Clinically Significant Prostate Cancer Detection Research Articles

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.

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). 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. 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). 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.

The diagnostic impact of UK regional variations in age-specific prostate-specific antigen guidelines.

The ideal prostate cancer diagnostic pathway would maximise detection of clinically-significant prostate cancer (csPCa) while avoiding unnecessary biopsies and other investigations. The introduction of pre-biopsy MRI has done much to aid this goal. However, referrals into the image-based diagnostic pathway still depends on prostate-specific antigen (PSA) testing performed in primary care and interpreted using referral guidelines. In the UK, the National Institute for Health and Care Excellence (NICE) only provides guidance on PSA thresholds for men aged 50-69 years (PSA ≥3.0 ng/mL) [1]. For other age groups, PSA thresholds are set by regional cancer networks without any unified consensus. Here we explored if different regional guidelines impacted csPCa detection in modern image-based pathways.

Analysis of risk factors for determining the need for prostate biopsy in patients with negative MRI

To analyze the clinical characteristics of patients with negative biparametric magnetic resonance imaging (bpMRI) who didn’t need prostate biopsies (PBs). A total of 1,012 male patients who underwent PBs in the First Affiliated Hospital of Nanjing Medical University from March 2018 to November 2019, of 225 had prebiopsy negative bpMRI (defined as Prostate Imaging Reporting and Data System (PI-RADS 2.1) score less than 3). The detection efficiency of clinically significant prostate cancer (CSPCa) was assessed according to age, digital rectal examination (DRE), prostate volume (PV) on bpMRI, prostate-specific antigen (PSA) and PSA density (PSAD). The definition of CSPCa for Gleason score > 6. Univariate and multivariable logistic regression analysis were used to identify predictive factors of absent CSPCa on PBs. Moreover, absent CSPCa contained clinically insignificant prostate cancer (CIPCa) and benign result. The detection rates of present prostate cancer (PCa) and CSPCa were 27.11% and 16.44%, respectively. Patients who were diagnosed as CSPCa had an older age (P < 0.001), suspicious DRE (P < 0.001), a smaller PV (P < 0.001), higher PSA value (P = 0.008) and higher PSAD (P < 0.001) compared to the CIPCa group and benign result group. PSAD < 0.15 ng/ml/cm3 (P = 0.004) and suspicious DRE (P < 0.001) were independent predictors of absent CSPCa on BPs. The negative forecast value of bpMRI for BP detection of CSPCa increased with decreasing PSAD, mainly in patients with naive PB (P < 0.001) but not in prior negative PB patients. 25.33% of the men had the combination of negative bpMRI, PSAD < 0.15 ng/ml/cm3 and PB naive, and none had CSPCa on repeat PBs. The incidence of PB was determined, CSPCa was 1.59%, 0% and 16.67% in patients with negative bpMRI and PSAD < 0.15 ng/ml/cm3, patients with negative bpMRI, PSAD < 0.15 ng/ml/cm3 and biopsy naive and patients with negative bpMRI, PSAD < 0.15 ng/ml/cm3 and prior negative PB, separately. We found that a part of patients with negative bpMRI, a younger age, no suspicious DRE and PSAD < 0.15 ng/ml/cm3 may securely avoid PBs. Conversely PB should be considered in patients regardless of negative bpMRI, especially who with a greater age, obviously suspicious DRE, significantly increased PSA value, a significantly small PV on MRI and PSAD > 0.15 ng/ml/cm3.

Interreader agreement in different PI-RADS systems in multiparametric prostate magnetic resonance imaging: A head-to-head comparison between PI-RADSv2 and v2.1

Aim The purpose of this study is to compare PI-RADSv2 with v2.1 in terms of interreader agreement and diagnostic performance in clinically significant prostate cancer (CSCa) detection. Materials and Methods Two hundred-two patients who had both multiparametric prostate magnetic resonance imaging (mpMRI) and 12 quadrant systematic biopsies were included in this retrospective study. Acquisition parameters were totally complied with proposal of PI-RADSv2 and 2.1 guidelines. mpMRIs were evaluated by two radiologists independently. Index lesion’s score was used to determine diagnostic performance of the systems. Gleason ≥ 3+4 tumors were considered CSCa. Kappa statistic was used to determine interreader agreement. Area under the curve (AUC) was calculated in detection of CSCa using receiver operating characteristic curve (ROC). Results The numbers of cases with PI-RADSv2 and v2.1 scores from 1 to 5 were 46, 21, 13, 41, 81 and 46, 26, 9, 43, 78, by reader 1 and 51, 10, 18, 43, 80 and 51, 15, 19, 37, 80 by reader 2, respectively. There was “substantial” agreement between two readers for both scoring systems. Kappa values were 0.600 in PI-RADSv2 and 0.624 in PI-RADSv2.1. Ninety-eight (48.5%) patients had CSCa. AUC values of PI-RADSv2 and v2.1 scoring systems were 0.861 and 0.851 for reader 1, 0.873 and 0.883 for reader 2, respectively. Conclusion Interreader agreement was “substantial” in mpMRI and slightly improved with PI-RADSv2.1. Diagnostic performance of the two systems were almost equal.

