Previous Negative Biopsy Research Articles

MP38-20 MRI-GUIDED ACTIVE SURVEILLANCE WITHOUT ANNUAL RE-BIOPSY IN PATIENTS WITH ISUP 1 AND 2 PROSTATE CANCER: THE PROSPECTIVE PROMM-AS STUDY

You have accessJournal of UrologyCME1 Apr 2023MP38-20 MRI-GUIDED ACTIVE SURVEILLANCE WITHOUT ANNUAL RE-BIOPSY IN PATIENTS WITH ISUP 1 AND 2 PROSTATE CANCER: THE PROSPECTIVE PROMM-AS STUDY Jan Philipp Radtke, Birte Valentin, Christian Arsov, Tim Ullrich, Rouvier Al-Monajjed, Matthias Boschheidgen, Markus Giessing, Cristina Lopez-Cotarelo, Gerald Antoch, and Lars Schimmöller Jan Philipp RadtkeJan Philipp Radtke More articles by this author , Birte ValentinBirte Valentin More articles by this author , Christian ArsovChristian Arsov More articles by this author , Tim UllrichTim Ullrich More articles by this author , Rouvier Al-MonajjedRouvier Al-Monajjed More articles by this author , Matthias BoschheidgenMatthias Boschheidgen More articles by this author , Markus GiessingMarkus Giessing More articles by this author , Cristina Lopez-CotareloCristina Lopez-Cotarelo More articles by this author , Gerald AntochGerald Antoch More articles by this author , and Lars SchimmöllerLars Schimmöller More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003276.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: There is evidence that multiparametric magnetic resonance imaging (mpMRI) may avoid repeat prostate biopsies in monitoring of patients during active surveillance (AS) for prostate cancer (PC).To assess the ability of mpMRI to risk stratify men on AS, including ISUP grade group (GG) 1 and 2 PC to reduce guideline-mandated biopsy, and to predict ISUP GG upgrading. METHODS: Prospective 2-year single-center outcome of an mpMRI-guided AS protocol (PROMM-AS). 12 months after AS inclusion with MRI/TRUS fusion-guided biopsy, all men underwent mpMRI. In case of stable mpMRI according to PRECISE criteria, re-biopsy was deferred and follow-up mpMRI after 24 months performed. In case of mpMRI progression or at the end of study, follow-up MRI/TRUS fusion-guided biopsy was indicated. Primary endpoint was a reduction of histopathological AS disqualification from previous published 25% to 15%. A sample size of in total 150 men was calculated to achieve 80% power to detect this rate difference. We calculated sensitivity, specificity, positive (PPV) and negative predictive values (NPV) for ISUP GG upgrading on MRI and performed regression analyses. RESULTS: In total, 101 men (60 with GG1 and 41 with GG2 PC) were available for analysis. Histopathological progression occurred in total in 29 men. Thus, the primary endpoint could not be reached and we performed an interim-analysis. In the GG1 subgroup 18 men had progression (30%), whereas 11 men progressed in GG2 subgroup (27%). Sensitivity, specificity, PPV and NPV for PRECISE was 94%, 64%, 81% and 88% in the GG1 subgroup and 91%, 50%, 91% and 50% in GG2 subgroup. On regression analysis, higher PRECISE scores (4-5), initial PI-RADS, PSA, age and prostate volume were significant predictors of histological progression in ISUP GG1 and higher PRECISE score, initial PI-RADS and previous negative biopsy in ISUP GG2 PC. CONCLUSIONS: MRI-guided monitoring of men on AS including PRECISE criteria avoids unnecessary follow-up biopsies in 88% of men with ISUP GG1 and sufficiently predicts GG upgrading over a follow-up period of two years in both ISUP GG1 and GG2. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e532 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jan Philipp Radtke More articles by this author Birte Valentin More articles by this author Christian Arsov More articles by this author Tim Ullrich More articles by this author Rouvier Al-Monajjed More articles by this author Matthias Boschheidgen More articles by this author Markus Giessing More articles by this author Cristina Lopez-Cotarelo More articles by this author Gerald Antoch More articles by this author Lars Schimmöller More articles by this author Expand All Advertisement PDF downloadLoading ...

