Clinically-significant Cancer Research Articles

Optimal size threshold for PIRADSv2 category 5 upgrade and its positive predictive value: is it predictive of “very high” likelihood of clinically-significant cancer?

To identify the optimal size metric and threshold for Prostate Imaging Reporting and Data System (PIRADS) 5 upgrade, calculate its positive predictive value (PPV) for clinically-significant prostate cancer (csPCA), and determine if it is indicative of a "very high" likelihood of csPCA. One hundred and forty-three PIRADS 4 or 5 lesions were evaluated. Lesion diameters were used to calculate lesion volume (LV). Pearson correlation between maximum lesion diameter (MLD) and LV was calculated. Area under the curve (AUC) for discriminating csPCA (Gleason grade ≥ 3+4) was calculated using MLD and LV. Optimal size thresholds (using Youden index) and highly predictive size thresholds were identified for the whole prostate (WP), peripheral zone (PZ), and transitional zone (TZ). There was high correlation between MLD and LV (r=0.77-0.81), with comparable AUCs for MLD and LV in the identification of csPCA in the WP (0.73, 0.72), PZ (0.73, 0.73), and TZ (0.79, 0.75). Optimal MLD thresholds were 1.4, 1.4, and 1.6 cm in the WP, PZ, and TZ respectively, with PPVs of 76%, 81%, and 69%, respectively. An MLD threshold of 2.7 cm would be needed in the WP to achieve a PPV approaching 90%, with sensitivity decreasing to 10%. There is high correlation between MLD and LV with comparable discrimination of csPCA using each. PIRADSv2's 1.5 cm MLD threshold is near the optimal threshold for PIRADS 5 upgrade but has moderate PPV. A much higher threshold would be needed to increase its PPV, with significant sacrifice in sensitivity.

MP44-01 OPTIMAL SEQUENCING OF MRI AND PROSTATE HEALTH INDEX AS RISK STRATIFICATION TOOLS IN A BIOMARKER-IMAGING PROSTATE CANCER SCREENING PATHWAY

You have accessJournal of UrologyCME1 Apr 2023MP44-01 OPTIMAL SEQUENCING OF MRI AND PROSTATE HEALTH INDEX AS RISK STRATIFICATION TOOLS IN A BIOMARKER-IMAGING PROSTATE CANCER SCREENING PATHWAY Yi Quan Tan, Woon Chau Tsang, Ziting Wang, and Edmund Chiong Yi Quan TanYi Quan Tan More articles by this author , Woon Chau TsangWoon Chau Tsang More articles by this author , Ziting WangZiting Wang More articles by this author , and Edmund ChiongEdmund Chiong More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003290.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To determine the optimal sequence of MRI and Prostate Health Index (PHI) as risk stratification tools in the early detection of prostate cancer. METHODS: 181 men presented between Aug 2016 and Oct 2020, undergoing MRI and PHI before MRI-fusion biopsy. Biopsy included targeted and saturation cores. PIRADS score, PHI, and histology results were recorded. To determine the optimal sequence of MRI and PHI, modelling was performed with 4 pathways designed to guide biopsy decisions. PIRADS 3 or more, and PHI of 30 or more, were considered as screen-positive tests and patients proceeded with biopsy. The 4 pathways were: (1) PHI first then MRI to stratify PHI-negative cases; (2) MRI first then PHI to stratify MRI-negative cases; (3) PHI first then MRI to stratify PHI-positive cases; and (4) MRI first then PHI to stratify MRI-positive cases. For each pathway, the key outcomes measured were (1) the percentage of biopsies avoided, (2) clinically-significant cancers missed (Grade Group 2 and above); and (3) unnecessary biopsies (negative and Grade Group 1). RESULTS: Overall cancer detection rate was 61.3%, and the clinically-significant cancer detection rate was 37.6%. 88.4% had a PIRADS 3 or higher lesion, and 82.9% had a PHI level of 30 or more. In Pathway 1, where PHI was used first-line, with MRI as second-line when PHI was negative, 2.21% of biopsies would be avoided, and no clinically-significant cancers would be missed. In Pathway 2, where MRI was used first-line, with PHI as second-line when MRI was negative, 2.21% of biopsies would be avoided, and no clinically significant cancers would be missed. In Pathways 3 and 4, 26% of biopsies were avoided, yet 3.9% of clinically-significant cancers would be missed (see Figure 1). CONCLUSIONS: The combination of PHI and MRI did not miss any clinically-significant cancers. This was only evident in the pathways where the second-line test was used in cases when the first-line test was negative. Whether PHI or MRI was sequenced as the first-line test did not affect the overall diagnostic performance in the detection of prostate cancer. We propose that MRI and PHI be combined to achieve the optimal screening performance for prostate cancer detection. Source of Funding: There are no sources of funding © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e610 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Yi Quan Tan More articles by this author Woon Chau Tsang More articles by this author Ziting Wang More articles by this author Edmund Chiong More articles by this author Expand All Advertisement PDF downloadLoading ...

The utility of two-dimensional shear wave elastography for predicting prostate cancer: a preliminary study.

