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Prostate cancer is the commonest cancer in men in Europe and many countries worldwide, and the second commonest cause of cancer-related death. A screening programme to detect clinically relevant prostate cancer at a time when it can be cured, without burdensome overdiagnosis and subsequent overtreatment, is a laudable goal. We will set out the advances in MRI imaging, and the progress in MRI for men prior to biopsy, discussing whether MRI has a place before biopsy, or as a primary screening tool, in a modern approach to prostate cancer screening. [ABSTRACT FROM AUTHOR]

Currently available data from long-running single- and multi-center active surveillance (AS) studies show that AS has excellent cancer-specific survival rates. For AS to be effective the 'right' patients should be selected for which up until 5-to-10 years ago systematic prostate biopsies were used. Because the systematic prostate strategy relies on sampling efficiency for the detection of prostate cancer (PCa), it is subject to sampling error. Due to this sampling error, many of the Gleason 3+3 PCas that were included on AS in the early days and were classified as low-risk, may in fact have had a higher Gleason score. Subsequently, AS-criteria were more strict to overcome or limit the number of men missing the potential window of curability in case their tumor would be reclassified. Five to ten years ago the prostate biopsy landscape changed drastically by the addition of magnetic resonance imaging (MRI) into the diagnostic PCa-care pathway, which has by now trickled down into the EAU guidelines. At the moment, the EAU guidelines recommend performing a (multi-parametric) MRI before prostate biopsy and combine systematic and targeted prostate biopsy when the MRI is positive (i.e. PIRADS ≥3). So because of the introduction of the MRI into the diagnostic PCa-care pathway, literature is showing that more Gleason 3+4 PCas are being diagnosed. But can it not be that the inclusion of MRI into the diagnostic PCa-care pathway causes risk inflation, resulting in men earlier eligible for AS, now being labelled ineligible for AS? Would it not be possible to include these current Gleason 3+4 PCas on AS? The authors hypothesize that the improved accuracy that comes with the introduction of MRI into the diagnostic PCa-care pathway permits to widen both the AS-inclusion and follow-up criteria. Maintaining our inclusion criteria for AS from the systematic biopsy era will unnecessarily and undesirably expose patients to the increased risk of overtreatment. The evidence behind the addition of MRI-targeted biopsies to systematic biopsies calls upon the re-evaluation of the AS inclusion criteria and research from one-size-fits-all protocols used so far, into the direction of more dynamic and individual risk-based AS-approaches. [ABSTRACT FROM AUTHOR]

Prostate magnetic resonance imaging (MRI) is increasingly used prior to biopsy in response to the overdiagnosis and overtreatment of prostate cancer (CaP) associated with prostate-specific antigen (PSA) based screening. However, technical limitations in the conventional diffusion-weighted imaging (DWI) sequences as well as the high degree of radiologist-to-radiologist variability in interpreting prostate MRI result in inadequate accuracy. Specifically, the insufficient negative predictive value (NPV) of prostate MRI (76%–87%) does not allow biopsy to be omitted in the negative MRI setting. Additionally, the variable, and relatively low positive predictive value (PPV) of MRI (27%–44%) provides only an incremental improvement in risk prediction compared to readily available clinical tools such as the Prostate Cancer Prevention Trial risk calculator. This small benefit is likely confined to the minority of patients with positive MRI findings in a typically under-sampled region of the prostate (e.g., anterior lesions), which may be obviated by newer biopsy approaches and tools such as transperineal prostate biopsy and micro-ultrasound technology. With these considerations in mind, pre-biopsy prostate MRI in its current form is unlikely to provide a clinically significant benefit, and should not be considered as routine practice until its accuracy is sufficiently improved. [ABSTRACT FROM AUTHOR]

• PIRADS 3 lesion represents a "gray zone" where further tools are needed for decision making for risk stratification and prostate biopsy. • 4k score has better performance in predicting clinically significant prostate cancer in patients with PIRADS 3 lesions and PSA density less than 0.15 ng/mL/cm3. • Using a threshold of PSA density of 0.1 ng/mL/cm3 or 4k score of 10% would help reduce unnecessary biopsy without missing a significant proportion of clinically significant prostate cancer. The recommendation to perform biopsy of PIRADS 3 lesions has not been adopted with strength as compared to higher scored lesions on multiparametric MRI. This represents a challenging scenario and an unmet need for clinicians to apply a risk adapted approach in these cases. In the present study, we examined clinical and radiologic characteristics in men with PI-RADS 3 index lesions that can predict csPCa on mpMRI-target biopsy. Revision of a prospective database with patients who underwent targeted and systematic biopsies from 2015 to 2023 for PI-RADS 3 lesions identified on mpMRI. Baseline variables were collected, such as PSA density (PSAd), 4Kscore, prostate size, and the apparent diffusion coefficient (ADC) value of the lesion on mpMRI. Logistic regression, receiver operating characteristic (ROC) and decision curve analyses (DCA) assessing the association between clinic-radiologic factors and csPCa were performed. Overall, 230 patients were included in the study and the median age was 65 years. The median prostate size and PSA were 50 g and 6.26 ng/mL, respectively. 17.4% of patients had csPCa, while 27.5% had Gleason group 1. In univariable logistic analyses, we found that age, BMI, prostate size, PSAd, ADC, and 4Kscore were significant csPCa predictors (P < 0.05). PSAd showed the best prediction performance in terms of AUC (= 0.679). On multivariable analysis, PSAd and 4Kscore were associated with csPCa. The net benefit of PSAd combined with clinical features was superior to those of other parameters. Within patients with PSAd < 0.15, 4Kscore was a statistically significant predictor of csPCa (OR = 3.25, P = 0.032). PSAd and 4Kscore are better predictors of csPCa in patients with PIRADS 3 lesions compared to ADC. The predictive role of 4Kscore is higher in patients with low PSAd. These results can assist practitioners in the risk stratification of patients with equivocal lesions to determine the need of biopsy. [ABSTRACT FROM AUTHOR]

• Initial timing of mpMRI in active surveillance does not change progression rates. • Higher initial PIRADS score is associated with upgrading during AS. • PSA density ≥0.15 is associated with worse progression-free survival. • PSA density ≥0.15 is associated with worse intervention-free survival. Active surveillance (AS) is a management strategy for patients with favorable risk prostate cancer. Multi-parametric magnetic resonance imaging (mpMRI) may impact upgrading rates, but there is mixed evidence on the appropriate timing to introduce mpMRI. We evaluated timing of initial mpMRI use for patients on AS and compared upgrading and intervention rates for AS candidates who received initial mpMRI before diagnostic biopsy vs. confirmatory biopsy. Patients enrolled in AS captured by the Prospective Loyola Urology mpMRI (PLUM) Prostate Biopsy Cohort which captures men undergoing MRI-fusion prostate biopsy. We included patients enrolled in AS between January 2014 and October 2022. We conducted a retrospective analysis of patients who underwent MRI-fusion prostate biopsy while on AS at our institution. The cohort was stratified by men who underwent first mpMRI prior to diagnostic biopsy (MRI-DBx), confirmatory biopsy (MRI-CBx), or a subsequent surveillance biopsy. Oncologic outcomes including pathologic reclassification, intervention-free survival, progression-free survival, and overall survival were evaluated. Of 346 patients identified on AS, 94 (27.2%) received mpMRI at the time of diagnostic biopsy, 182 (52.6%) at confirmatory biopsy, and 70 (20.2%) at a later biopsy. At confirmatory biopsy (median 14 months), there was no difference in upgrading (HR 0.95, P = 0.78) or intervention rates (HR 0.97, P = 0.88) between MRI-DBx and MRI-CBx. PI-RADS score on initial mpMRI was associated with upgrading during AS follow-up relative to men with negative mpMRI (HR 4.20 (P = 0.04), 3.24 (P < 0.001), and 1.99 (P < 0.001) for PI-RADS 5, 4, and 3, respectively), and PSA density was associated with intervention (HR 1.52, P = 0.03). mpMRI can serve as a prognostic tool to select and monitor AS patients, but there was no difference in upgrading or intervention rates based on initial timing of MRI. [ABSTRACT FROM AUTHOR]

• TUA nomogram predicts csPCa with 82.3% sensitivity. • High specificity (73.3%) minimizes overtreatment. • Reduces unnecessary biopsies by 60.5% in practice. • Incorporates PSA-D, age, lesion size, and DRE findings. • Enhances decision-making process for prostate biopsies and follow-up strategies. This study aimed to develop a novel nomogram to predict clinically significant prostate cancer in patients undergoing multi-parametric prostate MRI-assisted lesion biopsies, addressing the challenges in deciding on biopsy for patients with PI-RADS 3 lesions and follow-up strategies for patients with negative PI-RADS 4 or 5 lesions. A retrospective case-control study was conducted using the Turkish Urooncology Association Databases (UROCaD). The final dataset included 2428 lesion biopsy data. Univariate analysis, logistic regression, and validation were performed, with 1942 and 486 lesion biopsy data in the training and validation datasets, respectively. Age, initial total PSA value, PSA density, prostate volume, lesion length, DRE findings, and PI-RADS score were significantly different between benign or non-significant cancer and clinically significant prostate cancer groups. The developed nomogram incorporated PSA density, age, PI-RADS score, lesion length, and DRE findings. The mean area under the curve for the 6-fold cross-validation was 0.836, while the area under the curve values for the training and validation datasets were 0.827 and 0.861, respectively. The nomogram demonstrated a sensitivity of 75.6% and a specificity of 74.8% at a cut-off score of 24.9, with positive and negative predictive values of 42.2% and 92.6%, respectively. The TUA nomogram, based on PSA density, age, PI-RADS score, lesion length, and DRE findings, provides a reliable and accurate prediction tool for detecting clinically significant prostate cancer in patients undergoing multi-parametric prostate MRI-assisted lesion (fusion) biopsies, potentially improving patient management and reducing unnecessary biopsies. [ABSTRACT FROM AUTHOR]

The European Association of Urology currently recommends the use of risk-organized models to decrease the demand of prebiopsy magnetic resonance imaging (MRI) and unnecessary prostate biopsies in men with suspected prostate cancer (CaP). Low evidence suggests that men with prostate-specific antigen >10 ng/ml and an abnormal digital rectal examination (DRE) do not benefit from prebiopsy MRI and targeted biopsies. We aim to validate this low evidence in a sizable cohort and knowing how many clinically significant CaP (csCaP) would go undetected if only random biopsies were performed in these cases. We analyze a subset of 545 men with PSA >10 ng/ml and an abnormal DRE who met the previous criteria among 5,329 participants in a prospective trial in whom random biopsy was always performed and targeted biopsies of PI-RADS ≥3 lesions (10.2%). CsCaP (grade group ≥2) was detected in 370 men (67.9%), with 11 of 49 with negative MRI (22.5%) and 359 of 496 (72.4%) having PI-RADS ≥3. CsCaP was identified in random and targeted biopsies in 317 (88.7%) men, in targeted biopsies only in 23 (6.4%), and in random biopsies only in 19 (5.3%). If only random biopsies were performed in these men, 23 of overall 1,914 csCaP (1.2%) would go undetected in this population. Prebiopsy MRI can be saved in men with serum PSA >10 ng/ml and an abnormal DRE and only random biopsy performed. However, a close follow-up of men with negative random biopsy seems appropriate due to the high-risk of csCaP in these men. [ABSTRACT FROM AUTHOR]

