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Background: Multiparametric magnetic resonance imaging (MRI) and MRI-targeted biopsy are nowadays recommended in the prostate cancer (PCa) diagnostic pathway. Ploussard and Mazzone have integrated these tools into novel risk classification systems predicting the risk of early biochemical recurrence (eBCR) in PCa patients who underwent radical prostatectomy (RP). We aimed to assess available risk classification systems and to define the best-performing., Methods: Data on 1371 patients diagnosed by MRI-targeted biopsy and treated by RP between 2014 and 2022 at eight European tertiary referral centers were analyzed. Risk classifications systems included were the European Association of Urology (EAU) and National Comprehensive Cancer Network (NCCN) risk groups, the Cancer of the Prostate Risk Assessment (CAPRA) score, the International Staging Collaboration for Cancer of the Prostate (STAR-CAP) classification, the Ploussard and Mazzone models, and ISUP grade group. Kaplan-Meier analyses were used to compare eBCR among risk classification systems. Performance was assessed in terms of discrimination quantified using Harrell's c-index, calibration, and decision curve analysis (DCA)., Results: Overall, 152 (11%) patients had eBCR at a median follow-up of 31 months (interquartile range: 19-45). The 3-year eBCR-free survival rate was 91% (95% confidence interval [CI]: 89-93). For each risk classification system, a significant difference among survival probabilities was observed (log-rank test p < 0.05) except for NCCN classification (p = 0.06). The highest discrimination was obtained with the STAR-CAP classification (c-index 66%) compared to CAPRA score (63% vs. 66%, p = 0.2), ISUP grade group (62% vs. 66, p = 0.07), Ploussard (61% vs. 66%, p = 0.003) and Mazzone models (59% vs. 66%, p = 0.02), and EAU (57% vs. 66%, p < 0.001) and NCCN (57% vs. 66%, p < 0.001) risk groups. Risk classification systems demonstrated good calibration characteristics. At DCA, the CAPRA score showed the highest net benefit at a probability threshold of 9%-15%., Conclusions: The performance of risk classification systems using MRI and MRI-targeted information was less optimistic when tested in a contemporary set of patients. CAPRA score and STAR-CAP classification were the best-performing and should be preferred for treatment decision-making., (© 2023 Wiley Periodicals LLC.)

Background and Purpose: A virtual-reality learning environment dedicated to prostate biopsies was designed to overcome the limitations of current classical teaching methods. The aim of this study was to validate reliability, face, content, and construct of the simulator., Materials and Methods: The simulator is composed of (a) a laptop computer, (b) a haptic device with a stylus that mimics the ultrasound probe, (c) a clinical case database including three-dimensional (3D) ultrasound volumes and patient data, and (d) a learning environment with a set of progressive exercises including a randomized 12-core biopsy procedure. Both visual (3D biopsy mapping) and numerical (score) feedback are given to the user. The simulator evaluation was conducted in an academic urology department on 7 experts and 14 novices who each performed a virtual biopsy procedure and completed a face and content validity questionnaire., Results: The overall realism of the biopsy procedure was rated at a median of 9/10 by nonexperts (7.1-9.8). Experts rated the usefulness of the simulator for the initial training of urologists at 8.2/10 (7.9-8.3), but reported the range of motion and force feedback as significantly less realistic than novices (P=0.01 and 0.03, respectively). Pearson r correlation coefficient between correctly placed biopsies on the right and left side of the prostate for each user was 0.79 (P<0.001). The 7 experts had a median score of 64% (59%-73%), and the 14 novices a median score of 52% (43%-67%), without reaching statistical significance (P=0.19)., Conclusion: The newly designed virtual-reality learning environment proved its versatility and its reliability, face, and content were validated. Demonstrating the construct validity will necessitate improvements to the realism and scoring system used.