This study investigated whether two-dimensional shear wave elastography (2D-SWE), using a newly developed device, is useful for predicting prostate cancer (PCa). In this prospective study, 38 patients with suspected PCa underwent 2D-SWE, followed by a standard systematic 12-core biopsy with and without a targeted biopsy. Tissue stiffness on SWE was measured in the target lesion and in 12 regions of the systematic biopsies, and the maximum (Emax), mean (Emean), and minimum (Emin) values of stiffness were generated. The area under the receiver operating characteristic curve (AUROC) for predicting clinically significant cancer (CSC) was calculated. Interobserver reliability and variability were evaluated using the intraclass correlation coefficient (ICC) and Bland-Altman plots, respectively. PCa was found in 78 of 488 regions (16%) in 17 patients. In region-based and patientbased analyses, the Emax, Emean, and Emin values of PCa were significantly higher than those of benign prostate tissue (P<0.001). For the prediction of CSC, the AUROCs of Emax, Emean, and Emin in the patient-based analysis were 0.865, 0.855, and 0.828, while that of prostate-specific antigen density was 0.749. In the region-based analysis, the AUROCs of Emax, Emean, and Emin values were 0.772, 0.776, and 0.727, respectively. The interobserver reliability for the SWE parameters was moderate to good (ICC, 0.542 to 0.769), and the mean percentage differences on Bland-Altman plots were less than 7.0%. The 2D-SWE method appears to be a reproducible and useful tool for the prediction of PCa. A larger study is warranted for further validation.

Multi-reader evaluation of different image quality scoring systems in prostate MRI

ObjectivesTo evaluate different image quality scoring systems in the assessment of factors limiting diagnostic accuracy of prostate MRI. MethodsThis retrospective IRB-approved study included 281 patients undergoing prostate MRI prior to biopsy. Four readers (2 experienced, 2 novice) independently reviewed all MRI examinations (n = 295) and assigned scores for subjective image quality (1–5; 1:poor, 5:excellent), the PI-QUAL and the PSHS scoring system. The original PI-RADS scores were extracted from the report and transperineal template saturation biopsy served as histopathological reference. ResultsInter-reader agreement was found to be good, with PSHS showing highest agreement (kappa: 0.65). The PSHS scoring system performed well assessing the influence of image quality on sensitivity of MR for clinically-significant cancer for the experienced readers using a PI-RADS score cut-off ≥ 3/≥4, as did the PI-QUAL scoring system with a PI-RADS cut-off ≥ 4. For the less experienced radiologist, this was true for PSHS (clinically-significant and all cancers) and PI-QUAL scores (clinically-significant cancers) for a PI-RADS score ≥ 3. PSHS scores were positively associated with the detection of clinically-significant cancer based on a PI-RADS cut-off ≥ 4, OR 1.86 (95 % CI 1.22–2.82), and had the highest Somers’ D. ConclusionsThe PSHS scoring system performed well in assessing the effect of image quality on detection rates, as did the PI-QUAL system. Since both systems focus on different aspects of image quality, their incorporation into prostate MRI reports could further enhance standardization and allow for a reliable assessment of image quality as a potential confounder in prostate MRI.

High-resolution 3D T2-weighted SPACE sequence with compressed sensing for the prostate gland: diagnostic performance in comparison with conventional T2-weighted images.

To compare the diagnostic performance of high-resolution 3D T2-weighted imaging (T2WI) with compressed sensing (CS) sampling perfection with application-optimized contrasts using different flip angle evolution (SPACE) to that of conventional T2WI with turbo spin echo (TSE) in prostate MRI. This study evaluated 179 patients (mean age 69.1 ± 9.3) who underwent prostate biopsy after prostate prebiopsy MRI, including two sets of three-plane T2WI with TSE (thickness: 3mm, scan time: 10min 4s) and CS SPACE (thickness: 0.6mm, scan time: 4min 55s). Two radiologists evaluated two sets of images with the Prostate Imaging-Reporting and Data System (PIRADS) classification and determined the extraprostatic extension (EPE) of the lesion. The diagnostic performance to detect prostate cancer (PIRADS classification) and EPE was compared between the two T2WI sets. Clinically significant cancer (CSC) was diagnosed in 103 patients (57.5%). Areas under the receiver operating characteristic curve of the PIRADS classification on both image sets with T2 TSE and T2 CS SPACE were higher than 0.7 and did not show significant differences for either radiologist (p > 0.05). EPE was confirmed in 25 of 70 patients underwent prostatectomy. For evaluating EPE on MRI, the sensitivity and specificity did not differ between the two T2WI sequences (p > 0.05). High-resolution 3D T2WI using CS SPACE, which was acquired within a shorter acquisition time than three-plane T2 TSE, showed comparable diagnostic performance to conventional T2 TSE for detecting CSC and evaluating EPE.

Concordance of MRI-Guided Fusion and Systematic 12-Core Prostate Biopsy for the Detection of Prostate Cancer.

