI would have also led to the detection of 80% of men with csPCa, requiring only 27 men to receive biopsies (csPCa in 30% of the 27 biopsies). The combination of TRUS and in-bore biopsies, limited to men with suspicious mpMRI, resulted in a similar detection rate of csPCa compared to TRUS biopsies of all men but required only one-third of men to undergo biopsy. Our results indicate that in-bore and TRUS biopsies continue to complement each other.

Optimal Prostate Cancer Diagnostic Pathways for Men With Prostatomegaly in the MRI Era

To evaluate utilities of multiparametric MRI and targeted biopsy to detect clinically significant prostate cancer in men with prostatomegaly. We conducted a retrospective review of multiparametric MRI obtained for elevated PSA between 2017 and 2020. We selected patients with prostates ≥80g who had undergone biopsy. Clinically significant prostate cancer was defined as grade group ≥2. Predictive and logistic regression analyses quantified impacts of diagnostic components. A total of 338 patients met inclusion criteria: 89 (26.3%) had clinically significant prostate cancer. On MRI, positive predictive value for clinically significant prostate cancer was 26.5% for PIRADS 4% and 73.5% for PIRADS 5; negative predictive value for MRI without suspicious lesions was 98.8%. Applying PSA density to MRI yielded a negative predictive value of 78.9% for PIRADS 4 lesions at PSA density <0.05 and a positive predictive value of 90.5% for PIRADS 5 lesions at PSA density ≥0.15. Targeted (versus standard) biopsy reduced likelihood of missing clinically significant prostate cancer by >50% (12.2% vs 28.3%). MRI in-bore biopsies trended towards better accuracy versus MRI-transrectal ultrasound fusion biopsies (75% versus 52%). On logistic regression analyses, MRI improved predictive accuracy (area under the curve 0.91), and PIRADS score demonstrated the strongest association with clinically significant prostate cancer (odds ratio 6.42, P<.001). For large prostates, MRI is less predictive of clinically significant prostate cancer but effectively rules out malignancy. PSA density better informs biopsy decisions for PIRADS 4 and 5 lesions. There may be a pronounced role for targeted biopsy, specifically in-bore, in prostatomegaly.

The role of the size and number of index lesion in the diagnosis of clinically significant prostate cancer in patients with PI-RADS 4 lesions detected by multiparametric MRI of the prostate.

44 Background: This study aimed to evaluate the contribution of the size and number of the sampled lesions to the diagnosis of clinically significant prostate cancer (CSPC) in patients who had PI-RADS 4 lesions detected by multiparametric MRI (mpMRI) of the prostate and underwent in-bore biopsy (IB). Methods: In this retrospective study, data of 295 patients who underwent IB for PI-RADS 4-5 lesions between 2012 and 2021 were analyzed, and a total of 159 patients with only PI-RADS 4 lesions were included. Clinical and radiological data, including age, PSA level, previous biopsy information, and the size and the number of PI-RADS 4 lesions were recorded. Patients with a lesion classified as Grade Group 2 and above were considered to have CSPC. Univariate and multivariate regression analyses were used to evaluate the factors affecting the diagnosis of prostate cancer (PCa) and CSPC. Results: A great majority (86.8%) of the patients had undergone a biopsy for the first time. About three-fourths (71.7%) of the patients had PCa, and half (54.1%) had CSPC. In multivariate analysis, the relationship between PCa and age, index lesion size, low PSA levels, and first biopsy patients were found significant, while CSPC exhibited a significant relationship with age and first biopsy patients. When the patients were divided into three groups according to the index lesion size (&lt;5 mm, 5-10 mm, and &gt;10 mm), the prevalence of PCa was 64.3%, 67.5%, and 82.4% and the prevalence of CSPC was 42.9%, 51.2%, and 64.7% respectively. Conclusions: While the size of PI-RADS 4 lesions was significant in predicting PCa, it had no significance in detecting CSPC. The number of lesions was insignificant in predicting both conditions. However, the prevalence of PCa was high, especially in patients with PI-RADS 4 lesions larger than 10 mm, which in turn increased the probability of the lesion being Grade Group 2 or above. [Table: see text]

In-bore MR prostate biopsy - initial experience.