Real life data of MRI-targeted biopsy – experience from a single nonacademic centre using cognitive fusion and 1.5 tesla scanning

Objectives To date, it is unknown whether systematic biopsies can be safely omitted in patients with unsuspicious MRI findings or if systematic biopsies should be required when targeting focal lesions (PI-RADS 3–5). Methods A series of 366 patients (249 without a previous biopsy) were examined in a 1.5 Tesla MRI scanner. All patients were submitted to systematic biopsies (12–14 regions) with additional targeted biopsies (by cognitive fusion) of focal PI-RADS lesions (PI-RADS 3–5). Results In our series, patients with PI-RADS 1/2 findings had rates of adenocarcinoma of any grade, >GG1 and GG4/5 of 34%, 14% and 3%, respectively. The use of MRI prior to biopsy in our series increased the detection of clinically significant prostate cancer (CSPCa) in 28% of patients with focal lesions, and focal lesions were present in 293/366 (80%) of all patients. For CSPCa (>GG1), targeted biopsies improved the diagnosis in 28% of patients, while systematic biopsies resulted in an additional 19% of cancer cases in the series. Conclusion Systematic biopsies should still be considered in patients with PI-RADS 1/2 findings. Our findings also suggest a stronger benefit of the combined strategy of targeted and systematic biopsies than the findings of previous studies concerning the detection of CSPCa in biopsy-naïve patients.

Systematic review and meta-analysis comparing cognitive vs. image-guided fusion prostate biopsy for the detection of prostate cancer

ObjectiveTo perform a systematic review and meta-analysis comparing overall prostate cancer detection rate and clinically-significant prostate cancer detection rate between MRI-ultrasound image guided fusion biopsy (MRI-US FB) and cognitive biopsy (CB). MethodsA systematic review of Pubmed, EMBASE, MEDLINE, and Cochrane library databases was performed. Identified studies were assessed for clinical relevance and excluded based on a set of predefined criteria. Final articles included in the analysis comprised only prospective trials that compared CB vs. MRI-US FB in men with MRI-identifiable lesions (Prostate Imaging Reporting and Data System score 2+). Articles were reviewed for patient demographics, MRI protocol, and rates of overall and clinically significant prostate cancer detection by both modalities. ResultsNine studies were analyzed. A composite 1,714 men with mean age 64.6 years and mean PSA 8.2 ng/dL were reviewed. When comparing FB to CB, the odds ratio for overall and for clinically significant prostate cancer detection was 1.11 (95%CI 0.91–1.36, P = 0.30) and 1.13 (95%CI 0.89–1.44, P = 0.32), respectively. Heterogeneity among the studies was moderate but not significant for either overall (X2 = 14.67; I2 = 45%; P = 0.07) or clinically significant prostate cancer detection (X2 = 11.81; I2 = 49%; P = 0.07). ConclusionMRI-US FB demonstrates a trend toward improved rates of prostate cancer detection compared to CB, although this is not statistically significant. Further comparative studies may help to further elucidate whether one of these modalities is superior over the other.

MP56-17 SYSTEMATIC BIOPSY IS UNNECESSARY FOR MEN WITH PIRADS 5 AND PSA DENSITY GREATER THAN 15%

INTRODUCTION AND OBJECTIVE: To evaluate the detection of clinically significant prostate cancer (CSPCa) by systematic (SB) and target biopsy (TB) in men with Prostate Imaging Reporting and Data System - PIRADS 5; and the need for SB in this population. METHODS: We identified consecutive patients with PIRADS 5 lesion on multiparametric MRI (mpMRI; 3T, T2W, DWI, ADC, DCE) undergoing prostate biopsy (PBx) for suspicion of PCa, from our PBx database (IRB# HS-13–00663). Patients underwent mpMRI followed by 12-core SB and at least two TB cores per PIRADS 5 lesion. All MRIs were re-reviewed by an experienced radiologist. PBx were performed by an expert urologist using an MRI-transrectal ultrasound fusion system (Koelis). Each core-biopsy was labeled individually and interpreted according to ISUP Grade Group (GG) standards. Men with prior treatment for PCa or poor-quality MRI were excluded. The positive predictive value (PPV) of PIRADS 5 on MRI for CSPCa (GG ≥2) detection on PBx was analyzed. PSA density (PSAD) was calculated by dividing PSA by prostate volume on MRI. RESULTS: A total of 124 patients met inclusion criteria. The median (IQR) age, PSAD, number of positive cores, cancer core length and percent were: 69Y (64-75), 0.23ng/ml/cc (0.13-0.36), 7 (5-9), 12mm (9-15) and 90% (70-95), respectively. The CSPCa detection rate for SB+TB, TB and SB was: 88%, 82% and 65%, respectively. SB added 6% CSPCa detection to TB. The PPV for SB + TB of PIRADS 5 for any GG PCa and for CSPCa was 95% and 88%. Only 6 (6/124 = 5%) patients were not diagnosed with PCa on PBx: 2 with granuloma, 2 HGPIN, 1 focal inflammation, 1 benign prostatic tissue, but with metastatic PCa on pelvic lymph node biopsy. Considering only patients with PSAD>0.15ng/ml/cc (N = 86; 68% of the entire cohort), the CSPCa detection rate for SB+TB, TB and SB was: 95%, 92% and 72%. SB added 3% CSPCa detection to TB. Three (3/86=3.5%) patients with PSAD>0.15ng/ml/cc were diagnosed with CSPCa only on SB, and GG 1 PCa on TB. Had they been diagnosed with GG 1 on TB alone; these patients would not meet criteria for active surveillance because of high PSA or large cancer volume. The PPV for SB + TB of PIRADS 5 for any GG PCa and for CSPCa in men with PSAD>0.15ng/ml/cc was 98% and 95%, respectively. CONCLUSIONS: PIRADS 5 on mpMRI showed high positive predictive value for CSPCa on prostate biopsy. In those with PSAD>0.15ng/ml/cc, systematic biopsy marginally increased CSPCa, but not overall PCa detection in comparison to target biopsy alone. Systematic biopsy didn’t affect patients’ management and could be omitted on this population. Source of Funding: This study was funded in part by the R01 grant CA205058-01 from the National Institutes of Health/ National Cancer Institute (M.C.S, I.S.G. and A.L.A.).