BackgroundMRI-guided fusion biopsy is increasingly utilized over systematic 12-core biopsy for men with MRI-visible prostate lesions.Patients and MethodsPatients with MRI visible lesions who underwent MRI-guided fusion and systematic 12-core biopsy from 2016-2020 in the Intermountain Healthcare (IHC) system were consecutively analyzed. This was in the setting of a continuous quality assurance initiative among the reading radiologists. Primary outcome was prostate cancer (PCa) detection defined by Gleason grade group (GGG) 1 or higher. Clinically significant cancer (CSC) was defined as GGG 2 or higher. Patients were stratified by biopsy date, 2016-2017 and 2018-2021, and lesions were stratified by PI-RADS v2 category.ResultsA total of 184 patients with 324 MRI-detectable lesions underwent both biopsy modalities in the IHC system from 2016 to 2021. CSC was detected in 23.5% of MRI-guided fusion biopsies. Comparing PI-RAD v2 categories 1-3 to categories 4-5, rate of CSC was 10% and 42% respectively. MRI-guided fusion and systematic 12-core biopsies were concordant for PCa in 77% of men and CSC in 83%. MRI-guided fusion biopsy detected PCa in 26/103 and CSC in 20/131 men in whom systematic 12-core biopsy was negative. Systematic 12-core biopsy detected PCa in 17/94 and CSC in 11/122 men in whom MRI-guided fusion was negative.ConclusionsOmitting MRI-guided fusion or systematic 12-core biopsy would have resulted in underdiagnosis of CSC in 11% or 6% of patients respectively. Combining biopsies increased detection rate of CSC. This was in the setting of a continuous quality assurance program at a large community-based hospital.

MP16-13 CAN WE USE THE PROSTATE HEALTH INDEX TO AVOID A PROSTATE BIOPSY IN AFRICAN AMERICAN MEN?

You have accessJournal of UrologyCME1 May 2022MP16-13 CAN WE USE THE PROSTATE HEALTH INDEX TO AVOID A PROSTATE BIOPSY IN AFRICAN AMERICAN MEN? Kostantinos Morris, Srinath Kotamarti, and Judd Moul Kostantinos MorrisKostantinos Morris More articles by this author , Srinath KotamartiSrinath Kotamarti More articles by this author , and Judd MoulJudd Moul More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002549.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: African American (AA) race is a well-known risk factor for prostate cancer (PCa). However, the aggressive push to maximize detection of clinically significant cancer (CSC) is inevitably prone to high rates of over-biopsy. Prostate Health Index (PHI) is a Food and Drug Administration-approved tool to aid in the diagnosis of PCa in men with PSA 4-10 ng/ml. We sought to assess the effectiveness of PHI to avoid a prostate biopsy in AA men with an equivocal PSA. METHODS: Within the Duke Health System, AA men undergoing prostate biopsy with a PSA 4-10 ng/ml and PHI scores from 2016-2020 were identified. The cohort was analyzed for a PHI score cutoff for which 10% or less of men would be identified with CSC, defined as Gleason score ≥7. Representative 95% confidence intervals (CI) were calculated along with cancer detection rates. ROC curves for all PCa and CSC at biopsy were used to identify the area under the curve (AUC) and the diagnostic value of the proposed cutoff point. RESULTS: A total of 236 AA men with an average age of 61.2 years met inclusion criteria out of the 1,131 men who had PHI testing during the study period. Mean PHI and PSA for the entire cohort were 48.5 (SD 21.6) and 6.5 ng/ml (SD 1.7), respectively. Using the established lowest PHI cutoff of 27 led to six of 25 (24.0%) men diagnosed with CSC and 12 of 25 (48%) diagnosed with all PCa. Below a proposed PHI level of 23, one of 12 men were diagnosed with CSC (8.3% [CI: 0.002 – 0.385]) and two of 12 men were diagnosed with any PCa (16.7% [CI: 0.021 – 0.484]). Overall, PHI showed an AUC for all PCa and CSC of 0.705 (0.636 – 0.774) and 0.688 (0.621 – 0.755), respectively. PHI cut point of 23 was associated with a 98.7% sensitivity for all PCa and 99.0% for CSC, at a cost of specificities of 11.8% and 8.4%, respectively. Using this cut point 11 negative biopsies could be avoided, equating to 4.7% of the cohort. CONCLUSIONS: The currently accepted lowest PHI cut point leads to an excessively high rate of PCa in this cohort of AA men. Alternatively, men with a PHI below a proposed cutoff of 23 had optimally low rates of cancer detection and excellent sensitivity to minimize false negative biopsies. While our cohort is the largest reported of AA men undergoing PHI, further validation is needed to confirm these findings. Though generally at higher risk, AA men with an equivocal PSA and a PHI below 23 should be considered candidates to avoid a prostate biopsy. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e280 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kostantinos Morris More articles by this author Srinath Kotamarti More articles by this author Judd Moul More articles by this author Expand All Advertisement PDF DownloadLoading ...

