Bimodal imaging: Detection rate of clinically significant prostate cancer is higher in MRI lesions visible to transrectal ultrasound.

BACKGROUND: To explore the detection rates of clinically significant prostate cancer (csPCa; ISUP ≥2) in patients with a single MRI lesion that is visible or invisible on transrectal ultrasound (TRUS) during biopsy. METHODS: Retrospective analyses of patients who underwent targeted and systematic biopsy of the prostate for one MRI-visible lesion (PI-RADS score ≥ 3) between 2017 and 2022. TRUS-visibility, PI-RADS score, and clinical parameters were recorded prospectively. Univariable and multivariable logistic regression models were used to identify predictors of csPCa. RESULTS: 277 consecutive patients with one MRI-visible lesion were identified. A correlating lesion on TRUS was present in 147/277 (53%). The median age, PSA level, and prostate volume were 68.0 years (IQR: 62.0-73.0), 7.3 ng/ml (IQR: 5.4-10.8) and 45.0 cc (IQR: 32.0-68.0), respectively. Baseline parameters were not significantly different between the two groups. CsPCa was detected in 59/130 (45%) without and in 102/147 (69%) patients with a corresponding TRUS lesion. In multivariable logistic regression analysis predicting csPCa, TRUS-visibility (OR: 2.13, CI: 1.14-4.03, p = 0.02) and PI-RADS score (PI-RADS 4: OR: 7.28, CI: 3.33-17.19; PI-RADS 5: OR: 13.39, CI: 5.27-36.83, p < 0.001) achieved independent predictor status. CONCLUSIONS: Bimodal-visible lesions more often harbored csPCa and were easier to target. TRUS-visibility of MRI lesions is an independent predictor of csPCa. Therefore, education in both modalities is essential. Despite MRI, the ultrasound should still be diligently examined.

[Causes of missed diagnosis of clinically significant prostate cancer by targeted biopsy].

OBJECTIVE: To retrospectively analyze the causes of missed diagnosis of clinically significant PCa (csPCa) by targeted biopsy (TB). METHODS: This retrospective study included 652 males aged (71.32 ± 16.53) years with elevated PSA and abnormal MRI signals detected in our hospital from June 2018 to December 2020. We further examined the patients by transperineal prostatic TB and systematic biopsy (SB), analyzed the detection rates of PCa and csPCa by TB and SB, and investigated the causes of missed diagnosis of csPCa in TB using the fishbone diagram. RESULTS: The total detection rate of PCa and csPCa by TB combined with SB was 45.7% (298/652), and that of csPCa was 37.4% (244/652), with 38 cases of csPCa missed in TB, including 23 cases of negative TB and 15 cases of low ISUP grade. The causes of missed diagnosis of csPCa by TB included low MRI image quality, PSA density ≤0.15 ng/ml/cm3, target area <10 mm, and PI-RADS 2 score ≤3. The detection rate of csPCa by TB alone was 31.6%, which was increased by 5.8% (P = 0.027) when TB combined with SB. CONCLUSION: TB combined with SB yields a higher detection rate of csPCa than either used alone. Missed diagnosis of csPCa by TB is closely related to the characteristics of tumor and MR image of the target area.

A Comparison of Systematic, Targeted, and Combined Biopsy Using Machine Learning for Prediction of Prostate Cancer Risk: A Multi-Center Study.

OBJECTIVES: The aims of the study were to construct a new prognostic prediction model for detecting prostate cancer (PCa) patients using machine-learning (ML) techniques and to compare those models across systematic and target biopsy detection techniques. METHODS: The records of the two main hospitals in Riyadh, Saudi Arabia, were analyzed for data on diagnosed PCa from 2019 to 2023. Four ML algorithms were utilized for the prediction and classification of PCa. RESULTS: A total of 528 patients with prostate-specific antigen (PSA) greater than 3.5 ng/mL who had undergone transrectal ultrasound-guided prostate biopsy were evaluated. The total number of confirmed PCa cases was 234. Age, prostate volume, PSA, body mass index (BMI), multiparametric magnetic resonance imaging (mpMRI) score, number of regions of interest detected in MRI, and the diameter of the largest size lesion were significantly associated with PCa. Random Forest (RF) and XGBoost (XGB) (ML algorithms) accurately predicted PCa. Yet, their performance for classification and prediction of PCa was higher and more accurate for cases detected by targeted and combined biopsy (systematic and targeted together) compared to systematic biopsy alone. F1, the area under the curve (AUC), and the accuracy of XGB and RF models for targeted biopsy and combined biopsy ranged from 0.94 to 0.97 compared to the AUC of systematic biopsy for RF and XGB algorithms, respectively. CONCLUSIONS: The RF model generated and presented an excellent prediction capability for the risk of PCa detected by targeted and combined biopsy compared to systematic biopsy alone. ML models can prevent missed PCa diagnoses by serving as a screening tool.

[Diagnostic efficacy of targeted biopsy combined with regional systematic biopsy in prostate cancer in patients with PI-RADS 4-5].

