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Background: The rise in advanced prostate cancer has coincided with increased use of Magnetic Resonance Imaging (MRI), leading to the hypothesis that this increase in surveillance registries is an artifact of more sensitive imaging tools. We assessed the association between regional variation in prostate MRI and advanced prostate cancer diagnoses., Methods: We utilized SEER-Medicare data (2004-2015), including men > 65 diagnosed with localized prostate cancer. The predictor variable was the utilization of prostate MRI in each hospital referral region (HRR, representing regional healthcare markets). We compared the proportion of disease recorded as locally advanced or of regional risk group (cT3, cT4, and cN1) which would plausibly have been detected by prostate MRI. We conducted adjusted multivariable analysis and performed correlation analysis with Spearman rank coefficient at the level of the HRR. Sensitivity analysis for years 2011 to 2015 was conducted., Results: Of 98,921 men diagnosed, 4.01% had locally advanced or regional disease. The median prostate MRI utilization rate was 4.58% (IQR [3.03%, 8.12%]). Adjusted multivariable analysis revealed no statistically significant correlation between MRI utilization and proportion of advanced prostate cancer (aOR = 1.01, 95% CI, [0.99,1.03]) in each region. The correlation between MRI usage and advanced diagnosis was not significant (Spearman Ρ = 0.09, P = 0.4). Sensitivity analysis conducted between 2011 and 2015 showed similar results (aOR = 1.008, 95% CI, [0.989, 1.027]; Spearman Ρ = 0.16, P = 0.1)., Conclusions: During our study period, HRR-level utilization of MRI was not associated with higher incidences of advanced prostate cancer. This suggests the rising advanced prostate cancer diagnoses observed in this period are unlikely an artifact of greater sensitivity of modern imaging tests, but potentially due to other factors such as changes in screening or risk factors. With increased utilization and evolving techniques in recent years, the association between MRI and advanced prostate cancer detection warrants continued monitoring., Competing Interests: Declaration of competing interest QDT reports personal fees from Astellas, Bayer, Janssen, and Pfizer, outside the submitted work. QDT reports research funding from the American Cancer Society, the Defense Health Agency, and Pfizer Global Medical Grants. APC reports research funding from the American Cancer Society and Pfizer Global Medical Grants., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Purpose: Demonstrating and assessing self-supervised machine-learning fitting of the VERDICT (vascular, extracellular and restricted diffusion for cytometry in tumors) model for prostate cancer., Methods: We derive a self-supervised neural network for fitting VERDICT (ssVERDICT) that estimates parameter maps without training data. We compare the performance of ssVERDICT to two established baseline methods for fitting diffusion MRI models: conventional nonlinear least squares and supervised deep learning. We do this quantitatively on simulated data by comparing the Pearson's correlation coefficient, mean-squared error, bias, and variance with respect to the simulated ground truth. We also calculate in vivo parameter maps on a cohort of 20 prostate cancer patients and compare the methods' performance in discriminating benign from cancerous tissue via Wilcoxon's signed-rank test., Results: In simulations, ssVERDICT outperforms the baseline methods (nonlinear least squares and supervised deep learning) in estimating all the parameters from the VERDICT prostate model in terms of Pearson's correlation coefficient, bias, and mean-squared error. In vivo, ssVERDICT shows stronger lesion conspicuity across all parameter maps, and improves discrimination between benign and cancerous tissue over the baseline methods., Conclusion: ssVERDICT significantly outperforms state-of-the-art methods for VERDICT model fitting and shows, for the first time, fitting of a detailed multicompartment biophysical diffusion MRI model with machine learning without the requirement of explicit training labels., (© 2024 The Author(s). Magnetic Resonance in Medicine published by Wiley Periodicals LLC on behalf of International Society for Magnetic Resonance in Medicine.)