MP38-08 IS A CONFIRMATORY PROSTATE BIOPSY BEFORE ENTRY INTO AN ACTIVE SURVEILLANCE PROTOCOL STILL NECESSARY IN THE ERA OF PROSTATE CANCER DIAGNOSIS WITH MRI-GUIDED BIOPSY?

You have accessJournal of UrologyCME1 Apr 2023MP38-08 IS A CONFIRMATORY PROSTATE BIOPSY BEFORE ENTRY INTO AN ACTIVE SURVEILLANCE PROTOCOL STILL NECESSARY IN THE ERA OF PROSTATE CANCER DIAGNOSIS WITH MRI-GUIDED BIOPSY? Omri Schwarztuch Gildor, Anna Itshak, Yarden Fleischer, Ilan Leibovitch, Itay Sagy, and Itay Sternberg Omri Schwarztuch GildorOmri Schwarztuch Gildor More articles by this author , Anna ItshakAnna Itshak More articles by this author , Yarden FleischerYarden Fleischer More articles by this author , Ilan LeibovitchIlan Leibovitch More articles by this author , Itay SagyItay Sagy More articles by this author , and Itay SternbergItay Sternberg More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003276.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In patients with low-risk prostate cancer who are considering active surveillance (AS), it is common to repeat a biopsy within a year of diagnosis, as a confirmatory biopsy. The necessity of this biopsy was tested in the era before diagnosis based on MRI and showed a risk of 25-35% for reclassification in the confirmatory biopsy. Currently, most biopsies and new diagnoses of patients with a tumor suitable for AS are performed under the guidance of MRI. Our goal is to check the chance of reclassification when the diagnosis was made with an MRI-guided biopsy. METHODS: A retrospective review of all confirmatory biopsies performed at our center between 2015-2021. Data were collected about the diagnostic biopsy and the confirming biopsy based on the medical sheet and the pathological report. RESULTS: Of the 114 patients who underwent a confirmatory biopsy during the study period, 75 (65.8%) were diagnosed with a TRUS biopsy (group 1) and 39 (34.2%) with an MRI-guided biopsy (group 2). Patient age, PSA level, prostate size, PSA-D, and MRI findings were similar between groups. All confirmatory biopsies were performed with MRI guidance and included also systematic sampling. Reclassification to grade group (GG) ≥ 2 in the confirming biopsy was found in 31/75 (41.3%) and 15/39 (38.5%) patients in groups 1 and 2, respectively. This difference is not statistically significant (p=0.77). Similar reclassification rate (3/8, 37.5%) occurred in a subgroup (of group 2) of patients with previous negative systematic biopsy. In 9/75 (12.0%) and 4/39 (10.3%) patients in groups 1 and 2, respectively, the MRI-guided samples were found without significant prostate cancer and reclassification was made only because of the systematic samples. CONCLUSIONS: The risk of reclassification in a confirmatory biopsy continues to be significant even in the era of MRI-guided diagnosis of prostate cancer. We emphasize the importance of continuing to perform confirmatory biopsies and ensuring systematic sampling alongside sampling the region of interest. Source of Funding: Self funding © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e526 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Omri Schwarztuch Gildor More articles by this author Anna Itshak More articles by this author Yarden Fleischer More articles by this author Ilan Leibovitch More articles by this author Itay Sagy More articles by this author Itay Sternberg More articles by this author Expand All Advertisement PDF downloadLoading ...

A risk-organised model for clinically significant prostate cancer early detection.

A risk-organised model for clinically significant prostate cancer early detection.

Analysis of false-positive biopsy results of PIRADS 4 lesions in multiparametric magnetic resonance imaging of the prostate: Experience from a single nonacademic center using cognitive fusion.

