(1) Background: To identify a particular setting of biopsy-naïve patients in which it would be reasonable to offer only cognitive targeted prostate biopsy (PBx) with a transrectal approach. (2) Methods: We designed an observational retrospective pilot study. Patients with a prostatic specific antigen (PSA) level > 10 ng/mL, either a normal or suspicious digital rectal examination (DRE), and a lesion with a PI-RADS score ≥ 4 in the postero-medial or postero-lateral peripheral zone were included. All patients underwent a transrectal PBx, including both systematic and targeted samples. The detection rate of clinically significant prostate cancer (csPCa) (Gleason Score ≥ 7) was chosen as the primary outcome. We described the detection rate of csPCa in systematic PBx, targeted PBx, and overall PBx. (3) A total of 92 patients were included. Prostate cancer was detected in 84 patients (91.30%) with combined biopsies. A csPCa was diagnosed in all positive cases (100%) with combined biopsies. Systematic PBxs were positive in 80 patients (86.96%), while targeted PBxs were positive in 84 men (91.30%). Targeted PBx alone would have allowed the diagnosis of csPCa in all positive cases; systematic PBx alone would have missed the diagnosis of 8/84 (9.52%) csPCa cases (4 negative patients and 4 not csPCa) (p = 0.011). (4) Conclusions: Cognitive targeted PBx with a transrectal approach could be offered alone to diagnose csPCa in biopsy-naïve patients with PSA ≥ 10 ng/mL, either normal or suspicious DRE, and a lesion with PI-RADS score ≥ 4 in the postero-medial or postero-lateral peripheral zone.

OBJECTIVE: 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).
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.

OBJECTIVE: In recent decades, there has been an increasing role for magnetic resonance imaging (MRI) in the detection of clinically significant prostate cancer (csPC). The purpose of this review is to provide an update and outline future directions for the role of MRI in the detection of csPC.
RESULTS: In diagnosing clinically significant prostate cancer pre-biopsy, advances include our understanding of MRI-targeted biopsy, the role of biparametric MRI (non-contrast) and changing indications, for example the role of MRI in screening for prostate cancer. Furthermore, the role of MRI in identifying csPC is maturing, with emphasis on standardization of MRI reporting in active surveillance (PRECISE), clinical staging (EPE grading, MET-RADS-P) and recurrent disease (PI-RR, PI-FAB). Future directions of prostate MRI in detecting csPC include quality improvement, artificial intelligence and radiomics, positron emission tomography (PET)/MRI and MRI-directed therapy.
CONCLUSIONS: The utility of MRI in detecting csPC has been demonstrated in many clinical scenarios, initially from simply diagnosing csPC pre-biopsy, now to screening, active surveillance, clinical staging, and detection of recurrent disease. Continued efforts should be undertaken not only to emphasize the reporting of prostate MRI quality, but to standardize reporting according to the appropriate clinical setting.

Quality control of programs for detection of significant prostate cancer (sPCa) could be defined by the correlation between observed and reference 95% confidence intervals (CIs) for Prostate Imaging-Reporting and Data System (PI-RADS) categories. We used the area under the receiver operating characteristic curve (AUC) for the Barcelona magnetic resonance imaging (MRI) predictive model to screen the quality of ten participant centers in the sPCa opportunistic early detection program in Catalonia. We set an AUC of <0.8 as the criterion for suboptimal quality. Quality was confirmed in terms of the correlation between actual sPCa detection rates and reference 95% CIs. For a cohort of 2624 men with prostate-specific antigen >3.0 ng/ml and/or a suspicious digital rectal examination who underwent multiparametric MRI and two- to four-core targeted biopsies of PI-RADS ≥3 lesions and/or 12-core systematic biopsy, AUC values ranged from 0.527 to 0.914 and were <0.8 in four centers (40%). There was concordance between actual sPCa detection rates and reference 95% CIs for one or two PI-RADS categories when the AUC was <0.8, and for three or four PI-RADS categories when the AUC was ≥0.8. A review of procedures used for sPCa detection should be recommended in centers with suboptimal quality.
UNASSIGNED: We tested a method for assessing quality control for centers carrying out screening for early detection of prostate cancer. We found that the method can identify centers that may need to review their procedures for detection of significant prostate cancer.