PD11-04 THE LIMITED UTILITY OF PROSTATE HEALTH INDEX IN AFRICAN AMERICAN MEN WITH A PSA 4-10

You have accessJournal of UrologyCME1 May 2022PD11-04 THE LIMITED UTILITY OF PROSTATE HEALTH INDEX IN AFRICAN AMERICAN MEN WITH A PSA 4-10 Kostantinos Morris, Judd Moul, and Srinath Kotamarti Kostantinos MorrisKostantinos Morris More articles by this author , Judd MoulJudd Moul More articles by this author , and Srinath KotamartiSrinath Kotamarti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002537.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Prostate Health Index (PHI) is a blood test approved for men being evaluated for prostate cancer (PCa) with a prostate specific antigen (PSA) in the “gray zone” of 4-10 ng/ml. As such, in the largest examination of PHI in African American (AA) men, we sought to assess PHI utility in the pre-biopsy work-up of this demographic, who notably were minimally represented in the original validation studies. METHODS: AA men in the Duke Health System with a PSA of 4-10 ng/mL, a PHI score, and subsequent prostate biopsy between 2016-2020 were identified. Established PHI cutoffs were utilized to stratify patients (Table 1). Multivariable logistical regressions were performed to assess possible predictors of cancer detection with the lowest PHI cutoff serving as reference. Clinically significant cancer (CSC) was defined as Gleason ≥7. RESULTS: A total of 1,131 AA men underwent PHI testing, and 236 met final inclusion criteria. Average age was 61.2 years. Mean PSA and PHI for the entire cohort were 6.5 ng/ml (SD 1.7) and 48.5 (SD 21.6), respectively. Detection rate at biopsy was 64.0% (n=151) for any PCa, ranging from 48.0% for PHI 0-26.9 to 84.1% for PHI ≥55 (Table 1). For CSC, overall detection rate was 44.5% (n=105), ranging from 24.0% for PHI 0-26.9 to 66.7% for PHI ≥55 (Table 1). On multivariable analysis, PHI ≥55 cutoff was the only PHI category associated with identification of all PCa (OR 5.66, p <0.01) and CSC (OR 6.15, p <0.01) (Table 2). CONCLUSIONS: Two-thirds of patients in the highest PHI category (≥ 55) were found to have CSC. This cutoff was the only stratification significantly associated with PCa detection. However, alarmingly, all established PHI cutoffs featured high rates of PCa and CSC. While elevated PHI in AA men with equivocal PSA should be regarded with heightened suspicion, our findings also highlight the difficulty in identifying patients at low risk who may benefit from a less fastidious approach. Likely, the current established stratification for PHI needs to be re-evaluated for the high-risk cohort of AA men. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e190 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kostantinos Morris More articles by this author Judd Moul More articles by this author Srinath Kotamarti More articles by this author Expand All Advertisement PDF DownloadLoading ...

MP33-20 UTILITY OF ADDITIONAL TARGETED AND SYSTEMIC BIOPSIES IN THE PRESENCE OF AN INDEX PI-RADS 5 LESION

You have accessJournal of UrologyCME1 May 2022MP33-20 UTILITY OF ADDITIONAL TARGETED AND SYSTEMIC BIOPSIES IN THE PRESENCE OF AN INDEX PI-RADS 5 LESION Ahmad Alzubaidi, Michael Maidaa, Mohammad Said, Grant Owens, Max Yudovich, R. Scott Grant, Thomas F. Stringer, Chad Tracy, and Jay D. Raman Ahmad AlzubaidiAhmad Alzubaidi More articles by this author , Michael MaidaaMichael Maidaa More articles by this author , Mohammad SaidMohammad Said More articles by this author , Grant OwensGrant Owens More articles by this author , Max YudovichMax Yudovich More articles by this author , R. Scott GrantR. Scott Grant More articles by this author , Thomas F. StringerThomas F. Stringer More articles by this author , Chad TracyChad Tracy More articles by this author , and Jay D. RamanJay D. Raman More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002587.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Prostatic mpMRI targeted biopsy is increasingly utilized for the diagnosis of prostate cancer (CaP). Traditionally, systematic biopsy (SB) and targeted biopsies are performed for all index and non-index lesions. The diagnostic yield of additional biopsies is not clearly defined. We evaluate the utility of additional biopsies of non-index and SB in patients with a PI-RADS 5 index lesion to detect clinically significant cancer (CSC). METHODS: Records of 1029 patients undergoing transrectal mpMRI targeted biopsy across 4 medical centers were reviewed. Those with a PI-RADS 5 index lesion were included. Pathology obtained from the index PI-RADS 5 lesion was then compared to SB pathology, and that of the other PI-RADS lesions to evaluate for pathologic upgrade from benign or clinically insignificant cancer (CIC) to clinically significant cancer (CSC) (Grade Group≥2). RESULTS: We identified 326 Index PI-RADS 5 lesions in patients. 191 (59%) targeted PI-RADS 5 biopsies had CSC, while 135 (41%) noted CIC or benign pathology. Figure summarizes pathologic findings in these respective subgroups. Of the 191 CSC lesions, SB further upgraded 40 patients (21%). Of the 135 CIC or benign lesions, SB upgraded 22 (16%) to CSC. 119 patients had ≥2 lesions; biopsy of non-index lesions showed an upgrade in only 15 (13%) patients, while 104 patients (87%) showed no change or downgraded Grade group. CONCLUSIONS: When performing MRI targeted biopsy of an index PI-RADS 5 lesion, additional biopsies of non-index lesions offers minimal additional clinical value and could potentially be omitted. However, SB potentially identifies significant malignancies whereby 37% upgraded to CSC or higher Grade group Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e577 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ahmad Alzubaidi More articles by this author Michael Maidaa More articles by this author Mohammad Said More articles by this author Grant Owens More articles by this author Max Yudovich More articles by this author R. Scott Grant More articles by this author Thomas F. Stringer More articles by this author Chad Tracy More articles by this author Jay D. Raman More articles by this author Expand All Advertisement PDF DownloadLoading ...

Artificial intelligence trained with integration of multiparametric MR-US imaging data and fusion biopsy trajectory-proven pathology data for 3D prediction of prostate cancer: A proof-of-concept study.

