The Utility of Transperineal Template Saturation Biopsy in the Detection of Clinically Significant Prostate Cancer.

Background Gallium 68 (68Ga) prostate-specific membrane antigen (PSMA) PET/MRI may improve detection of clinically significant prostate cancer (CSPC). Purpose To compare the sensitivity and specificity of 68Ga-PSMA PET/MRI with multiparametric MRI for detecting CSPC. Materials and Methods Men with prostate specific antigen levels of 2.5-20 ng/mL prospectively underwent 68Ga-PSMA PET/MRI, including multiparametric MRI sequences, between June 2019 and March 2020. Imaging was evaluated independently by two radiologists by using the Prostate Imaging Reporting and Data System (PI-RADS) version 2.1. Sensitivity and specificity for CSPC (International Society of Urological Pathology grade group ≥ 2) were compared for 68Ga-PSMA PET/MRI and multiparametric MRI by using the McNemar test. Decision curve analysis compared the net benefit of each imaging strategy. Results Ninety-nine men (median age, 67 years; interquartile range, 62-71 years) were included; 79% (78 of 99) underwent biopsy. CSPC was detected in 32% (25 of 78). For CSPC, specificity was higher for 68Ga-PSMA PET/MRI than multiparametric MRI (76% [95% CI: 62, 86] vs 49% [95% CI: 35, 63], respectively; P < .001). Sensitivity was similar (88% [95% CI: 69, 98] vs 92% [95% CI: 74, 99], respectively; P > .99). For PI-RADS 3 lesions, specificity was also higher for 68Ga-PSMA PET/MRI than for multiparametric MRI: 86% (95% CI: 73, 95) versus 59% (95% CI: 43, 74), respectively (P = .002). Decision curve analysis showed that biopsies targeted to PSMA uptake increased the net benefit of multiparametric MRI only among PI-RADS 3 lesions. The net benefit of targeted biopsy for a PI-RADS 3 lesion with PSMA uptake was higher across all threshold probabilities over 8%. The net benefit of targeted biopsy was similar for PI-RADS 4 and 5 lesions, regardless of PSMA uptake. Conclusions Gallium 68 prostate-specific membrane antigen PET/MRI improved specificity for clinically significant prostate cancer compared with multiparametric MRI, particularly in Prostate Imaging Reporting and Data System grade 3 lesions. © RSNA, 2021 Online supplemental material is available for this article. See also the editorial by Williams and Estes in this issue.

Men with prior negative prostate biopsies have a lower risk of being diagnosed with prostate cancer in comparison with biopsy-naive men. However, the relative clinical utility of identified lesions on multiparametric magnetic resonance imaging (mpMRI) is uncertain between the 2 settings. Patients from the Prospective Loyola University mpMRI (PLUM) Prostate Biopsy Cohort (January 2015 to June 2020) were examined. The detection of any prostate cancer and clinically significant prostate cancer (Gleason score ≥ 3 + 4) was stratified by Prostate Imaging-Reporting and Data System (PI-RADS) scores in the prior negative and biopsy-naive settings. Multivariable logistic regression models (PLUM models) assessed predictors, and decision curve analyses were used to estimate the clinical utility of PI-RADS cutoffs relative to the models. Nine hundred men (420 prior negative patients and 480 biopsy-naive patients) were included. Prior negative patients had lower risks of any prostate cancer (27.9% vs 54.4%) and clinically significant prostate cancer (20.0% vs 38.3%) in comparison with biopsy-naive patients, and this persisted when they were stratified by PI-RADS (eg, PI-RADS 3: 13.6% vs 27.4% [any prostate cancer] and 5.2% vs 15.4% [clinically significant prostate cancer]). The rate of detection of clinically significant prostate cancer was 5.3% among men with prior negative biopsy and PI-RADS ≤ 3. Family history and Asian ancestry were significant predictors among biopsy-naive patients. PLUM models demonstrated a greater net benefit and reduction in biopsies (45.8%) without missing clinically significant cancer in comparison with PI-RADS cutoffs (PI-RADS 4: 34.0%). Patients with prior negative biopsies had lower prostate cancer detection by PI-RADS score category in comparison with biopsy-naive men. Decision curve analyses suggested that many biopsies could be avoided by the use of the PLUM models or a PI-RADS 4 cutoff without any clinically significant cancer being missed. Men with a prior negative prostate biopsy had a lower risk of harboring prostate cancer in comparison with those who never had a biopsy. This was true even when patients in each group had similar multiparametric magnetic resonance imaging (mpMRI) findings in terms of Prostate Imaging-Reporting and Data System (PI-RADS)-graded lesions. Decision curve analyses showed that many biopsies could be avoided by the use of the Prospective Loyola University mpMRI prediction models or a PI-RADS 4 cutoff for patients with prior negative biopsies.