Background and Objective: Comparative studies among biopsy strategies have not been conducted evaluating pathologic concordance at radical prostatectomy(RP), especially with novel micro-ultrasound (micro-US) image-guided biopsy., Methods: A retrospective study among patients with PCa who underwent RP following TRUS, MRI-TRUS fusion, microUS, or MRI-microUS fusion biopsy in a multi-site single institution. We compared GG-upgrade from biopsy to RP based on highest GG in any biopsy core and examined clinical/pathologic factors associated with pathologic upgrading using descriptive statistics, and multivariable logistic-regression analysis., Results: 429 patients between 1/2021 and 6/2023 including 10 (25.6%) who underwent systematic TRUS, 237 (55.2%) MRI-TRUS, 67 (15.6%) MRI-microUS and 15 (3.5%) micoUS-alone biopsy prior to RP. 78 (18.2%) were upgraded on final pathology (TRUS 31 (28.2%), MRI-TRUS 31 (13.1%), MRI-microUS 10 (14.9%), microUS: 6 (40%)) and 99 downgraded. 14 (3.5%) experienced a major upgrade (≥2 GG increase). On multivariable-analysis both MRI-TRUS (odds ratio, OR: 0.31,95% CI:0.17-0.56, P < 0.001) and MRI-microUS (OR: 0.43,95%CI: 0.19-0.98, P = 0.044) were associated with lower odds pathological-upgrade compared with TRUS biopsy alone. No significant differences in the odds of upgrade between TRUS and microUS alone (P > 0.05), or between MRI-microUS and MRI-TRUS(P = 0.696) on pairwise comparisons. MRI-microUS was associated with lower upgrade compared with microUS (OR: 0.26,95% CI:0.08-0.90, P = 0.034). No difference among the biopsy strategies in pathologic downgrading or overall GG concordance. Limitations include retrospective analysis, inter-clinician experience and lesion selection in varying biopsy techniques., Conclusion: Both MRI-microUS and MRI-TRUS fusion were associated with similarly improved GG concordance compared with TRUS biopsy. No significant differences between microUS-alone and TRUS or between MRI-microUS and MRI-TRUS fusion approaches, may suggest similar accuracy performance for disease sampling., What Does the Study Add: To our knowledge, this is the first study to investigate GG concordance based on type of biopsy, especially microUS related GG upgrading after RP. In a moderately sized cohort this is the first to investigate pathologic concordance in MRI-microUS fusion compared to MRI-TRUS fusion biopsy. Our study may help urologists in counseling patients after biopsy and choosing the ideal image guided biopsy technique, however randomized controlled trials are needed to validate our results., Patient Summary: We performed a study to see if the type of prostate biopsy, including use of MRI assistance as well as a new image-guided biopsy using a more advanced ultrasound, was better able to identify the aggressiveness of prostate cancer patients had. We found that the new biopsy type when fused with MRI and the existing MRI-guided biopsy type were similar in predicting the type of prostate cancer found at prostate surgery. These were both more accurate than the conventional ultrasound only biopsy., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Active surveillance (AS) is the currently the recommended treatment for very low- and low-risk prostate cancer. AS is also being more frequently used for favorable intermediate risk prostate cancer in select patients.;Clinical tools such as prostate multiparametric MRI (mpMRI) and genomic classifiers such as Decipher® GC are recommended to risk stratify newly diagnosed prostate cancer (PCa) patients in the pre-treatment setting. Our aim for this study was to examine the relationship between pre-treatment parameters such as PSA, biopsy Gleason Grade Group (GGG), MRI Prostate Imaging-Reporting and Data System (PI-RADS) score and Decipher® GC, and progression to treatment in patients currently on AS for PCa. We retrospectively examined patients at our institution who underwent Decipher® GC testing on prostate biopsy tissue (n=888) between December 2016 and March 2023. Data regarding PSA, PI-RADS lesion on MRI, biopsy GGG, Decipher® GC and treatment modality were collected. Of these patients, 235 were placed on AS initially. Ultimately, 88 patients progressed to treatment. We performed a multivariable Cox proportional hazards model with time to treatment as the outcome and PSA, PI-RADS score and Decipher® GC as potential predictors. Our final cohort included 235 patients initially placed on AS. The cohort had a mean PSA of 7.4 and Decipher® GC score of 0.38. 25.5% of these patients (n = 60) had PIRADS 1-2 lesions on MRI, 14% (n = 33) had PIRADS 3 lesions and 60.4% (n = 142) had PIRADS 4-5 lesions. 40% of these patients (n = 94) had GGG1, 48.1% (n = 113) had GGG2, and the rest (n = 28) had GGG3 or higher on biopsy.We found that a Decipher® GC above 0.4 (p = 0.002) and 0.6 (p = 0.006) was associated with progression to treatment while on AS, whereas having a PI-RADS 3 lesion (p = 0.92) and having a PI-RADS 4-5 lesion (p = 0.05) were not (Table 1). Survival curves showed that increased Decipher® GC was associated with decreased freedom from treatment, whereas PI-RADS score was not (Table 2). Tumor-based molecular assays such as Decipher® GC are included in the NCCN guidelines for localized prostate cancer management. Decipher® GC has been shown to independently predict adverse pathology with ver low-, low- and intermediate-risk PCa. Previous studies have shown the association of Decipher® GC score with progression to treatment on AS without incorporating mpMRI data.;We found that an increased Decipher® GC is an independent predictor of progression to treatment in a cohort of patients on AS, while mpMRI (PI-RADS) is not. [ABSTRACT FROM AUTHOR]

Partial gland ablation is an emerging treatment option for localized prostate cancer (PCa). While radical prostatectomy (RP) or radiation are associated with a significant impact on functional outcomes, partial gland ablation may attenuate some of the negative adverse effects of whole-gland treatments. However, there is a lack of high-quality evidence comparing cancer control outcomes of partial vs. whole-gland therapies. For instance, prior series comparing partial gland ablation to RP demonstrated similar oncologic outcomes, but these studies did not standardize oncologic endpoints, as recommended by expert consensus. We aimed to compare outcomes between partial gland cryoablation (PGC) and robotic-assisted RP in a cohort of men whereby regular surveillance biopsies were performed after PGC. We assessed men treated with cryoablation (n=71) or RP (n=448) by a single surgeon at Weill Cornell Medical Center from January 2017 to December 2022. Exclusion criteria were those who were treated for low risk PCa (Grade Group [GG] <2) and those who underwent salvage PGC or RP. Only men who underwent at least one post-PGC prostate biopsy were included. Primary outcome was treatment failure, defined as recurrent cancer on surveillance biopsy after PGC or post-RP biochemical recurrence (PSA >0.1), need for any salvage treatment, or metastases. Exact matching was performed for the PGC and RP cohorts based on biopsy GG, and 1:1 propensity score-matched analysis was performed based on age, year of treatment, pre-treatment PSA, and biopsy GG. Kaplan-Meier and Cox proportional hazards models were performed to compare oncologic outcomes. Sixty-eight men in each group were compared after propensity score matching. There were no significant differences in median age, pre-treatment PSA, year of treatment, or biopsy GG between the PGC and RP groups (Table). All men were treated for clinical T1c prostate cancer. Median follow-up was shorter for PGC (44 months, interquartile range [IQR] 18-54;vs. 51 months, IQR 23-59,;p=0.070),;but the difference did not reach statistical significance. Men who received PGC experienced more treatment failures (52% vs. 8.8%, p<0.001) and required more salvage therapies (41% vs. 7.4%, p<0.001). Log-rank survival analysis demonstrated significantly lower treatment failure-free and salvage treatment-free survival with PGC (Figure). Adjusted analyses showed PGC was associated with higher risk of treatment failure (hazard ratio [HR] 7.6, 95% confidence interval [CI] 2.9-20.0, p<0.001) and salvage therapy (HR 7.8, 95% CI 3.2-18.6, p<0.001). Our novel study is the first comparative effectiveness analysis of PGC biopsy endpoints and RP oncologic outcomes. Those undergoing PGC are at higher risk of treatment failure and salvage treatment. Although these findings require confirmation by others, our results highlight the need for patients and providers to carefully consider the risks of retreatment when considering the tradeoffs between partial gland ablation and RP. [ABSTRACT FROM AUTHOR]

The impact of biopsy approach on the detection rate of prostate cancer (PCa) is an active area of investigation. While recent evidence suggests higher cancer detection rates for targeted biopsies using a transperineal approach, the impact of lesion location remains unclear. This study aims to investigate the relative performance of transperineal (TP) MRI-targeted prostate biopsy (TBx) for the detection of clinically significant prostate cancer (csPCa) in the apex, compared to transrectal (TR) TBx. A prospectively maintained database of patients who underwent MRI-guided prostate biopsy at our institution between 2016-2023 was queried for patients with MRI lesions in the apex.;Biopsies were performed using the UroNav MRI/ultrasound fusion biopsy system using an endfire ultrasound probe. Overall cancer detection rate, as well as rate of Gleason grade group (GG) ≥2 and GG≥3, were compared on a per-lesion basis between patients undergoing TP-TBx and patients undergoing TR-TBx. Clinical factors including PSA levels, prostate volume, and the location of the lesion in the apex were assessed using two-sample t-tests and chi-squared tests, and PIRADS scores were compared between groups using the Kruskal-Wallis test. To account for patients who underwent both TP-TBx and TR-TBx, chi-squared tests were conducted to compare the diagnoses for the same patient cohort. Between 2016-2023, 1034 apical prostate lesion biopsies were identified, of which 159 were TP-TBx and 875 were TR-TBx (Table 1). A univariate analysis of pre-biopsy PSA, prostate volume and PIRADS demonstrated no statistically significant difference between the TP-TBx and TR-TBx groups. The rate of ≥GG2 cancers diagnosed was statistically greater for TP-TBx vs TR-TBx (44.26% vs 35.66%, p =0.03). The overall cancer detection rate (CDR) and CDR of cancers ≥ GG 3 were not statistically different between biopsy types. Amongst the sub cohort with available zonal delineation (n = 764), there was a higher CDR of GG>2 cancers in the peripheral zone, but not transition zone (Table 2). Among a subset of patients who underwent TR biopsy followed by TP (n= 34), 35.29% were upgraded on TP biopsy, while 0% of patients who underwent TR after TP biopsy (n= 5) were upgraded on TR biopsy. In this analysis, targeted transperineal biopsy was associated with higher GG≥2 detection rate compared to transrectal biopsy for apical lesions. Prospective studies are warranted to validate transperineal biopsy as a potentially superior approach for prostate cancer detection in apical lesions in the MRI era. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the learning curve of a transperineal (TP) magnetic resonance imaging (MRI) and transrectal ultrasound (TRUS) fusion prostate biopsy (PBx)., Materials and Methods: Consecutive patients undergoing MRI followed by TP PBx from May/2017 to January/2023, were prospectively enrolled (IRB# HS-13-00663). All participants underwent MRI followed by 12 to 14 core systematic PBx (SB), with at least 2 additional targeted biopsy (TB) cores per PIRADS ≥3. The biopsies were performed transperineally using an organ tracking image-fusion system. The cohort was divided into chronological quintiles. An inflection point analysis was performed to determine proficiency. Operative time was defined from insertion to removal of the TRUS probe from the patient's rectum. Grade Group ≥2 defined clinically significant prostate cancer (CSPCa). Statistically significant if P < 0.05., Results: A total of 370 patients were included and divided into quintiles of 74 patients. MRI findings and PIRADS distribution were similar between quintiles (P = 0.08). The CSPCa detection with SB+TB was consistent across quintiles: PIRADS 1 and 2 (range, 0%-18%; P = 0.25); PIRADS 3 to 5 (range, 46%-70%; P = 0.12). The CSPCa detection on PIRADS 3 to 5 TB alone, for quintiles 1 to 5, was respectively 44%, 58%, 66%, 41%, and 53% (P = 0.08). The median operative time significantly decreased for PIRADS 1 and 2 (33 min to 13 min; P < 0.01) and PIRADS 3 to 5 (48 min to 19 min; P < 0.01), reaching a plateau after 156 cases. Complications were not significantly different across quintiles (range, 0-5.4%; P = 0.3)., Conclusions: The CSPCa detection remained consistently satisfactory throughout the learning curve of the Transperineal MRI/TRUS fusion prostate biopsy. However, the operative time significantly decreased with proficiency achieved after 156 cases., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Receives consultancy fees from Merck, MSD, and Novartis and has equity in Rocketlane Medical Ventures GmbH - Severin Rodler; Has equity interest in OneLine Health and Karkinos - Inderbir Gill; Is a consultant for Koelis, a speaker for EDAP, and a proctor for Sonablate - Andre Luis Abreu; Other authors do not have any competing interests. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Prostate cancer remains one of the most frequently diagnosed cancers among men in the world today. Since its introduction in 1987 and FDA approval in 1994, prostate specific antigen (PSA) has reduced prostate cancer specific mortality considerably. However, the positive and negative predictive value of PSA is less than ideal and can lead to the over-detection of clinically insignificant prostate cancer. In the search for better screening measures to identify this cohort, liquid biomarkers for prostate cancer have emerged. In this review we will explore the commonly used urine and blood based prostate cancer liquid biomarkers. We detail the mechanism of each test and the validation studies that underscore their efficacy. Additionally, we will examine each test's effect on shared decision making as well as their cost efficacy in clinical practice., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Philip Olson reports was provided by UConn Health. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Since the "prostate-specific antigen (PSA) era," we have seen an increase in unnecessary biopsies, which has ultimately lead to an overtreatment of low-risk cancers. Given the limitations of prostate-specific antigen and the invasive nature of prostate biopsy several serum and urinary biomarkers have been developed. In this paper, we provide a comprehensive review of the available biomarkers for the detection clinically significant prostate cancer namely PHI, 4Kscore, PCA3, MiPS, SelectMDx, ExosomeDX. Current literature suggests that these biomarkers can improve detection of clinically significant prostate cancer reducing overtreatment and making treatment strategies more cost-effective. Nevertheless, large prospective studies with head-to-head-comparisons of the available biomarkers are necessary to fully assess the potential of incorporating biomarkers in routine clinical practice. [ABSTRACT FROM AUTHOR]