The introduction of multiparametric MRI (mpMRI) has been a breakthrough in the diagnosis of noninvasive clinically significant prostate cancer. Currently, MR-guided prostate biopsy (in-bore biopsy) is the only biopsy method that uses real-time MRI in patients with suspected prostate cancer. The aim of the study was a retrospective analysis of the correlation between MRI results and histological findings of prostate samples suspected of malignancy, which were taken during MRI-guided biopsy. Thirty-nine patients with 57 lesion biopsies were enrolled in the study. Patients were aged 48-84 years (mean age 67.2 ± 9.4 years). Cancer was histologically confirmed in 24 lesions, including primary cancer in 14 lesions and local recurrence in 10 lesions. Cancer was not detected in the remaining lesions (n = 33). Malignancy was confirmed in 90% of lesions previously reported as PI-RADS 5. Only one Prostate Imaging and Reporting and Data System (PI-RADS 5) lesion was histologically negative (prostatitis). Cancer was detected in 50% of lesions defined as PI-RADS 4. Cancer cells were not found in any of 23 lesions defined as PI-RADS 3 (53.5%). Most of the lesions assessed as PI-RADS 3 were located in the transitional zone (n = 19). Only four PI-RADS 3 lesions were found in the peripheral zone. Large lesions or lesions feasible for cognitive TRUS biopsy were not referred for MRI biopsy, which resulted in a higher proportion of lesions assessed as PI-RADS 3. Fourteen lesions suspected of local recurrence were assessed in our study. Cancer was found in approximately 72% of the lesions. Performing prostate biopsy under the guidance of real-time MRI allows precise collection of material for histological examination (even from a very small lesion). As a result, both primary cancer and local recurrence after previous radiotherapy of prostate cancer can be confirmed.

MP09-11 THE RELATIVE IMPACT OF SPATIAL PARAMETERS ON THE PERFORMANCE OF MRI-US FUSION BIOPSY VS. MRI IN-BORE BIOPSY OF THE PROSTATE