To evaluate magnetic resonance imaging (MRI)-targeted biopsy (MRI-TB) performance in detecting clinically significant prostate cancer (csPCa) with a Prostate Imaging Reporting and Data System (PI-RADS) score of ≥3 peripheral zone (PZ) lesions using multiparametric MRI (mpMRI)-histopathology correlation. This retrospective study included 141 patients with 187 PZ lesions who underwent mpMRI followed by both MRI-TB and transrectal ultrasound-guided systematic biopsy (SB) between December 2021 and December 2024. All mpMRI scans were evaluated by a board-certified experienced radiologist in accordance with the PI-RADS version 2.1 criteria. The csPCa detection rates of SB, MRI-TB, and combined biopsy (CB) were compared. Statistical analyses included McNemar's test, Fisher's exact test, and the Mann-Whitney U test. A P value <0.05 was considered statistically significant. Among the 141 patients (187 PI-RADS ≥3 PZ lesions), patients with csPCa exhibited significantly higher prostate-specific antigen (PSA) levels (15.3 vs. 8.2 ng/mL; P = 0.02), lower prostate volume (52.4 vs. 78.6 mL; P < 0.001), and three-fold higher PSA density (PSAD) (0.30 vs. 0.10 ng/mL/mL; P < 0.001) than non-csPCa cases. Notably, PSAD > 0.15 ng/mL/mL occurred in 78% of patients with csPCa vs. 18% in non-csPCa cases (P < 0.001). Moreover, MRI-TB detected significantly more csPCa than SB (17.7% vs. 10.7% of lesions; P < 0.001), with maximal advantage in PI-RADS 4 lesions (20.7% vs. 10.9%; P = 0.004). By contrast, CB did not significantly increase csPCa detection over MRI-TB alone (19.8% vs. 17.7%; P = 0.125). Chronic prostatitis (CP) (34.0% of benign cases) confounded PI-RADS specificity. For csPCa detection in PI-RADS ≥3 PZ lesions, particularly PI-RADS 4, MRI-TB outperforms SB. For PI-RADS 5, SB and MRI-TB showed equivalent efficacy. However, MRI-TB alone suffices for PI-RADS ≥4 lesions or PSAD >0.15 ng/mL/mL, whereas CB remains preferable for PI-RADS 3. The high CP prevalence underscores the need for adjunctive biomarkers to improve specificity. MRI-TB optimizes csPCa detection for PI-RADS ≥4 PZ lesions, reducing reliance on SBs. A PSAD threshold >0.15 ng/mL/mL effectively stratifies biopsy necessity, and high CP prevalence (34% of benign cases) underscores the need for adjunct biomarkers to improve specificity in PI-RADS 3-4 lesions.