OBJECTIVE: To investigate the diagnostic efficacy of targeted biopsy combined with regional systematic biopsy in prostate cancer (PCa) in patients with prostate imaging reporting and data system v2.1 (PI-RADS v2.1) 4-5. METHODS: From January 2023 to October 2023, patients who underwent prostate biopsy for the first time with total prostate specific antigen (tPSA) ≤ 20 ng/mL and had a multi-parametric magnetic resonance imaging (mpMRI) PI-RADS of 4-5 in Peking University First Hospital were prospectively collected. All the patients underwent transrectal ultrasound-guided cognitive fusion targeted biopsy (3 cores) followed by systematic biopsy (12 cores). Various hypothetical biopsy schemes were defined based on different biopsy sites. The detection effectiveness of targeted biopsy combined with regional systematic biopsy and other biopsy schemes for prostate cancer were compared using Cochran's Q and McNemar tests. RESULTS: A total of 255 patients were enrolled, of whom 204 (80.0%) were detected with prostate adenocarcinoma and 187 (73.3%) were clinically significant with prostate cancer (csPCa). The detection rate of PCa with targeted biopsy was significantly lower than that of targeted biopsy combined with 12-core system biopsy (77.3% vs. 80.0%, P=0.016), and 71.4% (5/7) of the missed patients was csPCa. There was no significant difference in the detection rate between targeted biopsy combined with 4-core regional system biopsy and 12-core system biopsy (P>0.999), and 1 case of csPCa and clinically insignificant prostate cancer (cisPCa) were missed. There was no significant difference in the detection rate of PCa between targeted combined regional system biopsy and targeted combined lateral or traditional 6-core system biopsy and the number of cores were reduced. Missed diagnosis of targeted biopsy was correlated with the maximum diameter of the lesion (OR=0.086, 95%CI: 0.013-0.562, P=0.010). For the patients with PI-RADS 5, only 1 case of PCa was missed in 122 cases by targeted biopsy alone. For patients with PI-RADS 4, 6 PCa cases were missed among the 133 patients with targeted biopsy alone, and 1 case of csPCa and cisPCa were missed by targeted biopsy combined with regional system biopsy. The statistics of positive core counts for different biopsy schemes indicated that targeted combined regional systematic biopsy had a higher proportion of positive cores second only to targeted biopsy alone. CONCLUSION: Targeted biopsy combined with regional systematic biopsy has high diagnostic efficacy in patients with PI-RADS 4-5 and can be considered as one of the improved schemes for combined biopsy. Targeted biopsy alone is also a feasible option for patients for patients with a PI-RADS score of 5.

Clinically significant prostate cancer detection rate in biopsy-naïve patients with mpMRI and microultrasound topographically discordant lesions: A single-center retrospective analysis.

INTRODUCTION AND OBJECTIVES: Multiparametric magnetic resonance imaging (mpMRI) has improved the detection of clinically significant prostate cancer (csPCa), and microultrasound (micro-US) shows promise in enhancing detection rates. We compared mpMRI-guided targeted biopsy (MTBx) and micro-US-guided targeted biopsy (micro-US-TBx) in biopsy-naïve patients with discordant lesions at micro-US and mpMRI to detect csPCa (grade group ≥2) and clinically insignificant PCa (ciPCa; grade group 1) and assessed the role of nontargeted systematic biopsy (SBx). MATERIAL AND METHODS: We analyzed 178 biopsy-naive men with suspected PCa and discordant lesions at mpMRI and micro-US. All patients underwent mpMRI followed by micro-US, the latter being performed immediately before the biopsy. Imaging findings were interpreted blindly, followed by targeted and SBx. Median age was 63 years (IQR, 57-70), median prostate-specific antigen level was 7 ng/mL (IQR, 5-9 ng/mL), and median prostate volume was 49 cm^3 (IQR, 35-64 cm^3). Overall, 86/178 (48%) patients were diagnosed with PCa, 51/178 (29%) with csPCa. RESULTS: Micro-USTBx detected csPCa in 36/178 men (20%; 95% CI: 26-46), and MTBx detected csPCa in 28/178 men (16%; 95% CI: 36-50), resulting in a -8% difference (95% CI: -10, 4; P = 0.022) and a relative detection rate of 0.043. Micro-USTBx detected ciPCa in 9/178 men (5%; 95% CI: 3, 15), while MTBx detected ciPCa in 12/178 men (7%; 95% CI: 5, 20), resulting in a -3% difference (95% CI: -2 to 4; P = 0.2) and a relative detection rate of 0.1. SBx detected ciPCa in 29 (16%) men. mpMRI plus micro-US detected csPCa in 51/178 men, with no additional cases with the addition of SBx. Similarly, MTBx plus micro-USTBx plus SBx detected ciPCa in 35/178 men (20%; 95% CI: 18, 37) compared to 9 (5%) in the micro-US pathway (P = 0.002) and 14/178 (8%; 95% CI: 6, 26) in the mpMRI plus micro-US pathway (P = 0.004). CONCLUSIONS: In conclusion, a combined micro-US/mpMRI approach could characterize primary disease in biopsy-naïve patients with discordant lesions, potentially avoiding SBx. Further studies are needed to validate our findings and assess micro-US's role in reducing unnecessary biopsies.

