Prostate Cancer Detection by Novice Micro-Ultrasound Users Enrolled in a Training Program

A Single Center Evaluation of the Diagnostic Accuracy of Multiparametric Magnetic Resonance Imaging against Transperineal Prostate Mapping Biopsy: An Analysis of Men with Benign Histology and Insignificant Cancer following Transrectal Ultrasound Biopsy

Combined Utility of 68Ga-Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography and Multiparametric Magnetic Resonance Imaging in Predicting Prostate Biopsy Pathology

344 - Trans-perineal MR/US fusion Prostate Biopsy: Evaluating the Benefits of Targeted Biopsy alone vs. Targeted Plus Random Biopsy in diagnosing clinically significant disease.

Clinically Significant Prostate Cancer Detection Following Transrectal and Transperineal Biopsy: Results of the Prostate Biopsy Efficacy and Complications Randomized Clinical Trial.

What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel

Introduction: Transperineal prostate biopsy is as effective as the transrectal biopsy in detecting prostate cancer and has a lower risk of infection. However, concerning the procedural pain of the transperineal route, a higher level of anaesthesia is needed, which prevents this approach from being widely used. Although several methods of local anaesthesia to relieve pain during transperineal biopsy have been described, few well-designed trials have been conducted to assess the efficacy of local anaesthesia.Methods: This is a prospective, multicentre, randomised controlled study in men suspected of having prostate cancer and planning to undergo transperineal prostate biopsy. The aim of this trial is to determine whether the perineal nerve block and periprostatic block relieve pain to different extents in men undergoing transperineal biopsy. The main inclusion criteria are men aged between 18 and 80 years old, a prostate-specific antigen (PSA) level of 4–20 ng/ml, or/and suspicious rectal examination findings. A sample size of 190 participants, accounting for a 10% loss, is required. All participants will be randomly allocated at a ratio of 1:1 to the perineal nerve block (n = 95) and periprostatic block groups (n = 95). The primary outcome will be the level of the worst pain experienced during the transperineal prostate biopsy procedure, which will be measured by a numerical rating scale (NRS). The key secondary outcomes will include the pain severity score at 1, 6, and 24 h after prostate biopsy.Results: The primary outcome is the level of the worst pain experienced during the prostate biopsy procedure. The main secondary outcomes are as follows: (1) Post-biopsy pain severity score at 1, 6, and 24 h after the prostate biopsy; (2) Changes in blood pressure, heart rate and breathing rate during the biopsy procedure; (3) External manifestations of pain during biopsy; (4) Anaesthesia satisfaction; (5) The detection rate for clinically significant prostate cancer and any prostate cancer.Conclusion: Anaesthesia in PROstate biopsy Pain Obstruction Study (APROPOS) is randomised controlled trial aiming to determine the efficacy of the perineal nerve block in controlling pain in patients undergoing prostate biopsy via the transperineal approach.Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04501055.

BACKGROUND The aim of this study was to investigate the impact of computer aided diagnostic (CAD) system on the detection rate of prostate cancer (PCa) in a series of fusion prostate biopsy (FPB). METHODS Two prospective transperineal FPB series (with or without CAD assistance) were analyzed and PCa detection rates compared with per-patient and per-target analyses. The χ2 and Mann-Whitney test were used to compare categorical and continuous variables, respectively. Univariable and multivariable regression analyses were applied to identify predictors of any and clinically significant (cs) PCa detection. Subgroup analyses were performed after stratifying for PI-RADS Score and lesion location. RESULTS Out of 183 FPB, 89 were performed with CAD assistance. At per-patient analysis the detection rate of any PCa and of cs PCa were 56.3% and 30.6%, respectively; the aid of CAD was negligible for either any PCa or csPCa detection rates (P=0.45 and P=0.99, respectively). Conversely in a per-target analysis, CAD-assisted biopsy had significantly higher positive predictive value (PPV) for any PCa versus MRI-only group (58% vs. 37.8%, P=0.001). PI-RADS Score was the only independent predictor of any and csPCa, either in per-patient or per-target multivariable regression analysis (all P<0.029). In a subgroup per-patient analysis of anterior/transitional zone lesions, csPCa detection rate was significantly higher in the CAD cohort (54.5%vs.11.1%, respectively; P=0.028), and CAD assistance was the only predictor of csPCa detection (P=0.013). CONCLUSIONS CAD assistance for FPB seems to improve detection of csPCa located in anterior/transitional zone. Enhanced identification and improved contouring of lesions may justify higher diagnostic performance.

A Novel Magnetic Resonance Imaging/Ultrasound Fusion Prostate Biopsy Technique Using Transperineal Ultrasound: An Initial Experience

Prostate Cancer Detection and Complications of Transperineal Versus Transrectal Magnetic Resonance Imaging-fusion Guided Prostate Biopsies

At present, increased early detection of prostate cancer appears to be the most feasible way to reduce cancer-related mortality. As a result significant efforts have been made to identify more men with curable cancer. This article reviews the role of serum prostate-specific antigen in an early detection or screening strategy and describes efforts to enhance the specificity of prostate-specific antigen testing.