14 Background: Our practice utilizes a biopsy-based 17 gene test that is clinically validated as a predictor of favorable pathology and used to guide use of active surveillance for men with very low, low, and intermediate risk prostate cancer. The purpose of this study was to evaluate the imaging characteristics and PIRADS score of prostate cancer patients with a Genomic Prostate Score (GPS) indicating favorable pathology. Methods: 300 consecutive 3T Multiparametric Prostate MRI (MP-MRI) were identified from March 26, 2012, to June 29, 2015. Thirty patients (age 44-84 years) with GPS scores indicating favorable pathology were included in the study. Prostate Imaging Reporting and Data System (PIRADS) scores were assigned to each MP-MRI. MRI index lesions were defined as discrete hypointense T2 signal with at least one anatomically corresponding abnormal functional MRI parameter (diffusion weighted and dynamic contrast-enhanced images). The MRI examinations were evaluated for number and laterality of MRI index lesions and in relation to biopsy pathology findings after the MP-MRI was performed. Results: Out of 30 MP-MRI, 7 (23.3%) PIRADS 5, 10 (33.3%) PIRADS 4, 10 (33.3%) PIRADS 3, 1 (3.3%) PIRADS 2, and 2 (6.7%) PIRADS 1. Thirteen (43%) had bilateral MRI index lesions. Twenty-six (87%) MP-MRI had 1-3 MRI index lesions, 2 (7%) had 4-6 MRI index lesions and 2 (7%) had no index lesions. Six (20%) patients underwent curative treatment. Four (13.3%) patients underwent a transrectal ultrasound guided targeted biopsy and one underwent a prostatectomy after the MP-MRI. One harbored Gleason 7 with a PIRADS 1, 2 harbored Gleason 7 with PIRADS 5, and two were benign with PIRADS scores of 3 and 4. Conclusions: Patients with prostate cancer with a GPS score indicating favorable pathology had PIRADS scores ranging from 5 to 1, with the majority indicating either high or very high likelihood of harboring clinically significant cancer. This may imply that MP-MRI should continue to play an important role in stratifying patients with prostate cancer, even in those with favorable pathology. A study with a larger sample size and biopsy results after the initial MP-MRI to look for tumor upgrading is needed.

Background. Multiparametric magnetic resonance imaging and Prostate Imaging Reporting and Data System (PI-RADS) are widely used to diagnose clinically significant prostate cancer. Meanwhile, PI-RADS diagnostic accuracy varies between 30 % for PI-RADS score 3 to 80 % for PI-RADS score 5. The value of PI-RADS scores in patients already diagnosed with prostate cancer remains unclear.Aim. To evaluate the impact of PI-RADS score on adverse surgical outcomes: prostate cancer upstaging, increased Gleason score, lymph node metastases, positive surgical margin, and oncological outcomes in patients of the ISUP grade 1 group per the International Society of Urological Pathology (ISUP) scale who underwent radical prostatectomy.Materials and methods. Forty patients with ISUP grade 1 prostate cancer underwent radical prostatectomy (robotic or laparoscopic). All patients underwent diagnostic multiparametric magnetic resonance imaging with PI-PADS score v2 (v2.1) prior to radical prostatectomy. PI-RADS 3 was determined in 14 (35 %), PI-RADS 4 – in 10 (25 %) and PI-RADS 5 – in 16 (40 %) patients, respectively. The age of patients was 62.7 ± 6.6 years. Stage cT2a was diagnosed in 19 (47.5 %), cT2b – in 5 (12.5 %), cT2c – in 11 (27.5 %), cT3a – in 5 (12.5 %) patients, respectively. Pelvic lymph node dissection was performed in 23 (57.5 %) cases. The median follow-up was 12.6 months.Results. Upstaging events to pT3a occurred in 2 (15.2 %) patients with PI-RADS 3 lesions, in 5 (31.3 %) patients with PI-RADS 5 lesions; upstaging events to pT3b occurred in 1 (10 %) patient with PI-RADS 4 lesions, and in 1 (6.25 %) patient with PI-RADS 5 lesions. Increased Gleason score (GS) was observed in 22 (55 %) patients: GS increase ≥2 was diagnosed in 8 (57.1 %) patients with PI-RADS 3 lesions, in 3 (30 %) patients with PI-RADS 4 lesions, in 11 (68.7 %) patients with PI-RADS 5 lesions, respectively. Lymph node metastases were observed only in 1 (4.3 %) patient with PI-RADS 5 lesions. Positive surgical margin (&gt;3 mm) was observed in 2 (12.4 %) patients with PI-RADS 5 lesions. Biochemical recurrence occurred in 1 (2.5 %) patient with PI-RADS 3 lesions. One-year biochemical recurrence-free survival was 97.5 %.Conclusion. Increased PI-RADS score from 3 to 5 is accompanied by increased frequency of prostate cancer upstaging and Gleason score increase in patients with ISUP grade 1 prostate cancer. PI-RADS scores 3–5 can be important in selecting patients for nerve-sparing prostatectomy, pelvic lymph node dissection, and play a part in prediction of biochemical recurrence and lymph node metastasis.