321 Background: Multiparametric magnetic resonance imaging (mpMRI) of the prostate has been increasingly used in the algorithm of the initial diagnosis of patients suspected to harbor prostate cancer (PCa) with the aim of improving the selection of patients who really need a biopsy. Yet patients with PI-RADS 5 lesions almost always have cancer found in their prostates, the same is not true for patients with PI-RADS 4. In this study we sought to describe pathological findings in target biopsies of PI-RADS4, and to identify clinical data that could predict those patients with benign findings. Methods: A retrospective study was conducted in a data bank collected prospectively from December 2015 through April 2022 in a single nonacademic center. The whole series consist of 547 patients, all of whom had a mpMRI of the prostate (reports as per PI-RADS version 2) followed by cognitive fusion prostate biopsy performed by a single, experienced radiologist. All biopsy specimens were read by a specialist in urological pathology. Out of these, 259 had PI-RADS 4 lesion, and 83 had PI-RADS 5. Results: We found a false positive rate of 29% and 3.7% for any cancer in PI-RADS 4 and 5 lesions, respectively. Different histologic patterns were observed among target biopsies. At multivariate analysis, PIRADS lesion ≤ 6 mm and previous negative biopsy were independent predictors of false positive PI-RADS4 lesions. The 76 cases showed normal histology (n = 22), a combination of chronic inflammation, reactive epithelium, and glandular atrophy (n = 18), glandular atrophy (n = 9), stromal proliferation consistent with nodular hyperplasia (n =7), a combination of chronic inflammation, reactive epithelium and glandular atrophy (n = 6), chronic inflammation (n = 4) and HGPIN (n = 10). The small number (n=3) of false PI-RADS5 lesions precluded further analyses. Conclusions: Benign findings are common in PI-RADS4 lesions and most of them did not show obvious glandular or stromal hypercellularity as expected in hyperplastic nodules. Size ≤ 6 mm and previous negative biopsy predict higher probability of false positive results in patients with PI-RADS 4 lesions.[Table: see text]

Analysis of false positive PI-RADS 4 lesions: experience from a single nonacademic center using cognitive fusion.

We evaluated pathological findings in targeted biopsies of PI-RADS4 and PI-RADS5 lesions, and clinical data that could predict those patients with benign findings. A retrospective study was conducted to summarize the experience from a single nonacademic center using cognitive fusion and a 1.5 or 3.0 Tesla scanner. We found a false positive rate of 29 and 3.7% for any cancer in PI-RADS 4 and 5 lesions, respectively. Diverse histologic patterns were observed among target biopsies. At multivariate analysis, size ≤ 6mm and previous negative biopsy were independent predictors of false positive PI-RADS4 lesions. The small number of false PI-RADS5 lesions precluded further analyses. Benign findings are common in PI-RADS4 lesions and most of them do not show obvious glandular or stromal hypercellularity as expected in hyperplastic nodules. Size ≤ 6mm and previous negative biopsy predict a higher probability of false positive results in patients with PI-RADS 4 lesions.

Comparison of the diagnostic performance between multiparametric MRI and microUS in the detection of clinically significance prostate cancer among patients with previous negative biopsy

Comparison of the diagnostic performance between multiparametric MRI and microUS in the detection of clinically significance prostate cancer among patients with previous negative biopsy

MyProstateScore in men considering repeat biopsy: validation of a simple testing approach

BackgroundMen with persistent risk of Grade Group (GG) ≥ 2 cancer after a negative biopsy present a unique clinical challenge. The validated MyProstateScore test is clinically-available for pre-biopsy risk stratification. In biopsy-naïve patients, we recently validated a straightforward testing approach to rule-out GG ≥ 2 cancer with 98% negative predictive value (NPV) and 97% sensitivity. In the current study, we established a practical MPS-based testing approach in men with a previous negative biopsy being considered for repeat biopsy.MethodsPatients provided post-digital rectal examination urine prior to repeat biopsy. MyProstateScore was calculated using the validated, locked model including urinary PCA3 and TMPRSS2:ERG scores with serum PSA. In a clinically-appropriate primary (i.e., training) cohort, we identified a lower (rule-out) threshold approximating 90% sensitivity and an upper (rule-in) threshold approximating 80% specificity for GG ≥ 2 cancer. These thresholds were applied to an external validation cohort, and performance measures and clinical outcomes associated with their use were calculated.ResultsMyProstateScore thresholds of 15 and 40 met pre-defined performance criteria in the primary cohort (422 patients; median PSA 6.4, IQR 4.3–9.1). In the 268-patient validation cohort, 25 men (9.3%) had GG ≥ 2 cancer on repeat biopsy. The rule-out threshold of 15 provided 100% NPV and sensitivity for GG ≥ 2 cancer and would have prevented 23% of unnecessary biopsies. Use of MyProstateScore >40 to rule-in biopsy would have prevented 67% of biopsies while maintaining 95% NPV. In the validation cohort, the prevalence of GG ≥ 2 cancer was 0% for MyProstateScore 0–15, 6.5% for MyProstateScore 15–40, and 19% for MyProstateScore >40.ConclusionsIn patients who previously underwent a negative prostate biopsy, the MyProstateScore values of 15 and 40 yielded clinically-actionable rule-in and rule-out risk groups. Using this straightforward testing approach, MyProstateScore can meaningfully inform patients and physicians weighing the need for repeat biopsy.