Objectives: The Biopsym simulator, a virtual-reality simulator for prostate biopsies, was designed to offer enhanced teaching of the biopsy procedure. The objectives of the present article are to describe the new version of the simulator and report the results of a new validation study. Material and methods: A prospective validation study was conducted between January and March 2017. The new version of the simulator, with improved physical realism, ultrasound image deformation, and a new scoring system, was evaluated by novice and confirmed users. Results: Twenty-one users evaluated the simulator, including ten novices and 11 confirmed users. The overall realism of the biopsy procedure was rated at 7.7/10 (IQR 5.7–9). The differences between the rates given by confirmed users and novices were not statistically significant. The median overall score obtained for the performance of 12 systematic ultrasound-guided biopsies was 43% (IQR 33–55). The median score obtained by confirmed users was 54% (IQR 46–62), and the median score obtained by novices was 31% (IQR 20–35). The difference between the scores was statistically significant (p = 0.005). Conclusions: This study allowed us to gather evidence towards the validation, and particularly towards the construct validation of the new version of the Biopsym simulator. [ABSTRACT FROM AUTHOR]

Purpose In men with suspicion of prostate cancer the standard of cancer detection is transrectal ultrasound guided 10 to 12-core systematic biopsy. The targeted biopsy only strategy using magnetic resonance imaging-transrectal ultrasound image registration is gaining in popularity. We assessed the noninferiority of targeted vs systematic biopsy. Materials and Methods Between June and October 2014 a total of 108 biopsy naïve patients with prostate specific antigen between 4 and 20 ng/ml, normal rectal examination and a single suspicious image on magnetic resonance imaging were included in study at 7 centers. Patients underwent systematic biopsy by a first operator blinded to magnetic resonance imaging, immediately followed by 3 targeted biopsies within the suspicious image by a second operator. The primary end point was the cancer detection rate. The noninferiority margin was set at −5%. The secondary end points were the detection rate of clinically significant prostate cancer (maximum cancer core length 5 mm or greater for Gleason 6 or any Gleason 7 or greater disease) and procedure duration. Results Systematic and targeted biopsies detected cancer in 66 (61.1%) and 61 patients (56.5%), respectively. The mean difference was −4.5% with a 95% CI lower bound of −11.8%. A total of 13 patients with protocol violations were excluded from the per protocol analysis, which showed a mean difference of −5.2% with a 95% CI lower bound of −13.1%. Clinically significant prostate cancer was detected in 50 (46.2%) and 52 patients (48.1%) with systematic and targeted biopsies, respectively (p = 0.69). The mean ± SD duration of image fusion plus targeted biopsy was 16.7 ± 7 minutes vs 7.4 ± 3 for systematic biopsy (p <0.001). Conclusions Targeted biopsy seemed to be inferior to systematic biopsy for overall cancer detection. Detection of clinically significant prostate cancer did not differ between targeted and systematic biopsies. [ABSTRACT FROM AUTHOR]

Objective: To prove the feasibility and evaluate the initial clinical results of targeted prostate biopsies using the Urostation novel platform using magnetic resonance imaging (MRI)/transrectal ultrasound (TRUS) registration to help steer the biopsy needle to suspicious areas. Methods: We prospectively included 30 patients for suspicion of prostate cancer from November 2011 to August 2012. All patients were previously evaluated by a multiparametric MRI, interpreted by a single radiologist who attributed a Prostate Imaging-Reporting and Data System (PI-RADS) score to each lesion. A conventional 12-core randomized biopsy protocol was performed and 2 additional targeted biopsies were performed on suspicious area(s). The results of randomized and targeted biopsies were compared. Results: Among the 30 patients, suspicious area(s) were found on MRI in 20 cases (67%). Median procedure time was 23 minutes. Targeting success rate (biopsy visualized inside the target) was 83%, with at least 1 biopsy reaching the target in all cases. Prostate cancer was detected in 14 cases (47%), including 11 cases with an abnormal MRI. Targeted biopsies detected cancer in all 11 cases and all but 1 were clinically significant. Randomized biopsies detected 10 of these 11 cases, and 3 more cases that MRI considered normal. Sensitivity to detect a significant cancer was 91% in both modalities. Conclusion: This initial clinical study showed encouraging results for targeted MRI-guided prostate biopsies using MRI-TRUS fusion. Although further studies are needed to determine the role of prostate MRI before biopsy and the relevance of targeted biopsies, the Urostation is an MRI-TRUS fusion device that has good accuracy for targeting suspicious areas on MRI. [ABSTRACT FROM AUTHOR]