The detection rate for prostate cancer in systematic and targeted prostate biopsy in biopsy-naive patients, according to the localization of the lesion at the mpMRI: A single-center retrospective observational study.

OBJECTIVE: Evaluate the detection rates of systematic, targeted and combined cores at biopsy according to tumor positions in biopsy-naïve patients. MATERIAL AND METHODS: A retrospective analysis of a single-center patient cohort (n = 501) that underwent transrectal prostate biopsy between January 2017 and December 2019 was performed. Multi-parametric MRI was executed as a prebiopsy investigation. Biopsy protocol included, for each patient, 12 systematic cores plus 3 to 5 targeted cores per lesion identified at the mpMRI. Pearson and McNemar chi-squared tests were used for statistical analysis to compare tumor location-related detection rates of systematic, targeted and combined (systematic + targeted) cores at biopsy. RESULTS: Median age of patients was 70 years (IQR 62-72), with a median PSA of 8.5 ng/ml (IQR 5.7-15.6). Positive biopsies were obtained in 67.7% of cases. Overall, targeted cores obtained higher detection rates compared to systematic cores (54.3% vs. 43.1%, p < 0.0001). Differences in detection rates were, however, higher for tumors located at the apex (61.1% vs. 26.3%, p < 0.05) and anteriorly (44.4% vs. 19.3%, p < 0.05). Targeted cores similarly obtained higher detection rates in the posterior zone of the prostate gland for clinically significant prostate cancer. A poor agreement was reported between targeted and systematic cores for the apex and anterior zone of the prostate with, respectively κ = 0.028 and κ = -0.018. CONCLUSION: A combined approach of targeted and systematic biopsy delivers the highest detection rate in prostate cancer (PCa). The location of the tumor could however greatly influence overall detection rates, indicating the possibility to omit (as for the base or posterior zone of the gland) or add (as for the apex or anterior zone of the gland) further targeted cores.

Image-guided multiparametric magnetic resonance imaging-transrectal ultrasound fusion biopsy augmented with a sextant versus an extended template random biopsy: Comparison of cancer detection rates, complication and functional outcomes.

PURPOSE: To compare the efficacy of a novel fusion template "reduced six-core systemic template and multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion targeted biopsy" (TBx+6c), with mpMRI/TRUS fusion-targeted biopsy and 12-core systematic biopsy template (TBx+12c) in the diagnosis of prostate cancer (PCa). MATERIALS AND METHODS: This is an institutional review board approved single-center observational study involving adult men undergoing fusion-targeted biopsies for the diagnosis of PCa. Patients were sorted into cohorts of TBx+6c or TBx+12c based on the systematic biopsy template used. The study's main objective was to determine the cancer detection rate (CDR) for overall PCa and clinically significant PCa (csPCa) and the secondary objectives were to compare complication rates and functional outcome differences between the cohort. RESULTS: A total of 204 patients met study's inclusion criteria. TBx+6c group had 120 patients, while TBx+12c cohort had 84 patients. The groups had similar baseline characteristics and overall CDR in the TBx+6c cohort was 71.7% versus 79.8%, compared to the TBx+12c (p = 0.18) whereas, the csPCa detection rate in the TBx+6c group was 50.8% versus 54.8% in the TBx+12c group (p = 0.5). TBx+6c cohort had lower overall complication rate of 3% versus 13%, (p = 0.01) and ≥ grade 2 complication rates (1 (1%) vs. 3(4%), p = 0.03) compared to the TBx+12c cohort. There were no differences in IIEF-5 (p = 0.5) or IPSS (p = 0.1) scores at baseline and 2-weeks and 6-weeks post-biopsy. CONCLUSION: TBx+6c cohort, when compared to the TBx+12c cohort, demonstrated comparable diagnostic performance along with similar functional outcomes and lower complication rates. These results suggest the importance of further exploring the clinical implications of adopting a TBx+6c schema for PCa diagnosis in comparison to the widely used TBx+12c schema through a multicenter randomized controlled trial.

Targeted biopsy added to systematic biopsy improves cancer detection in prostate cancer screening.