You have accessJournal of UrologyCME1 May 2022MP09-11 THE RELATIVE IMPACT OF SPATIAL PARAMETERS ON THE PERFORMANCE OF MRI-US FUSION BIOPSY VS. MRI IN-BORE BIOPSY OF THE PROSTATE Mitch Hayes, Solange Bassale, Sudhir Isharwal, Christopher Amling, Bryan Foster, Fergus Coakley, and Jen-Jane Liu Mitch HayesMitch Hayes More articles by this author , Solange BassaleSolange Bassale More articles by this author , Sudhir IsharwalSudhir Isharwal More articles by this author , Christopher AmlingChristopher Amling More articles by this author , Bryan FosterBryan Foster More articles by this author , Fergus CoakleyFergus Coakley More articles by this author , and Jen-Jane LiuJen-Jane Liu More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002531.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Multiparametric magnetic resonance imaging (mpMRI) has improved the accuracy of prostate cancer detection. Prior data suggests that in-bore biopsy may have improved accuracy over other fusion modalities, such as MRI-US fusion using software registration. We sought to compare the relative impact of selected MRI spatial parameters on prostate cancer detection between MRI-US fusion and MRI in-bore biopsy. METHODS: Patients with at least one PIRADS 4 or higher lesion on mpMRI that underwent MRI-US or MRI in-bore biopsy at one institution between 2013 and 2020 were included. The majority of patients had 3T MRI with endorectal coil. Patients on active surveillance were excluded. The primary endpoint was the detection of Gleason Grade Group 2 or higher (GG2+) on targeted biopsy on a per lesion basis. Propensity score matching was performed, and the overall GG2+ detection rate was compared using the Chi-square test. Generalized estimated equations were used to test interaction terms between biopsy modality and pre-specified variables: maximum lesion dimension, lesion volume, prostate volume, and lesion location (transitional zone vs. peripheral zone). Inclusion of number of biopsy cores to each model was also pre-specified. Analysis was performed using SAS, version 9.4. RESULTS: 53 MRI-US fusion patients and 133 MRI in-bore patients were evaluated for matching. 68 patients and 84 lesions were then matched for clinical and MRI factors, and all prebiopsy covariates were balanced. Overall GG2+ detection rate was higher amongst lesions sampled with in-bore biopsy compared to MRI-US fusion biopsy (59.5% v 45.2%, p=0.190). Lesion maximum dimension, lesion volume, prostate volume, and lesion location did not affect GG2+ detection for in-bore biopsy technique. However, the interaction between biopsy modality and lesion volume (OR 1.2, CI 1.03-1.43, p-value 0.024) and between modality and prostate volume were significant for the detection of GG2+ with MRI-US fusion biopsy (OR 0.97, CI 0.96-1.00, p-value 0.030). CONCLUSIONS: In a propensity score matched cohort of patients without prostate cancer undergoing MRI-US fusion biopsy or in-bore biopsy for PIRADS 4 or 5 lesions, overall GG2+ detection rate was higher for patients undergoing in-bore biopsy, which was independent of lesion volume or prostate size. GG2+ detection rate was lower for MRI-US fusion biopsy patients with smaller lesions or larger prostates, which may reflect inaccurate coregistration or increased tissue deformation with this approach. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e139 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mitch Hayes More articles by this author Solange Bassale More articles by this author Sudhir Isharwal More articles by this author Christopher Amling More articles by this author Bryan Foster More articles by this author Fergus Coakley More articles by this author Jen-Jane Liu More articles by this author Expand All Advertisement PDF DownloadLoading ...

Imaging of clinically silent rectoprostatic hematoma in MRI guided in-bore prostate biopsy

MR imaging provides awareness for rectoprostatic hematomas as a complication in prostate biopsy. We evaluated the frequency and size of clinically silent bleeding after in-bore MRI-guided prostate biopsy according to documentation in MRI. From 2007 until 2020 in-bore MRI-guided prostate biopsy was performed in 283 consecutive patients with suspected prostate cancer. Interventional image documentation was reviewed for rectoprostatic hematomas and rectal blood collections in this retrospective observational single-center study. Correlation to patient characteristics was analyzed using a multivariable logistic regression model. 283 consecutive patients with a mean age of 66 ± 8 years were included. We diagnosed bleeding complications in 41 (14.5%) of the patients. Significant rectoprostatic hematomas were found in 24 patients. Intra-rectal blood collections were observed in 16 patients and one patient showed bleeding in the urinary bladder. The volume of rectoprostatic hematomas was determined with a median of 7.5 ml (range 2–40 ml, IQR 11.25). We found no correlation between the presence of a rectoprostatic hematoma and malignant findings, patient position in biopsy, number of cores, age, prostate volume nor PSA density (p > 0.05). Rectoprostatic hematomas and rectal blood collections are rare complications after in-bore MR-guided prostate biopsy. MR imaging provides benefits not only for lesion detection in prostate biopsy but also for the control of bleeding complications, which can be overlooked in standard TRUS biopsy. Their significance in pain, erectile dysfunction, and urinary retention remains to be investigated.