BackgroundMultiparametric MRI (mpMRI) is strongly recommended by current clinical guidelines for improved detection of clinically significant prostate cancer (csPCa). However, major limitations of mpMRI are the need for intravenous (IV) contrast and dependence on reader expertise. Efforts to address these issues include use of biparametric MRI (bpMRI) and advanced, quantitative MRI techniques. One such advanced technique is the Restriction Spectrum Imaging restriction score (RSIrs), an imaging biomarker that has been shown to improve quantitative accuracy of patient-level csPCa detection.PurposeTo evaluate whether IV contrast can be avoided in the setting of standardized, state-of-the-art image acquisition, with or without addition of RSIrs, and to evaluate characteristics of RSIrs as a stand-alone, quantitative biomarker.Design, setting, and participantsART-Pro is a multisite, multinational trial that will be conducted in two stages, evaluating bpMRI, mpMRI, and RSIrs on accuracy of expert (ART-Pro-1) and non-expert (ART-Pro-2) radiologists’ detection of csPCa. Additionally, RSIrs will be evaluated as a stand-alone, quantitative, objective biomarker (ART-Pro-1). This study will include a total of 500 patients referred for a multiparametric prostate MRI with a clinical suspicion of prostate cancer at any of the five participating sites (100 patients per site).InterventionIn ART-Pro-1, patients receive standard of care mpMRI, with addition of the RSI sequence, and subsets of the patients’ images are read separately by two expert radiologists, one of whom is the standard of care radiologist (Reader 1). Three research reports are generated using: bpMRI only (Reader 1), mpMRI (Reader 1), and bpMRI + RSIrs (Reader 2). The clinical report is submitted by Reader 1. Patients’ future prostate cancer management will be recorded and used to evaluate the performance of the MRI techniques being tested.In ART-Pro-2, the dataset created in ART-Pro-1 will be retrospectively reviewed by radiologists of varying experience level (novice, basic, and expert). Radiologists will be assigned to read cases and record research reports while viewing subsets of either mpMRI only or RSIrs + mpMRI. Patient cases will be read by two readers from each experience level (6 reads total), and findings will be evaluated against the expertly created dataset from ART-Pro-1.Outcome measurements and statistical analysisThe primary endpoint is to evaluate if bpMRI is non-inferior to mpMRI among expert radiologists (ART-Pro-1) and non-expert radiologists (ART-Pro-2) for detection of grade group (GG) ≥2 csPCa. We will conduct one-sided non-inferiority tests of correlated proportions (ART-Pro-1) and use McNemar’s test and AUC to test the null hypothesis of non-inferiority (ART-Pro-1 and ART-Pro-2).ConclusionsThis trial is registered in the US National Library of Medicine Trial Registry (NCT number:NCT06579417) atClinicalTrials.gov. Patient accrual at the first site (UC San Diego) began in December 2023. The expected trial timeline is three years to complete accrual with a six-month endpoint.

Prostate magnetic resonance imaging (MRI) is increasingly integrated within the prostate cancer (PCa) early detection pathway. To systematically evaluate the existing evidence regarding screening pathways incorporating MRI with targeted biopsy and assess their diagnostic value compared with prostate-specific antigen (PSA)-based screening with systematic biopsy strategies. PubMed/MEDLINE, Embase, Cochrane/Central, Scopus, and Web of Science (through May 2023). Randomized clinical trials and prospective cohort studies were eligible if they reported data on the diagnostic utility of prostate MRI in the setting of PCa screening. Number of screened individuals, biopsy indications, biopsies performed, clinically significant PCa (csPCa) defined as International Society of Urological Pathology (ISUP) grade 2 or higher, and insignificant (ISUP1) PCas detected were extracted. The primary outcome was csPCa detection rate. Secondary outcomes included clinical insignificant PCa detection rate, biopsy indication rates, and the positive predictive value for the detection of csPCa. The generalized mixed-effect approach with pooled odds ratios (ORs) and random-effect models was used to compare the MRI-based and PSA-only screening strategies. Separate analyses were performed based on the timing of MRI (primary/sequential after a PSA test) and cutoff (Prostate Imaging Reporting and Data System [PI-RADS] score ≥3 or ≥4) for biopsy indication. Data were synthesized from 80 114 men from 12 studies. Compared with standard PSA-based screening, the MRI pathway (sequential screening, PI-RADS score ≥3 cutoff for biopsy) was associated with higher odds of csPCa when tests results were positive (OR, 4.15; 95% CI, 2.93-5.88; P ≤ .001), decreased odds of biopsies (OR, 0.28; 95% CI, 0.22-0.36; P ≤ .001), and insignificant cancers detected (OR, 0.34; 95% CI, 0.23-0.49; P = .002) without significant differences in the detection of csPCa (OR, 1.02; 95% CI, 0.75-1.37; P = .86). Implementing a PI-RADS score of 4 or greater threshold for biopsy selection was associated with a further reduction in the odds of detecting insignificant PCa (OR, 0.23; 95% CI, 0.05-0.97; P = .048) and biopsies performed (OR, 0.19; 95% CI, 0.09-0.38; P = .01) without differences in csPCa detection (OR, 0.85; 95% CI, 0.49-1.45; P = .22). The results of this systematic review and meta-analysis suggest that integrating MRI in PCa screening pathways is associated with a reduced number of unnecessary biopsies and overdiagnosis of insignificant PCa while maintaining csPCa detection as compared with PSA-only screening.