We aimed to develop an artificial intelligence (AI) algorithm that predicts the volume and location of clinically significant cancer (CSCa) using convolutional neural network (CNN) trained with integration of multiparametric MR-US image data and MRI-US fusion prostate biopsy (MRI-US PBx) trajectory-proven pathology data. Twenty consecutive patients prospectively underwent MRI-US PBx, followed by robot-assisted radical prostatectomy (RARP). The AI algorithm was trained with the integration of MR-US image data with a MRI-US PBx trajectory-proven pathology. The relationship with the 3D-cancer-mapping of RARP specimens was compared between AI system-suggested 3D-CSCa mapping and an experienced radiologist's suggested 3D-CSCa mapping on MRI alone according to the Prostate Imaging Reporting and Data System (PI-RADS) version 2. The characteristics of detected and undetected tumors at AI were compared in 22,968 image data. The relationships between CSCa volumes and volumes predicted by AI as well as the radiologist's reading based on PI-RADS were analyzed. The concordance of the CSCa center with that in RARP specimens was significantly higher in the AI prediction than the radiologist' reading (83% vs. 54%, p = 0.036). CSCa volumes predicted with AI were more accurate (r = 0.90, p < 0.001) than the radiologist's reading. The limitations include that the elastic fusion technology has its own registration error. We presented a novel pilot AI algorithm for 3D prediction of PCa. AI was trained by integration of multiparametric MR-US image data and fusion biopsy trajectory-proven pathology data. This deep learning AI model may more precisely predict the 3D mapping of CSCa in its volume and center location than a radiologist's reading based on PI-RADS version 2, and has potential in the planning of focal therapy.

Urinary MyProstateScore (MPS) to Rule out Clinically-Significant Cancer in Men with Equivocal (PI-RADS 3) Multiparametric MRI: Addressing an Unmet Clinical Need

ObjectiveTo evaluate the complementary value of urinary MyProstateScore (MPS) testing and multiparametric MRI (mpMRI) and assess outcomes in patients with equivocal mpMRI. Materials and MethodsIncluded patients underwent mpMRI followed by urine collection and prostate biopsy at the University of Michigan between 2015 –2019. MPS values were calculated from urine specimens using the validated model based on serum PSA, urinary PCA3, and urinary TMPRSS2:ERG. In the PI-RADS 3 population, the discriminative accuracy of PSA, PSAD, and MPS for GG≥2 cancer was quantified by the AUC curve. Decision curve analysis was used to assess net benefit of MPS relative to PSAD. ResultsThere were 540 patients that underwent mpMRI and biopsy with MPS available. The prevalence of GG≥2 cancer was 13% for PI-RADS 3, 56% for PI-RADS 4, and 87% for PI-RADS 5. MPS was significantly higher in men with GG≥2 cancer [median 44.9, IQR (29.4 –57.5)] than those with negative or GG1 biopsy [median 29.2, IQR (14.8 –44.2); P <.001] in the overall population and when stratified by PI-RADS score. In the PI-RADS 3 population (n = 121), the AUC for predicting GG≥2 cancer was 0.55 for PSA, 0.62 for PSAD, and 0.73 for MPS. MPS provided the highest net clinical benefit across all pertinent threshold probabilities. ConclusionIn patients that underwent mpMRI and biopsy, MPS was significantly associated with GG≥2 cancer across all PI-RADS scores. In the PI-RADS 3 population, MPS significantly outperformed PSAD in ruling out GG≥2 cancer. These findings suggest a complementary role of MPS testing in patients that have undergone mpMRI.

MP43-20 PREDICTING CANCER DETECTION RATES FROM MULTIPARAMETRIC PROSTATE MRI: REFINING BEYOND THE PI-RADS CLASSIFICATION SYSTEM

You have accessJournal of UrologyProstate Cancer: Detection & Screening IV (MP43)1 Sep 2021MP43-20 PREDICTING CANCER DETECTION RATES FROM MULTIPARAMETRIC PROSTATE MRI: REFINING BEYOND THE PI-RADS CLASSIFICATION SYSTEM Francisco Ramos, Aaron Fleishman, Sumedh Kaul, Ruslan Korets, Michael Johnson, Aria Olumi, Leo Tsai, and Boris Gershman Francisco RamosFrancisco Ramos More articles by this author , Aaron FleishmanAaron Fleishman More articles by this author , Sumedh KaulSumedh Kaul More articles by this author , Ruslan KoretsRuslan Korets More articles by this author , Michael JohnsonMichael Johnson More articles by this author , Aria OlumiAria Olumi More articles by this author , Leo TsaiLeo Tsai More articles by this author , and Boris GershmanBoris Gershman More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002064.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The PI-RADS categorization represents the standardized method for assessing risk of prostate cancer using prostate MRI. However, there exists a discrepancy in widely accepted cancer detection rates (CDRs) as reported in seminal prospective studies (e.g., PROMIS, PRECISION) and CDRs observed in real-world practice. We hypothesized that CDRs vary according to patient and MRI features beyond what is captured in the PI-RADS categorization system. Herein, we examine the associations of clinical and radiographic features with CDRs and develop a predictive model to improve clinical management. METHODS: We identified men aged 18-89 with elevated PSA or Gleason 6 prostate cancer on active surveillance and ≥1 PI-RADS 3-5 lesion on prostate MRI who underwent MRI-U/S fusion biopsy or in-bore MRI-targeted biopsy. The associations of features with the per-lesion cancer-detection rate (CDR; Gleason 6-10) and clinically-significant cancer detection rate (csCDR; Gleason 7-10) were examined using logistic regression. To operationalize results, a predictive model was developed using lasso regression to minimize overfitting. Patients with Gleason 6 prostate cancer on active surveillance were included only in csCDR analyses. RESULTS: Targeted biopsy was performed for 347 lesions in 281 patients, including MRI-U/S fusion biopsy in 129 lesions and in-bore MRI-targeted biopsy in 218 lesions. Median pre-biopsy PSA was 7.1 ng/mL (IQR 5.1-10.0). 37.7% of patients had no prior prostate biopsy, while 24.2% were on active surveillance for Gleason 6 prostate cancer. PI-RADS category was 3 in 13.8%, 4 in 62.2%, and 5 in 23.9% of lesions. Lesions were located in the anterior/transition zone in 36.7% of cases, and median lesion diameter was 12 mm (IQR 8-16 mm). Overall, the CDR was 49.0% and the csCDR was 28.0%. Multivariable associations of features with CDR and csCDR are presented in Table 1. A predictive model developed with lasso regression demonstrated optimism adjusted c-statistics of 0.77 and 0.75 for CDR and csCDR, respectively. CONCLUSIONS: Several clinical and radiographic features were independently associated with risk of cancer in men undergoing MRI-targeted biopsy. These findings were operationalized into a predictive model to provide personalized risk-stratification beyond the PI-RADS categorization. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e790-e791 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Francisco Ramos More articles by this author Aaron Fleishman More articles by this author Sumedh Kaul More articles by this author Ruslan Korets More articles by this author Michael Johnson More articles by this author Aria Olumi More articles by this author Leo Tsai More articles by this author Boris Gershman More articles by this author Expand All Advertisement Loading ...