Simple SummaryThe selection of proper candidates for prostate biopsy after magnetic resonance imaging (MRI) has usually been studied in the overall population with suspected prostate cancer (PCa). However, the performance of these tools can change regarding the Prostate Imaging-Reporting and Data System (PI-RADS) categories. We compared three different tools: PSA density, MRI-ERSPC risk calculator and Proclarix in 567 men with suspected PCa (PSA > 3 ng/mL and/or abnormal rectal examination) in one academic institution. All patients underwent multiple transrectal ultrasound guided biopsies after a multiparametric MRI was performed. We concluded that in the overall population, MRI-ERSPC RC outperformed PSA density and Proclarix, whereas in patients with lesions PI-RADS < 3 Proclarix was better than the other tools. However, no tool guaranteed 100% detection of clinically significant PCa in PI-RADS 4 and 5.Tools to properly select candidates for prostate biopsy after magnetic resonance imaging (MRI) have usually been analyzed in overall populations with suspected prostate cancer (PCa). However, the performance of these tools can change regarding the Prostate Imaging-Reporting and Data System (PI-RADS) categories due to the different incidence of clinically significant PCa (csPCa). The objective of the study was to analyze PSA density (PSAD), MRI-ERSPC risk calculator (RC), and Proclarix to properly select candidates for prostate biopsy regarding PI-RADS categories. We performed a head-to-head analysis of 567 men with suspected PCa, PSA > 3 ng/mL and/or abnormal rectal examination, in whom two to four core transrectal ultrasound (TRUS) guided biopsies to PI-RADS ≥ three lesions and/or 12-core TRUS systematic biopsies were performed after 3-tesla mpMRI between January 2018 and March 2020 in one academic institution. The overall detection of csPCa was 40.9% (6% in PI-RADS < 3, 14.8% in PI-RADS 3, 55.3% in PI-RADS 4, and 88.9% in PI-RADS 5). MRI-ERSPC model exhibited a net benefit over PSAD and Proclarix in the overall population. Proclarix outperformed PSAD and MRI-ERSPC RC in PI-RADS ≤ 3. PSAD outperformed MRI-ESRPC RC and Proclarix in PI-RADS > 3, although none of them exhibited 100% sensitivity for csPCa in this setting. Therefore, tools to properly select candidates for prostate biopsy after MRI must be analyzed regarding the PI-RADS categories. While MRI-ERSPC RC outperformed PSAD and Proclarix in the overall population, Proclarix outperformed in PI-RADS ≤ 3, and no tool guaranteed 100% detection of csPCa in PI-RADS 4 and 5.