Multiparametric MRI is the optimal primary investigation when prostate cancer is suspected, and its ability to rule in and rule out clinically significant disease relies on high-quality anatomical and functional images. Avenues for achieving consistent high-quality acquisitions include meticulous patient preparation, scanner setup, optimised pulse sequences, personnel training, and artificial intelligence systems. The impact of these interventions on the final images needs to be quantified. The prostate imaging quality (PI-QUAL) scoring system was the first standardised quantification method that demonstrated the potential for clinical benefit by relating image quality to cancer detection ability by MRI. We present the updated version of PI-QUAL (PI-QUAL v2) which applies to prostate MRI performed with or without intravenous contrast medium using a simplified 3-point scale focused on critical technical and qualitative image parameters. CLINICAL RELEVANCE STATEMENT: High image quality is crucial for prostate MRI, and the updated version of the PI-QUAL score (PI-QUAL v2) aims to address the limitations of version 1. It is now applicable to both multiparametric MRI and MRI without intravenous contrast medium. KEY POINTS: High-quality images are essential for prostate cancer diagnosis and management using MRI. PI-QUAL v2 simplifies image assessment and expands its applicability to prostate MRI without contrast medium. PI-QUAL v2 focuses on critical technical and qualitative image parameters and emphasises T2-WI and DWI., (© 2024. The Author(s).)

Introduction: RECONCILE (ClinicalTrials.gov:NCT04340245) will identify molecular and radiomic markers associated with clinical progression and radiological progression events in a cohort of localised, newly diagnosed Gleason 3 + 4 tumours. Molecular markers will be correlated against standard of care MRI-targeted histology and oncological outcomes., Methods: RECONCILE is an ethics approved (20/LO/0366) single centre, prospective, longitudinal, observational cohort study of recently diagnosed (within 12 months), organ-confined Gleason 3 + 4 cancers (MCCL ≤10mm) currently under active surveillance. 60 treatment-naïve participants with a concordant MRI lesion (Likert score 4 or 5) and PSA ≤ 15 ng/ml will be recruited. Blood, urine and targeted prostate tissue cores will be subject to next generation sequencing at baseline and one year in all participants. Semen will be collected from a specified sub-population. Baseline and interval MR images will be extracted from standard of care prostate MRI ahead of radiomic analysis. Data extracted from radiological and biological samples will be used to derive the association of molecular change and radiological progression, the primary outcome of the study. To compensate for spatial intratumoral heterogeneity and inherent sampling bias, a molecular index will be derived for each participant using the molecular profile of tumour tissue at both baseline (MolBL) and one year (MolFU). We will extract a ΔMolBL:MolFU score for each participant. Molecular progression will be defined as a MolBL:MolFU score >95% CI of the combined ΔMolBL scores. Radiological progression is defined as a PRECISE score of 4 or 5. The study is powered to detect an association with a statistical power of 80%., Results: Recruitment began in July 2020 (n = 62). To date, 37 participants have donated tissue for analysis., Conclusion: We have designed and implemented a prospective, longitudinal study to evaluate the underlying molecular landscape of intermediate risk, MR-visible prostate tumours. Recruitment is ongoing., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Mark Emberton serves as a consultant/educator/trainer to Sonacare Inc., Exact Imaging, Angiodynamics Inc and Profound Medical. Acknowledgements - Mark Emberton receives research support from the United Kingdom’s National Institute of Health Research (NIHR) UCLH/UCL Biomedical Research Centre. Caroline M Moore receives funding from the Prostate Cancer UK, Movember, the Medical Research Council, Cancer Research UK and the NIHR. She receives fees for HIFU proctoring from SonaCare. She has received speaker fees from Astellas, and Jannsen. She carries out research into photodyanamic therapy supported by Spectracure. Shonit Punwani receives research support from the United Kingdom’s National Institute of Health Research (NIHR) UCLH/UCL Biomedical Research Centre. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Marsden et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background and Objective: The Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) recommendations standardise the reporting of prostate magnetic resonance imaging (MRI) in patients on active surveillance (AS) for prostate cancer. An international consensus group recently updated these recommendations and identified the areas of uncertainty., Methods: A panel of 38 experts used the formal RAND/UCLA Appropriateness Method consensus methodology. Panellists scored 193 statements using a 1-9 agreement scale, where 9 means full agreement. A summary of agreement, uncertainty, or disagreement (derived from the group median score) and consensus (determined using the Interpercentile Range Adjusted for Symmetry method) was calculated for each statement and presented for discussion before individual rescoring., Key Findings and Limitations: Participants agreed that MRI scans must meet a minimum image quality standard (median 9) or be given a score of 'X' for insufficient quality. The current scan should be compared with both baseline and previous scans (median 9), with the PRECISE score being the maximum from any lesion (median 8). PRECISE 3 (stable MRI) was subdivided into 3-V (visible) and 3-NonV (nonvisible) disease (median 9). Prostate Imaging Reporting and Data System/Likert ≥3 lesions should be measured on T2-weighted imaging, using other sequences to aid in the identification (median 8), and whenever possible, reported pictorially (diagrams, screenshots, or contours; median 9). There was no consensus on how to measure tumour size. More research is needed to determine a significant size increase (median 9). PRECISE 5 was clarified as progression to stage ≥T3a (median 9)., Conclusions and Clinical Implications: The updated PRECISE recommendations reflect expert consensus opinion on minimal standards and reporting criteria for prostate MRI in AS., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Magnetic resonance imaging is the gold standard imaging modality for the diagnosis of prostate cancer (PCa). Image quality is a fundamental prerequisite for the ability to detect clinically significant disease. In this critical review, we separate the issue of image quality into quality improvement and quality assessment. Beginning with the evolution of technical recommendations for scan acquisition, we investigate the role of patient preparation, scanner factors, and more advanced sequences, including those featuring Artificial Intelligence (AI), in determining image quality. As means of quality appraisal, the published literature on scoring systems (including the Prostate Imaging Quality score), is evaluated. Finally, the application of AI and teaching courses as ways to facilitate quality assessment are discussed, encouraging the implementation of future image quality initiatives along the PCa diagnostic and monitoring pathway. EVIDENCE LEVEL: 3 TECHNICAL EFFICACY: Stage 3., (© 2023 The Authors. Journal of Magnetic Resonance Imaging published by Wiley Periodicals LLC on behalf of International Society for Magnetic Resonance in Medicine.)

Purpose: Functional problems such as incontinence and sexual dysfunction after radical prostatectomy (RP) are important outcomes to evaluate surgical quality in prostate cancer (PC) care. Differences in survival after RP between countries are known, but differences in functional outcomes after RP between providers from different countries are not well described., Methods: Data from a multinational database of patients with PC (nonmetastatic, treated by RP) who answered the EPIC-26 questionnaire at baseline (before RP, T0) and 1 year after RP (T1) were used, linking survey data to clinical information. Casemix-adjusted incontinence and sexual function scores (T1) were calculated for each country and provider on the basis of regression models and then compared using minimally important differences (MIDs)., Results: A total of 21,922 patients treated by 151 providers from 10 countries were included. For the EPIC-26 incontinence domain, the median adjusted T1 score of countries was 76, with one country performing more than one MID (for incontinence: 6) worse than the median. Eighteen percent of the variance ( R 2 ) of incontinence scores was explained by the country of the providers. The median adjusted T1 score of sexual function was 33 with no country performing perceivably worse than the median (more than one MID worse), and 34% ( R 2 ) of the variance of the providers' scores could be explained by country., Conclusion: To our knowledge, this is the first comparison of functional outcomes 1 year after surgical treatment of patients with PC between different countries. Country is a relevant predictor for providers' incontinence and sexual function scores. Although the results are limited because of small samples from some countries, they should be used to enhance cross-country initiatives on quality improvement in PC care.