The Role of [68Ga]PSMA PET/CT for Clinical Suspicion of Prostate Cancer in Patients with or without Previous Negative Biopsy: A Systematic Review.

Simple SummaryIn this paper we systematically evaluate the evidence regarding the role of [68Ga]PSMA PET/CT for clinical suspicions of prostate cancer in patients with or without previous negative biopsy. A critical review of PubMed and Web of Science according to the PRISMA statement was conducted. Eighteen publications were selected for inclusion in the analysis. In 8 articles, there was a direct comparison with mpMRI. [68Ga]PSMA PET/CT resulted more accurate in identifying primary prostate cancer with PSA values between 4 and 20 ng/mL than mpMRI. Moreover, its use combined with MRI improved sensitivity for csPCa detection, thus potentially avoiding unnecessary biopsies. Overall, [68Ga]PSMA PET/CT resulted a promising technique in patients with clinical suspicion of PCa and precedent negative biopsy or contraindications to MRI.The purpose of the study is to systematically evaluate the evidence regarding the role of [68Ga]PSMA PET/CT for clinical suspicions of prostate cancer in patients with or without previous negative biopsy. We performed a critical review of PubMed and Web of Science according to the PRISMA statement. Eighteen publications were selected for inclusion in this analysis. QUADAS-2 evaluation was adopted for quality analyses. [68Ga]PSMA-11 was the radiotracer of choice in 15 studies, while [68Ga]PSMA-617 was used in another 3. In 8 articles, there was a direct comparison with mpMRI. The total number of patients included was 1379, ranging from 15 to 291, with a median age of 64 years (range: 42–90). The median baseline PSA value was 12.9 ng/mL, ranging from 0.85 to 4156 ng/mL. Some studies evaluated the PSMA uptake comparing the SUVmax of suspicious lesions with the SUVmax of the normal biodistribution to find out optimal cut-off points. In addition, some studies suggested a significant association between PSA levels, PSA density, and [68Ga]PSMA PET/CT finding. [68Ga]PSMA PET/CT seems to be more accurate in identifying primary prostate cancer with PSA values between 4 and 20 ng/mL than mpMRI. Moreover, in some trials, the combination of PSMA PET/CT and MRI improved the NPV in the detection of clinically significant prostate cancer (csPCa) than MRI alone. Our findings are limited by the small numbers of studies and patient heterogeneity. [68Ga]PSMA PET/CT is a promising technique in patients with clinical suspicion of PCa and precedent negative biopsy or contraindications to MRI. Furthermore, its use combined with MRI improves sensitivity for csPCa detection and can avoid unnecessary biopsies.

Combining targeted and systematic prostate biopsy improves prostate cancer detection and correlation with the whole mount histopathology in biopsy naïve and previous negative biopsy patients.