Background Use of multi-parametric magnetic resonance imaging (mp-MRI) and Prostate Imaging Reporting and Data System (PI-RADS) scoring system allowed more precise detection of prostate cancer (PCa). Our study aimed at evaluating the diagnostic performance of mp-MRI in detection of PCa. Methods Eighty-six patients suspected to have prostate cancer were enrolled. All patients underwent mp-MRI followed by systematic and targeted trans-rectal ultrasound (TRUS) guided prostate biopsies. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of mp-MRI were evaluated. Results Forty-six patients (53.5%) had prostate cancer on targeted and systematic TRUS biopsies. On mp-MRI, 96.6% of lesions with PI-RADS < 3 revealed to be benign by TRUS biopsy, 73.3% of lesions with PI-RADS 4 showed ISUP grades ≥1, whereas all PI-RADS 5 lesions showed high ISUP grades ≥ 3. For PI-RADS 3 lesions, 62.5% of them revealed to be benign and 37.5% showed ISUP grades ≥1 by TRUS biopsy. PI-RADS scores ˃3 had 69.57% sensitivity and 85% specificity for detection of PCa. On adding the equivocal PI-RADS 3 lesions, PI-RADS scores ≥3 had higher sensitivity (97.83%), but at the cost of lower specificity (32.5%). Conclusion Mp-MRI using PI-RADS V2 scoring system categories ≤3 and >3 could help in detection of PCa. PI-RADS 3 lesions are equivocal. Including PI-RADS lesions ≥3 demonstrated higher sensitivity, but at the cost of lower specificity for mp-MRI in diagnosis for Pca. Abbreviations CDR: cancer detection rates; DRE: digital rectal examination; ISUP: international society of urological pathology; mp-MRI: multi-parametric magnetic resonance imaging; NPV: negative predictive value; PCa: prosatate cancer; PI-RADS: Prostate Imaging Reporting and Data System; PPV: Positive predictive value; PSA: prostate specific antigen; TRUS: transrectal ultrasound.

To compare the detection rates of prostate cancer (PCa) in men with Prostate Imaging-Reporting and Data System (PI-RADS) 3-5 abnormalities on 3-Tesla multiparametric (mp) magnetic resonance imaging (MRI) using in-bore MRI-guided biopsy compared with cognitively directed transperineal (cTP) biopsy and transrectal ultrasonography (cTRUS) biopsy. This was a retrospective single-centre study of consecutive men attending the private practice clinic of an experienced urologist performing MRI-guided biopsy and an experienced urologist performing cTP and cTRUS biopsy techniques for PI-RADS 3-5 lesions identified on 3-Tesla mpMRI. There were 595 target mpMRI lesions from 482 men with PI-RADS 3-5 regions of interest during 483 episodes of biopsy. The abnormal mpMRI target lesion was biopsied using the MRI-guided method for 298 biopsies, the cTP method for 248 biopsies and the cTRUS method for 49 biopsies. There were no significant differences in PCa detection among the three biopsy methods in PI-RADS 3 (48.9%, 40.0% and 44.4%, respectively), PI-RADS 4 (73.2%, 81.0% and 85.0%, respectively) or PI-RADS 5 (95.2, 92.0% and 95.0%, respectively) lesions, and there was no significant difference in detection of significant PCa among the biopsy methods in PI-RADS 3 (42.2%, 30.0% and 33.3%, respectively), PI-RADS 4 (66.8%, 66.0% and 80.0%, respectively) or PI-RADS 5 (90.5%, 89.8% and 90.0%, respectively) lesions. There were also no differences in PCa or significant PCa detection based on lesion location or size among the methods. We found no significant difference in the ability to detect PCa or significant PCa using targeted MRI-guided, cTP or cTRUS biopsy methods. Identification of an abnormal area on mpMRI appears to be more important in increasing the detection of PCa than the technique used to biopsy an MRI abnormality.