Competing Interests: Declaration of interests NDJ reports advisory board and personal fees from AstraZeneca, Bayer, Clovis, Janssen, Merck, Merck Sharp & Dohme, Novartis, Sanofi, Astellas, and AAA Accelerator Solutions. FF reports personal fees from Janssen, Astellas, Serimmune, Foundation Medicine, Exact Sciences, Bristol-Myers Squibb, Varian Medical Systems, Novartis, Roivant, Myovant, Bayer, BlueStar Genomics, Artera, Tempus, Genentech, PFS Genomics, and Amgen, and holds stock options in Serimmune, BlueStar Genomics, and Artera. SG reports fees from Tolremo, Ipsen, Silvio Grasso Consulting, WebMD–Medscape, the American Society of Clinical Oncology, European Society for Medical Oncology, Peer Voice, SAKK, the German-speaking European School of Oncology, Radiotelevisione Svizzera Italiana, the Swiss Academy of Multidisciplinary Oncology, Meister ConCept, AdMeTech Foundation, EPG Health, Intellisphere, and Schweizerische Gessellschaft für Medizineische Onkologie. SG also reports travel support from AstraZeneca, Bayer, Intellisphere, and Gilead, paid advisory board participation for Merck Sharp & Dohme, Telixpharma, Bristol-Myers Squibb, AAA International, Orion, Bayer, Novartis, Modra Pharmaceuticals, AstraZeneca, Myriad Genetic, Daiichi Sankyo, Boehringer Ingelheim, Innomedica, Macrogenics, and Pfizer, and holds a patent (WO2009138392). BA-L reports fees from the Cancer Prevention and Research Institute of Texas, the Commonwealth Foundation, the Lyda Hill Foundation, Cancer Research UK, the Wellcome Trust, the Bob Champion Trust, AstraZeneca, Astex Pharmaceuticals, the New York Genome Center, and Existentia, travel support from Cancer Research UK, Astex, the STAT summit, the American Society of Hematology, and the American Association for Cancer Research, and participation in a Cancer Research UK data strategy board. GA reports fees from Janssen, Novartis, Astellas, the Institute of Cancer Research, Veracyte, Artera, Pfizer, AstraZeneca, Astellas, Novartis, Arvinas, Bayer, Sanofi, Propella, and Orion, holds a patent related to blood-based methylation markers (GB1915469.9), and has received equipment from Agilent. EC reports fees from Janssen. RE reports book royalties plus support and fees from the UK National Institute for Health and Care Research, AstraZeneca, Bayer, Ipsen, the Active Surveillance Movember Committee, the American Society of Clinical Oncology, University of Chicago, Dana Farber Cancer Institute, the Spanish National Cancer Research Center, Our Future Health, Jnetics UK, the Institute of Cancer Research, and Convergence Science Centre. RE also reports a pending Cancer Research UK patent, a stock ISA, receipt of gifts from patients (within limits allowed), and other financial interests in private medical practice. SH reports participation on data safety monitoring boards and advisory boards. DH reports fees from Techtrials, Astellas, Adium, Ipsen, Janssen, Bayer, Merck Sharp & Dohme, and Pfizer. MSH reports fees or grant funding from the Prostate Cancer Foundation, the Prostate Cancer Theranostics and Imaging Centre of Excellence, the Australian National Health and Medical Research Council, Movember, the US Department of Defense, Medical Research Future Fund, Bayer, the Peter MacCallum Foundation, Isotopia, the Australian Nuclear Science and Technology Organisation, Merck Sharpe & Dohme, Novartis, AstraZeneca, and Astellas. MSH also reports unrenumerated leadership or fiduciary role in Australian Friends of Sheba. MMog reports fees from NHS England, the UK National Institute for Health and Care Research, and Bayer. CM reports fees from UK National Institute for Health and Care Research, the UK Medical Research Council, Prostate Cancer UK, Cancer Rsearch UK, Sonacare, Ipsen, Bayer, and Astellas. AMo reports fees from