ObjectiveGuidelines for previous negative biopsy (PNB) cohorts with a suspicion of prostate cancer (PCa) after positive multiparametric (mp) magnetic-resonance-imaging (MRI) often favour the fusion-guided targeted prostate-biopsy (TB) only approach for Prostate Imaging-Reporting and Data System (PI-RADS) ≥3 lesions. However, recommendations lack direct biopsy performance comparison within biopsy naïve (BN) vs. PNB patients and its prognostication of the whole mount pathology report (WMPR), respectively. We suppose, that the combination of TB and concomitant TRUS-systematic biopsy (SB) improves the PCa detection rate of PI-RADS 2, 3, 4 or 5 lesions and the International Society of Urological Pathology (ISUP)-grade predictability of the WMPR in BN- and PNB patients.MethodsPatients with suspicious mpMRI, elevated prostate-specific-antigen and/or abnormal digital rectal examination were included. All PI-RADS reports were intramurally reviewed for biopsy planning. We compared the PI-RADS score substratified TB, SB or combined approach (TB/SB) associated BN- and PNB-PCa detection rate. Furthermore, we assessed the ISUP-grade variability between biopsy cores and the WMPR.ResultsAccording to BN (n = 499) vs. PNB (n = 314) patients, clinically significant (cs) PCa was detected more frequently by the TB/SB approach (62 vs. 43%) than with the TB (54 vs. 34%) or SB (57 vs. 34%) (all p < 0.0001) alone. Furthermore, we observed that the TB/SB strategy detects a significantly higher number of csPCa within PI-RADS 3, 4 or 5 reports, both in BN and PNB men. In contrast, applied biopsy techniques were equally effective to detect csPCa within PI-RADS 2 lesions. In case of csPCa diagnosis the TB approach was more often false-negative in PNB patients (BN 11% vs. PNB 19%; p = 0.02). The TB/SB technique showed in general significantly less upgrading, whereas a higher agreement was only observed for the total and BN patient cohort.ConclusionDespite csPCa is more frequently found in BN patients, the TB/SB method always detected a significantly higher number of csPCa within PI-RADS 3, 4 or 5 reports of our BN and PNB group. The TB/SB strategy predicts the ISUP-grade best in the total and BN cohort and in general shows the lowest upgrading rates, emphasizing its value not only in BN but also PNB patients.

Transperineal Freehand US/MRI Fusion Target Prostate Biopsy using the Esaote MylabTM9 System: A Step by Step Guide

Objective: To document a step-by-step guide of transperineal Freehand US/MRI fusion target prostate biopsy using the Esaote MyLabTM9 System. Setting: “San Pio” Hospital of Castellaneta, Italy. Patients: The patients undergoing this procedure had a suspicion of prostate cancer based on a mpMRI of the prostate. Results: No major complications were seen during and after the biopsy, and the patients were discharged 30 minutes-1 hour after the procedure. Conclusions: Fusion-targeted biopsy has proven to be better than random technique for both biopsy-naïve and previous negative biopsy [1]. With a standardized step-by-step approach the procedure can give good detection rate results with little or without discomfort for the patients and with short operating times.

Routine systematic prostate biopsies not replaced by magnetic resonance imaging-targeted biopsy.

Multiparametric magnetic resonance imaging improves the performance of prostate cancer (PCa) diagnostics through a better selection of patients. The aim of the study was to study the detection rate (DR) of systematic and targeted cognitive biopsies in a cohort with the previous negative systematic biopsies. A secondary objective was to describe the value of prostate-specific antigen density (PSAd) in the detection of clinically significant PCa (CSPCa). We designed a prospective, single-center, and comparative study to determine the DR of systematic and targeted cognitive biopsies. The clinical and pathological characteristics of each patient were described. A total of 111 patients with Prostate Imaging Reporting and Data System lesions > 3 were included in the study. PCa was detected in 41.4% (46 of 111 patients); 42 (91.3%) were detected by systematic biopsy and 30 (65.2%) by targeted biopsy. CSPCa was detected in 26 (23.4%), 23 (88.5%) by systematic biopsy, and 21 (76.9%) by targeted biopsy. PSAd > 0.15 was directly associated with CSPCa. The detection of PCa by systematic biopsy in this series was higher than 80%; hence, its routine use should not be replaced by targeted biopsy, since it continues to be the cornerstone of the diagnosis in patients with prior negative biopsies.

Utility of serum biomarkers for predicting cancer in patients with previous negative prostate biopsy.