• Our study is the first report on how PHI and mpMRI should be used in concert to improve diagnostic capacity for CsCaP. • It is important to distinguish situations when more sensitivity is and is not more important than more specificity, especially for cancers. • The risk prediction model combining PHI and mpMRI (PHI-MRI model) was superior to using PHI or MRI alone in predicting CaP and CsCaP. • The use of PHI-MRI model alone or the sequential using PHI followed by PHI-MRI model can reduce unnecessary biopsies compared to the sequential use of PHI and MRI. To explore how prostate health index (PHI) and multiparametric magnetic resonance imaging (mpMRI) should be used in concert to improve diagnostic capacity for clinically significant prostate cancers (CsCaP) in patients with prostate-specific antigen (PSA) between 4 and 20 ng/ml. About 426 patients fulfilling the inclusion criteria were included in this study. Univariable and multivariable logistic analyses were performed to analyze the association between the clinical indicators and CaP/CsCaP. We used the Delong test to compare the differences in the area under the curve (AUC) values of four models for CaP and CsCaP. Decision curve analysis (DCA) and calibration plots were used to assess predictive performance. We compared clinical outcomes of different diagnostic strategies constructed using different combinations of the models by the chi-square test and the McNemar test. The AUC of PHI-MRI (a risk prediction model based on PHI and mpMRI) was 0.859, which was significantly higher than those of PHI (AUC = 0.792, P < 0.001) and mpMRI (AUC = 0.797, P < 0.001). PHI-MRI had a higher net benefit on DCA for predicting CaP and CsCaP in comparison to PHI and mpMRI. Adding the PHI-MRI in diagnostic strategies for CsCaP, such as use PHI-MRI alone or sequential use of PHI followed by PHI-MRI, could reduce the number of biopsies by approximately 20% compared to use PHI followed by mpMRI (256 vs 316, 257 vs 316, respectively). The PHI-MRI model was superior to PHI and MRI alone. It may reduce the number of biopsies and ensure the detection rate of CsCaP under an appropriate sensitivity at the cost of an increased number of MRI scans. [ABSTRACT FROM AUTHOR]

• With 3D Navigo™ system the targeted approach outperforms the systematic one. • The systematic biopsy detects high risk disease and should not be omitted. • Biopsy may be omitted when no visible lesion is demonstrated on mpMRI. The introduction of multi parameter magnetic resonance imaging (mpMRI) of the prostate in combination with MRI/TRUS fusion and systematic biopsy resulted in improved detection of prostate cancer. The aim of the current study was to document the performance of MRI/TRUS fusion biopsy of the prostate using the Navigo™ software in a contemporary cohort of patients from nonreferral centers. We performed a two centers prospective data collection (2014–2020) for men with clinically suspected Pca and patients on active surveillance for low-risk Pca that were referred for TRUS biopsy after performing mpMRI of the prostate with a visible lesion. The primary outcome was detection of clinically significant cancer (csPca) defined as ISUP grade group ≥2. Patients were stratified according to biopsy technique and PI-RADS category. The study group included 236 patients of whom 129 (54.9%) were diagnosed with Pca and 82 (34.7%) with csPca (GG ≥ 2) on combined biopsy. The overall detection of csPca was 31% for targeted vs. 25.4% for systematic biopsy with an absolute difference of 5.6% in favor of the fusion technique. No significant difference between the two techniques was observed for detection of benign prostate or GG1 disease. The improved performance of the targeted approach was noted only in patients with PI-RADS 4 and 5 lesions. Of the patients with csPca 10 (12%) were diagnosed only by the systematic biopsy while 20 (24%) were detected only in the fusion biopsy. Systematic biopsy of prostate lobe without MRI lesion detected only 2 cases (∼1%) with high grade disease. Detection of csPca by mpMRI/TRUS fusion biopsy using the 3D Navigo™ system is feasible. The targeted approach outperforms the systematic one, however the later technique also detects high risk disease and should be included in the biopsy procedure. The overall detection rate (34.9%) of clinically significant prostate cancer by both targeted and systematic sampling is relatively low. [ABSTRACT FROM AUTHOR]

• Risk-stratified pathways (RSPs) can improve the efficiency and sustainability of screening programs for csCaP by reducing the demand for MRI scans, prostate biopsies, and the overdetection of insignificant CaP. • The Barcelona-RSP uses three stratification steps from suspected CaP men. The first stratification is based on a serum PSA level > 10 ng/ml and suspicious DRE, the second on the BCN-RC 1, and the third on the BCN-RC 2. • The demand for MRI and prostate biopsies was reduced by 19.8 and 19.6% respectively. • The rate of csCaP detection decreased by 4.9%. • The overdetection of insignificant CaP decreased by 26.1% • The performance of prostate biopsy increased from 35.1 to 41.5%. To analyze the reduction in multiparametric magnetic resonance imaging (mpMRI) demand and prostate biopsies after the hypothetical implementation of the Barcelona risk-stratified pathway (BCN-RSP) in a population of the clinically significant prostate cancer (csCaP) early detection program in Catalonia. A retrospective comparation between the hypothetical application of the BCN-RSP and the current pathway, which relied on pre-biopsy mpMRI and targeted and/or systematic biopsies, was conducted. The BCN-RSP stratify men with suspected CaP based on a prostate specific antigen (PSA) level >10 ng/ml and a suspicious rectal examination (DRE), and the Barcelona-risk calculator 1 (BCN-RC1) to avoid mpMRI scans. Subsequently, candidates for prostate biopsy following mpMRI are selected based on the BCN-RC2. This comparison involved 3,557 men with serum PSA levels > 3.0 ng/ml and/or suspicious DRE. The population was recruited prospectively in 10 centers from January 2021 and December 2022. CsCaP was defined when grade group ≥ 2. CsCaP was detected in 1,249 men (35.1%) and insignificant CaP was overdeteced in 498 (14%). The BCN-RSP would have avoid 705 mpMRI scans (19.8%), and 697 prostate biopsies (19.6%), while 61 csCaP (4.9%) would have been undetected. The overdetection of insignificant CaP would have decrease in 130 cases (26.1%), and the performance of prostate biopsy for csCaP detection would have increase to 41.5%. The application of the BCN-RSP would reduce the demand for mpMRI scans and prostate biopsies by one fifth while less than 5% of csCaP would remain undetected. The overdetection of insignificant CaP would decrease by more than one quarter and the performance of prostate biopsy for csCaP detection would increase to higher than 40%. [ABSTRACT FROM AUTHOR]

Infections are the most feared complication of transrectal prostate biopsy. Unfortunately, these complications are not infrequent. With antibiotic resistance becoming increasingly common, our institution has transitioned to a transperineal approach without use of perioperative antibiotics or bowel preparation. Given this significant change in practice pattern, we retrospectively analyzed these patients for rates of post-operative complications, 30-day hospital readmissions, and detection of prostate cancer. We retrospectively analyzed 146 patients who underwent a transperineal prostate biopsy at our institution in 2022. We recorded rates of complications including UTIs, sepsis, hematuria, and 30-day hospital readmissions. We also analyzed the percentage of patients found to have prostate cancer. Of the 146 patients analyzed, 8 patients received peri-operative antibiotics (5.47%) - this was at the discretion of the surgeon performing the procedure.;;The reason 8 patients received peri-operative antibiotics was due to a prior infectious complication following a previous transrectal prostate biopsy. No patient received bowel preparation. Pre-procedure MRI was performed in 134 patients who had a MRI-ultrasound fusion biopsy. Hematuria was reported in 12 patients (8.21%) and there were zero infectious complications (UTI or sepsis). There were no 30-day readmissions amongst this cohort. Median procedure time was 24 minutes.;Adenocarcinoma was found in 86 patients (58.9%) while 40 patients had benign pathology (27.39%) (Table 2). Despite a small percentage of patients receiving perioperative antibiotics, we had zero patients develop sepsis or an UTI. Our 30-day readmission rate was also 0%. With the high reported rates of infectious complications after transrectal prostate biopsy and antibiotic resistance becoming increasingly common, our data supports the notion that transperineal prostate biopsies are safe and can largely be done without the use of perioperative antibiotics. [ABSTRACT FROM AUTHOR]

Hydrogel placement is recommended for men with prostate cancer undergoing definitive radiation therapy. However, risk factors for inadequate hydrogel placement are not well understood. Our goal was to examine whether type of prostate biopsy effects spacer placement quality using a large sample of patients treated in the ambulatory setting. A retrospective cohort study was conducted on patients diagnosed with prostate cancer who underwent hydrogel spacer placement before primary radiation treatment between 2018 to 2023 after transperineal (TP) or transrectal (TR) prostate biopsy. Study outcomes were Spacer Quality Score (SQS) (0-2, with;greater;values indicating better placement), Rectal Wall Invasion (RWI) (0-3, with;lower;values indicating lack of RWI), and the occurrence of other hydrogel complications. Prophylactic antibiotics were not routinely used. A total of 394 patients were included. A pre-hydrogel TR biopsy was performed in 273 patients (69.1%), while a TP biopsy occurred in 122 (30.9%). A SQS ≥ 1 occurred in 308 (77.9%) patients. A greater proportion of TP patients had a SQS ≥ 1 compared to those who underwent TR (87.7 vs. 73.5%, p<0.002). A RWI score ≥ 2 was found in 180 (45.6%) patients. The proportion of patients with a RWI score ≥ 2 did not differ significantly by type of biopsy performed. Patients who had an interval of >70 days between biopsy and hydrogel placement had significantly decreased odds of a RWI score ≥ 2 (OR = 0.42, 95% CI: 0.21 – 0.83). Only one infection was found after hydrogel placement. Figure 1 displays the quality of hydrogel placement overall and by type of biopsy. The quality of hydrogel placement was significantly better in men who had undergone TP biopsy. Rectal wall invasion was more common than previously reported and did not differ between TP and TR biopsy. [ABSTRACT FROM AUTHOR]

Over the past 10 years, MRI incorporation into prostate cancer screening protocols have been associated with decreased rates of low-risk prostate cancer diagnosis likely due to decreased numbers of overall biopsies performed. Whether this has changed characteristics of patients with newly diagnosed very low- or low-risk disease has not been fully described, especially in light of the recent removal of very low-risk disease from the AUA guidelines. The aim of this study was to evaluate the trend of newly diagnosed prostate cancer based on AUA and NCCN risk categories after screening with PSA and MRI at a single center equal access intuition. A prospective chart review study was conducted on all patients undergoing a prostate biopsy at our local VA hospital from 1/2018 to 12/2022. Patients were included into this study under the following criteria: 1) Male patients who underwent an MRI and PSA drawn prior to biopsy; 2) Uronav biopsy of ROI lesion; 3) Full data available at the time of data lock. Patients were excluded if the biopsy indication was solely based on PSA or diagnosed on TURP. Statistics were completed using R computational language. Non-parametric data was evaluated using a a Mann-Whitney U and categorical data using fisher tests. All tests were two sided using a significance;of 0.05.;Clinically significant prostate cancer (csPCa) was defined as any gleason grade ≥3+4. A total of 662 patients were entered into this study. The median age was 67.7 years old, BMI of 28.29, and PSA prior to biopsy of 5.9 with 62.2% (n = 412) of men self-identified as African American. Upon AUA risk stratifying, 260 (39.3%) had benign pathology, 105 (15.9%) low risk, 75 (11.3%) intermediate favorable, 107 (16.2%) intermediate unfavorable, and 115 (17.4%) patients were classified as high/very high risk. When stratifying the AUA low risk men;by;NCCN guidelines, 64 (10%) were categorized as very low and 41 (6%) as low risk prostate cancer. Patients were then separated by year and PI-RADS. There has been a stable trend in diagnosing new very low risk disease from 2018 through 2022 across all PI-RADS. Delineation was then completed based on race. African American (AA) and non-AA men showed comparable rates of csPCa across all PI-RADS and year over year trend. While MRI has been significantly;impactful to reduce overdiagnosis and overtreatment, patients with very low risk disease are routinely being identified. More research is needed to help elucidate patients who harbor clinically localized and indolent disease away from biopsy intense protocols.;This study also found AA patients, who have been;classically hypothesised;to harbor higher risk disease at higher rates, were diagnosed with csPCa at comparable rates to their non-AA counterparts. This builds on the body of research which advocates that;race no longer becomes a csPCa risk factor in an equal access setting. [ABSTRACT FROM AUTHOR]