People with suspected prostate cancer are usually offered either a local anaesthetic transrectal ultrasound-guided prostate biopsy or a general anaesthetic transperineal prostate biopsy. Transperineal prostate biopsy is often carried out under general anaesthetic due to pain caused by the procedure. However, recent studies suggest that performing local anaesthetic transperineal prostate biopsy may better identify cancer in particular regions of the prostate and reduce infection rates, while being carried out in an outpatient setting. Devices to assist with freehand methods of local anaesthetic transperineal prostate may also help practitioners performing prostate biopsies. To evaluate the clinical effectiveness and cost-effectiveness of local anaesthetic transperineal prostate compared to local anaesthetic transrectal ultrasound-guided prostate and general anaesthetic transperineal prostate biopsy for people with suspected prostate cancer, and local anaesthetic transperineal prostate with specific freehand devices in comparison with local anaesthetic transrectal ultrasound-guided prostate and transperineal prostate biopsy conducted with a grid and stepping device conducted under local or general anaesthetic. We conducted a systematic review of studies comparing the diagnostic yield and clinical effectiveness of different methods for performing prostate biopsies. We used pairwise and network meta-analyses to pool evidence on cancer detection rates and structured narrative synthesis for other outcomes. For the economic evaluation, we reviewed published and submitted evidence and developed a model to assess the cost-effectiveness of the different biopsy methods. We included 19 comparative studies (6 randomised controlled trials and 13 observational comparative studies) and 4 single-arm studies of freehand devices. There were no statistically significant differences in cancer detection rates for local anaesthetic transperineal prostate (any method) compared to local anaesthetic transrectal ultrasound-guided prostate (relative risk 1.00, 95% confidence interval 0.85 to 1.18) (n = 5 randomised controlled trials), as was the case for local anaesthetic transperineal prostate with a freehand device compared to local anaesthetic transrectal ultrasound-guided prostate (relative risk 1.40, 95% confidence interval 0.96 to 2.04) (n = 1 randomised controlled trial). Results of meta-analyses of observational studies were similar. The economic analysis indicated that local anaesthetic transperineal prostate is likely to be cost-effective compared with local anaesthetic transrectal ultrasound-guided prostate (incremental cost below £20,000 per quality-adjusted life-year gained) and less costly and no less effective than general anaesthetic transperineal prostate. local anaesthetic transperineal prostate with a freehand device is likely to be the most cost-effective strategy: incremental cost versus local anaesthetic transrectal ultrasound-guided prostate of £743 per quality-adjusted life-year for people with magnetic resonance imaging Likert score of 3 or more at first biopsy. There is limited evidence for efficacy in detecting clinically significant prostate cancer. There is comparative evidence for the PrecisionPoint™ Transperineal Access System (BXTAccelyon Ltd, Burnham, UK) but limited or no evidence for the other freehand devices. Evidence for other outcomes is sparse. The cost-effectiveness results are sensitive to uncertainty over cancer detection rates, complication rates and the numbers of core samples taken with the different biopsy methods and the costs of processing them. Transperineal prostate biopsy under local anaesthetic is equally efficient at detecting prostate cancer as transrectal ultrasound-guided prostate biopsy under local anaesthetic but it may be better with a freehand device. local anaesthetic transperineal prostate is associated with urinary retention type complications, whereas local anaesthetic transrectal ultrasound-guided prostate has a higher infection rate. local anaesthetic transperineal prostate biopsy with a freehand device appears to meet conventional levels of costeffectiveness compared with local anaesthetic transrectal ultrasound-guided prostate. This study is registered as PROSPERO CRD42021266443. This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR134220) and is published in full in Health Technology Assessment Vol. 28, No. 60. See the NIHR Funding and Awards website for further award information.

Prostate Specific Antigen Isoforms and Human Glandular Kallikrein 2—Which Offers the Best Screening Performance in a Predominantly Black Population?

Systematic Biopsy of the Prostate can Be Omitted in Men with PI-RADS™ 5 and Prostate Specific Antigen Density Greater than 15.