OBJECTIVE: To explore the feasibility and efficacy of clinical-imaging metrics in the diagnosis of prostate cancer (PCa) and clinically significant prostate cancer (csPCa) in prostate imaging-reporting and data system (PI-RADS) category 3 lesions.
METHODS: A retrospective analysis was conducted on lesions diagnosed as PI-RADS 3. They were categorized into benign, non-csPCa and csPCa groups. Apparent diffusion coefficient (ADC), T2-weighted imaging signal intensity (T2WISI), coefficient of variation of ADC and T2WISI, prostate-specific antigen density (PSAD), ADC density (ADCD), prostate-specific antigen lesion volume density (PSAVD) and ADC lesion volume density (ADCVD) were measured and calculated. Univariate and multivariate analyses were used to identify risk factors associated with PCa and csPCa. Receiver operating characteristic curve (ROC) and decision curves were utilized to assess the efficacy and net benefit of independent risk factors.
RESULTS: Among 202 patients, 133 had benign prostate disease, 25 non-csPCa and 44 csPCa. Age, PSA and lesion location showed no significant differences (P > 0.05) among the groups. T2WISI and coefficient of variation of ADC (ADCcv) were independent risk factors for PCa in PI-RADS 3 lesions, yielding an area under the curve (AUC) of 0.68. ADC was an independent risk factor for csPCa in PI-RADS 3 lesions, yielding an AUC of 0.65. Decision curve analysis showed net benefit for patients at certain probability thresholds.
CONCLUSIONS: T2WISI and ADCcv, along with ADC, respectively showed considerable promise in enhancing the diagnosis of PCa and csPCa in PI-RADS 3 lesions.

BACKGROUND: Accurate, reliable, non-invasive assessment of patients diagnosed with prostate cancer is essential for proper disease management. Quantitative assessment of multi-parametric MRI, such as through artificial intelligence or spectral/statistical approaches, can provide a non-invasive objective determination of the prostate tumor aggressiveness without side effects or potential poor sampling from needle biopsy or overdiagnosis from prostate serum antigen measurements. To simplify and expedite prostate tumor evaluation, this study examined the efficacy of autonomously extracting tumor spectral signatures for spectral/statistical algorithms for spatially registered bi-parametric MRI.
METHODS: Spatially registered hypercubes were digitally constructed by resizing, translating, and cropping from the image sequences (Apparent Diffusion Coefficient (ADC), High B-value, T2) from 42 consecutive patients in the bi-parametric MRI PI-CAI dataset. Prostate cancer blobs exceeded a threshold applied to the registered set from normalizing the registered set into an image that maximizes High B-value, but minimizes the ADC and T2 images, appearing \"green\" in the color composite. Clinically significant blobs were selected based on size, average normalized green value, sliding window statistics within a blob, and position within the hypercube. The center of mass and maximized sliding window statistics within the blobs identified voxels associated with tumor signatures. We used correlation coefficients (R) and p-values, to evaluate the linear regression fits of the z-score and SCR (with processed covariance matrix) to tumor aggressiveness, as well as Area Under the Curves (AUC) for Receiver Operator Curves (ROC) from logistic probability fits to clinically significant prostate cancer.
RESULTS: The highest R (R > 0.45), AUC (>0.90), and lowest p-values (<0.01) were achieved using z-score and modified registration applied to the covariance matrix and tumor signatures selected from the \"greenest\" parts from the selected blob.
CONCLUSIONS: The first autonomous tumor signature applied to spatially registered bi-parametric MRI shows promise for determining prostate tumor aggressiveness.

OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.