Evaluation of multiparametric prostate magnetic resonance imaging findings in patients with a Gleason score of 6 in transrectal ultrasonography-guided biopsy.

PurposeWe aimed to evaluate prostate multiparametric magnetic resonance imaging (mpMRI) findings of patients with a Gleason score (GS) of 6 and effectiveness of MRI based on the final pathology result in patients undergoing radical prostatectomy (RP).Material and methodsmpMRI findings of 80 patients who had a GS of 3 + 3 and who underwent mpMRI were evaluated retrospectively. The mpMRI were scored according to the PIRADS v2.1 guidelines. The patients were divided into those with a high probability of clinically significant cancer (CSC) (PI-RADS 4-5) and those with a low probability of CSC (PI-RADS 2-3).ResultsOf the 80 patients, 33.8% had PI-RADS 2-3, and 66.2% had PI-RADS 4-5 lesions. There was a significant difference between the groups in prostate specific antigen (PSA) value, PSA density, patient age, and tumour percentage on biopsy. When the pathology results were taken as the gold standard in the group that underwent RP, sensitivity, specificity, and accuracy of mpMRI were calculated as 94.74%, 100%, and 96.3%, respectively, an increase in the final GS was found in 9 (33.3%) of the 27 patients, and 70.35% of patients were identified as having CSC.ConclusionsPI-RADS 4-5 scores have high sensitivity and negative predictive value in the diagnosis of CSC. mpMRI is a reliable and non-invasive diagnostic method that can complement biopsy results in decision-making in patients who are initially evaluated as low risk.

The 31-month experience of transperineal template prostate biopsy at a rural district general hospital

Introduction: Transperineal template prostate biopsies (TPTPB) have been offered for prostate adenocarcinoma diagnosis since Mar 2017 at Hereford County Hospital, in conjunction with the Prostate Imaging Reporting and Data System (PI-RADS). This assesses the likelihood of clinically-significant cancer based on MRI prostate characteristics. Our study will evaluate this unit’s experience of TPTPB efficacy and safety.

EDITORIAL COMMENT

Multiparametric MRI (mpMRI) is increasingly used as part of the diagnostic evaluation for prostate cancer (PCa). While mpMRI with targeted biopsy appears to increase the detection of clinically-significant cancer and reduce overdiagnosis of low-risk cancer,1 a substantial proportion of Grade Group ≥2 (GG ≥2) lesions are not visible on mpMRI.2,3 The clinical significance of mpMRI-invisible lesions remains unclear, and limited data exist describing the course of mpMRI-negative PCa.

Concordance of MRI-guided and systematic prostate biopsy for the detection of prostate cancer (PCa).