PIRADS for Rad Oncs: A Multidisciplinary Educational Lecture to Improve Prostate MRI Interpretation for Radiation Oncology Residents

To evaluate accuracy and interobserver variability with the use of the Prostate Imaging Reporting and Data System (PI-RADS) version 2.0 for detection of prostate cancer at multiparametric magnetic resonance (MR) imaging in a biopsy-naïve patient population. This retrospective HIPAA-compliant study was approved by the local ethics committee, and written informed consent was obtained from all patients for use of their imaging and histopathologic data in future research studies. In 101 biopsy-naïve patients with elevated prostate-specific antigen levels who underwent multiparametric MR imaging of the prostate and subsequent transrectal ultrasonography (US)-MR imaging fusion-guided biopsy, suspicious lesions detected at multiparametric MR imaging were scored by five readers who were blinded to pathologic results by using to the newly revised PI-RADS and the scoring system developed in-house. Interobserver agreement was evaluated by using κ statistics, and the correlation of pathologic results with each of the two scoring systems was evaluated by using the Kendall τ correlation coefficient. Specimens of 162 lesions in 94 patients were sampled by means of transrectal US-MR imaging fusion biopsy. Results for 87 (54%) lesions were positive for prostate cancer. Kendall τ values with the PI-RADS and the in-house-developed scoring system, respectively, at T2-weighted MR imaging in the peripheral zone were 0.51 and 0.17 and in the transitional zone, 0.45 and -0.11; at diffusion-weighted MR imaging, 0.42 and 0.28; at dynamic contrast material-enhanced MR imaging, 0.23 and 0.24, and overall suspicion scores were 0.42 and 0.49. Median κ scores among all possible pairs of readers for PI-RADS and the in-house-developed scoring system, respectively, for T2-weighted MR images in the peripheral zone were 0.47 and 0.15; transitional zone, 0.37 and 0.07; diffusion-weighted MR imaging, 0.41 and 0.57; dynamic contrast-enhanced MR imaging, 0.48 and 0.41; and overall suspicion scores, 0.46 and 0.55. Use of the revised PI-RADS provides moderately reproducible MR imaging scores for detection of clinically relevant disease.

Purpose To characterize clinically important prostate cancers missed at multiparametric (MP) magnetic resonance (MR) imaging. Materials and Methods The local institutional review board approved this HIPAA-compliant retrospective single-center study, which included 100 consecutive patients who had undergone MP MR imaging and subsequent radical prostatectomy. A genitourinary pathologist blinded to MP MR findings outlined prostate cancers on whole-mount pathology slices. Two readers correlated mapped lesions with reports of prospectively read MP MR images. Readers were blinded to histopathology results during prospective reading. At histopathologic examination, 80 clinically unimportant lesions (<5 mm; Gleason score, 3+3) were excluded. The same two readers, who were not blinded to histopathologic findings, retrospectively reviewed cancers missed at MP MR imaging and assigned a Prostate Imaging Reporting and Data System (PI-RADS) version 2 score to better understand false-negative lesion characteristics. Descriptive statistics were used to define patient characteristics, including age, prostate-specific antigen (PSA) level, PSA density, race, digital rectal examination results, and biopsy results before MR imaging. Student t test was used to determine any demographic differences between patients with false-negative MP MR imaging findings and those with correct prospective identification of all lesions. Results Of the 162 lesions, 136 (84%) were correctly identified with MP MR imaging. Size of eight lesions was underestimated. Among the 26 (16%) lesions missed at MP MR imaging, Gleason score was 3+4 in 17 (65%), 4+3 in one (4%), 4+4 in seven (27%), and 4+5 in one (4%). Retrospective PI-RADS version 2 scores were assigned (PI-RADS 1, n = 8; PI-RADS 2, n = 7; PI-RADS 3, n = 6; and PI-RADS 4, n = 5). On a per-patient basis, MP MR imaging depicted clinically important prostate cancer in 99 of 100 patients. At least one clinically important tumor was missed in 26 (26%) patients, and lesion size was underestimated in eight (8%). Conclusion Clinically important lesions can be missed or their size can be underestimated at MP MR imaging. Of missed lesions, 58% were not seen or were characterized as benign findings at second-look analysis. Recognition of the limitations of MP MR imaging is important, and new approaches to reduce this false-negative rate are needed. © RSNA, 2017 Online supplemental material is available for this article.