MP81-04 SYSTEMATIC REVIEW AND META-ANALYSIS COMPARING COGNITIVE VS IMAGE-GUIDED FUSION PROSTATE BIOPSY FOR THE DETECTION OF PROSTATE CANCER

You have accessJournal of UrologyProstate Cancer: Detection & Screening VIII (MP81)1 Apr 2020MP81-04 SYSTEMATIC REVIEW AND META-ANALYSIS COMPARING COGNITIVE VS IMAGE-GUIDED FUSION PROSTATE BIOPSY FOR THE DETECTION OF PROSTATE CANCER Laena Frechette*, Ben Muller, Dan Ilinksy, Alex Sankin, Evan Kovac, Ahmed Aboumohamed, and Kara Watts Laena Frechette*Laena Frechette* More articles by this author , Ben MullerBen Muller More articles by this author , Dan IlinksyDan Ilinksy More articles by this author , Alex SankinAlex Sankin More articles by this author , Evan KovacEvan Kovac More articles by this author , Ahmed AboumohamedAhmed Aboumohamed More articles by this author , and Kara WattsKara Watts More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000973.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Data comparing MRI-ultrasound image guided fusion prostate biopsy (FB) and cognitive biopsy (CB) are lacking. We sought to perform a systematic review and meta-analysis comparing rates of overall and clinically-significant prostate cancer (PCa) detection between FB and CB. METHODS: A systematic review of Pubmed, EMBASE, MEDLINE, and Cochrane library databases was performed. Identified studies were assessed for clinical relevance and excluded based on a set of predefined criteria. Final articles included in the analysis comprised only prospective trials that directly compared CB versus FB in men with MRI-identifiable lesions (PIRADS score 2+). Articles were reviewed for patient demographics, prostate specific antigen (PSA), MRI protocol, and rates of overall and clinically significant prostate cancer detection by both modalities. RESULTS: Nine studies were analyzed. A composite 1714 men with mean age 64.6 years and mean PSA 8.2 ng/dL were reviewed. When comparing FB to CB, the odds ratio for overall and for clinically significant PCa detection was 1.11 (95% CI 0.91-1.36, p=0.30) and 1.13 (95% CI 0.89-1.44, p=0.32), respectively. Heterogeneity among the studies was moderate but not significant for either overall (X2 =14.67; I2 =45%; p = 0.07) or for clinically significant PCa detection (X2 =11.81; I2 =49%; p = 0.07). Operator experience with CB was not reported. CONCLUSIONS: MRI-US fusion biopsy demonstrates a trend toward improved rates of PCa detection compared to CB, although this did not reach statistical significance. Operator experience with CB is an important consideration for CB accuracy, and these data are not frequently reported. Further comparative studies may help to further elucidate whether one of these modalities is superior over the other. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1236-e1237 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Laena Frechette* More articles by this author Ben Muller More articles by this author Dan Ilinksy More articles by this author Alex Sankin More articles by this author Evan Kovac More articles by this author Ahmed Aboumohamed More articles by this author Kara Watts More articles by this author Expand All Advertisement PDF downloadLoading ...

PD57-01 MR/US FUSION-GUIDED PROSTATE BIOPSY IMPROVES CLINICALLY SIGNIFICANT PROSTATE CANCER DETECTION FOR BIOPSY-NAIVE PATIENTS ACROSS DIVERSE PRACTICE SETTINGS

You have accessJournal of UrologyProstate Cancer: Staging II (PD57)1 Apr 2020PD57-01 MR/US FUSION-GUIDED PROSTATE BIOPSY IMPROVES CLINICALLY SIGNIFICANT PROSTATE CANCER DETECTION FOR BIOPSY-NAIVE PATIENTS ACROSS DIVERSE PRACTICE SETTINGS Brett Watson*, MD Ji Qi, Anna Johnson, and for the Michigan Urological Surgery Improvement Collaborative Brett Watson*Brett Watson* More articles by this author , Ji QiJi Qi More articles by this author , Anna JohnsonAnna Johnson More articles by this author , and for the Michigan Urological Surgery Improvement Collaborative More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000967.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Multicenter trials have compared fusion to systematic prostate biopsy in the biopsy-naive population. These reports are predominantly from large academic centers with significant expertise. However, the added value of MR targeted biopsy for biopsy-naive patients in the community setting is largely unknown. METHODS: The Michigan Urological Surgery Improvement Collaborative (MUSIC) registry maintains a prospective MR and fusion biopsy database with technical, patient, provider, and lesion level data. All patients undergoing targeted and systematic biopsy in the same setting with no prior biopsy from August 2017 - May 2019 were included. Software-based MR/US fusion was used in all cases. Primary outcomes were the proportion of patients upgraded to ≥GG2 prostate cancer (PCa) by target and the proportion upgraded to ≥GG2 PCa based on systematic biopsy. RESULTS: Of 2375 fusion biopsies in the registry, 437 patients from 22 practices met inclusion criteria. Median age and pre-diagnosis PSA for the cohort was 66 years and 6.3 ng/ml, respectively. Overall cancer detection rate was 76.4% and the rate of clinically significant prostate cancer (csPCa) detection was 51.9%. Of the 227 cases of csPCa, 16% were detected by standard biopsy only, 17% by targeted biopsy only, and 67% by both techniques. Of all patients, 39 (8.9%) were upgraded to csPCa by targeted biopsy while 36 (8.2%) were upgraded to csPCa by standard biopsy. On bivariate analysis, we did not identify significant factors predictive of upgrading to csPCa by either technique. CONCLUSIONS: In biopsy-naïve patients, targeted biopsy upgrades approximately 1 in 10 patients to ≥GG2 prostate cancer. A similar proportion of patients with negative targeted biopsies were upgraded by systematic biopsy alone. There were no clinical variables associated with upgrading to ≥GG2 PCa by either biopsy method. Our findings suggest there is value in the community setting to adding mpMRI with targeted biopsy to the initial evaluation of biopsy-naive patients. Source of Funding: MUSIC is funded by Blue Cross Blue Shield of Michigan © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1193-e1193 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Brett Watson* More articles by this author Ji Qi More articles by this author Anna Johnson More articles by this author for the Michigan Urological Surgery Improvement Collaborative More articles by this author Expand All Advertisement PDF downloadLoading ...