BACKGROUND: Magnetic resonance imaging (MRI)/ultrasound targeted biopsy has frequently been used together with a 12-core systematic biopsy for prostate cancer screening in the past few years. However, the efficacy of targeted biopsy compared to systematic biopsy, as well as its clinical-histologic correlation, has been assessed by a limited number of studies and is further investigated in this study. DESIGN: We collected 960 cases with both targeted and systematic prostate biopsies from 04/2019 to 04/2022 (Table 1). We compared cancer detection rates between targeted and systematic prostate biopsies in different grade groups. Correlations with the size of prostate lesions, prostate-specific antigen (PSA) level, and Prostate Imaging-Reporting and Data System (PI-RADS) scale were also analyzed for each of these biopsy methods. RESULTS: Among the 960 men who underwent targeted biopsy with systematic biopsy, prostatic adenocarcinoma was diagnosed in 652 (67.9%) cases. 489 (50.9%) cases were diagnosed by targeted biopsy and 576 (60.0%) cases were diagnosed by systematic biopsy. In the 384 cases diagnosed negative by systematic biopsy, targeted biopsy identified cancer in 76 (8%) cases. Systematic biopsy was able to detect 163 cancer cases that were missed by targeted biopsy. Systematic biopsy detected more grade group 1 cancers compared to targeted biopsy. However, for higher grade cancers, the differences between the cancer detection rates of targeted biopsy and systematic biopsy became negligible. Targeted biopsy upgraded the grade group categorized by systematic biopsy in several cases (3.8%, 7.0%, 2.6%, 1.1% and 0.9% in Grade Groups 1, 2, 3, 4, and 5 respectively). Targeted biopsy was more likely to detect cancer in larger lesions (13.17 mm VS 11.41 mm, P=0.0056) and for higher PI-RADS scales (4.19 VS 3.68, P<0.0001). The cancers detected by targeted biopsy also had higher PSA levels (10.38 ng/ml VS 6.39 ng/ml, P=0.0026). CONCLUSION: Targeted biopsy with systematic biopsy improved cancer detection rate compared to systematic biopsy alone. Targeted biopsy is not more sensitive for grade groups 1, 4, or 5 cancers but is as sensitive as systematic biopsy for detecting grade group 2 and 3 cancers. Targeted biopsy is more effective at detecting cancers when patients have larger lesions, higher PI-RADS scales, and higher PSA levels.

Transition from Transrectal to Transperineal MRI-Fusion Prostate Biopsy Does Not Comprise Detection Rates of Clinically Significant Prostate Cancer at a Tertiary Care Center.

BACKGROUND: A remarkable paradigm shift has emerged regarding the preferred prostate biopsy approach, favoring the transperineal (TP) over the transrectal (TR) approach due to the reduced risk of severe urinary tract infections. However, its impact on the detection of clinically significant prostate cancer (csPCa) remains unclear. MATERIALS AND METHODS: We relied on a prospectively maintained tertiary care database to identify patients who underwent either TP or TR prostate biopsy between 01/2014 and 12/2023. Of those, only patients with suspicious magnetic resonance imaging (MRI) PIRADS lesions (Likert-scale: 3,4,5) received MRI-targeted and systematic biopsies. Detection rates of csPCa (International Society of Urological Pathology [ISUP] ≥ 2) were compared between biopsy approach (TP vs. TR) according to index lesion. Subsequently, uni- and multivariable logistic regression models were applied to investigate the predictive status of the biopsy approach within each subcohort. RESULTS: Of 2063 patients, 1118 (54%) underwent combined MRI-guided and systematic prostate biopsy and were included in the final cohort. Of those, 127 (11%) and 991 (89%) underwent TP vs. TR. CsPCa rates, regardless of differences in patients' demographics and distribution of index PIRDAS lesions, did not differ statistically significantly and were 51 vs. 52%, respectively (p = 0.8). CsPCa detection rates for PIRDAS-3, PIRADS-4 and PIRADS-5 did not differ and were 24 vs. 23%, 48 vs. 51% and 72 vs. 76% for PIRADS-3, PIRADS-4 and PIRADS-5 subgroups for TP vs. TR, respectively (all p ≥ 0.9) Conclusions: The current results support the available data indicating that TP biopsy approach is comparable to transrectal biopsy approach regarding csPCa detection rates.

Accuracy of MRI-ultrasound fusion-guided and systematic biopsy of the prostate.

OBJECTIVES: Prostate multiparametric MRI (mpMRI) with subsequent targeted biopsy of suspicious lesions has a critical role in the diagnostic workup of prostate cancer. The objective was to evaluate the diagnostic accuracy of systematic biopsies, targeted biopsies, and the combination of both in prostate cancer detection. METHODS: From January 1, 2013 to June 1, 2022, biopsy-naïve and prior biopsy-negative patients who underwent both systematic and targeted biopsies were included. MRIs were evaluated according to PI-RADS with biopsy threshold set at PI-RADS ≥3. Systematic biopsies consisted of 8-12 cores, based on prostate volume. Overall prostate cancer and clinically significant cancer (Gleason Score ≥3 + 4) detection rates were stratified based on PI-RADS and location within the prostate, and compared between biopsy types using McNemar test. RESULTS: Among 867 patients, 615 had prostate cancer, with 434 clinically significant cases. Overall detection rates were: PI-RADS 3 48%, PI-RADS 4 72%, and PI-RADS 5 90%. Detection rates for clinically significant cancer were 21%, 53%, and 72%, respectively. The combination of biopsy methods was most accurate in detecting clinically significant prostate cancer (P < .001). Targeted biopsies alone detected more clinically significant prostate cancer than systematic biopsies alone (43.1% vs 40.3%, P = .046). For posterior PI-RADS 5 lesions, no statistically significant difference was found between all biopsy methods. CONCLUSIONS: In the detection of clinically significant prostate cancer, the combination of systematic and targeted biopsies proves most effective. Targeted biopsies rarely missed significant cancer for posterior PI-RADS 5 lesions, suggesting systematic biopsies could be reserved for instances where targeted biopsy results are negative. ADVANCES IN KNOWLEDGE: This study emphasizes on the efficacy of mpMRI and targeted biopsies in suspected prostate cancer in real-world clinical context. For PI-RADS 5 lesions, systematic biopsies provide limited clinical benefit and may only be necessary when targeted biopsy results are negative.