To review the role of serum biomarkers: prostate-specific antigen (PSA), PSA density (PSAD), free:total PSA ratio, prostate health index (PHI) and PHI density (PHID), along with magnetic resonance imaging (MRI) for identification of clinically significant prostate cancer (PCa), comparing their utility in patients with persistently raised PSA levels after a prior negative prostate biopsy (PNB). In this single-centre prospective observational study conducted from September 2015 to October 2020, patients underwent a saturation biopsy via the transperineal route. If a Prostate Imaging Reporting and Data System version 2 (PIRADS) 3 and above lesion was seen on MRI, targeted biopsies were also obtained. Information on clinical history, lesion characteristics, PIRADS classification and follow-up was collected. The sensitivity, specificity and area under curve (AUC) for each of the biomarkers were calculated. 351 men underwent saturation biopsy with or without targeted biopsies. 103 patients had a PNB. Among this PNB cohort, 43 (41.7%) men had a benign outcome, while 60 (58.3%) men had histopathologically diagnosed PCa, of which 41 (39%) were clinically significant. All patients underwent multiparametric MRI scans prior to biopsy. Within this cohort, PHI and PHID had the best abilities to predict for clinically significant PCa with an AUC of 0.73 and 0.70 respectively, compared to 0.65 for PSAD, 0.34 for free:total PSA and 0.56 for PSA. A significant proportion of patients are diagnosed with PCa after a PNB. This study shows that PHI and PHI densities may be suitable adjuncts predicting for clinically significant PCa in patients with PNB.

50 - mpMRI and transrectal ultrasound fusion biopsy in prostate cancer detection in men with previous negative systematic biopsy: A single-center five years’ outcomes.

50 - mpMRI and transrectal ultrasound fusion biopsy in prostate cancer detection in men with previous negative systematic biopsy: A single-center five years’ outcomes.

Prostate biopsy in the era of MRI-targeting: towards a judicious use of additional systematic biopsy.

We aimed to develop and compare strategies that help optimize current prostate biopsy practice by identifying patients who may forgo concurrent systematic biopsy (SBx) in favor of MRI-targeted (TBx) alone. Retrospective study on 745 patients who underwent combined MRI-TBx plus SBx. Primary outcome was the upgrade to clinically significant prostate cancer (csPCa; grade group ≥ 2) on SBx versus MRI-TBx. Variables (age, previous biopsy status, Prostate Imaging Reporting and Data System (PI-RADS) score, index lesion size/location, number of lesions, PSA, PSA density, prostate volume) associated with the primary outcome were identified by logistic regression and used for biopsy strategies. Clinical utility was assessed by decision curve analysis (DCA). SBx detected 47 (6%) additional men with csPCa. The risk of detecting csPCa uniquely on SBx was significantly lower in men with PI-RADS 5 (versus PI-RADS 3: OR 0.30, p = 0.03; versus PI-RADS 4: OR 0.33, p = 0.01), and previous negative biopsy (versus previous positive biopsy: OR 0.40, p = 0.007), and increased with age (per 10 years: OR 1.64, p = 0.016). No significant association was observed for other variables. DCA identified the following strategies as most useful: (a) avoid SBx in men with PI-RADS 5 and (b) additionally in those with previous negative biopsy, resulting in avoiding SBx in 201 (27%) and 429 (58%), while missing csPCa in 5 (1%) and 15 (2%) patients, respectively. Not all men benefit equally from the combination of SBx and MRI-TBx. SBx avoidance in men with PI-RADS 5 and/or previous negative biopsy may reduce the risk of excess biopsies with a low risk of missing csPCa. • In men undergoing MRI-targeted biopsy, the risk of detecting clinically significant prostate cancer (csPCa) only on additional systematic biopsy (SBx) decreased in men with PI-RADS 5, previous negative biopsy, and younger age. • Using these variables may help select men who could avoid the risk of excess SBx. • If missing csPCa in 5% was acceptable, forgoing SBx in men with PI-RADS 5 and/or previous negative biopsy enabled the highest net reduction in SBx.

Evaluating the diagnostic role of in-bore magnetic resonance imaging guided prostate biopsy: a single-centre study.