277 Background: MRI/US guided biopsy (fusion biopsy) is increasingly utilized over systemic 12-core transrectal ultrasound biopsy (12-core biopsy) for men with MRI-visible prostate lesions. Methods: Patients with MRI visible prostate lesions who underwent fusion and 12-core biopsy from 2016-2020 in the Intermountain Healthcare (IHC) system were consecutively analyzed. This was in the setting of a continuous quality assurance initiative among the reading radiologists. Primary outcome was PCa detection defined by Gleason grade group (GGG) 1 or higher. Clinically significant cancer (CSC) was defined as GGG 2 or higher. Patients were stratified by date biopsy was performed, 2016-2017 and 2018-2020, and lesions were stratified by PI-RADS v2 category. For men with multiple lesions, the highest PI-RADS v2 category lesion was used. Results: A total of 142 men with 254 MRI-detectable lesions underwent both fusion and 12-core biopsies in the IHC system from 2016 to 2020. CSC was detected in 21.6% (55/254) of fusion biopsies. Comparing PI-RAD v2 categories 1-3 to PI-RADS v2 categories 4-5, the PPV for detecting CSC was 9% (15/162) compared to 44% (40/92) respectively. Fusion and 12-core biopsies were concordant for any PCa in 79% of men (112/142) and CSC in 83% (118/142). Fusion biopsy detected any PCa in 22/84 (26%) and CSC in 15/103 (15%) of men in whom 12-core biopsy was negative. 12-core biopsy detected any PCa in 8/70 (11%) and CSC in 9/97 (9%) of men in whom fusion was negative. In total, 15 patients (11%) had a CSC that would have been missed if fusion biopsy was omitted while 9 (6%) had a CSC that would have been missed without 12-core biopsy. Conclusions: Omitting fusion or 12-core biopsy for PI-RADS v2 lesions would have resulted in a missed CSC in 11% or 6% of patients from 2016-20, respectively. The combination of MRI/US-guided fusion biopsy and systematic 12-core biopsy increased detection rate of CSC. These results are in the setting of a continuous, multi-disciplinary quality assurance program and results are not necessarily applicable to other healthcare systems. [Table: see text]

Yield of concurrent systemic biopsy during MRI-targeted biopsy according to Prostate Imaging Reporting and Data System version 2 in patients with suspected prostate cancer

To investigate the yield of concurrent systemic biopsy (SB) during MRI-targeted biopsy (MRTB) as Prostate Imaging Reporting and Data System (PI-RADS) version 2 (v2) interpretations in patients with suspected prostate cancer (PCa). A total of 285 patients with suspected PCa underwent prebiopsy 3-T MRI, followed by MRI-transrectal ultrasound fusion targeted biopsy and concurrent standard SB for lesions with PI-RADS v2 scores 3-5. Detection rates and positive core rates of PCa and clinically significant cancer (CSC) were evaluated. In concurrent MRTB and SB, PCa and CSC detection rates were 18.9% and 9.4% for PI-RADS score 3, 45.9% and 32.4% for PI-RADS score 4, and 82.1% and 72.6% for PI-RADS score 5, respectively. Overall detection rate of CSCs (40.0%) for concurrent MRTB and SB was significantly higher than that of MRTB (34.4%, p = 0.004) or SB alone (27.7%, p < 0.001): an increase of 5.6% (16 patients) compared with MRTB alone. For patients with PI-RADS score 4 or 5, the CSC detection rate of concurrent MRTB and SB was 47.0%, an increase of 6.1% when compared with MRTB (40.9%) only (p < 0.001). Of the 110 patients with both MRTB- and SB-positive findings, 22 (20.0%) had the highest Gleason score in SB compared with that in MRTB. In 9.5% (27/285) patients including 12 patients with CSCs, only SB was positive, with negative MRTB. Concurrent SB with MRTB based on PI-RADS v2 can yield a higher CSC detection rate compared with MRTB alone in patients with suspected PCa. • Concurrent SB with MRTB yields an increase of 5.6% CSC detection compared with MRTB alone. • Of both MRTB- and SB-positive findings, 20.0% patients have upgraded Gleason score in SB. • In 18.4% patients, only SB was positive, with negative MRTB. Adding MRTB to SB is helpful for adequate risk stratification, reducing diagnostic uncertainty of PCa.

Population-based prostate cancer screening using a prospective, blinded, paired screen-positive comparison of PSA and fast MRI: The IP1-PROSTAGRAM study.

5513 Background: The prostate-specific antigen (PSA) test can lead to under- and over-diagnosis of prostate cancer and has not been recommended for population screening. A fast MRI scan might overcome the limitations of PSA. IP1-PROSTAGRAM is the first study to evaluate the performance of a 15-minute non-contrast MRI for prostate cancer screening in comparison to PSA. Methods: IP1-PROSTAGRAM was a prospective, population-based, screen-positive paired-cohort study. Men aged 50-69 years in the UK were invited for prostate cancer screening through seven primary care practices or community-based recruitment. Participants underwent a PSA and MRI scan (T2-weighted and diffusion). MRI was scored using PIRADS version 2.0 without knowledge of PSA; screen-positive MRI (defined as either PIRADS score 3-5 or 4-5) were compared against a screen-positive PSA defined as ≥3ng/ml. If any test was screen-positive, a systematic 12-core biopsy was performed with MRI-ultrasound image-fusion targeted biopsy to MRI suspicious areas, as appropriate. Clinically-significant cancer was defined as any Gleason score ≥3+4. The primary outcome was the proportion of screen-positive MRI at different scores; important secondary outcomes were the number of clinically-significant and insignificant cancers detected. Results: 2034 men were invited to participate of whom 408 consented and 406 were screened by both PSA and MRI (10/Oct/2018-15/May/2019). The proportion with a screen-positive MRI (score 3-5) was higher than the proportion with a screen-positive PSA (17.7% [95%CI 14.3-21.8] vs. 9.9% [95%CI 7.3-13.2]; p &lt; 0.001). A screen-positive MRI (score 4-5) was similar to a screen-positive PSA (10.6% [95%CI 7.9-14.0] vs. 9.9% [95%CI 7.3-13.2], p = 0.71). An MRI score 3-5 or 4-5 used to denote a screen-positive MRI, compared to PSA alone, detected 14, 11 and 7 clinically-significant cancers, respectively. There were 7, 5 and 6 clinically-insignificant cancers detected, respectively. No serious adverse events occurred. Conclusions: When screening the general population for prostate cancer, MRI using a score of 4-5 to define a screen-positive test, compared to PSA alone at ≥3ng/ml, could lead to more men diagnosed with clinically-significant cancer without increasing the number of men biopsied or diagnosed with clinically-insignificant cancer. Clinical trial information: NCT03702439 .