Clinical and Radiological Factors for Predicting Clinically Significant Prostate Cancer in Biopsy-Naive Patients With PI-RADS 3 Lesions.

OBJECTIVE: This study intends to examine the anticipatory power of clinical and radiological parameters in detecting clinically significant prostate cancer in patients demonstrating Prostate Imaging Reporting and Data System 3 lesions. METHODS: This was a retrospective study. The study included participation from 453 patients at the First Affiliated Hospital of Soochow University, sampled between September 2017 through August 2022. Each patient underwent a routine 12-core prostate biopsy followed by a 2 to 5 core fusion-targeted biopsy. We utilized both univariate and multivariate logistic regression analyses to identify the parameters that have a correlation with clinically significant prostate cancer. The predictive ability of these parameters was assessed using the receiver operating characteristic curve, leading to the creation of a nomogram. RESULTS: Clinically significant prostate cancer was detected in 68 out of 453 patients with Prostate Imaging Reporting and Data System 3 lesions (15.01%). Among Prostate Imaging Reporting and Data System 3a and 3b patients, 4.78% (3.09% of the total) and 33.75% (11.92% of the total), respectively, had clinically significant prostate cancer. Systematic biopsy improved prostate cancer and clinically significant prostate cancer detection rates by 7.72% and 3.09%, respectively, compared to targeted biopsy. Without systematic biopsy, there would be an undetected rate of 15% for prostate cancer and 8.13% for clinically significant prostate cancer in Prostate Imaging Reporting and Data System 3b patients. Several clinical parameters, including age, prostate-specific antigen density, lesion volume, apparent diffusion coefficient, and digital rectal examination, were statistically significant in the logistic regression analysis for clinically significant prostate cancer. The individual diagnostic accuracies of these parameters for clinically significant prostate cancer were 0.648, 0.645, 0.75, 0.763, and 0.7, respectively, but their combined accuracy improved to 0.866. A well-fit nomogram based on the identified risk factors was constructed (χ2 = 10.254, P = .248). CONCLUSION: The combination of age, prostate-specific antigen density, lesion volume, apparent diffusion coefficient, and digital rectal examination presented a higher diagnostic value for clinically significant prostate cancer than any single parameter in patients with Prostate Imaging Reporting and Data System 3 lesions. Systematic biopsy proved crucial for biopsy-naive patients with Prostate Imaging Reporting and Data System 3 lesions and should not be omitted.

The impact of mpMRI-targeted vs systematic biopsy on the risk of prostate cancer downgrading at final pathology.

PURPOSE: Although targeted biopsies (TBx) are associated with improved disease assessment, concerns have been raised regarding the risk of prostate cancer (PCa) overgrading due to more accurate biopsy core deployment in the index lesion. METHODS: We identified 1672 patients treated with radical prostatectomy (RP) with a positive mpMRI and ISUP ≥ 2 PCa detected via systematic biopsy (SBx) plus TBx. We compared downgrading rates at RP (ISUP 4-5, 3, and 2 at biopsy, to a lower ISUP) for PCa detected via SBx only (group 1), via TBx only (group 2), and eventually for PCa detected with the same ISUP 2-5 at both SBx and TBx (group 3), using multivariable logistic regression models (MVA). RESULTS: Overall, 12 vs 14 vs 6% (n = 176 vs 227 vs 96) downgrading rates were recorded in group 1 vs group 2 vs group 3, respectively (p < 0.001). At MVA, group 2 was more likely to be downgraded (OR 1.26, p = 0.04), as compared to group 1. Conversely, group 3 was less likely to be downgraded at RP (OR 0.42, p < 0.001). CONCLUSIONS: Downgrading rates are highest when PCa is present in TBx only and, especially when the highest grade PCa is diagnosed by TBx cores only. Conversely, downgrading rates are lowest when PCa is identified with the same ISUP through both SBx and TBx. The presence of clinically significant disease at SBx + TBx may indicate a more reliable assessment of the disease at the time of biopsy potentially reducing the risk of downgrading at final pathology.

A novel biopsy scheme for prostate cancer: targeted and regional systematic biopsy.