Traditionally, prostate-specific antigen (PSA) has been used to screen for prostate cancer (PCa). However, the utility of PSA has become controversial due to poor diagnostic accuracy. Other clinical tools such as prostate multiparametric MRI (mpMRI) and genomic classifiers like Decipher® genomic classifier (GC) are recommended to risk stratify newly diagnosed prostate cancer (PCa) patients in the pre-treatment setting.While mpMRI, interpreted with Prostate Imaging-Reporting and Data System (PI-RADS), is considered predictive of prostatectomy pathology, Decipher® GC has been shown to independently predict adverse pathology in patients with PCa.;;Our aim for this study was to examine the relationship between pre-treatment Decipher ® and mpMRI on prostatectomy pathology. We retrospectively examined patients at our institution who underwent Decipher® GC testing on prostate biopsy tissue (n=888) between December 2016 and March 2023. Data regarding PSA, MRI PIRADS score, biopsy Gleason grade group (GGG), Decipher® GC score and treatment modality were collected.; Of these patients, 142 underwent prostatectomy, of which 118 patients had GGG 1-3 on biopsy.We performed a multivariable ordinal logistic regression model with prostatectomy GGG upgrading (e.g., GGG increase from biopsy) as the outcome and PSA, biopsy GGG, Decipher and PIRADS score as potential predictors. Our final cohort included 104 patients who had an mpMRI, GGG 1-3 on biopsy, and Decipher® GC prior to prostatectomy (Table 1). We found that Decipher® GC on biopsy was associated upgrading on prostatectomy GGG (p = 0.043). There was no significant association with PIRADS score (p = 0.196), PSA (p = 0.217) or biopsy GGG2 compared to GGG1 (p = 0.345). As expected, there is a strong association with prostatectomy GGG upgrading with biopsy GGG3 (p = 0.003) (Table 2). Tumor based molecular assays such as Decipher® GC are included in the NCCN guidelines for localized prostate cancer management. Decipher® GC has been shown to independently predict adverse pathology in patients with very low-, low- and intermediate-risk PCa.; We found that Decipher® GCand unfavorable intermediate risk biopsy are predictors of upgrading on prostatectomy, while mpMRI (PIRADS) and PSA are not. [ABSTRACT FROM AUTHOR]

The risk of early-onset and clinically aggressive prostate cancer is elevated in carriers of certain rare pathogenic germline variants.;;The utility of augmenting traditional PSA-based screening measures with multiparametric MRI imaging in this population is not yet known. The Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS) seeks to evaluate an intensified screening program that incorporates prostate MRI-based screening for early detection of prostate cancer among individuals at elevated genetic risk. Male carriers of pathogenic/likely-pathogenic germline variants in 19 prostate cancer risk genes between the ages of 35-75 are eligible for participation. Enrolled participants undergo a screening protocol consisting of annual PSA and DRE and triennial multiparametric MRI. Triggers for recommending prostate biopsy include elevated PSA, abnormal DRE or suspicious MRI (PI-RADS ≥3). PSA is considered elevated based on age-adjusted cutoffs of >1.5 ng/mL for 35-49 years of age, >2.0 ng/mL for 50-54 years of age, and >3.0 ng/ml for 55-70 years of age. Decision curve analysis was performed to compare the relative benefit of three screening strategies for the detection of clinically significant prostate cancer: 1) elevated PSA alone, 2) abnormal MRI alone and 3) elevated PSA followed by abnormal MRI. 101 men have completed the first round of screening. The greatest proportion are carriers of;BRCA2;(n = 44),;BRCA1;(n= 35), and;ATM;(n = 7) variants. Thirteen had elevated age-adjusted PSA, 2 had abnormal DRE, and 17 had abnormal MRIs. Twenty have undergone biopsy, detecting 9 cancers (7 clinically significant). MRI was the sole indication for 11 of 20 biopsies and detected all biopsy-diagnosed prostate cancers. PSA-based screening alone would have detected 4 cancers (44%) but missed 5, including three clinically significant cases. Of the three screening strategies, MRI-based screening alone or with PSA-triage were superior in decision curve analysis. MRI screening alone was equivalent to a strategy that detects ∼1 cancer per 5 patients without any unnecessary biopsies (compared to conducting no biopsies, threshold probability, 15%). Net reduction in biopsies was greatest using strategies of biopsy triggered by MRI alone and PSA-triaged MRI, across all threshold probabilities. Disease prevalence is high among carriers of prostate cancer-associated pathogenic germline variants. Early results suggest MRI-based screening alone or in conjunction with PSA screening enhances early detection of clinically significant disease. [ABSTRACT FROM AUTHOR]

Prostate cancer is heterogeneous and multi-focal, and biopsy sampling often under-samples the tumor or samples different tumor foci. Such multiple sampling may cause molecular heterogeneity that leads to an underestimation of risk. Consequently, this impacts treatment decision making and management in localized prostate cancer.Herein, we evaluate the degree of variability in genetic alterations, and genomic risk between different biopsy cores with respect to the sampling method (mpMRI vs template). Methods A total of 348 biopsy samples from 156 patients from the Miami MRI selection for Active Surveillance versus Treatment (MAST) trial (NCT02242773) were used in this study. Across the whole time-course, all biopsy cores with successful gene expression profiling were categorized by mpMRI targeted (110 samples) or template (187 samples) sampling. Cores of higher Gleason score from each group were selected.;Variation in expression was analyzed across biopsy samples from same patients. The Decipher genomic score was statistically different across template or targeted biopsy in unpaired analysis (p=0.02), but no difference in paired analysis. Of the different molecular pathways, there was no difference regarding gene expression between both groups, except for E2F transcription factor.MRI targeted biopsy Decipher genomic score did not vary according to PIRADS score (p=0.6). Angiogenesis pathway, E2F transcription factor pathway, G2/M checkpoint pathway were highly expressed in PIRADS 5 lesions, whereas estrogen response signaling was lower in PIRADS 5. mpMRI sampling could lead to could result in better genomic assessment for prostate cancer, however, radiologic lesion scoring is not correlated to the genomic risk. [ABSTRACT FROM AUTHOR]

Proton pump inhibitors (PPIs);were initially intended for short-term usage (<8 weeks); however, population-level data demonstrate that long-term, off-label use of PPIs continues to worsen (6-10% of all Americans).;Initially thought to have anti-tumor effects via regulation of cancer cell apoptosis, metastasis, and autophagy,;recent evidence suggests that;PPI use may be associated with increased prostate cancer (PCa);risk. An Icelandic population-based, case-control study demonstrated that 'ever' PPIs use was associated with 12% increased odds of a PCa diagnosis,;and a population-level analysis of 20,000 Ontario men;with a history of a single negative prostate biopsy demonstrated that PPI use was associated with a 40% increase in PCa mortality rate.The objective of this study was to longitudinally evaluate the association of cumulative PPI use with PCa diagnosis and adverse outcomes in a population-based cohort of men with no prior PCa diagnosis or diagnostic work up. This is a population-based study, using provincewide-linked administrative data from Ontario, Canada. We identified all;Ontario men age ≥66 years with no prior PCa diagnosis, work-up (prostate biopsy and/or TRUS),;or treatment, and no PPI/H2-blocker prescriptions within the year preceding study inclusion (Ontario Drug Benefit coverage starts at age 65).;The study inclusion period was January 2003 to December 2018. Men were;followed until death, administrative censoring, or March 31st, 2020.The primary exposure was cumulative PPI use. H2-blocker and glaucoma eye drop use were included as 'positive' and 'negative' controls, respectively.;The primary outcome was time to PCa diagnosis. Secondary outcomes included time to first PSA value ≥4 ng/ml, PSA velocity >0.75 ng/ml/year, clinically significant PCa, high-grade PCa, PSADT;≤6 months, and ADT;prescription/bilateral orchiectomy. Associations between;study exposure and time-to-event outcomes were evaluated using multivariable complementary log-log logistic regression. The median follow-up was 10.1 years. Median age was 66 years. Any PPI use was observed in 26.1% of men. Annual PPI use increased from 0.9% to 15% between 2003 and 2019. On multivariable modeling, adjusted for age, income quintile and comorbidities, cumulative PPI exposure was associated with significantly increased rates of PCa diagnosis (HR=4.10, 95% CI:3.97-4.23). This association persisted following further adjustment for frequency of general practitioner visits and PSA testing (HR=2.87, p<0.001). Cumulative PPI exposure was also associated with increased rates of clinically significant (HR=4.42, 95% CI:4.11-4.75) and high-grade PCa (HR=3.78, 95% CI:3.37-4.24), time to first ADT prescription/bilateral orchiectomy (HR=2.93, 95% CI:2.77-3.09), and PSA doubling time ≤6 months (HR=3.12, 95% CI:2.98-3.27). Compared to PPI use, the associations between H2-blocker use and study outcomes were of significantly lower magnitudes of effect. In a population-based cohort of elderly men with no prior PCa work-up, diagnosis, or treatment and no known prior PPI exposure, cumulative PPI intake was associated with clinically significant increases in the rates of PCa diagnosis, independent of PSA testing frequency and/or general practitioner;visits, as well as adverse PCa-related outcomes. In lieu of prospective data, these results should be used to counsel long-term PPI users regarding the long-term risks of adverse PCa outcomes. [ABSTRACT FROM AUTHOR]

Urologists are increasingly performing prostate biopsies (PBx) via a transperineal (TP) approach. The two predominant methods for performing TP PBx employ either a grid template (G) or a more freehand approach, often with devices such as PrecisionPoint® (PP). As existing data are sparse, our objective was to compare the two techniques on rates of clinically significant prostate cancer (csPCa) detection and complications when MRI-fusion targeted (MRI) TP PBx is performed. We queried a prospectively maintained prostate biopsy database to identify men ages 18-89 who underwent TP MRI-PBx (including concurrent systematic PBx) between August 1, 2020 and September 30, 2022. G-MRI-PBx were performed until April 1, 2022, and PP-MRI-PBx were performed subsequently. All PBx were performed using UroNav software. The primary outcome was detection of csPCa in the MRI region of interest (ROI). 30 day complications and overall rates of csPCa were examined at the patient level. Subgroup outcomes included csPCa detection in anterior MRI ROIs (as anterior ROIs can be challenging to access due to pubic bone interference) and stratification by prior PBx status (active surveillance, prior negative biopsy, or biopsy-naive). csPCa was defined as Grade Group ≥2. 551 MRI ROIs in 452 patients were included in the analysis.;Prior biopsy status differed between groups (Table 1); however, when stratified by prior biopsy status, there was no difference in csPCa detection found between a grid or PP approach (Table 2). PP-MRI-PBx and G-MRI-PBx had similar overall and ROI csPCa detection rates (Table 2).;PP-MRI-PBx identified csPCa in 32.1% of ROIs, and G-MRI-PBx identified csPCa in 34.8% of ROIs (p = 0.57). PP-MRI-PBx identified csPCa in 48.1% of patients, and G-MRI-PBx identified csPCa in 48.9% of patients (p = 0.89). Complication rates and the ability to detect csPCa in anterior ROIs was similar between the two groups (Table 2). PP-MRI-PBx and G-MRI-PBx identified similar rates of csPCa, including in anterior MRI lesions and when stratified by prior biopsy status. Complication rates were low and did not differ based on biopsy technique. [ABSTRACT FROM AUTHOR]