Targeted and Systematic Biopsy for Diagnosis and Management of Prostate Cancer

The value of multi-parametric magnetic resonance imaging in the detection of clinically-significant prostate cancer is increasingly well-established, and has been adopted in current diagnostic pathways and clinical guidelines. Concurrently, the role of conventional ultrasound-guided systematic prostate biopsy is increasingly questioned. In this brief review, we evaluate the continued value of systematic biopsy including a review of prospective studies on targeted and systemic biopsies in the same patients. We also address current limitations of multi-parametric magnetic resonance imaging of the prostate.

How to make clinical decisions to avoid unnecessary prostate screening in biopsy-naïve men with PI-RADs v2 score ≤ 3?

To determine whether patients can avoid systematic prostate biopsy (PBx) if their Prostate Imaging Reporting and Data System version 2 (PI-RADs v2) score is ≤ 3 and how we clinicians make decisions that can maximize benefit. We reviewed our prospectively maintained database of consecutive men who received transrectal ultrasound-guided 24-core biopsy as well as pre-biopsy multi-parametric magnetic resonance imaging (mp-MRI). Of the 1276 men who were performed PBx in our institution from 2012 to July 2018, 491 patients conformed to the criteria. Negative predictive value (NPV) of negative mp-MRI (defined as PI-RADs < 3) combined prostate-specific antigen density (PSAD) were calculated. Models based on PI-RADs v2 were developed to predict the absence of clinically significant prostate cancer (CSPCa) and prostate cancer (PCa). Nomograms as well as receiver operating curves (ROC) were established to estimate the discrimination. Calibration curves were used to assess the concordance between predictive value and true risk. Decision curves were made to measure the overall net benefit. Prostate cancer and CSPCa detection rates were 21.6%, 7.3% and 36.7%, 23.4% in PIRADs v2 < 3 cohort and PIRADs v2 = 3 cohort, respectively. Men with biopsy-proved CSPCa had higher prostate-specific antigen (PSA), lower prostate volume (PV) and higher PSAD (all p < 0.05 in the two cohorts) than patients with clinically insignificant prostate cancer (CIPCa) or negative results. NPV of negative mp-MRI for detection of PCa was much higher when the PSAD was less than 0.15 (p < 0.001) and 0.2 for CSPCa (p = 0.007). According to multivariate analysis, we developed the model comprising Age, PSAD and PI-RADs v2 to predict the absence of CSPCa and PCa. The area under the curve (AUC) of the model for non-CSPCa was 0.75 (95% CI 0.68-0.80, PSAD cutoff 0.20), better than 0.71 (95% CI 0.65-0.80, PSAD cutoff 0.15). As for model for non-PCa, the AUC was 0.76 (95% CI 0.70-0.80, PSAD cutoff 0.15), higher than 0.71(95% CI 0.67-0.78, PSAD cutoff 0.20). Internally validated calibration curves showed that the model might overestimated the risk of the absence of CSPCa when the threshold was between 53 and 72%, and if the threshold was between 72 and 87%, it might underestimate the risk. As for the absence of PCa, the model might overestimate the risk between 52 and 76%. Decision curves showed that a better clinical net benefit was met when the threshold was 55% for non-PCa and 70% for non-CSPCa. NPV of negative mp-MRI for detection of CSPCa and PCa was improved with decreasing PSAD. The nomograms based on PI-RADs v2, age and PSAD showed internally validated high discrimination and calibration for the absence of PCa and CSPCa. When the predictive value was greater than 70% for the absence of CSPCa and 55% for the absence of PCa, we could avoid unnecessary PBx to maximize net benefit.

Association Between Tumor Multifocality on Multi-parametric MRI and Detection of Clinically-Significant Prostate Cancer in Lesions with Prostate Imaging Reporting and Data System (PI-RADS) Score 4

ObjectiveTo investigate whether presence of multifocality on multi-parametric magnetic resonance imaging would increase the likelihood of detecting clinically-significant prostate cancer in a PI-RADS 4 lesion. MethodsWe identified patients with at least 1 PI-RADS 4 lesion who underwent multi-parametric magnetic resonance imaging-ultrasound fusion prostate biopsy. Patients were grouped into 1 of 4 cohorts–cohort 1 (a PI-RADS 4 index lesion and an additional PI-RADS 2 or 3 lesion), cohort 2 (single lesion with PI-RADS 4), cohort 3 (2 or more PI-RADS 4 lesions), or cohort 4 (a PI-RADS 4 lesion and an index lesion with PI-RADS 5). We compared the rate of grade group (GG) ≥ 2 pathology on targeted biopsy of PI-RADS 4 lesions between cohorts and evaluated clinical and radiological factors associated with cancer detection. ResultsThe overall rate of GG ≥ 2 pathology in the PI-RADS 4 lesions was 35.2%. The rate of GG ≥ 2 pathology in the cohorts 1, 2, 3, and 4 was 21.7%, 36.3%, 49.1%, and 42.7%, respectively (P< .001). On multivariable analysis, age (OR1.06, P < .001), clinical stage T2 (OR1.59, P= .03), prostate-specific antigen density (OR1.43, P < .001), peripheral zone lesion (OR1.62, P = .04), and study cohort (cohort 2 vs 1, OR1.93, P = .006; and cohort 3 vs 1, OR3.28, P < .001) were significantly associated with the risk of GG ≥ 2 in the PI-RADS 4 lesion. ConclusionOn targeted biopsy of the PI-RADS 4 lesions, the proportion of GG ≥ 2 pathology is approximately 35%. Rate of GG ≥ 2 detection in PI-RADS 4 lesions might differ based on their location, multifocality, and PI-RADS classifications of other lesions identified.