PURPOSE: To explore a novel biopsy scheme for prostate cancer (PCa), and test the detection rate and pathological agreement of standard systematic (SB) + targeted (TB) biopsy and novel biopsy scheme. METHODS: Positive needles were collected from 194 patients who underwent SB + TB (STB) followed by radical prostatectomy (RP). Our novel biopsy scheme, targeted and regional systematic biopsy (TrSB) was defined as TB + regional SB (4 SB-needles closest to the TB-needles). The McNemar test was utilized to compare the detection rate performance for clinical significant PCa (csPCa) and clinical insignificant PCa (ciPCa). Moreover, the accuracy, positive predictive value (PPV) and negative predictive value (NPV) were investigated. The agreement between the different biopsy schemes grade group (GG) and RP GG were assessed. The concordance between the biopsy and the RP GG was evaluated using weighted κ coefficient analyses. RESULTS: In this study, the overall detection rate for csPCa was 83.5% (162 of 194) when SB and TB were combined. TrSB showed better NPV than TB (97.0% vs. 74.4%). Comparing to STB, the TB-detection rate of csPCa had a significant difference (p < 0.01), while TrSB showed no significant difference (p > 0.999). For ciPCa, the overall detection rate was 16.5% (32 of 194). TrSB showed better PPV (96.6% vs. 83.3%) and NPV (97.6% vs. 92.9%) than TB. Comparing to STB, the detection rate of both schemes showed no significant difference (p = 0.077 and p = 0.375). All three schemes GG showed poor agreement with RP GG (TB: 43.3%, TrSB: 46.4%, STB: 45.9%). Using weighted κ, all three schemes showed no difference (TB: 0.48, TrSB: 0.51, STB: 0.51). In our subgroup analysis (PI-RADS = 4/5, n = 154), all three schemes almost showed no difference (Weighted κ: TB-0.50, TrSB-0.51, STB-0.50). CONCLUSION: Our novel biopsy scheme TrSB (TB + 4 closest SB needles) may reduce 8 cores of biopsy compared with STB (standard SB + TB), which also showed better csPCa detection rate than TB only, but the same as STB. The pathological agreement between three different biopsy schemes (TB/TrSB/STB) GG and RP GG showed no difference.

The Added Value of MRI-Based Targeted Biopsy in Biopsy-Naïve Patients: A Propensity-Score Matched Comparison.

BACKGROUND: Multiparametric Magnetic Resonance Imaging (mpMRI)-based targeted biopsy has shown to be beneficial in detecting Clinically Significant Prostate Cancer (csPCa) and avoiding diagnosis of Non-csPCa (ncsPCa); however, its role in the treatment of biopsy-naïve patients is still under discussion. METHODS: After identifying predictors for the diagnosis of csPCa via Multivariate Logistic Regression Analysis (MLRA), a propensity-score (1:1 nearest neighbor) matched comparison was performed between a Systematic-Only Biopsy (SOB) cohort and a mpMRI-based Combined (systematic + targeted) Biopsy (CB) cohort from two tertiary urologic centers (SOB: Department of Urology, University General Hospital of Heraklion, University of Crete, School of Medicine, Heraklion, Crete, Greece; CB: LKH Hall in Tirol, Austria). Only biopsy-naïve patients were included in the study. The study period for the included patients was from February 2018 to July 2023 for the SOB group and from July 2017 to June 2023 for the CB group. The primary outcome was the diagnosis of csPCa (≥ISUP 2); secondary outcomes were overall cancer detection, the added value of targeted biopsy in csPCa detection, and the reduction in ncsPCa diagnosis with CB compared to SOB. To estimate the Average Treatment effect of the Treated groups (ATT), cluster-robust standard errors were used to perform g-computation in the matched sample. p-values < 0.05 with a two-sided 95% confidence interval were considered statistically significant. RESULTS: Matching achieved well-balanced groups (each n = 140 for CB and SOB). In the CB group, 65/140 (46.4%) patients were diagnosed with csPCa compared to 44/140 (31.4%) in the SOB group (RR 1.48, 95%-CI: 1.09-2.0, p = 0.01). In the CB group, 4.3% (6/140) and 1.4% (2/140) of csPCa cases were detected with targeted-only and systematic-only biopsy cores, respectively. In the CB group, 22/140 (15.7%) patients were diagnosed with ncsPCa compared to 33/140 (23.6%) in the SOB group (RR = 0.67, 95% CI: 0.41-1.08, p = 0.1). When comparing SOB to CB (ATT), the marginal OR was 0.56 (95% CI: 0.38-0.82, p = 0.003) for the diagnosis of csPCa and 0.75 (95% CI: 0.47-1.05, p = 0.085) for the diagnosis of overall cancer (≥ISUP 1). CONCLUSION: The CB approach was superior to the SOB approach in detecting csPCa, while no additional detection of ncsPCa was seen. Our results support the application of mpMRI for biopsy-naïve patients with suspicions of prostate cancer.

The Impact of Omitting Contralateral Systematic Biopsy on the Surgical Planning of Patients with a Unilateral Suspicious Lesion on Magnetic Resonance Imaging Undergoing Robot-assisted Radical Prostatectomy for Prostate Cancer.