Transperineal ultrasound-guided prostate biopsy (TPUSPB) is proven to be superior to the traditional transrectal approach due to its lower infection rate1. This reduced infection rate has also been seen in patients who have undergone TPUSPB without antibiotic prophylaxis2. Many institutions have yet to embrace withholding pre-procedure antibiotics in this population. We examined infectious outcomes in patients undergoing TPUSPB at two institutions with different antibiotic practices to determine if differences exist. Four hundred and fifty-two patients from Fox Chase Cancer Center (FCCC) and Vanderbilt University Medical Center (VUMC) were examined. We evaluated outcomes between those who had received antibiotic prophylaxis and those who did not. Outcomes included urinary tract infection (UTI), fever and sepsis within 30 days post-procedure.;;We calculated differences in these outcomes via 2-sided Fisher-exact tests. In our cohort, 217 received no antibiotics and 235 received antibiotics prior to biopsy. We found patient's receiving antibiotics were significantly more likely to have had their biopsy performed at Vanderbilt, Caucasian, Non-Hispanic/Latino and undergone biopsy in a surgery center (Table 1). Among patients without antibiotic prophylaxis, 2 patients (1%) developed a urinary tract infection, versus 1 patient (0.4%) in the antibiotic group (p;= 0.6). Fever (1 (0.4%) vs. 1 (0.4%),;p;= 1.0) and sepsis (1 (0.4%) vs. 1 (0.4%),;p;= 1.0) were equally prevalent between the antibiotic and no antibiotic groups. Four (1.8%) patients without antibiotic exposure developed an infectious complication (including UTI, fever, and sepsis together) versus 3 (1.3%) for those who received antibiotics (p;= 0.7). ;Between these two institutions, we found no difference in infection rates regardless of prophylaxis antibiotic utilization. We did however find significant differences in our two institution antibiotic practices and thus patient populations who were more likely to receive antibiotics due to the demographic differences between these institutions. Omitting antibiotics prior to TPUSPB is safe and further advances the goal of antibiotic stewardship within the field of Urology. [ABSTRACT FROM AUTHOR]

Generative Artificial Intelligence (AI) has become prominent in healthcare, particularly as an oncology aid in clinical documentation, which has implications for treatment decisions.1 National guidelines favor synoptic reporting of prostate biopsy specimens to aid in proper risk stratification of prostate cancer (PCa).2;Thus, AI is a potential tool to analyze synoptic reports and reduce the variation in algorithmic risk stratification. We questioned whether a trained AI model could review pathology reports, along with clinical vignettes, for PCa to provide an accurate risk assessment and recommendations.1. Sorin, V, Barash, Y, Konin, E., et al.. Deep-learning natural language processing for oncological applications. The Lancet Oncology. 2020 Dec 2020;21(12)doi:10.1016/S1470-2045(20)30615-X2. https://www.nccn.org/professionals/physician%5fgls/pdf/prostate%5fblocks.pdf Retrospective review of localized PCa patients from January 2022 – January 2023 was performed. Following initial prostate biopsy, all patients were consulted and risk stratified based on NCCN guidelines by a urologic oncologist. We provided a generative AI model, ChatGPT3, the PCa risk stratification algorithm from NCCN Version 1.2023. Then queried the model to ensure accurate recall of the algorithm rules. Clinical features (PSA, cT stage) and histologic features (synoptic path report) from each case were provided and the model was prompted to "risk stratify the following patient." In addition, we requested additional evaluation (ex: imaging) and initial therapy recommendations were also queried. 10 patients from each NCCN risk category were reviewed.3. ChatGPT. https://chat.openai.com 60 patients were reviewed. The generative AI model correctly risk stratified 39/60 patients (65.0%). The AI model incorrectly risk stratified 21/60 patients, however, it did assign them to an adjacent risk group (Figure 1).; Notably, 14/20 patients were correctly assigned as intermediate risk group, but the model required further prompting for categorization into favorable or unfavorable risk. Once prompted, only 12/20 were correctly risk stratified (Figure 1). Finally, when queried, the model was able to recommend treatment and imaging modalities appropriate to the stated risk group (ex: very low risk favor active surveillance, and high risk required imaging). Generative AI demonstrated poor performance in algorithmic risk stratification using standardized synoptic reports. The implications of inaccurate assessments need to be considered as more healthcare professionals and systems look to incorporating generative AI into clinical tools. A healthy amount of skepticism and close review is needed to vet any clinical tool. Ultimately when it comes to the nuance of the PCa, a trained provider is still needed to interpret the information and recommendations in line with the patient's goals and preferences. [ABSTRACT FROM AUTHOR]

Magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) has emerged as a new option for treatment of localized prostate cancer (PCa). Here we report on our institutional experience with the TULSA procedure regarding initial disease status and follow-up imaging and pathology from our cohort. This is a single-center study of prospectively collected data of men with localized PCa who underwent TULSA as primary treatment of their disease. All men were evaluated with prostate MRI and prostate biopsy prior to treatment. Men with prior PCa therapy were excluded. Treatment plans were individualized based on disease characteristics and patient preference, spanning lesion specific to whole gland. Patients were followed at routine intervals with PSA evaluation every 3 months and repeat prostate MRI and biopsy at 1 year. Primary treatment efficacy was defined as the number of men after 1-year imaging/biopsy follow-up who underwent salvage treatment. Wilcoxon signed-rank test was used for comparative statistics. From October 2020 through June 2023, 126 patients underwent TULSA as primary treatment for PCa. Patient characteristics are listed in Table 1. At 1-year post-TULSA, PSA decreased by 72.1% (IQR 56.3-92.1%), p<0.0001. 63/126 (50.0%) patients have undergone follow-up MRI. Prostate volume decreased by 51.4.% (IQR 26.2-68.9%) and median PSA density decreased by 49.9% (IQR 14.1-86.6%). On 1-year MRI, 18/63 (28.6%) patients had focal lesions (1 PIRADS-5, 8 PIRADS-4, 7 PIRADS ≤3, 2 indeterminate PIRADS). 23/63 (36.5%) patients refused 1-year biopsy after negative 1-year MRI. 40/63 (63.5%) patients underwent repeat systematic plus targeted (when applicable) biopsy at 1 year with 14 PCa recurrences: 1 GG3, 6 GG2, 4 GG1, and 3 ungraded due to treatment effect. 4/63 (6.3%) men with 1-year follow-up have undergone salvage treatment (2 repeat TULSA, 1 surgery, 1 radiation). Our experience with TULSA demonstrates substantial post-procedure decreases in PSA, PSA density and prostate volume. While 35% (14/40) of men had PCa on 1 year follow-up biopsy, only 28% (4/14) underwent additional treatment, with the remaining 10 men electing for active surveillance. Including men with negative MRIs who refused follow-up biopsy, 6% of men reaching the 1-year post-TULSA endpoint have undergone salvage treatment, demonstrating promising primary treatment efficacy at this early timepoint in our TULSA experience. [ABSTRACT FROM AUTHOR]

There is high level evidence showing the addition of MRI to the diagnostic pathway for prostate cancer improves the detection rate of clinically significant (CS) disease at time of biopsy. However, the majority of landmark studies only included patients who received prostate biopsies via transrectal (TR) approach. It is well known that transperineal (TP) approach is now preferred over TR approach due to decreased risk post-biopsy infection/sepsis. In this study, we sought to compare the impact of pre-biopsy MRI on prostate cancer detection rates;when using;TR vs. TP approach. Our institutional database was queried for all patients who underwent prostate biopsy from 2018 through 2022. Patients were then stratified by biopsy approach (TR vs. TP) and MRI status prior to biopsy. Patients were excluded from this study if they had previous diagnosis of prostate cancer or received prostate biopsy prior to referral. Patients who had a positive lesion on MRI (PIRADS >/=;3) underwent combined MRI/TRUS fusion plus systematic biopsy. Patients with a negative MRI (PIRADS < 3) or patients without pre-biopsy MRI;underwent systematic biopsy only. CS cancer (defined as Gleason Grade Group >/=;2) detection rates were compared amongst groups;with p-values < 0.05 considered to be statistically significant. We identified 318 biopsy naïve patients with an elevated PSA who were referred for biopsy. Median age and PSAD was 66 (IQR 60-70) and 0.16 ng/mL2;(IQR 0.10-0.31), respectively. Overall, 51.3% (163/318) of patient received MRI prior to biopsy, with 50.6% (161/318) and 49.4% (157/318) undergoing TR and TP biopsies, respectively. PSAD of;TR and TP cohorts were 0.14 ng/mL2;(0.09-0.28) and 0.17 ng/mL2;(IQR 0.11-0.32), repectively.;There was a significantly increased CS cancer detection rate for patients who received MRI prior to TR biopsy (19/26) compared with those who did not (50/135) receive MRI prior;(73.1% vs. 37.0%, p=0.001). There was no significant difference in CS cancer detection rates;for patients who received MRI prior to TP biopsy (96/137) when compared with those who did not (12/20) receive MRI;(70.1% vs. 60%, p=0.516). The addition of pre-biopsy MRI improves cancer detection rates for clinically significant disease when utilizing the transrectal approach. However, the same increase in cancer detection rates was not seen for patients who received MRI prior to transperineal biopsy. It is hypothesized that the transperineal systematic biopsy provides a more thorough sample of the prostate, especially for the anterior gland, therefore potentially;limiting the additive benefit of MRI when compared with transrectal biopsy. [ABSTRACT FROM AUTHOR]

Most Prostate Imaging Reporting and Data System (PI-RADS) 5 lesions on prostate MRI are found to harbor Gleason grade group ≥2 prostate cancer on initial biopsy. As a result, the optimal management of patients found to have Gleason grade group 1 (GG1) prostate cancer despite PI-RADS 5 lesions on prostate MRI remains unclear. To estimate risks of grade misclassification, we evaluated the occurrence of Gleason upgrade on subsequent active surveillance (AS) prostate biopsy or radical prostatectomy among patients diagnosed with GG1 prostate cancer with PI-RADS 5 lesions on MRI. We conducted a retrospective analysis at a single institution to identify patients diagnosed with GG1 prostate cancer whose MRI nearest to diagnosis demonstrated ≥1 lesion classified as PI-RADS 5. The primary study outcome was the presence of Gleason reclassification to GG≥2 prostate cancer on subsequent prostate biopsy or radical prostatectomy. The secondary outcomes included rates of grade reclassification on prostate biopsy, or conversion to active treatment among patients managed with initial active surveillance. We used multivariable logistic regression to identify factors associated with Gleason reclassification on subsequent biopsy or radical prostatectomy. Among 3,042 patients undergoing prostate biopsy between 01/2013-12/2022, we identified 110 with GG1 prostate cancer and PI-RADS 5 lesions on;MRI who received a total of 216 biopsies. The median age was 69 years and median PSA at diagnosis was 6.4 ng/mL. There were 104 patients (94.6%) who elected initial AS and six (5.5%) were treated. Sixty-one patients managed with AS underwent ≥1 additional biopsy. Among this group, 43 (70.5%) experienced Gleason upgrade including 32 (74.4%) on second, 9 (20.9%) on third, and one (2.3%) each on fourth and fifth biopsy. A total of 44 (40%) patients received definitive treatment including prostatectomy in 15 (13.6%) and radiation in 25 (22.73%). Two patients (1.8%) developed metastatic disease, of whom one patient later demonstrated higher grade disease on biopsy, and one died of disease. In multivariable logistic regression, no clinical or pathological factors were significantly associated with odds of Gleason upgrade. The majority of patients diagnosed with GG1 prostate cancer in the setting of a PI-RADS 5 lesion will be found to have GG2 or higher disease in the short term during active surveillance or during treatment, suggesting substantial initial misclassification. These findings reinforce the need for confirmatory testing in these patients due to risks of disease under-sampling. [ABSTRACT FROM AUTHOR]