How Would MRI-Targeted Prostate Biopsy Alter Radiation Therapy Approaches in Treating Prostate Cancer?

Magnetic resonance (MR)/ultrasound fusion-targeted prostate biopsy has been shown to improve detection of clinically-significant prostate cancer over systematic biopsy sampling. The effects of targeted biopsy on radiation therapy recommendations are not well understood. We aim to determine if targeted biopsy would lead to increased recommendations of aggressive radiotherapy treatments for higher risk prostate cancer compared to standard biopsy results. This is a retrospective review of prospectively gathered clinicopathologic data of 533 men who underwent both standard and targeted prostate biopsy from 2014-2017. Three patient cohorts were established: (1) biopsy naïve (80/533), (2) active surveillance (185/533), and (3) prior negative biopsy (268/533). Cancer risk category criteria were established with recommended radiotherapy treatment for each (Table 1). Variation of risk classification due to biopsy method for all patients and within each cohort were analyzed using either a chi-squared statistic or Fisher’s Exact test. McNemar’s pairwise analyses were performed for all risk categories between targeted and standard biopsy to assess the effects of targeted biopsy on high-risk cancer identification and subsequent radiotherapy recommendations. Distribution of patients within cancer risk categories varied due to targeted and standard biopsies among all patients (p<0.0001), in cohort 2 (p=0.0005), and in cohort 3 (p<0.0001). Further, among all patients, targeted biopsy increased cancer risk classification and, correspondingly, would likely result in more aggressive radiotherapy recommendations: Low-Risk to Intermediate-Risk (Gleason 4+3) (29/343, p<0.0001), Low-Risk to High-Risk (31/353, p<0.0001), and Intermediate-Risk (Gleason 3+4) to Intermediate-Risk (Gleason 4+3) (6/63, p=0.01). Among men with prostate cancer, the addition of targeted biopsy commonly led to reclassification to a higher risk group, which is likely accompanied by more aggressive radiotherapy treatment recommendations when compared with systematic biopsy sampling findings alone. Future prospective studies are needed to validate the degree of altered clinical recommendations regarding radiotherapy approaches due to targeted prostate biopsy.Abstract SU_26_2254; Table 1Prostate cancer risk category classification criteria and associated radiotherapy recommendations.Cancer Classification CriteriaTreatmentLow Risk CA- Gleason ≤ 6 - and PSA < 10 ng/mL - and ≤T2b by DRE- Fractionated EBRT - SBRT - Brachytherapy without EBRTFavorable Intermediate Risk CA- Gleason 7 (3+4) - or PSA 10-20 ng/mL - or T2c by DRE- Same as Low Risk CAUnfavorable Intermediate Risk CA- Gleason 7 (4+3) - or PSA 10-20 ng/mL - or T2c by DRE- Fractionated EBRT - SBRT - Brachytherapy with EBRT - ADTHigh Risk CA- Gleason ≥8 - or PSA ≥ 20 ng/mL - or ≥ T3a by DRE- Fractionated EBRT - EBRT with brachytherapy boost - ADT Open table in a new tab

Which Patients with Negative Magnetic Resonance Imaging Can Safely Avoid Biopsy for Prostate Cancer?

PurposeTo determine if there is a sub-set of men who can avoid prostate biopsy (PBx), based on multi-parametric MRI (mpMRI) and clinical characteristics. Materials and MethodsOf 1,149 consecutive men undergoing PBx (10/2011–03/2017), 135 had a pre-biopsy negative mpMRI (Prostate Imaging-Reporting and Data System score<3). Detection rates of clinically-significant prostate cancer (CSPCa) were evaluated according to PSA density (PSAD) and prior biopsy history. CSPCa was defined as Grade Group ≥ 2. Multivariable logistic regression analysis was performed to identify predictors for non-CSPCa on biopsy. ResultsPCa and CSPCa detection rates were 38% and 18%, respectively. Men with biopsy-detected CSPCa had smaller prostates (p=0.004), higher PSAD (p=0.02) and no history of prior negative biopsy (p=0.01) compared to the non-CSPCa cohort. PSAD<0.15ng/mL/cc (p<0.001) and prior negative biopsy (p=0.005) were independent predictors of absence of CSPCa on biopsy. Negative predictive value of mpMRI for biopsy-detection of CSPCa improved with decreasing PSAD, primarily in men with prior negative biopsy (p=0.001), but not for biopsy-naïve men. Thirty-two percent of men had the combination of negative mpMRI, PSAD<0.15ng/mL/cc and negative prior biopsy; none had CSPCa on repeat biopsy. Incidence of biopsy-identified CSPCa in men with negative mpMRI only; men with negative mpMRI and PSAD<0.15ng/mL/cc; and men with negative mpMRI, PSAD <0.15ng/mL/cc and negative prior biopsy was 18%, 10% and 0%, respectively. ConclusionWe propose a sub-set of men (with negative mpMRI, PSAD<0.15ng/mL/cc and prior negative biopsy) who may safely avoid re-biopsy. Conversely, PBx should be considered in biopsy-naïve men, regardless of negative mpMRI, particularly those with PSAD>0.15ng/mL/cc.