Background/Objectives: Multiparametric MRI (mpMRI) and targeted biopsies have revolutionized prostate cancer (PC) detection through the Prostate Imaging Reporting and Data System (PIRADS). However, the effect of prostate volume on cancer detection and the predictive accuracy of PIRADS in the mpMRI-guided biopsy era remains unclear. The aim was to assess whether prostate volume affects detection rates of clinically significant prostate cancer (CSPC) and high-risk prostate cancer (HRPC) and modifies the predictive performance of the PIRADS score. Methods: We retrospectively analyzed 361 biopsy-naïve men who underwent mpMRI-fusion transperineal biopsies between 2016 and 2023. Lesions graded PIRADS ≥ 3 were targeted alongside systematic sampling. A receiver-operating characteristic (ROC) curve (AUC = 0.74) defined a 44 mL cutoff separating small (<44 mL; n = 160) and large (≥44 mL; n = 193) prostates. Logistic regression and cubic-spline analyses evaluated associations between prostate volume, PIRADS, and cancer outcomes. Results: Any cancer was detected in 74.3% of small versus 35.5% of large prostates (p < 0.001); CSPC in 42.5% vs. 19.6% (p < 0.001); HRPC in 14.3% vs. 5.5% (p < 0.001). Small prostate volume independently predicted any cancer (OR 7.31; 95% CI 4.22–12.7), CSPC (OR 5.08; 95% CI 2.87–8.99), and HRPC (OR 4.50; 95% CI 1.80–11.3). Between 40 and 70 mL, each 10 mL increase in volume reduced CSPC risk by 61% (p = 0.008). Prostate volume significantly modified PIRADS accuracy: in large glands, PIRADS 3 lesions carried only 2% risk for CSPC and 0% for HRPC, while in small prostates, PIRADS 3 conferred a 16.9-fold increased CSPC risk. Conclusions: Prostate volume inversely correlates with cancer detection and aggressiveness. PIRADS performance is volume-dependent; PIRADS 3 lesions in large prostates rarely represent significant cancer and may not warrant biopsy.

Background:Prostate Imaging Reporting and Data System (PI-RADS) is a globally acceptable standardization for multiparametric magnetic resonance imaging (mp-MRI) in prostate cancer (PCa) diagnosis. The American College of Radiology revised the PI-RADS to address the limitations of version 1 in December 2014. This study aimed to determine whether the PI-RADS version 2 (PI-RADS v2) scoring system improves the diagnostic accuracy of mp-MRI of the prostate compared with PI-RADS v1.Methods:This retrospective study was approved by the institutional review board. A total of 401 consecutive patients, with clinically suspicious PCa undergoing 3.0 T mp-MRI (T2-weighted imaging + diffusion-weighted imaging + DCE) before transrectal ultrasound-guided biopsy between June 2013 and July 2015, were included in the study. All patients were scored using the 5-point PI-RADS scoring system based on either PI-RADS v1 or v2. Receiver operating characteristics were calculated for statistical analysis. Sensitivity, specificity, and diagnostic accuracy were compared using McNemar's test.Results:PCa was present in 150 of 401 (37.41%) patients. When we pooled data from both peripheral zone (PZ) and transition zone (TZ), the areas under the curve were 0.889 for PI-RADS v1 and 0.942 for v2 (P = 0.0001). Maximal accuracy was achieved with a score threshold of 4. At this threshold, in the PZ, similar sensitivity, specificity, and accuracy were achieved with v1 and v2 (all P > 0.05). In the TZ, sensitivity was higher for v2 than for v1 (96.36% vs. 76.36%, P = 0.003), specificity was similar for v2 and v1 (90.24% vs. 84.15%, P = 0.227), and accuracy was higher for v2 than for v1 (92.70% vs. 81.02%, P = 0.002).Conclusions:Both v1 and v2 showed good diagnostic performance for the detection of PCa. However, in the TZ, the performance was better with v2 than with v1.