Multiparametric Magnetic Resonance Imaging (MP-MRI)/ ultrasound fusion guided biopsy (targeted biopsy) is emerging as an alternative diagnostic tool for Prostate cancer (PCa) in addition to historically used Transrectal Ultrasound-guided (TRUS) biopsy. Many patients, such as active surveillance patients, require repeat biopsies with serial MRI's.;Furthermore, upwards of 80% of PIRADS 3 lesions, and 50% of PIRADS 4 lesions are benign.;TRUS may provide insights into when lesions need to be biopsied and when they do not.;Here, we tested the hypothesis that echogenicity observed during the fusion of MRI and ultrasound images may be associated with the detection of clinically significant prostate cancer in targeted biopsy of MP-MRI lesions. This retrospective observational study was performed from March 2017 to February 2022, on patients who underwent both standard extended-sextant 12-core biopsy (random) and MP-MRI/US fusion guided (target) biopsy at our institution and had lesion-specific echogenicity on ultrasound recorded. PCa lesions during MR/US fusion (target biopsy) biopsy were characterized as strongly, weakly, or not hypoechoic. Clinically significant PCa (csPCA) was defined as a Gleason score ≥ 7 and intermediate was defined as a Gleason score = 6. Among a total of 221 patients who underwent biopsy, 131 (59.3%) were diagnosed with PCa and 89 (68%) of those had csPCA. Of the 429 lesions, 82 (19.1%) were strongly hypoechoic with 45% considered csPCA. 128 (29.8%) lesions were weakly hypoechoic with 25% considered csPCA and 219 (51.1%) lesions were not hypoechoic with 11.8% considered csPCA (p<0.0001). Figure 1 shows the distribution of Gleason grades with respect to echogenicity and PIRADS score.; Some notable findings were that within PIRADS ≤3, echogenicity was able to enrich detection of csPCA from 7% (non-hypoechoic) to 27% (strongly hypoechoic).;; Within PIRADS 4 echogenicity was enriched from 13.1% to 35.1%.;; Lastly within PIRAD 5, echogenicity enriched from 42% to 64%. The echogenicity of the lesion detected on US at the time of prostate biopsy is complementary to PIRADS for the diagnosis of csPCa. A lesion that is strongly hypoechoic, despite a low PIRADS score, still carries a significant risk for csPCa and biopsy should be considered. Echogenicity can be used by clinicians for cancer risk stratification and aid in their decision-making process during biopsy. [ABSTRACT FROM AUTHOR]

The negative predictive value (NPV) for multi-parametric prostate magnetic resonance imaging (mpMRI) in the detection of clinically significant prostate cancer (csPCa) approaches 90%. Consequently, mpMRI has been proposed as a stratification and staging tool to detect csPCA while limiting unnecessary biopsies. However, wide variation exists in the application and interpretation of mpMRI. It remains to be seen if the high NPV published from expert centers remains reproducible and generalizable. We aimed to determine the real-world NPV of mpMRI across diverse practices in the Michigan Urological Surgery Improvement Collaborative (MUSIC). The MUSIC clinical registry was used to determine the NPV for mpMRI in the detection of csPCa, defined as Grade Group (GG) ≥ 2 PCa. We identified patients between 7/2016 – 7/2022 with negative mpMRI, defined as an absence of PI-RADS 3-5 lesions, who underwent biopsy within 1 year. Patients were classified into 2 groups: (1) biopsy naïve and (2) active surveillance (AS). NPV of MRI was summarized overall and for each subgroup. Multivariable logistic regression identified factors associated with csPCa. 857 patients who underwent 871 biopsies within 1 year of negative mpMRI were identified across 26 practices. 439 biopsies were performed in the biopsy naïve setting, and 432 while on AS. Median age was 65 years (IQR 60-69) and median PSA was 5.6 ng/dl (IQR 4.1-8.1). The NPV of prostate MRI for ≥GG2 PCa in biopsy-naïve patients, those undergoing AS, and the entire cohort was 80%, 75%, and 77%, respectively.;On multivariable analysis, PSA density ≥ 0.1 was associated with higher risk of having csPCa diagnosis after negative MRI (OR 5.1 [95% CI 3.22-8.01], p<0.001). Across diverse urologic practices, the NPV of prostate MRI is 77%, lower than previously reported. Real-world data suggests that approximately 25% of men may miss a diagnosis of csPCA, most commonly GG2, if they do not undergo biopsy with a negative MRI. This likely represents limitations with current mpMRI implementation, and an opportunity to more accurately identify which patients should undergo biopsy, despite negative mpMRI findings.;PSA density ≥ 0.1 should be utilized as a stratification tool for pursuing prostate biopsy after a negative mpMRI. [ABSTRACT FROM AUTHOR]

Although MRI has aided in prostate cancer diagnosis, including with risk stratification and targeted-biopsies, and have high negative predictive values, false positives have continued to be a limitation, and is thought to be approximately 40-60% for PIRADS 4 or "high suspicion" lesions, with positives defined pathologically as at least Gleason 3+4. We hypothesized that this low positive predictive value for PIRADS 4 suggests heterogeneity within this category, that PIRADS 4 lesions can be further risk-stratified, and that there is a subset of PIRADS 4 lesions that are higher suspicion, and would therefore have higher cancer detection rates when biopsied. The aim of this retrospective cohort study is to determine whether this subset of PIRADS 4 lesions can be identified on biparametric prostate MRI (bpMRI). All bpMRIs performed;at a single healthcare system;from July 2021 to December 2022;and interpreted by a single board-certified radiologist with over ten years experience;were identified as part of our;HIPAA-compliant, IRB-approved investigation. Studies with PIRADS 4 lesions were retrospectively reviewed. A;strategy of inclusion and exclusion was used to identify lesions that can be categorized into a higher suspicion group, "4c (concern)". Inclusion criteria included focal, homogeneous, circumscribed, T2 moderate to marked hypodensity and marked restricted diffusion for peripheral zone lesions,;while exclusion criteria included any possible mimicker of prostate cancer, or;with any other uncertainty that the lesion could definitively represent a cancer. Then, radiology-pathology correlation was performed for all the patients with "4", "4c" and PIRADS 5 lesions who underwent prostate biopsies. Statistical analysis was performed using Fisher's exact test. 413 bpMRIs were identified (3 PIRADS 1, 136 PIRADS 2, 100 PIRADS 3, 120 PIRADS 4, 42 PIRADS 5, and 12 nondiagnostic). 45;of 120 PIRADS 4 were categorized as "4c", with 75;remaining as "4". 53 out of;75 "4", 38 out of 45 "4c", and 30 out of 42;PIRADS 5 underwent biopsies. 35, 5, and 13 of "4"; 36, 2, and 0 of "4c"; 26, 1, and 3 of PIRADS 5 had ≥Gleason 3+4 (clinically significant cancer or "csPCa"), Gleason 3+3 (clinically insignificant cancer;or "ciPCa"), and negative biopsy, respectively. The cancer detection rates for csPCa (defined as csPCa/(csPCa+ciPCa+negative biopsy));for patients who underwent biopsy for "4" was 66% and "4c" was 95%, which was statistically significant (p=0.0016), while that for all PIRADS 4 was 78% and PIRADS 5 was 87%. (Please see Table 1 and Figure 1). There is a distinct subset of PIRADS 4 lesions that can be identified on biparametric prostate MRI. When biopsied, these lesions, termed "4c", have cancer detection rates higher than other PIRADS 4 lesions and similar to those of PIRADS 5 or "very high suspicion" lesions. These findings indicate that PIRADS 4 lesions can be further risk stratified on MRI. Risk stratifying and, if possible, identifying;PIRADS 4 lesions that are higher or "very high suspicion";will mitigate the limitation of false positives on prostate MRIs, and aid;patient management and prostate cancer diagnosis. For example, in the context of a negative prostate biopsy of a patient with a "very high suspicion" PIRADS 4c lesion, it is not unreasonable to consider a repeat biopsy or close clinical followup. [ABSTRACT FROM AUTHOR]

The combination of systematic and targeted biopsy in Magnetic Resonance Imaging (MRI)/ Ultrasound (US) fusion technique improves the diagnosis of clinically significant prostate cancer. Using in-bore MR-guided prostate biopsy (IBMRGpB), which is considered to be the most accurate MR-guided sampling technique, many practitioners omit systematic biopsy. We sought to quantify the additive value of systematic biopsy (SB) using in-bore magnetic resonance (MR)-guided prostate biopsy (IBMRGpB). We retrospectively reviewed the records of 189 patients who underwent IBMRGpB in Sheba Medical Center between 2017-2022. SB;was performed in all patients. Endpoints included clinically significant and non-clinically significant cancer diagnoses. A subgroup analysis for 73 biopsy naïve patients was performed. We used Chi-square, T-test, and Mann-Whitney for statistical analysis. Logistic regression was used to find indicators for clinically significant disease on systematic biopsy. Statistical analysis was performed using SPSS Version 22 (IBM corps). Median age was 68y (IQR 62-71.5), mean PSA was 8.7±8.2 ng/dL.;The median number of cores per biopsy was 17 (IQR 16-19) of which 5 (IQR 4-7) were targeted.;SB detected clinically significant disease in 67 (35.5%) patients. Five (2.65%) patients whose targeted biopsies found benign or non-clinically significant disease had clinically significant disease on SB. SB from the lobe contralateral to the lesion detected clinically significant disease in 15 (12%) patients. The size of the prostate was larger, and the percentage of lesions located in the peripheral zone of the prostate was higher in patients with SB-detected clinically significant disease. The location of the main lesion in the peripheral zone of the prostate was a predictor for clinically significant disease on SB in multivariate analysis (OR=8.26, p=0.04), a finding supported by a subgroup analysis of biopsy-naïve patients (OR=10.52, p=0.034). The addition of SB during IBMRGpB increased the diagnosis of clinically significant as well as non-clinically significant prostate cancer. The location of the main lesion in the peripheral zone emerged as a positive predictive factor for clinically significant disease on SB. These findings may enhance patient-tailored management. [ABSTRACT FROM AUTHOR]

Historically, the primary objection to partial gland ablation (PGA) for management of prostate cancer (CaP) has been disease multifocality and inability to localize significant disease. Improved disease localization and risk stratification with multiparametric magnetic resonance imaging and targeted biopsy, along with its minimal adverse impact on quality of life has enabled PGA to gain acceptance. Today, the primary barrier for adopting PGA is its unknown oncological outcomes. Objectives of this review are to provide a rationale for PGA for managing intermediate-risk (IR) CaP; review oncological outcomes following PGA for IR disease; and assess whether there is adequate data to justify PGA for management of IR CaP. There is no consensus how to assess or define oncological outcomes following PGA. We propose the following definitions for oncological outcomes: Oncological control (detection of any cancer following biopsy), oncological failure (detection of Gleason grade group >1 on follow-up biopsy), and oncological treatment failure (any disease that precipitate salvage treatment). There are only 3 reports in the literature where inclusion criteria specified pretreatment targeted biopsy and reflex prostate biopsy within 1 year of PGA in cohorts of men where >50% had Gleason grade group >1 disease. These studies reported that prostate-specific antigen is not a reliable surrogate and multiparametric magnetic resonance imaging is reliable when prevalence of in-field CaP is high. "Freedom from failure" is used to assess longer-term oncologic outcomes, and is defined by freedom from CaP mortality, androgen deprivation therapy, or whole-gland treatment. Rationale for PGA in selected cases of IR CaP is compelling and early oncological studies are reassuring. If patient selection is done judiciously, oncologic outcomes are disclosed, and follow-up plan is rigorously implemented, it is unlikely rates of metastasis or CaP mortality with be adversely impacted and many men will avoid or defer adverse effects of whole-gland treatment. [ABSTRACT FROM AUTHOR]

Targeted biopsy using multiparametric magnetic resonance imaging increases the detection rate of clinically significant prostate cancer (csCaP). In this meta-analysis, we compare the diagnostic accuracy of transrectal (TR) vs transperineal (TP) approaches for MRI-guided software fusion biopsy (FB) in the detection of csCaP. A literature search was performed in PubMed, Cochrane and Embase electronic databases up until July 2019 following the preferred reporting items for systematic review and meta-analysis system. The pooled sensitivity and specificity of either approach was evaluated using radical prostatectomy or systematic biopsies with ≥24 biopsy cores to be the reference standard. Fourteen papers with a total of 2002 patients were selected. Seven hundred and sixty-five patients underwent TR FB, while 1,387 underwent TP FB. One hundred and fifty of the patients underwent both TR and TP approaches. Both approaches were similar in terms of sensitivity (TR vs. TP: 0.81 vs 0.80) and specificity (TR vs. TP: 0.99 vs 0.95). In terms of likelihood ratios and diagnostic odds ratio, TR performed better than TP approach. The area under the receiving operator curve for both approaches was similar (0.91 vs 0.88 respectively). However, there was substantial heterogeneity across the studies for both approaches. TP and TR approaches to software-based FB yield similar diagnostic performance for the detection of csCaP. When deciding on the approach, physicians should consider other inherent features of either technique that suit their practice. [ABSTRACT FROM AUTHOR]