Background and objective: A combined approach of magnetic resonance imaging (MRI)-targeted biopsy (TBx) and bilateral systematic biopsy (SBx) is advised in patients who have an increased risk of prostate cancer (PCa). The diagnostic gain of SBx in detecting PCa for treatment planning of patients undergoing robot-assisted radical prostatectomy (RARP) is unknown. This study aims to determine the impact of omitting contralateral SBx on the surgical planning of patients undergoing RARP in terms of nerve-sparing surgery (NSS) and extended pelvic lymph node dissection (ePLND). Methods: Case files from 80 men with biopsy-proven PCa were studied. All men had a unilateral suspicious lesion on MRI, and underwent TBx and bilateral SBx. Case files were presented to five urologists for the surgical planning of RARP. Each case file was presented randomly using two different sets of information: (1) results of TBx + bilateral SBx, and (2) results of TBx + ipsilateral SBx. The urologists assessed whether they would perform NSS and/or ePLND. Key findings and limitations: A change in the surgical plan concerning NSS on the contralateral side was observed in 9.0% (95% confidence interval [CI] 6.4-12.2) of cases. Additionally, the indication for ePLND changed in 5.3% (95% CI 3.3-7.9) of cases. Interobserver agreement based on Fleiss' kappa changed from 0.44 to 0.15 for the indication of NSS and from 0.84 to 0.83 for the indication of ePLND. Conclusions and clinical implications: In our series, the diagnostic information obtained from contralateral SBx has limited impact on the surgical planning of patients with a unilateral suspicious lesion on MRI scheduled to undergo RARP. Patient summary: In patients with one-sided prostate cancer on magnetic resonance imaging, omitting biopsies on the other side rarely changed the surgical plan with respect to nerve-sparing surgery and the indication to perform extended lymph node dissection.

Are systematic prostate biopsy still necessary in biopsy naive men?

PURPOSE: Multiparametric MRI and the transperineal approach have become standard in the diagnostic pathway for suspected prostate cancer. Targeting of MRI lesions is performed at most centers, but the routine use of systematic cores is controversial. We aim to assess the value of obtaining systematic cores in patients undergoing cognitive fusion targeted double-freehand transperineal prostate biopsy. MATERIALS AND METHODS: Patients who underwent a cognitive fusion, freehand TPB at a single tertiary urology service (Perth, Australia) between November 2020 and November 2021 were retrospectively reviewed. Patients were included if they were biopsy naive and had a clinical suspicion of prostate cancer, based on their mpMRI results. Both targeted and systematic cores were taken at the time of their biopsy. RESULTS: One hundred forty patients suited the selection criteria. Clinically significant cancer was identified in 63% of patients. Of those that had clinically significant cancer, the target lesion identified 91% of the disease, missing 9% of patients whom the target biopsy detected non-clinically significant cancer but was identified in the systematic cores. Higher PI-RADS category patients were also found to be associated with an increasing likelihood of identifying clinically significant cancer within the target. CONCLUSIONS: In patients with PI-RADS 3 and higher, the target biopsy can miss up to 9% of clinically significant cancer. Systematic cores can add value as they can also change management by identifying a high-risk disease where only intermediate cancer was identified in the target. A combination of targeted and systematic cores is still required to detect cancer.

Do we need MRI in all biopsy naïve patients? A multicenter cohort analysis.

PURPOSE: The combined approach (CB) of magnetic resonance imaging (MRI)-guided biopsy (TB) and systematic biopsy (SB) is strongly recommended based on numerous studies in biopsy naïve men with suspicion of clinically significant prostate cancer (csPCA). However, the unbalanced accessibility of MRI, challenges related to reimbursement and the scarcity of specialized medical practitioners continue to impede a widespread implementation. Therefore, our objective was to determine a subset of men that could undergo SB without an increased risk of underdiagnosis at reduced expenses. METHODS: A multicenter analysis of 2714 men with confirmed PCA and suspicious MRI who underwent CB were enrolled. Cancer detection rates were compared between the different biopsy routes SB, TB and CB using McNemar paired test. Additionally, Gleason grade up- and down-grading was determined. RESULTS: CB detected more csPCA than TB and SB (p < 0.001), irrespective of MRI findings or biopsy route (transperineal vs. transrectal). Thereby, single biopsy approaches misgraded > 50% of csPCA. TB showed higher diagnostic efficiency, defined as csPCA detection per biopsy core than CB and SB (p < 0.001). For patients with abnormal DRE and PSA levels > 12.5 ng/ml, PSAD > 0.35 ng/ml/cm3, or > 75 years, SB and CB showed similar csPCA detection rates. CONCLUSION: Conducting CB provides the highest level of diagnostic certainty and minimizes the risk of underdiagnosis in almost all biopsy-naive men. However, in patients with suspicious DRE and high PSA levels, PSAD, or advanced age solely using SB leads to similar csPCA detection rates. Thus, a reduced biopsy protocol may be considered for these men in case resources are limited.

Clinical significance of prostate cancer identified by transperineal standard template biopsy in men with nonsuspicious multiparametric magnetic resonance imaging.