A0280 - A phase II prospective trial of MRI and in-bore biopsy in the reclassification of men considering active surveillance for prostate cancer

A0280 - A phase II prospective trial of MRI and in-bore biopsy in the reclassification of men considering active surveillance for prostate cancer

The urologist\u2019s learning curve of \u201cin-bore\u201d magnetic resonance-guided prostate biopsy

BackgroundThe combination of multi-parametric MRI to locate and define suspected lesions together with their being targeted by an MRI-guided prostate biopsy has succeeded in increasing the detection rate of clinically significant disease and lowering the detection rate of non-significant prostate cancer. In this work we investigate the urologist’s learning curve of in-bore MRI-guided prostate biopsy which is considered to be a superior biopsy technique.Materials and methodsFollowing Helsinki approval by The Chaim Sheba Medical Center ethics committee in accordance with The Sheba Medical Center institutional guidelines (5366-28-SMC) we retrospectively reviewed 110 IB-MRGpBs performed from 6/2016 to 1/2019 in a single tertiary center. All patients had a prostate multi-parametric MRI finding of at least 1 target lesion (prostate imaging reporting and data system [PI-RADS] score ≥ 3). We analyzed biopsy duration and clinically significant prostate cancer detection of targeted sampling in 2 groups of 55 patients each, once by a urologist highly trained in IB-MRGpBs and again by a urologist untrained in IB-MRGpBs. These two parameters were compared according to operating urologist and chronologic order.ResultsThe patients’ median age was 68 years (interquartile range 62–72). The mean prostate-specific antigen level and prostate size were 8.6 ± 9.1 ng/d and 53 ± 27 cc, respectively. The mean number of target lesions was 1.47 ± 0.6. Baseline parameters did not differ significantly between the 2 urologists’ cohorts. Overall detection rates of clinically significant prostate cancer were 19%, 55%, and 69% for PI-RADS 3, 4 and 5, respectively. Clinically significant cancer detection rates did not differ significantly along the timeline or between the 2 urologists. The average duration of IB-MRGpB targeted sampling was 28 ± 15.8 min, correlating with the number of target lesions (p < 0.0001), and independent of the urologist’s expertise. Eighteen cases defined the cutoff for the procedure duration learning curve (p < 0.05).ConclusionsOur data suggest a very short learning curve for IB-MRGpB-targeted sampling duration, and that clinically significant cancer detection rates are not influenced by the learning curve of this technique.

Histologically benign PI-RADS 4 and 5 lesions contain cancer-associated epigenetic alterations.

The detection rate of clinically significant prostate cancer has improved with the use of multiparametric magnetic resonance imaging (mpMRI). Yet, even with MRI-guided biopsy 15%-35% of high-risk lesions (Prostate Imaging-Reporting and Data System [PI-RADS] 4 and 5) are histologically benign. It is unclear if these false positives are due to diagnostic/sampling errors or pathophysiological alterations. To better understand this, we tested histologically benign PI-RAD 4 and 5 lesions for common malignant epigenetic alterations. MRI-guided in-bore biopsy samples were collected from 45 patients with PI-RADS 4 (n = 31) or 5 (n = 14) lesions. Patients had a median clinical follow-up of 3.8 years. High-risk mpMRI patients were grouped based on their histology into biopsy positive for tumor (BPT; n = 28) or biopsy negative for tumor (BNT; n = 17). From these biopsy samples, DNA methylation of well-known tumor suppressor genes (APC, GSTP1, and RARβ2) was quantified. Similar to previous work we observed high rates of promoter methylation at GSTP1 (92.7%), RARβ2 (57.3%), and APC (37.8%) in malignant BPT samples but no methylation in benign TURP chips. Interestingly, similar to the malignant samples the BNT biopsies also had increased methylation at the promoter of GSTP1 (78.8%) and RARβ2 (34.6%). However, despite these epigenetic alterations none of these BNT patients developed prostate cancer, and those who underwent repeat mpMRI (n = 8) demonstrated either radiological regression or stability. Histologically benign PI-RADS 4 and 5 lesions harbor prostate cancer-associated epigenetic alterations.

Multiparametric Prostate MRI in Biopsy-Naïve Men: A Prospective Evaluation of Performance and Biopsy Strategies.