Multiparametric MRI to improve detection of prostate cancer compared with transrectal ultrasound-guided prostate biopsy alone: the PROMIS study.

Men with suspected prostate cancer usually undergo transrectal ultrasound (TRUS)-guided prostate biopsy. TRUS-guided biopsy can cause side effects and has relatively poor diagnostic accuracy. Multiparametric magnetic resonance imaging (mpMRI) used as a triage test might allow men to avoid unnecessary TRUS-guided biopsy and improve diagnostic accuracy. To (1) assess the ability of mpMRI to identify men who can safely avoid unnecessary biopsy, (2) assess the ability of the mpMRI-based pathway to improve the rate of detection of clinically significant (CS) cancer compared with TRUS-guided biopsy and (3) estimate the cost-effectiveness of a mpMRI-based diagnostic pathway. A validating paired-cohort study and an economic evaluation using a decision-analytic model. Eleven NHS hospitals in England. Men at risk of prostate cancer undergoing a first prostate biopsy. Participants underwent three tests: (1) mpMRI (the index test), (2) TRUS-guided biopsy (the current standard) and (3) template prostate mapping (TPM) biopsy (the reference test). Diagnostic accuracy of mpMRI, TRUS-guided biopsy and TPM-biopsy measured by sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) using primary and secondary definitions of CS cancer. The percentage of negative magnetic resonance imaging (MRI) scans was used to identify men who might be able to avoid biopsy. Diagnostic study - a total of 740 men were registered and 576 underwent all three tests. According to TPM-biopsy, the prevalence of any cancer was 71% [95% confidence interval (CI) 67% to 75%]. The prevalence of CS cancer according to the primary definition (a Gleason score of ≥ 4 + 3 and/or cancer core length of ≥ 6 mm) was 40% (95% CI 36% to 44%). For CS cancer, TRUS-guided biopsy showed a sensitivity of 48% (95% CI 42% to 55%), specificity of 96% (95% CI 94% to 98%), PPV of 90% (95% CI 83% to 94%) and NPV of 74% (95% CI 69% to 78%). The sensitivity of mpMRI was 93% (95% CI 88% to 96%), specificity was 41% (95% CI 36% to 46%), PPV was 51% (95% CI 46% to 56%) and NPV was 89% (95% CI 83% to 94%). A negative mpMRI scan was recorded for 158 men (27%). Of these, 17 were found to have CS cancer on TPM-biopsy. Economic evaluation - the most cost-effective strategy involved testing all men with mpMRI, followed by MRI-guided TRUS-guided biopsy in those patients with suspected CS cancer, followed by rebiopsy if CS cancer was not detected. This strategy is cost-effective at the TRUS-guided biopsy definition 2 (any Gleason pattern of ≥ 4 and/or cancer core length of ≥ 4 mm), mpMRI definition 2 (lesion volume of ≥ 0.2 ml and/or Gleason score of ≥ 3 + 4) and cut-off point 2 (likely to be benign) and detects 95% (95% CI 92% to 98%) of CS cancers. The main drivers of cost-effectiveness were the unit costs of tests, the improvement in sensitivity of MRI-guided TRUS-guided biopsy compared with blind TRUS-guided biopsy and the longer-term costs and outcomes of men with cancer. The PROstate Magnetic resonance Imaging Study (PROMIS) was carried out in a selected group and excluded men with a prostate volume of > 100 ml, who are less likely to have cancer. The limitations in the economic modelling arise from the limited evidence on the long-term outcomes of men with prostate cancer and on the sensitivity of MRI-targeted repeat biopsy. Incorporating mpMRI into the diagnostic pathway as an initial test prior to prostate biopsy may (1) reduce the proportion of men having unnecessary biopsies, (2) improve the detection of CS prostate cancer and (3) increase the cost-effectiveness of the prostate cancer diagnostic and therapeutic pathway. The PROMIS data set will be used for future research; this is likely to include modelling prognostic factors for CS cancer, optimising MRI scan sequencing and biomarker or translational research analyses using the blood and urine samples collected. Better-quality evidence on long-term outcomes in prostate cancer under the various management strategies is required to better assess cost-effectiveness. The value-of-information analysis should be developed further to assess new research to commission. Current Controlled Trials ISRCTN16082556 and NCT01292291. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 39. See the NIHR Journals Library website for further project information. This project was also supported and partially funded by the NIHR Biomedical Research Centre at University College London (UCL) Hospitals NHS Foundation Trust and UCL and by The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research Biomedical Research Centre and was co-ordinated by the Medical Research Council's Clinical Trials Unit at UCL (grant code MC_UU_12023/28). It was sponsored by UCL. Funding for the additional collection of blood and urine samples for translational research was provided by Prostate Cancer UK.

