Hiten D. Patel

In this study of 22,445 prostate MRI examinations from 22 countries, an AI system’s performance was comparable to radiology readings for prostate cancer detection in external diagnostic and screening datasets.

Multiparametric MRI (mpMRI) is increasingly employed to reduce unnecessary prostate biopsies while maintaining detection of clinically significant prostate cancer (csPCa). False-negative (FN) mpMRI lead to delayed diagnosis. This study aimed to identify clinical and reader-associated factors associated with FN mpMRI. We retrospectively identified patients who underwent prostate mpMRI followed by prostate biopsy within one year. FN cases were compared to true negative (TN) cases in Analysis #1 and to true positive (TP) cases in Analysis #2 using logistic regression and propensity score matching. A sensitivity analysis assessed patients who initially deferred biopsy after negative mpMRI. csPCa was defined as Gleason Grade Group (GG)≥2 and positive mpMRI as PI-RADS ≥3. 6,679 biopsied patients were identified with 663 TN, 133 FN, and 2993 TP cases included. Multivariable models predicting csPCa in the negative mpMRI setting found FN cases more frequently had a positive family history, Black race, high PSA density, and more PI-RADS 2 compared to TN cases. FN mpMRIs were more often read by radiologists without fellowship training (p=0.001) and with fewer cumulative annual mpMRI reads (68/yr vs. 84/yr, p50 radiologist reads/year was protective against FN mpMRI in both analyses. Of 4,069 patients initially deferring biopsy after negative mpMRI, 17% had repeat mpMRI, 12% had biopsy, and 3.4% had csPCa at a median of 2 years. Clinical predictors of csPCa remain similar among patients with negative mpMRI. MRI BPH and prostatitis along with lower radiologist read volume differentiated FN from TP cases. Enhanced clinical stratification tools and mpMRI refinements could improve confidence in forgoing biopsy for patients with a negative mpMRI.

Background: Improvements in imaging and technique have led to a greater role for renal mass biopsy (RMB) to risk‐stratify localized renal masses. We sought to assess the contemporary diagnostic accuracy of RMB for identifying renal cell carcinoma (RCC) based on concordance with final surgical pathology. Materials and Methods: Consecutive patients undergoing RMB between 2013 and 2023 across an 11‐hospital health system were identified. Concordance between RMB and final pathology for patients receiving partial or radical nephrectomy was compared. We calculated sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of RMB for identifying RCC among patients who underwent surgery. Results: A total of 733 patients underwent RMB with an overall non‐diagnostic rate of 11% and most biopsies (67%) identified RCC. A total of 243 patients with surgical pathology were analysed, and 229 (94%) had RCC on surgical pathology. Excluding non‐diagnostic cases, RMB had a 98% concordance with surgical pathology for RCC; RMB had 94% sensitivity, 71% specificity, 98% PPV and 42% NPV for identifying RCC with non‐diagnostic cases considered as benign biopsies. For the nine RMB oncocytic cases receiving surgery, six (66%) were RCC and only two (22%) were confirmed oncocytomas. For patients with biopsy grade reported, 100% of high‐grade RCC were confirmed while 26% of low‐grade RCC were upgraded at nephrectomy (overall 80% concordance). Conclusions: In a large, contemporary cohort of patients, RMB had high PPV and sensitivity for identifying RCC and high concordance for specific histology at nephrectomy. However, upgrading was common, and oncocytic lesions selected for surgery due to clinical suspicion often harboured RCC.

Background: As antimicrobial resistance increases, safer alternative approaches to prostate biopsy are needed. PREVENT was a multi‐institutional, randomized controlled trial comparing transperineal (TP) biopsy without antibiotic prophylaxis versus transrectal (TR) biopsy with targeted prophylaxis. The authors conducted a secondary cost‐effectiveness analysis of PREVENT. Methods: The authors designed a Markov model with a simulated cohort of 1000 biopsied men. They assessed the short‐term cost‐effectiveness over a 2‐week period, comparing relative costs in US dollars and utility measured in quality‐adjusted life years (QALYs). The strategies they compared were office‐based, magnetic resonance imaging‐guided biopsy using two approaches: (1) TP without antibiotics; or (2) TR with targeted antibiotic prophylaxis. Analysis was from a health care payer perspective using a willingness‐to‐pay (WTP) threshold of $100,000/QALY. Probabilistic sensitivity analysis was performed with 5000 Monte Carlo simulations. Results: Compared to TR, TP was dominant, offering lower cost and higher utility per patient. This finding was robust to sensitivity analyses with TP having >89% probability of cost‐effectiveness regardless of WTP threshold. TP remained dominant when real‐world infection rates were used. TP biopsy needed to prevent >0.5% infections compared to TR to maintain cost‐effectiveness. Per 1000 patients, TP biopsy prevented 16 infections, and the additional cost to prevent a single infection was $3.18/patient. Conclusions: In this model, TP biopsy was more cost‐effective than TR from a health care payer perspective. In the setting of increasing concerns about the risk of infection from traditional TR biopsy, these findings suggest that office‐based TP biopsy is a more cost‐effective population‐level alternative.