OBJECTIVE: Multiparametric magnetic resonance imaging (mpMRI) of the prostate has excellent sensitivity in detecting clinically significant prostate cancer (csCaP). However, whether a negative mpMRI in patients with a clinical suspicion of CaP can omit a confirmatory biopsy remains less understood and without consensus. Transperineal (TP) standard template biopsy (SBx) provides an effective approach to CaP detection. Our aim is to provide a comprehensive understanding of the CaP characteristics detected through TP SBx that are systematically overlooked by mpMRI. METHODS: We conducted a retrospective analysis of all men who underwent prebiopsy mpMRI and subsequent a 20-core TP SBx at our hospital from September 2019 to February 2021. Patients with suspicious mpMRI received a combined TP SBx and targeted biopsy (TBx) (suspicious group), while those without suspicious (negative) mpMRI and who proceeded to biopsy, received TP SBx only (nonsuspicious group). A negative mpMRI was defined as the absence of suspicious findings and/or the presence of low-risk areas with a PI-RADS score of ≤2. Subsequently, we compared and evaluated the clinical and biopsy characteristics between these 2 groups. RESULTS: We identified 301 men in suspicious group and 215 men in nonsuspicious group. The overall CaP detection rate and csCaP detection rate by TP SBx were 74.1%, 38.9% for suspicious group and 43.3%, 14.9% for nonsuspicious group, respectively. csCaP NPV of mpMRI was 85.1% with a csCaP prevalence 28.9%. The greatest percentage of cancer involvement (GPC) in biopsy core from nonsuspicious group was significantly lower than those of suspicious group (40% vs. 50%, p = 0.005), In multivariate logistic analysis, only PSAD > 0.15 ng/ml/cc was identified as an independent and significant predictor of csCaP in nonsuspicious group. CONCLUSION: Within our cohort, false-negative rates of mpMRI for csCaP are substantial, reaching 15%. Nonsuspicious cases may contain a large volume tumor since the high GPC of SBx. For cases with nonsuspicious imaging and higher PSAD, a confirmatory biopsy may be necessary due to the increased risk of missed csCaP by mpMRI.

The Added Value of Side-specific Systematic Biopsy in Patients Diagnosed by Magnetic Resonance Imaging-targeted Prostate Biopsy.

BACKGROUND: Systematic biopsy (SB) combined with magnetic resonance imaging (MRI)-targeted biopsy is still recommended considering the risk of missing clinically significant prostate cancer (csPCa). OBJECTIVE: To evaluate the added value in csPCa detection on side-specific SB relative to MRI lesion and to externally validate the Noujeim risk stratification model that predicts the risk of csPCa on distant SB cores relative to the index MRI lesion. DESIGN, SETTING, AND PARTICIPANTS: Overall, 4841 consecutive patients diagnosed by MRI-targeted biopsy and SB for Prostate Imaging Reporting and Data System score ≥3 lesions were identified from a prospectively maintained database between January 2016 and April 2023 at 15 European referral centers. A total of 2387 patients met the inclusion criteria and were included in the analysis. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: McNemar's test was used to compare the csPCa detection rate between several biopsy strategies including MRI-targeted biopsy, side-specific SB, and a combination of both. Model performance was evaluated in terms of discrimination using area under the receiver operation characteristic curve (AUC), calibration plots, and decision curve analysis. Clinically significant prostate cancer was defined as International Society of Urological Pathology grade group ≥2. RESULTS AND LIMITATIONS: Overall, the csPCa detection rate was 49%. Considering MRI-targeted biopsy as reference, the added values in terms of csPCa detection were 5.8% (relative increase of 13%), 4.2% (relative increase of 9.8%), and 2.8% (relative increase of 6.1%) for SB, ipsilateral SB, and contralateral SB, respectively. Only 35 patients (1.5%) exclusively had csPCa on contralateral SB (p < 0.001). Considering patients with csPCa on MRI-targeted biopsy and ipsilateral SB, the upgrading rate was 2% (20/961) using contralateral SB (p < 0.001). The Noujeim model exhibited modest performance (AUC of 0.63) when tested using our validation set. CONCLUSIONS: The added value of contralateral SB was negligible in terms of cancer detection and upgrading rates. The Noujeim model could be included in the decision-making process regarding the appropriate prostate biopsy strategy. PATIENT SUMMARY: In the present study, we collected a set of patients who underwent magnetic resonance imaging (MRI)-targeted and systematic biopsies for the detection of prostate cancer. We found that biopsies taken at the opposite side of the MRI suspicious lesion have a negligible impact on cancer detection. We also validate a risk stratification model that predicts the risk of cancer on biopsies beyond 10 mm from the initial lesion, which could be used in daily practice to improve the personalization of the prostate biopsy.

Cognitive fusion-targeted biopsy versus transrectal ultrasonography-guided systematic biopsy: comparison and analysis of the risk of Gleason score upgrading.

PURPOSE: The aim of this study is to assess the precision of the Gleason score (GS) obtained through cognitive fusion-targeted biopsy (COG-TB) in comparison to transrectal ultrasonography-guided systematic biopsy (TRUS-SB), and to identify factors that can predict Gleason score upgrading (GSU) in a cohort of Chinese patients. METHODS: A final enrollment of 245 patients was recorded. Between 2020 and 2022, 132 patients underwent TRUS-SB, and 113 patients underwent COG-TB. The Chi-square test was performed to analyze the variation in downgrading, concordance, and upgrading between TRUS-SB and COG-TB. Multivariable analyses were performed to seek factors predicting Gleason score upgrading. Finally, a model which utilizes multivariable logistic regression was developed to predict the likelihood of GSU. RESULTS: The concordance for TRUS-SB and COG-TB were 42.4% and 65.5%, respectively. TRUS-SB and COG-TB exhibited notable disparities in downgrading, concordance, and upgrading. Age, prostate volume, body mass index (BMI), and the biopsy modality were significant predictive factors. CONCLUSION: COG-TB can significantly increase concordance with final histopathology. Age, prostate volume, BMI, and the biopsy modality were predictive factors of GSU.