The Role of Systematic and Targeted Biopsies in Light of Overlap on Magnetic Resonance Imaging Ultrasound Fusion Biopsy

BackgroundThe value of a systematic biopsy in men with magnetic resonance imaging (MRI)–visible regions of interest (ROIs) undergoing fusion biopsy (FBx) is unclear. ObjectiveTo determine the utility of concurrent systematic biopsy with ROI biopsy in detecting clinically significant prostate cancer (CSPC). Design, setting, and participantsRetrospective study of 240 men who underwent FBx with the Artemis platform. Software captured biopsy distribution maps. Biopsy distribution maps were reviewed to determine which systematic cores overlapped with the ROI. Histopathology for overlapping systematic cores were reclassified as ROI cores. Outcome measurements and statistical analysisDetection of CSPC on true systematic biopsy was the outcome measured. Multivariable logistic regression was used to determine if age, prostate-specific antigen, prostate volume, prior biopsy status, and Prostate Imaging-Reporting and Data System categorization were associated with CSPC detection and Gleason grade upgrading on systematic biopsy. Results and limitationsThe median number of systematic cores overlapping with ROIs was 2 (interquartile range 1–2). After accounting for overlap, 14 men (5.8%) had a higher Gleason grade on systematic biopsy. Of these, seven (2.9%) were upgraded from benign and three (1.3%) from clinically insignificant cancer on systematic biopsy. In adjusted analysis, prior negative biopsy (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.21–0.99; p=0.046) was associated with absence of CSPC on systematic biopsy, while age (OR 1.11, 95% CI 1.02–1.21; p=0.015) was associated with upgrading. Limitations include the retrospective data and the use of a single biopsy platform. ConclusionsDetection of CSPC on systematic biopsy that might influence clinical decision-making is uncommon in men undergoing FBx. In men with a prior negative biopsy, a target-only FBx strategy could be considered because of the low yield on systematic biopsy. Patient summaryWe found that random prostate sampling adds little diagnostic value in men who are undergoing a targeted biopsy of suspicious lesions found on imaging, especially for men who have had a prior negative biopsy.

Automated Detection of Clinically Significant Prostate Cancer in mp-MRI Images Based on an End-to-End Deep Neural Network.

Automated methods for detecting clinically significant (CS) prostate cancer (PCa) in multi-parameter magnetic resonance images (mp-MRI) are of high demand. Existing methods typically employ several separate steps, each of which is optimized individually without considering the error tolerance of other steps. As a result, they could either involve unnecessary computational cost or suffer from errors accumulated over steps. In this paper, we present an automated CS PCa detection system, where all steps are optimized jointly in an end-to-end trainable deep neural network. The proposed neural network consists of concatenated subnets: 1) a novel tissue deformation network (TDN) for automated prostate detection and multimodal registration and 2) a dual-path convolutional neural network (CNN) for CS PCa detection. Three types of loss functions, i.e., classification loss, inconsistency loss, and overlap loss, are employed for optimizing all parameters of the proposed TDN and CNN. In the training phase, the two nets mutually affect each other and effectively guide registration and extraction of representative CS PCa-relevant features to achieve results with sufficient accuracy. The entire network is trained in a weakly supervised manner by providing only image-level annotations (i.e., presence/absence of PCa) without exact priors of lesions' locations. Compared with most existing systems which require supervised labels, e.g., manual delineation of PCa lesions, it is much more convenient for clinical usage. Comprehensive evaluation based on fivefold cross validation using 360 patient data demonstrates that our system achieves a high accuracy for CS PCa detection, i.e., a sensitivity of 0.6374 and 0.8978 at 0.1 and 1 false positives per normal/benign patient.

PD23-07 INCREASED DETECTION OF HIGHER GRADE PROSTATE CANCER WITH MRI-FUSION PROSTATE BIOPSY AT HIGHER PSA

You have accessJournal of UrologyProstate Cancer: Detection & Screening II1 Apr 2018PD23-07 INCREASED DETECTION OF HIGHER GRADE PROSTATE CANCER WITH MRI-FUSION PROSTATE BIOPSY AT HIGHER PSA Nabeel Shakir, Niccolo Passoni, Daniel Wong, Samuel Gold, Graham Hale, Kareem Rayn, Joseph Baiocco, Jonathan Bloom, Vladimir Valero, Maria Merino, Baris Turkbey, Peter Choyke, Bradford Wood, Peter Pinto, Daniel Costa, and Claus Roehrborn Nabeel ShakirNabeel Shakir More articles by this author , Niccolo PassoniNiccolo Passoni More articles by this author , Daniel WongDaniel Wong More articles by this author , Samuel GoldSamuel Gold More articles by this author , Graham HaleGraham Hale More articles by this author , Kareem RaynKareem Rayn More articles by this author , Joseph BaioccoJoseph Baiocco More articles by this author , Jonathan BloomJonathan Bloom More articles by this author , Vladimir ValeroVladimir Valero More articles by this author , Maria MerinoMaria Merino More articles by this author , Baris TurkbeyBaris Turkbey More articles by this author , Peter ChoykePeter Choyke More articles by this author , Bradford WoodBradford Wood More articles by this author , Peter PintoPeter Pinto More articles by this author , Daniel CostaDaniel Costa More articles by this author , and Claus RoehrbornClaus Roehrborn More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.1188AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Lower threshold values for undertaking prostate biopsy based on serum prostate-specific antigen (PSA) improve overall cancer detection but conversely may result in overdiagnosis of lower-risk prostate cancer (PCa). Multiparametric magnetic resonance imaging (MP-MRI) fusion biopsy has been demonstrated to detect higher grade PCa as compared to standard template transrectal ultrasound (TRUS) guided biopsy but an optimal PSA threshold for its use is unclear. We evaluated the performance of MRI fusion biopsy stratified across PSA cutoffs. METHODS We reviewed 1913 men undergoing first-time MP-MRI followed by MRI-fusion and standard template transrectal ultrasound guided prostate biopsy at two institutions. Patients were divided into 4 groups by PSA: 0-2.5, 2.5-4, 4-10, and >10 ng/mL. The greatest grade group (GG) from either MRI-fusion or standard biopsy was compared across groups with McNemar's test, with clinically-significant (CS) PCa defined as >GG2. RESULTS A total of 1235/1913 (65%) men were diagnosed with PCa by either biopsy method. MRI-fusion biopsy detected higher grade PCa and specifically more CS PCa than did standard biopsy overall (423/1913 vs 340/1913, and 151/1913 vs 63/1913 respectively, p<0.0001 for both). By PSA groups, significantly more patients with PSA 4-10 and >10 ng/mL had CS PCa found by MRI-fusion vs standard biopsy (Figure 1). However, more patients with PSA 2.5-4 ng/mL had CS PCa found by standard biopsy (9/232 vs 2/232, p=0.03). PSA cutoff remained significantly associated with upgrading to CS PCa by targeted biopsy when controlling for age and MRI volume in multivariable analysis (p<0.0001). CONCLUSIONS The detection of CS PCa by MRI-fusion biopsy may be maximized in patients with PSA 4-10 and >10 ng/mL. Below these threshold values, standard template biopsy may identify slightly more CS PSA, emphasizing the importance of performing standard biopsy in conjunction with MRI-targeted biopsy in this population. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e482-e483 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Nabeel Shakir More articles by this author Niccolo Passoni More articles by this author Daniel Wong More articles by this author Samuel Gold More articles by this author Graham Hale More articles by this author Kareem Rayn More articles by this author Joseph Baiocco More articles by this author Jonathan Bloom More articles by this author Vladimir Valero More articles by this author Maria Merino More articles by this author Baris Turkbey More articles by this author Peter Choyke More articles by this author Bradford Wood More articles by this author Peter Pinto More articles by this author Daniel Costa More articles by this author Claus Roehrborn More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