Objective: To report on the outcomes of magnetic resonance imaging (MRI)/ultrasonography (US)-fusion transperineal prostate (TP) biopsy at a tertiary medical centre in the Middle East including detection rate of clinically significant prostate cancer (csPCa), complications, and tolerability of the procedure. Patients and methods: Between May 2019 and June 2020, 98 MRI/US-fusion TP biopsies were performed in the US suite using light sedation. All patients had pre-biopsy 3-T multiparametric MRI. Data on patient characteristics, PCa detection rate and complication rates were collected retrospectively. A Gleason score ≥3 + 4 was defined as csPCa. Results There were 98 patients, with a mean (SD) age of 65 (9.1) years, and a median (SD) prostate-specific antigen level prior to biopsy of 7.53 (12.97) ng/mL and prostate volume of 51 (31.1) mL. PCa was detected in 54 (55%) patients, with csPCa detected in 43 (44%). A total of 124 Prostate Imaging-Reporting and Data System (PI-RADS) 3–5 lesions were targeted. Grade Group ≥2 PCa was found in 35.5% of the targeted lesions. Random biopsies detected one csPCa Gleason score 3 + 4 in one patient with a negative target. None of the patients had post-biopsy haematuria or retention. Only one patient developed acute prostatitis requiring in-patient intravenous antibiotics. Conclusions MRI/US-fusion TP biopsy has an adequate detection rate of csPCa with minimal complications and low infection rates after biopsy. This is one of the first TP biopsy series in the Middle East paving the way for wider adoption in the region. Abbreviations AS: active surveillance; AUR: acute urinary retention; GG: Grade Group; IQR: interquartile range; mpMRI: multiparametric MRI; (cs)PCa: (clinically significant) prostate cancer; PI-RADS: Prostate Imaging-Reporting and Data System; TP: transperineal; US: ultrasonography; TRUS: transrectal Ultrasound guided.

The objective of this study is to determine the frequency of clinically significant cancer (CSC) in Prostate Imaging Reporting and Data System (PI-RADS) category 3 (equivocal) lesions prospectively identified on multiparametric prostate MRI and to identify risk factors (RFs) for CSC that may aid in decision making. Between January 2015 and July 2016, a total of 977 consecutively seen men underwent multiparametric prostate MRI, and 342 underwent MRI-ultrasound (US) fusion targeted biopsy. A total of 474 lesions were retrospectively reviewed, and 111 were scored as PI-RADS category 3 and were visualized using a 3-T MRI scanner. Multiparametric prostate MR images were prospectively interpreted by body subspecialty radiologists trained to use PI-RADS version 2. CSC was defined as a Gleason score of at least 7 on targeted biopsy. A multivariate logistic regression model was constructed to identify the RFs associated with CSC. Of the 111 PI-RADS category 3 lesions, 81 (73.0%) were benign, 11 (9.9%) were clinically insignificant (Gleason score, 6), and 19 (17.1%) were clinically significant. On multivariate analysis, three RFs were identified as significant predictors of CSC: older patient age (odds ratio [OR], 1.13; p = 0.002), smaller prostate volume (OR, 0.94; p = 0.008), and abnormal digital rectal examination (DRE) findings (OR, 3.92; p = 0.03). For PI-RADS category 3 lesions associated with zero, one, two, or three RFs, the risk of CSC was 4%, 16%, 62%, and 100%, respectively. PI-RADS category 3 lesions for which two or more RFs were noted (e.g., age ≥ 70 years, gland size ≤ 36 mL, or abnormal DRE findings) had a CSC detection rate of 67% with a sensitivity of 53%, a specificity of 95%, a positive predictive value of 67%, and a negative predictive value of 91%. Incorporating clinical parameters into risk stratification algorithms may improve the ability to detect clinically significant disease among PI-RADS category 3 lesions and may aid in the decision to perform biopsy.