Randomized Study of Systematic Biopsy Versus Magnetic Resonance Imaging and Targeted and Systematic Biopsy in Men on Active Surveillance (ASIST): 2-year Postbiopsy Follow-up

BackgroundThe initial report from the ASIST trial showed little benefit from targeted biopsy for men on active surveillance (AS) for prostate cancer. Data after 2-yr follow-up are now available for analysis. ObjectiveTo determine if there was a difference in the AS failure rate in a 2-yr follow-up period among men undergoing magnetic resonance imaging (MRI) before initial confirmatory biopsy (CBx) compared to those who did not. Design, setting, and participantsThis is the 2-yr post-CBx follow-up for the ASIST trial, a prospective, randomized, multicenter, open-label study for men with Gleason grade group (GG) 1 cancer eligible for AS. Patients were randomized to CBx with 12-core systematic sampling or MRI with systematic and targeted sampling. Outcome measurements and statistical analysisPatients with GG ≤ 1 on CBx were followed for 2 yr and had MRI and biopsy at that time point. Patients failed AS if they were no longer under AS because of grade progression, clinical progression, subject choice, clinical judgment, treatment, or lost to follow-up. Clinically significant cancer (CSC) was defined as GG ≥ 2. Results and limitationsIn total, 259 men underwent CBx, 132 in the non-MRI and 127 in the MRI arm. After biopsy, 101 men in the non-MRI arm (76%) and 98 in the MRI arm (77%) continued AS. There were fewer men with AS failures in the MRI (19/98, 19%) compared to the non-MRI group (35/101, 35%; p = 0.017). At 2-yr biopsy there were fewer men with CSC in the MRI arm (9.9%, 8/81) than in the non-MRI arm (23%, 17/75; p = 0.048). Significant differences in AS failure rates were detected across the three centers in the MRI arm only (4.2% [2/48] vs 17% [4/24] vs 27% [7/26]; p = 0.019). ConclusionsBaseline MRI before CBx during AS results in 50% fewer AS failures and less grade progression over 2 yr. The center where MRI and targeted biopsy is performed may influence AS failure rates. Patient summaryThe ASIST trial randomized 273 men on active surveillance with low-grade prostate cancer diagnosed within the last year to systematic biopsy or magnetic resonance imaging (MRI) with systematic and targeted biopsy. The initial report showed little benefit from targeted biopsy. However, after 2 yr of follow-up we found that baseline MRI before confirmatory biopsy resulted in 50% fewer failures of surveillance and less progression to higher-grade cancer. This confirms the value of MRI in men on surveillance.This study is registered at ClinicalTrials.gov (NCT01354171).

In-Bore MRI-guided Prostate Biopsies: Retrospective Observational Study of Complementary Nontargeted Sampling of Normal-appearing Areas at Multiparametric MRI.

To investigate the pathologic outcomes of additional random biopsies from areas with no visible MR targets in the setting of targeted in-bore MRI-guided biopsy and to assess the negative predictive value (NPV) of areas with no visible MR targets stratified according to patients' different biopsy statuses. A retrospective analysis of patients who underwent in-bore MRI-guided biopsy with additional random biopsies in areas with no visible MR targets (Prostate Imaging-Reporting and Data System, version 2 category 1 or 2) was conducted in this study. Diagnostic scans and in-bore MRI-guided biopsy were performed with a 3-T MRI scanner. Areas with no visible MR targets were biopsied in a random fashion whenever a zone or side did not have a visible focal target. Clinically significant cancers (CSCs) were defined as a Gleason score of 7 or greater. NPVs were stratified based on patient's prior biopsy status. Descriptive analysis was performed. A total of 59 consecutive patients were included, with a median age of 65 years (interquartile range [IQR], 59-71 years). The median prostate-specific antigen level was 7 ng/mL (IQR, 4.9-10.8 ng/mL). Of the 59 patients, 16 (27.1%) were biopsy naive, 24 (40.7%) had prior negative transrectal US-guided biopsy findings, and 19 (32.2%) had prior positive transrectal US-guided biopsy findings. Forty-two (71.2%) biopsies revealed prostate cancer. A total of 112 areas with no visible MR targets were biopsied, of which 20 (17.9%) were cancers and 11 (9.8%) were CSCs. The NPV of areas with no visible MR targets was approximately 78% for all cancers and was 88.1% for CSCs. NPVs in biopsy-naive patients, patients with prior negative transrectal US-guided biopsy findings, and patients with prior positive transrectal US-guided biopsy findings were 62.5%, 83.3%, and 84.2%, respectively, for all cancers and 75.0%, 91.7%, and 94.7%, respectively, for CSCs. Areas with no visible MR targets in patients with MR-suspicious foci may still harbor CSCs that may significantly affect management plans. Additional biopsies from areas with no visible MR targets are warranted in this population.Keywords: Biopsy/Needle Aspiration, Interventional-Body, MR-Imaging, Prostate, Urinary© RSNA, 2019.