The validity of repeat prostate biopsy in prior biopsy negative patients: MRI-TRUS fusion guided biopsy.

95 Background: To investigate validity of magnetic resonance imaging (MRI)-transrectal ultrasound fusion target biopsy (Fusion-Bx) compared with transrectal ultrasound-guided biopsy (TRUS-Bx) by evaluating detection rate of prostate cancer (PCa). Methods: Medical records of 376 patients with prior negative TRUS-Bx who underwent repeat prostate biopsy between Aug. 2015 and Apr. 2017 were retrospectively reviewed. The cohort was stratified into two groups (TRUS-Bx and Fusion-Bx) and clinical and biopsy characteristics patterns were analyzed. Conventional systemic randomized 12-core biopsy was performed in TRUS-Bx group whereas Fusion-Bx group applied additional 2-croes of target biopsy against suspicious lesions in MRI. Results: There were total 195 and 181 patients in TRUS-Bx and Fusion-Bx group, respectively. The overall cancer detection rate was slightly higher in Fusion-Bx group, but no statistical significance was observed (24.6% vs 28.7%, p = 0.367). Fusion-Bx group showed a significantly greater detection rate in target core analysis (5.0% vs 17.7%, p = 0.044). In confirmed positive biopsy patients, Fusion-Bx group had a higher rate of clinically significant prostate cancer (CsPCa) cases, but failed to achieve statistical significance (85.4% vs 92.3%, p = 0.271). When the patients with highly or very highly suspicious MRI (maximum image grade 4-5) findings in Fusion-Bx group was compared to the whole cohort of TRUS-Bx group, Fusion-Bx group was significantly greater in terms of overall detection rate (24.6% vs 38.0%, p = 0.017) and CsPCa detection rate (85.4% vs 97.0%, p = 0.009). Higher the target image grade, greater biopsy yield was achieved. Conclusions: For the patients who underwent repeat biopsy due to prior negative results, fusion-Bx showed better clinical significance including detection rate. A further study with a larger cohort size and prospective design is still needed to confirm the validity of Fusion-Bx.

Multiparametric MRI/ultrasound fusion-guided biopsy decreases detection of indolent cancer in African-American men.

Analysis of systematic 12-core biopsies (SBx) has shown that African-American (AA) men tend to harbor higher risk prostate cancer (PCa) at presentation relative to other races. Multiparametric magnetic resonance imaging (mpMRI) and MRI-ultrasound fusion-guided biopsy (FBx) have been shown to diagnose more intermediate- and high-risk PCa in the general population; however, the efficacy in AA remains largely uncharacterized. We aim to evaluate the utility of FBx in an AA patient cohort. Men suspected of PCa underwent an mpMRI and FBx with concurrent SBx from 2007 to 2015 in this institutional review board-approved prospective cohort study. Patient demographics, imaging and fusion biopsy variables were collected. χ2, Mann-Whitney U-test and McNemar's tests were performed to compare proportions, means and paired variables, respectively. Clinically significant PCa (CSPCa) was defined as Gleason score ⩾3+4. Fusion biopsy demonstrated exact agreement with SBx risk categories in 64% of AA men. There was no statistically significant difference in the detection of CSPCa between FBx vs SBx (68 vs 62 cases, P=0.36). However, FBx detected 41% fewer cases of clinically insignificant PCa (CIPCa) compared with SBx (FBx 30 vs SBx 51 cases, P=0.0004). The combined FBx/SBx biopsy approach detected significantly more cases of CSPCa (FBx/SBx 80 vs SBx 62 cases, P=0.004) while detecting comparable number of cases of CIPCa (FBx/SBx 45 vs SBx 51 cases, P=0.37) compared with SBx alone. FBx/SBx also detected more CSPCa in patients with a history of prior negative SBx (FBx/SBx 28 vs 19 cases, P=0.003). FBx when used in combination with SBx detected more cases of CSPCa while not significantly increasing the diagnosis of CIPCa in AA men. Future multicenter studies will be needed to validate ultimately the clinical implications of FBx in AA patients.