Background: In the systematic biopsy era, prostate biopsy grading followed the rule that the International Society of Urological Pathology grade group assigned was the highest grade group of any core. This rule has been retained in the era of multiparametric magnetic resonance imaging (MRI)–guided biopsy in the case of discordance between systematic biopsy and targeted biopsy samples. We assessed whether oncologic risk in patients undergoing systematic biopsy and targeted biopsy was driven by the highest grade group of the two. Methods: Overall, 6588 patients received systematic biopsy plus MRI-targeted biopsy and radical prostatectomy. We assessed advanced stage (seminal vesicle or lymph node invasion with or without extraprostatic extension), adverse pathology (advanced stage or high grade group), and biochemical recurrence for each systematic biopsy and MRI-targeted biopsy grade group combination. Results: Overall, 3405 (52%) had discordant grade groups. When systematic biopsy and MRI-targeted biopsy grades were discordant, the risk of advanced-stage disease was intermediate. For instance, the risk of advanced pathologic stage was 23% for grade group 3 on both systematic biopsy and targeted biopsy and 8.8% for concordant grade group 2. The risk was 18% for patients with systematic biopsy grade group 3 but targeted biopsy grade group 2 and 15% if the reverse were true. Similar results were seen for other outcomes. Conclusions: When the grade group is discordant between systematic biopsy and targeted biopsy, the risk is intermediate. The current approach of assigning the highest grade group should be abandoned, and urologists should consider deescalating treatment intensity for patients with discordant systematic biopsy and MRI-targeted biopsy grade groups. Our findings are plausibly explained by pattern 4 volume being the primary driver of risk.

Prostate Imaging Reporting and Data System (PIRADS) v2.1 scoring with multiparametric MRI (mpMRI) has a pooled 90% negative predictive value (NPV). PSA density (PSAD) ≤0.15ng/ml/cm³ has been shown to enhance mpMRI's NPV in non-Black men. Populations with higher disease prevalence are known to have lower NPVs. Given that Black men have higher PCa prevalence, we evaluate sensitivity and NPV of mpMRI in Black vs. non-Black men to assess possible mpMRI performance differences. As an exploratory objective, we investigate PSAD thresholds providing ≥90% sensitivity in Black men. We prospectively recruited Black and non-Black men referred to outpatient urology clinics for abnormal PSA or prostate exam in three similar biomarker validation studies from 2017-23 before MRI-informed diagnostic prostate biopsy. We combined the research cohorts with a retrospective clinical cohort of clinically similar Black and non-Black men from one academic institution who also underwent mpMRIs and MRI-informed biopsies. MRIs were scored using PIRADS version 2.0 or 2.1. Our analysis included 286 Black men and 965 non-Black men with PSA ≤15.0ng/ml. PIRADS <3 had an NPV of 77.1% versus 87.6% and a sensitivity of 90.7% vs. 96.3% for GG2-5 PCa in Black versus non-Black men, respectively (both p <0.05). Using PSAD ≥0.09 for Black men with PIRADS 1-2 lesions increased sensitivity to 92.9%. PIRADS <3 has a lower NPV and sensitivity in Black men. For negative prostate MRIs, PSAD ≥0.09 may be a better threshold for safe biopsy deferral in Black men to maintain a ≥90% sensitivity.

Background and Objectives: The American Urological Association (AUA) guidelines recommend evaluating asymptomatic microhematuria (MH) at ≥ 3 red blood cells per high powered field (RBCs/hpf), resulting in significant costs with limited bladder cancer detections. This study evaluates alternative diagnostic strategies to improve the cost‐effectiveness of asymptomatic MH evaluation.Methods: The cost‐effectiveness analysis compared three alternative strategies: Strategy 1 (cystoscopy at ≥ 26 RBCs/hpf) was compared to a 3 RBCs/hpf threshold, while Strategy 2 (cystoscopy and renal ultrasound at ≥ 3 RBCs/hpf) and Strategy 3 (cystoscopy and renal ultrasound at ≥ 26 RBCs/hpf) were compared to the AUA guidelines. Total costs, cost per patient evaluated, costs per cancer detected, and incremental cost‐effectiveness ratios (ICERs) were calculated.Results: Strategy 3 minimized costs without significantly reducing early cancer detection rates. It was cost‐effective for females (ICER = $120,649) and the total sample (ICER = $50,648) but not specifically for males (ICER = $23,326). Strategies 1 and 2 yielded lower cost savings and were less efficient.Conclusions: Strategy 3—performing cystoscopy and renal ultrasound for higher‐risk patients ( ≥ 26 RBCs/hpf)—offers a more cost‐effective approach than the AUA guidelines, particularly for women. Future studies should incorporate additional patient variables and diagnostic test characteristics.