BackgroundTo evaluate the role of in‐bore MRI‐guided biopsy (IB‐MRGB) in the diagnosis of clinically significant prostate cancer (csPCa).MethodsIn this tertiary single centre study, a total of 125 consecutive patients receiving IB‐MRGB over a three‐year period were evaluated, including 73 patients who had prior biopsies and 52 biopsy‐naïve patients. We assessed cancer detection rate of patients according to the degree of suspicion based on mpMRI findings. Histopathological data were reviewed by experienced uropathologists.ResultsThe mpMRI was suspicious for PCa (PI‐RADS 4/5) in 77% (96/125) and equivocal (PI‐RADS 3) in 23% (29/125). The detection rate for csPCa was 54.2% (52/96) and 20.7% (6/29) for suspicious lesions (PI‐RADS 4/5) and equivocal lesions (PI‐RADS 3), respectively. In subgroup analysis, patients with previous negative biopsy, overall positive biopsy rate and csPCa detection rate were 48.3% (19/35) and 34.5% (13/35), respectively. In patients on AS, 36/44 (81.8%) and 21/44 (47.8%) had PCa and csPCa respectively. In biopsy‐naïve patients 34/52 (65.4%) and 27/52 (51.92%) had PCa and csPCa respectively. Of the patients on AS, 18/44 (41.6%) upgraded from ISUP 1 to ISUP 2 PCa, and 4/44 (9.1%) upgraded from ISUP 1 to ISUP 3 PCa on IB‐MRGB. A total of 14 Clavien‐Dindo≤2 complications occurred in 14 patients (11.2%) that were directly related to the biopsy. No Clavien‐Dindo≥3 complications occurred.ConclusionMRI‐targeted biopsy is suitable for assessment of csPCa. Given the favourable complications profile, its use may be considered in both the initial biopsy and re‐biopsy settings.

Association between previous negative biopsies and lower rates of progression during active surveillance for prostate cancer

PurposeTo test any-cause discontinuation and ISUP GG upgrading rates during Active Surveillance (AS) in patients that underwent previous negative biopsies (PNBs) before prostate cancer (PCa) diagnosis vs. biopsy naive patients.MethodsRetrospective analysis of 961 AS patients (2008–2020). Three definitions of PNBs were used: (1) PNBs status (biopsy naïve vs. PNBs); (2) number of PNBs (0 vs. 1 vs. ≥ 2); (3) histology at last PNB (no vs. negative vs. HGPIN/ASAP). Kaplan–Meier plots and multivariable Cox models tested any-cause and ISUP GG upgrading discontinuation rates.ResultsOverall, 760 (79.1%) vs. 201 (20.9%) patients were biopsy naïve vs. PNBs. Specifically, 760 (79.1%) vs. 138 (14.4%) vs. 63 (6.5%) patients had 0 vs. 1 vs. ≥ 2 PNBs. Last, 760 (79.1%) vs. 134 (13.9%) vs. 67 (7%) patients had no vs. negative PNB vs. HGPIN/ASAP. PNBs were not associated with any-cause discontinuation rates. Conversely, PNBs were associated with lower rates of ISUP GG upgrading: (1) PNBs vs. biopsy naïve (HR:0.6, p = 0.04); (2) 1 vs. 0 PNBs (HR:0.6, p = 0.1) and 2 vs. 0 PNBs, (HR:0.5, p = 0.1); (3) negative PNB vs. biopsy naïve (HR:0.7, p = 0.3) and HGPIN/ASAP vs. biopsy naïve (HR:0.4, p = 0.04). However, last PNB ≤ 18 months (HR:0.4, p = 0.02), but not last PNB > 18 months (HR:0.8, p = 0.5) were associated with lower rates of ISUP GG upgrading.ConclusionPNBs status is associated with lower rates of ISUP GG upgrading during AS for PCa. The number of PNBs and time from last PNB to PCa diagnosis (≤ 18 months) appear also to be critical for patient selection.