Objective: To determine whether Prostate Imaging-Reporting and Data System version 2 (PIRADS v2) and neutrophil-to-lymphocyte ratio(NLR) improve the detection of clinically significant prostate cancer(csCaP) in men with prostate-specific antigen (PSA) <10 ng/ml at first biopsy.Methods: Univariable and multivariable binary logistic regression analysis were used to screen for independent risk factors of csCaP. The multivariable model based on the risk factors was to build the nomogram predicting csCaP and assessed by receiver operator characteristic curve analysis, calibration plot, and decision curve analysis.Results: This retrospective study included 335 men with PSA < 10 ng/ml who underwent initial biopsy. A total of 78 (23.3%) men had csCaP. The nomogram was built based on the multivariable model including age, digital rectal examination, free prostate-specific antigen, PIRADS v2, and NLR. It had high area under the curve of 0.876 and was well calibrated in internal validation. Decision curve analysis also demonstrated that it would improve the prediction of csCaP.Conclusion: PIRADS v2 and NLR improve the detection of csCaP in men with PSA < 10 ng/ml at first biopsy. Due to lack of external validation, relatively small cohort and homogenous population, the study has several limitations. Despite of this, the nomogram based on our study is a promising tool for patients to understand their risk of csCaP and for urologists to make clinical decisions. [ABSTRACT FROM AUTHOR]

Purpose: To investigate focal therapy using High Intensity Focused Ultrasound (HIFU) for the treatment of localized prostate cancer (CaP), we analyzed the safety and complications of this procedure.Methods: Patients (pts) eligible for this multicenter prospective cohort study suffered from low to intermediate risk localized CaP with no prior treatment. After tumor identification on multiparametric MRI and in prostate biopsy, the lesions were treated with HIFU observing a safety margin of 8 to 10 mm. Adverse events (AE) after 30 and 90 days, as well as the required interventions were assessed and stratified for treatment localizations.Results: Of the 98 men included in the study in two European centers, 35 (35.7%) experienced AEs in the first 30 days after HIFU intervention with Clavien-Dindo grade ≤ II: 15 pts (15.3%) had a postoperative urinary tract infection and 26 pts (26.5%) a urinary retention. Four pts (4.1%) underwent subsequent intervention (Clavien-Dindo grade IIIa/b). The number of late postoperative complications occurring between 30 and 90 days after intervention was low (2.0%). The highest complication rate was associated with tumors located at the anterior base (50.0%). The inclusion of the urethra in the ablation zone led to AEs in 20 out of 41 cases (48.8%) and represented a significant risk factor for complications within 30 days (odds ratio = 2.53; 95% confidence interval: 1.08-5.96; P = 0.033).Conclusions: Focal therapy of CaP lesions with a robotic HIFU-probe is safe and renders an acceptable rate of minor early AEs. The inclusion of the urethra in the ablation zone leads to an increase in early complications and should be avoided whenever possible. [ABSTRACT FROM AUTHOR]

Introduction: The Memorial Sloan Kettering Cancer Center (MSKCC) Preprostatectomy nomogram is a widely used resource that integrates clinical factors to predict the likelihood of adverse pathology at radical prostatectomy. Adoption of magnetic resonance imaging targeted biopsy (TB) permits optimized detection of clinically-significant cancer over systematic biopsy (SB) alone. We aim to evaluate the prognostic utility of the MSKCC Preprostatectomy nomogram with TB pathology results.Methods: Men who underwent SB and magnetic resonance imaging TB who later underwent radical prostatectomy at our institution were included. Patient information was entered into the MSKCC Preprostatectomy nomogram using 5 biopsy reporting schemes with TB reported by both individual core (IC) and aggregate group (AG) methods. The likelihood of extraprostatic extension, seminal vesicle invasion, and lymph node involvement as predicted by the nomogram for each biopsy reporting schema were compared to radical prostatectomy pathology.Results: We identified 63 men from January 2014 to November 2017. On receiver operating characteristic analysis, IC-TB, AG-TB, SB plus IC-TB, and SB plus AG-TB exhibited similar, if not improved, area under the curve compared to SB alone in predicting extraprostatic extension (0.671, 0.674, 0.658, and 0.6613 vs. 0.6085). This was similarly observed for seminal vesicle invasion prediction using SB plus IC-TB compared to SB alone (0.727 vs. 0.733). For lymph node involvement, superior but nonsignificant area under the curve was observed for AG-TB (0.647) compared to IC-TB (0.571) and SB alone (0.524) CONCLUSIONS: Using TB pathology results either alone or combined with SB pathology results as input to the MSKCC Preprostatectomy nomogram appears comparable for prognosticating adverse pathology on radical prostatectomy compared to SB alone, but robust validation is warranted prior to adoption into clinical practice. [ABSTRACT FROM AUTHOR]

• CFB and IGFB offer similar detection rates of cs-CaP in a multiethnic population. • For cs-CaP, CFB and IGFB had similar rates of concordance to systematic biopsy. • For overall CaP, CFB had higher rates of discordance than IGFB. Transrectal ultrasound-guided prostate biopsy remains the most used method for the detection of prostate cancer. We recently reported that detection of clinically significant prostate cancer (cs-CaP) using image-guided fusion biopsies (IGFB) varied by race/ethnicity, which calls for further comparison between cognitive fusion biopsy (CFB) and IGFB among non-Hispanic black and Hispanic populations. Therefore, the aim of our study is to compare the rates of detection of cs-CaP and overall CaP by CFB and IGFB in a multiethnic community. We performed a retrospective, cross-sectional review of men who underwent MRI-transrectal ultrasound-guided prostate biopsy at our diverse, urban academic medical center. Agreement and discordance between fusion biopsies and systematic biopsies for detection of cs-CaP and overall CaP were determined using Kappa statistics. Univariate and multivariate mixed-effects logistic regression models were used to find associations between fusion modalities and prostate cancer detection. In total, 710 men underwent fusion prostate biopsies between December 2015 and June 2021. Upon univariate and multivariate logistic regression analysis, there was no significant association between IGFB vs. CFB and risk of overall CaP (OR = 0.66, 95% CI: 0.36–1.21, P = 0.18) or cs-CaP (OR = 0.57, 95% CI: 0.30–1.08, P = 0.09). We found moderate agreement between fusion and systematic biopsies for both CFB (κ = 0.56) and IGFB (κ = 0.52) in cs-CaP. CFB and IGFB offer similar detection rates of cs-CaP in a multiethnic population. CFB represents an effective and accessible means of accurately diagnosing prostate cancer. [ABSTRACT FROM AUTHOR]

• Clinically-integrated randomized controlled trial of a brief mind-body intervention during prostate biopsy using 2-staged consent. • Assessed patient reported pain anxiety and discomfort. • A clinically meaningful benefit for this brief mind-body intervention is unlikely. • Robust patient enrollment is feasible using 2-stage consent. Many patients experience pain, anxiety, and discomfort with prostate biopsy, which may discourage enrollment in active surveillance programs or follow-up biopsy. Guided meditation can significantly reduce pain and anxiety during percutaneous biopsy. We sought to evaluate the effectiveness of a brief mind-body intervention on patient-reported outcomes after prostate biopsy. We performed a clinically-integrated randomized controlled trial of a brief mind-body intervention during biopsy compared to usual care at a single tertiary care center from 2018 to 2022. All patients offered transrectal ultrasound-guided prostate biopsy in the clinic with local anesthesia were eligible for enrollment. This clinically integrated trial was conducted simultaneously with a randomized controlled trial of 1-stage and 2-stage consent. The primary outcome was patient-reported pain, anxiety, discomfort, and tolerability on a visual-analog scale (0–10). A 15% improvement was prespecified as clinically relevant. We compared the proportion of men in each arm reporting a severe score (7–10) on any of the 4 scales using Fisher's exact test and then compared means for each scale separately using ANCOVA with randomization stratum (first vs. prior biopsy) as a covariate. Of 263 eligible patients, 238 enrolled (119 per arm). One hundred seventy-two (72%) enrolled with 2-stage consent. A total of 37/94 (39%) and 38/102 (37%) patients randomized to usual care and intervention, respectively, reported severe scores in any of the 4 domains, a difference of 2.1% (95% confidence interval [CI] -13, 17%, P = 0.8). There was no evidence of a difference in mean postbiopsy anxiety (P = 0.3), discomfort (P = 0.09), pain (P = 0.4) or tolerability scores (P = 0.2). A clinically meaningful benefit for this brief mind-body intervention during prostate biopsy is unlikely. Robust patient enrollment is feasible using 2-stage consent. [ABSTRACT FROM AUTHOR]

Objectives: Recent years have seen the development of biomarkers and imaging technologies designed to improve the specificity of PSA. Widespread implementation of imaging technologies, such as mp-MRI raises considerable logistical challenges. Our objective was to evaluate a biopsy strategy that utilizes selective mp-MRI as a follow-up test to biomarkers to improve the detection of significant prostate cancer.Methods and Materials: We developed a conceptual approach based on the risk calculated from the 4Kscore using results from the US prospective validation study, multiplied by the likelihood ratio of mp-MRI from the PROMIS trial. The primary outcome was Gleason grade ≥ 7 (grade group ≥ 2) cancer on biopsy. Using decision curve analysis, the net benefit was determined for our model and compared with the use of the 4Kscore and mp-MRI independently at various thresholds for biopsy.Results: For a cut-point of 7.5% risk of high-grade disease, patients with <5% risk from a blood marker would not have risk of significant prostate cancer sufficiently increased by a positive mp-MRI to warrant biopsy; comparably, patients with a risk >23% would not have risk sufficiently reduced by a negative imaging study to forgo biopsy. From the 4Kscore validation study, 46% of men considered for biopsy in the US have risks 5% to 23%. Net benefit was highest for the combined strategy, followed by 4Kscore alone.Conclusions: Selective mp-MRI in men with intermediate scores on a secondary blood test results in a biopsy strategy that is more scalable than mp-MRI for all men with elevated PSA. Prospective validation is required to demonstrate if the predicted properties of combined blood and imaging testing are empirically confirmed. [ABSTRACT FROM AUTHOR]

Objectives: To assess if a multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy (TB) strategy is precise enough to replace systematic biopsies (SB) among men with different biopsy indications since an imaging-based pathway to guide indication and targeted prostate biopsy is currently under debate.Materials and Methods: Retrospective analysis was performed of 594 patients with one or more lesions according to Prostate Imaging and Reporting Data System (PI-RADS) receiving a consecutive TB and SB for one of the 3 indications: primary cancer suspicion (51.7%), persistent cancer suspicion after prior negative biopsy (35.4%), or control of a confirmed cancer (12.9%). Detection rates for overall cancer (CaP) and clinically significant cancer (csCaP, Gleason Score ≥3+4) were compared between TB and SB and to a combined approach for all patients and within the subgroups. Characteristics of cancers missed by one biopsy strategy were analyzed.Results: TB detected less CaP (302 vs. 366, P < 0.001) and csCaP (204 vs. 210 patients, P = 0.409) compared to SB except for men with prior negative biopsies (65 vs. 64 csCaP, P = 0.363). Cancer detection by TB or SB was independent of cancer localization and imaging characteristics. Combined TB and SB outperformed the single approaches for CaP and csCaP detection in each subgroup.Conclusions: A single mpMRI and TB approach leads to a substantial number of missed CaP and csCaP across biopsies with different indications. Ongoing improvements of imaging, reading standardization, and biopsy techniques are required before replacing SB. [ABSTRACT FROM AUTHOR]

• Evaluated men from 8 institutions who underwent magnetic resonance imaging (MRI), 4K score, and prostate biopsy. • Using both an MRI and 4K score together was superior to using either test alone. • Sequencing MRI and 4K score tests resulted in the largest biopsy reduction. • Strategies starting with biomarkers had a lower cost. Prostate magnetic resonance imaging (MRI) and biomarkers are often used in conjunction to enhance the selection process for prostate biopsy. However, the optimal sequence of ordering these tests has not been established. A comprehensive evaluation was conducted on a large multi-institutional cohort of patients who underwent MRI, 4K score, and biopsy of the prostate to examine the impact of utilizing both tests vs. either test alone and to determine if the order in which these tests are administered affects the ability to detect clinically significant prostate cancer (csCaP). We evaluated men from 8 different institutions who were referred for prostate cancer evaluation and underwent MRI, 4K score test, and prostate biopsy. The primary outcome was the presence of csCaP, defined as grade group 2 or higher cancer on a biopsy of the prostate. We used logistic regression, calibration plots, and decision curve analysis to evaluate using a 4K score or MRI alone vs. both tests together for detecting csCaP. In addition, we evaluated several strategies using one or both tests for selecting men for biopsy and compared them based on the proportion of biopsies avoided and the csCaP's missed. Among the 1,111 men who formed the final cohort, 553 (49.8%) had prostate cancer, and 353 (31.8%) had csCaP. We found that using MRI and 4K score together had better discrimination, calibration, and a higher clinical utility on decision curve analysis compared to using either test individually. Using both tests together resulted in fewer biopsies avoided and missed cancers compared to using either test alone. Strategies that sequence MRI and 4K score tests resulted in the largest biopsy reduction, with no appreciable difference between starting with an MRI vs. a biomarker. We found that using both an MRI and 4K score together was superior to using either test alone but found no appreciable difference between starting with an MRI vs. starting with a 4K score. Prospective studies are needed to identify the best strategy to sequence MRI and biomarkers in the evaluation of csCaP. [ABSTRACT FROM AUTHOR]