ObjectivesThis study aims to prospectively estimate the diagnostic performance of multiparametric prostate MRI (mpMRI) and compare the detection rates of prostate cancer using cognitive targeted transrectal ultrasound (TRUS) guided biopsies, targeted MR-guided in-bore biopsies (MRGB), or both methods combined in biopsy-naïve men.MethodsThe biopsy-naïve men referred for mpMRI (including T2-weighted, diffusion-weighted and dynamic contrast enhanced MRI) due to prostate cancer suspicion (elevated prostate-specific antigen or abnormal digital rectal examination) were eligible for inclusion. The images were scored according to Prostate Imaging Reporting and Data System (PI-RADS) v2, and men with PI-RADS 1–2 lesions were referred for routine systematic TRUS, while those with PI-RADS 3–5 lesions were randomized to MRGB or cognitive targeted TRUS. Men randomized to MRGB were referred to a secondary TRUS 2 weeks after MRGB. Gleason grade group ≥2 was defined as clinically significant prostate cancer. The performance of mpMRI was estimated using prostate cancer detected by any biopsy method as the reference test.ResultsA total of 210 men were included. There was no suspicion of prostate cancer after mpMRI (PI-RADS 1–2) in 48% of the men. Among these, significant and insignificant prostate cancer was diagnosed in five and 11 men, respectively. Thirty-five men who scored as PI-RADS 1–2 did not undergo biopsy and were therefore excluded from the calculation of diagnostic accuracy. The overall sensitivity, specificity, negative predictive value, and positive predictive value of mpMRI for the detection of significant prostate cancer were 0.94, 0.63, 0.92, and 0.67, respectively. In patients with PI-RADS 3–5 lesions, the detection rates for significant prostate cancer were not significantly different between cognitive targeted TRUS (68.4%), MRGB (57.7%), and the combination of the two biopsy methods (64.4%). The median numbers of biopsy cores taken per patient undergoing systematic TRUS, cognitive targeted TRUS, and MRGB were 14 [8-16], 12 [6-17], and 2 [1-4] respectively.ConclusionsmpMRI, in a cohort of biopsy-naïve men, has high negative predictive value, and our results support that it is safe to avoid biopsy after negative mpMRI. Furthermore, MRGB provides a similar diagnosis to the cognitive targeted TRUS but with fewer biopsies.

MRI-directed biopsy for primary detection of prostate cancer in a population of 223 men: MRI In-Bore vs MRI-transrectal ultrasound fusion-targeted techniques

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.ConclusionNo 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 knowledgeMRI 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.

Results from a PI-RADS-based MRI-directed diagnostic pathway for biopsy-naive patients in a non-university hospital

PurposeTo assess the safety and performance of a MRI-directed diagnostic pathway for patients with first-time suspicion of prostate cancer in a non-university hospital.MethodsBetween May 2017 and December 2018 all biopsy-naive patients examined in our hospital followed a MRI-directed diagnostic work-up algorithm based on PI-RADS score. In short, PI-RADS 1–2 was generally not biopsied and PI-RADS 3–5 was reviewed by a multidisciplinary team. Patients with PI-RADS 4-5 were all referred to biopsy, either transrectal ultrasound-guided biopsy or MRI in-bore biopsy for small tumors and for sites difficult to access. PI-RADS scores were compared to the histopathology from biopsies and surgical specimens for patients who had prostatectomy. Non-biopsied patients were referred to a safety net monitoring regimen.ResultsTwo hundred and ninety-eight men were enrolled. 97 (33%) had PI-RADS 1–2, 44 (15%) had PI-RADS 3, and 157 (53%) had PI-RADS 4–5. 116 (39%) of the patients avoided biopsy. None of these were diagnosed with significant cancer within 2–3.5 years of safety net monitoring. Almost all high ISUP grade groups (≥ 3) were in the PI-RADS 4–5 category (98%). Prostatectomy specimens and systematic biopsies from MRI-negative areas indicated that very few clinically significant cancers were missed by the MRI-directed diagnostic pathway.ConclusionOur findings add to evidence that a MRI-directed diagnostic pathway can be safely established in a non-university hospital. The pathway reduced the number of biopsies and reliably detected the site of the most aggressive cancers.Graphic abstract