Cost-Effectiveness of Multiparametric Magnetic Resonance Imaging and Targeted Biopsy Versus Systematic Transrectal Ultrasound-Guided Biopsy for Prostate Cancer Diagnosis: A Systematic Review

ObjectivesThis study aimed to systematically review the cost-effectiveness studies of multiparametric magnetic resonance imaging (mpMRI)-guided biopsy (MRGB) compared with systematic transrectal ultrasonography (TRUS)-guided biopsy for diagnosing prostate cancer (PCa). MethodsPubMed, Web of Science core collection, Embase and Scopus, and reference lists of the included studies were searched with no date and language restrictions through January 2020 for full economic evaluation studies (cost-effectiveness, cost-utility analysis, cost-benefit analysis) that assessed mpMRI and MRGB compared with systematic TRUS-guided biopsy or other sequential biopsy strategies in men undergoing initial prostate biopsy or men with previous negative prostate biopsy, with clinical suspicion of PCa based on abnormal prostate-specific antigen or digital rectal examination increase or both. Data were tabulated and analyzed using narrative synthesis. The reporting quality of included studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards checklist. This systematic review was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. ResultsFinally, 9 studies were included. All studies were conducted in high-income countries. All studies found that mpMRI and MRGB was cost-effective in the initial and before repeat biopsy in men with previous negative biopsy. The cognitive-targeted TRUS-guided biopsy was cost-effective in the initial biopsy (dominant or cost-effective at willingness-to-pay threshold of the countries); it was not evaluated for repeat biopsy in men. The direct in-bore magnetic resonance imaging (MRI)-guided biopsy was cost-effective for the initial biopsy (€323 per quality-adjusted life-year gained). The superiority of one of the targeted biopsy approaches (fusion, cognitive, or in-bore) over other approaches has not yet been established. ConclusionsThis study showed that pre-TRUS-guided biopsy MRI is more cost-effective than TRUS-guided biopsy alone. Furthermore, the use of MRI-ultrasound fusion targeted biopsy in the diagnosis of PCa in the initial biopsy and repeat biopsy and cognitive-targeted TRUS-guided biopsy in the initial biopsy is cost-effective.

Compаrative study: Efficacy and safety of MRI / ultrasound transperineal vs systematic transrectal prostate biopsy in patients with previous negative TRUS biopsy

Objective The aim of the study was to compare the efficacy and safety of magnetic resonance imaging / ultrasound-targeted transperineal prostate biopsy versus standard transrectal systemic biopsy, in detection of prostate cancer, in patients with evidence of previous negative systematic transrectal ultrasound prostate biopsy. Material and Methods From February 2019 to February 2021 in the Clinic of Endourology and SWL of the Military Medical Academy – Sofia, in 59 patients repeated prostate biopsy was performed after a previous negative systematic transrectal ultrasound-guided biopsy. In 35/59 patients in the group, MRI / ultrasound transperineal prostate biopsy was performed (group A), and in the remaining 24/59 patients a repeat systemic TRUS biopsy was performed (group B). The main indications for repeat prostate biopsy were persistent elevated PSA values, a finding on rectal digital examination, and / or a suspected area of prostate MRI. Results. Preoperative data were comparable in the two groups of patients, with no statistically significant differences. The mean value of PSA in group A was 17.27 ± 14.6 ng / ml, compared to 25.93 ± 24.19 ng / ml in group B, p = 0.264. MRI / ultrasound transperineal prostate biopsy revealed the presence of prostate cancer in 28 patients (80%) of the study group, compared to 8 patients (33.3%) in the group who underwent systematic TRUS biopsy, p = 0.001. The histopathological results of group A revealed the presence of low-grade prostate cancer in 15 patients (42.9%), compared to 13 patients (37.1%) in whom high-grade cancer was detected. The results show a statistically significant difference compared to patients in group B, where 3 patients (12.5%) showed low-grade prostate cancer, and 5 patients (20.8%) had a high-grade malignant process, p = 0.005. There was no statistically significant difference in intra- and postoperative complications in the two groups. Conclusion. Performing MRI / ultrasound targeted biopsy showed significant higher efficacy and identical safety in diagnosing a prostate neoplastic process compared to standard 12-core transrectal systemic biopsy in patients with previous negative systemic TRUS biopsy.

SC266 - Association between previous negative biopsies and lower rates of disease progression during active surveillance for prostate cancer

SC266 - Association between previous negative biopsies and lower rates of disease progression during active surveillance for prostate cancer

SC102 - Accuracy of PI-RADS v2 categories to predict prostate cancer at prostate biopsy in a large institutional cohort of men with previous negative biopsy

SC102 - Accuracy of PI-RADS v2 categories to predict prostate cancer at prostate biopsy in a large institutional cohort of men with previous negative biopsy