• Transperineal prostate biopsies are the new gold standard in the diagnosis of prostate cancer according to most recent international guidelines. • Transperineal prostate biopsies under local anesthesia can be performed with similar pain scores and complication rates compared to the transrectal procedure. • Transperineal biopsies are feasible in the outpatient clinic. An increasing number of urologists is switching from transrectal (TR) to transperineal (TP) biopsy procedures for the diagnosis of prostate cancer. Local anesthesia (LA) might be advantageous in terms of patient management, risks and costs. We aimed to evaluate the tolerability and complication rates of TP prostate biopsy performed under LA. This is a monocentric, prospective, comparative, observational cohort study. Between July 2020 and July 2021 we included 128 consecutive patients (TR, n = 61; TP, n = 67), with a suspicion of prostate cancer. Transrectal vs. transperineal prostate biopsies were both performed under LA. To evaluate the tolerability we administered a validated visual analog pain score (VAS) during the different steps of the biopsy procedure as well as at 12-, 24- and 48-hours post procedure. The International Prostate Symptom Score (IPSS) questionnaire was administered before the procedure and at the same time intervals. The presence of hematuria, hematospermia, rectal blood loss, acute retention and febrile urinary tract infection (UTI) were also monitored. There were no significant differences in pain or IPSS between groups, except for a significantly higher pain score during the LA of the prostate in the TP group. In general, complication rates were similar, only the prevalence of hematuria at 24 hours was significantly higher in the TP group, as was rectal blood loss at 12 hours postprocedure in the TR group. In conclusion, our study showed that transperineal prostate biopsy under local anesthesia could be performed with similar pain scores and complication rates, compared to the transrectal procedure. [ABSTRACT FROM AUTHOR]

• Over one-third of prostate cancer patients on active surveillance have negative confirmatory biopsy. • Disease progression on active surveillance less likely after negative confirmatory biopsy. • Small subset of patients had adverse pathology after negative confirmatory biopsy. • Overall negative confirmatory biopsy associated with favorable long-term outcomes. Most prostate cancer active surveillance (AS) protocols suggest a confirmatory biopsy within 12 to 18 months of diagnosis to mitigate the risk of unsampled high-grade disease. We investigate whether the results of confirmatory biopsy impact AS outcomes and could be used to tailor surveillance intensity. We retrospectively reviewed our institutional database of prostate cancer patients managed by AS from 1997 to 2019 who underwent confirmatory biopsy and ≥3 biopsies overall. Biopsy progression was defined as either an increase in grade group or an increase in the proportion of positive biopsy cores to >34% and was compared between patients with a negative vs positive confirmatory biopsy using the Kaplan-Meier method and Cox proportional hazards regression. We identified 452 patients meeting inclusion criteria for this analysis, of whom 169 (37%) had a negative confirmatory biopsy. With a median follow-up of 6.8 years, 37% of patients progressed to treatment, most commonly due to biopsy progression. A negative confirmatory biopsy was significantly associated with biopsy progression-free survival in multivariable analysis (HR 0.54, 95% CI 0.34–0.88, P = 0.013), adjusting for known clinical and pathologic factors, including use of mpMRI prior to confirmatory biopsy. Negative confirmatory biopsy was also associated with an increased risk of adverse pathologic features at prostatectomy but not with biochemical recurrence among men who ultimately underwent definitive treatment. A negative confirmatory biopsy is associated with a lower risk of biopsy progression. While the increased risk of adverse pathology at time of definitive treatment sounds a small cautionary note regarding decreasing surveillance intensity, the majority of such patients have a favorable outcome on AS. [ABSTRACT FROM AUTHOR]

• Briganti nomograms discrimination decreases with increasing delay between biopsy and surgery. • Including the time elapsed between biopsy and surgery to the Briganti nomograms can improve their calibration. • The indication of lymphadenectomy should be carefully evaluated in men undergoing prostatectomy after a significant delay from biops. We aimed to investigate whether the performance characteristics of available nomograms predicting lymph node invasion (LNI) in prostate cancer patients undergoing radical prostatectomy (RP) change according to the time elapsed between diagnosis and surgery. We identified 816 patients who underwent RP with extended pelvic lymph node dissection (ePLND) after combined prostate biopsy at 6 referral centers. We plotted the accuracy (ROC-derived area under the curve [AUC]) of each Briganti nomogram according to the time elapsed between biopsy ad RP. We then tested whether discrimination of the nomograms improved after accounting for the time elapsed between biopsy ad RP. The median time between biopsy and RP was 3 months. The LNI rate was 13%. The discrimination of each nomogram decreased with increasing time elapsed between biopsy and surgery, where the AUC of the 2019 Briganti nomogram was 88% vs. 70% for men undergoing surgery <2 vs. >6 months from the biopsy. The addition of the time elapsed between biopsy ad RP improved the accuracy of all available nomograms (P < 0.003), with the Briganti 2019 nomogram showing the highest discrimination. Clinicians should be aware that the discrimination of available nomograms decreases according to the time elapsed between diagnosis and surgery. The indication of ePLND should be carefully evaluated in men below the LNI cut-off who had a diagnosis more than 6 months before RP. This has important implications when considering the longer waiting lists related to the impact of COVID-19 on healthcare systems. [ABSTRACT FROM AUTHOR]

• In patients with a prostate imaging reporting and data system 3 lesion, the detection rate of clinically significant prostate cancer (csPCa) is about 17%. Therefore, the management of this patients can be discussed. • Prostate-specific antigen density (PSAD) ≥ 0.15 ng/ml/cm3 and age were independent predictive factors of csPCa and previous negative prostate biopsy (PBx) was negatively associated with csPCa. • Using PSAD alone to select patient to undergo PBx, would omit 71.5% of PBx at the cost of missing 15.0% of csPCa. • Other predictive factors as age and PBx history should also be considered in the discussion with the patient, to avoid several PBx while missing few csPCa. • Combining predictive factors could be an option to avoid unnecessary PBx. Indeed, in patient with PSAD < 0.15 ng/ml/cm3, younger than 65 years old with previous negative PBx, there was no csPCa. While Prostate Imaging Reporting and Data System (PI-RADS) 4 and 5 lesions usually justify prostate biopsy (PBx), the management of a PI-RADS 3 lesion can be discussed. The aim of our study was to determine the optimal prostate-specific antigen density (PSAD) threshold and predictive factors of clinically significant prostate cancer (csPCa) in patients with a PI-RADS 3 lesion on MRI. Using our prospectively maintained database, we conducted a monocentric retrospective study, including all patients with a clinical suspicious of prostate cancer (PCa), all of them had a PI-RADS 3 lesion on the mpMRI prior to PBx. Patients under active surveillance or displaying suspicious digital rectal examination were excluded. Clinically significant (csPCa) was defined as PCa with any ISUP grade group ≥ 2 (Gleason ≥ 3 + 4). We included 158 patients. The detection rate of csPCa was 22.2%. In case of PSAD ≤ 0.15 ng/ml/cm3, PBx would be omitted in 71.5% (113/158) of men at the cost of missing 15.0% (17/113) of csPCa. With a threshold of 0.15 ng/ml/cm3, the sensitivity and the specificity were 0.51 and 0.78 respectively. The positive predictive value was 0.40 and the negative predictive value was 0.85. According to multivariate analysis, age (OR = 1.10, CI95% 1.03–1.19, P = 0.007), and PSAD ≥ 0.15 ng/ml/cm3 (OR = 3.59, CI95% 1.41–9.47, P = 0.008) were independent predictive factors of csPCa. Previous negative PBx was negatively associated with csPCa (OR = 0.24, CI 95% 0.07–0.66, P = 0.01). Our result suggests that the optimal PSAD threshold was 0.15 ng/ml/cm3. However, in this case omitting PBx in 71.5% of cases would be at the cost of missing 15.0% of csPCa. PSAD should not be used alone, other predictive factors as age and PBx history should also be considered in the discussion with the patient, to avoid PBx while missing few csPCa. [Display omitted] [ABSTRACT FROM AUTHOR]

• The proportion of prostate cancer patients diagnosed by transperineal biopsy has increased. • This is now the predominant form of prostate cancer diagnosis in Australia and New Zealand. • Transperineal biopsy use varies between jurisdictions, hospitals, and patient groups. To describe changes in the use of prostate biopsy techniques among men diagnosed with prostate cancer in Australia and New Zealand and examine factors associated with these changes. We extracted data between 2015 and 2019 from 7 jurisdictions of the Australia and New Zealand Prostate Cancer Outcomes Registry (PCOR-ANZ). Distribution and time trend of transrectal (TR) vs. transperineal (TP) biopsy type, differences in the proportion of biopsy type by geographic jurisdiction, diagnosing institute characteristics (public vs. private, metropolitan vs. regional, case volume) and patient characteristics such as socio-economic status (SES), and location of residence were analyzed. We analyzed data from 37,638 patients. The overall proportion of prostate cancer diagnosed by TP increased from 26% to 57% between 2015 and 2019. Patients living in a major city, a more socioeconomically advantaged area or who were diagnosed in a metropolitan or private hospital were more likely to have TP than TR. While all subgroups were observed to increase their use of TP over the study period, uptake grew faster for men from low SES areas and those diagnosed at a regional or low-volume hospital but slower for men living in outer regional/remote areas or treated at a public hospital. In this binational registry, prostate cancer is now more commonly diagnosed by TP than the TR approach. While the gap between uptakes of TP has diminished for patients with low vs. high SES, disparity has widened for patients from outer regional areas vs major cities and public vs. private hospitals. [ABSTRACT FROM AUTHOR]

• Tumor density is calculated by dividing the tumor and prostate volumes. • Median peripheral zone tumor density was 0.01. • Peripheral tumor density was associated with clinically significant prostate cancer. • The peripheral tumor density threshold was defined as 0.006. • Sensitivity, specificity, PPV, and NPV were 0.9, 0.51, 0.57, and 0.88, respectively. Multiparametric magnetic resonance imaging (mpMRI) is central to diagnosing prostate cancer; however, not all imaged lesions represent clinically significant tumors. We aimed to evaluate the association between the relative tumor volume on mpMRI and clinically significant prostate cancer on biopsy. We retrospectively reviewed the medical records of 340 patients who underwent combined transperineal targeted and systematic prostate biopsies between 2017 and 2021. Tumor volume was estimated based on the mpMRI diameter of suspected lesions. Relative tumor volume (tumor density) was calculated by dividing the tumor and prostate volumes. The study outcome was clinically significant cancer on biopsy. Logistic regression analyses were used to evaluate the association between tumor density and the outcome. The cutoff for tumor density was determined with ROC curves. Median estimated prostate and peripheral zone tumor volumes were 55cm3 and 0.61cm3, respectively. Median PSA density was 0.13 and peripheral zone tumor density was 0.01. Overall, 231 patients (68%) had any cancer and 130 (38%) had clinically significant cancer. On multivariable logistic regression age, PSA, previous biopsy, maximal PI-RADS score, prostate volume, and peripheral zone tumor density were significant predictors of outcome. Using a threshold of 0.006, the sensitivity, specificity, positive and negative predictive values of peripheral zone tumor density were 0.9, 0.51, 0.57, and 0.88, respectively. Peripheral zone tumor density is associated with clinically significant prostate cancer in patients with PI-RADS 4 and 5 mpMRI lesions. Future studies are required to validate our findings and evaluate the role of tumor density in avoiding unnecessary biopsies. [ABSTRACT FROM AUTHOR]