Introduction: Conventionally, confirmation of clinically significant prostate cancer (csPCa) (Gleason grade group ≥ 2) involves an initial multiparametric magnetic resonance imaging (mpMRI) followed by biopsy. Prostate biopsy incurs inherent risks of infection, bleeding, patient discomfort, and a 6-week delay before robot-assisted laparoscopic radical prostatectomy (RALP). We explored the feasibility of immediate RALP in men with PIRADS 5 lesions without preceding biopsy. Methodology: After obtaining institutional review board approval, a prospective analysis was conducted on 235 patients with PIRADS 5 lesions on mpMRI from December 2018 to February 2023. Patients were divided into 2 groups as follows: Group NoBiopsy (biopsy not done before RALP, cases, n = 118) and Group YesBiopsy (biopsy done before RALP, controls, n = 117). Baseline preoperative, intraoperative, and postoperative parameters were analyzed. Functional outcomes were monitored at 1, 3-, 6-, 9-, and 12-months follow-up post-RALP. Statistical analysis was performed using SPSS and STATA. Results: Ninety-five percent of cases and 87.17% controls had csPCa on final pathology post-RALP. Multivariable analysis did not find significant association between biopsy status and csPCa. Abnormal digital rectal examination (DRE), family history, preoperative PSA, and MRI lesion volume predicted csPCa. Significant differences were observed in console time (NoBiopsy vs. YesBiopsy, 60 ± 10 vs. 70 ± 9 minutes, p < 0.001) and estimated blood loss (80 ± 20 vs. 100 ± 30 mL, p < 0.01) between groups. At 6 months post-RALP, 96% of men in Group NoBiopsy were continent, compared with 88% of men in Group YesBiopsy (p < 0.04). All men in the study cohort were continent (0 pads) at 12 months post-RALP. Ninety-eight percent of cases and 92% of controls at 9 months and 12 months, respectively, were able to have penetrative sex with or without PDE-5 inhibitors post-RALP. Conclusion: RALP without antecedent prostate biopsy in men with PIRADS 5 lesions demonstrated substantial csPCa detection rates and superior functional outcomes, warranting further validation.

The diagnostic accuracy of clinically significant prostate cancer (csPCa) of Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) is limited by subjectivity in result interpretation and the false positive results from certain similar anatomic structures. We aimed to establish a new model combining quantitative contrast-enhanced ultrasound, PI-RADSv2, clinical parameters to optimize the PI-RADSv2-based model. The analysis was conducted based on a data set of 151 patients from 2019 to 2022, multiple regression analysis showed that prostate specific antigen density, age, PI-RADSv2, quantitative parameters (rush time, wash-out area under the curve) were independent predictors. Based on these predictors, we established a new predictive model, the AUCs of the model were 0.910 and 0.879 in training and validation cohort, which were higher than those of PI-RADSv2-based model (0.865 and 0.821 in training and validation cohort). Net Reclassification Index analysis indicated that the new predictive model improved the classification of patients. Decision curve analysis showed that in most risk probabilities, the new predictive model improved the clinical utility of PI-RADSv2-based model. Generally, this new predictive model showed that quantitative parameters from contrast enhanced ultrasound could help to improve the diagnostic performance of PI-RADSv2 based model in detecting csPCa.

OBJECTIVE: The goal of this study is to address if detection rates of clinically significant prostate cancer (csPCa) can be increased by additional perilesional biopsies (PB) in magnetic resonance (MR)/ultrasound fusion prostate biopsy in biopsy-naïve men.
METHODS: This prospective, non-randomized, surgeon-blinded study was conducted between February 2020 and July 2022. Patients were included with PSA levels < 20 ng/ml and ≥ one PI-RADS lesion (grades 3-5) per prostate lobe. Prostate biopsy was performed by two urologists. The first performed the MR-fusion biopsy with 3-5 targeted biopsies (TB) and 6 PB in a standardized pattern. The second performed the systematic (12-fold) biopsy (SB) without knowledge of the MR images. Primary outcome of this study is absence or presence of csPCa (≥ ISUP grade 2) comparing TB, PB and SB, using McNemar test.
RESULTS: Analyses were performed for each PI-RADS lesion (n = 218). There was a statistically significant difference in csPC detection rate of TB + SB between PI-RADS 3, 4 and 5 lesions (18.0% vs. 42.5% vs. 82.6%, p < 0.001) and TB + PB (19.7% vs. 29.1% vs. 78.3%). Comparing only maximum ISUP grade per lesion, even SB plus TB plus PB did not detect more csPCa compared to SB plus TB (41.3% vs. 39.9%, p > 0.05).
CONCLUSIONS: We present prospective study data investigating the role of perilesional biopsy in detection of prostate cancer. We detected no statistically significant difference in the detection of csPCa by the addition of PB. Therefore, we recommend continuing 12-fold bilateral SB in addition to TB.