Bayer, Myovant, Pfizer, Astellas, AstraZeneca, AAA, Bayer, Exelixis, Janssen, Lantheus, Myovant, Merck, Novartis, Sanofi, and Telix, participation in data Safety monitoring boards and advisory boards for Gilead, and a leadership or fiduciary role in ZERO Prostate Cancer. MMor reports fees from the National Cancer Institute Comprehensive Cancer Center, Lantheus, AstraZeneca, Amgen, Daiichi, Convergent, Pfizer, Clarity, Blue Earth Diagnostics, POINT Diagnostics, Z-Alpha, Ambrx, Flare, Fusion, Curium, Transtherabio, Doximity, BMS, and Celgene, reports a US patent application (18/448 609) for a method of treating prostate cancer, and holds stock options in Doximity. DM reports fees from Novartis, Janssen, Bayer, Astellas, Ipsen, and AstraZeneca. PLN reports fees from Bayer, Astellas, Boston Scientific, AIQ, Astellas, Novartis, Janssen, Blue Earth, Nanocan, and Theranano, and holds stock options in Stratagen Bio, Nanocan, and Reversal Therapeutics. CP reports fees from Artera, which has a financial relationship with University College London (his employer) as part of a data licensing agreement. All other authors declare no competing interests.

Multiparametric magnetic resonance (MR) imaging has had an expanding role in active surveillance (AS) for prostate cancer. It can improve the accuracy of prostate biopsies, assist in patient selection, and help monitor cancer progression. The PRECISE recommendations standardize reporting of serial MR imaging scans during AS. We summarize the evidence on MR imaging-led AS and provide a clinical primer to help report using the PRECISE criteria. Some limitations to both serial imaging and the PRECISE recommendations must be considered as we move toward a more individualized risk-stratified approach to AS., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Real-world data on racial differences in the side effects of radical prostatectomy on quality of life (QoL) are lacking. We aimed to evaluate differences in patient-reported outcome measure (PROM) among non-Hispanic Black (NHB) and non-Hispanic White (NHW) men using the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire to measure health-related QoL after radical prostatectomy., Methods: We retrospectively assessed prospectively collected PROMs using EPIC-CP scores at a tertiary care center between 2015 and 2021 for men with prostate cancer undergoing radical prostatectomy. The primary endpoint was the overall QoL score for NHB and NHW men, with a total score of 60 and higher scores indicating worse QoL. An imputed mixed linear regression model was used to examine the effect of covariates on the change in overall QoL score following surgery. A pairwise comparison was used to estimate the mean QoL scores before surgery as well as up to 24 months after surgery., Results: Our cohort consisted of 2229 men who answered at least one EPIC-CP questionnaire before or after surgery, of which 110 (4.94%) were NHB and 2119 (95.07%) were NHW men. The QoL scores differed for NHB and NHW at baseline (2.34, 95% confidence interval [CI] 0.36-4.31, p = 0.02), 3 months (4.36, 95% CI 2.29-6.42, p < 0.01), 6 months (3.26, 95% CI 1.10-5.43, p < 0.01), and 12 months after surgery (2.48, 95% CI 0.19-4.77, p = 0.03) with NHB having worse scores. There was no difference in QoL between NHB and NHW men 24 months after surgery., Conclusions: A significant difference in QoL between NHB and NHW men was reported before surgery, 3, 6, and 12 months after surgery, with NHB having worse QoL scores. However, there was no long-term difference in reported QoL. Our findings inform strategies that can be implemented to mitigate racial differences in short-term outcomes., (© 2023 Wiley Periodicals LLC.)

Background: The role of multiparametric magnetic resonance imaging (MRI) for detecting recurrent prostate cancer after radiotherapy is unclear., Objective: To evaluate MRI and MRI-targeted biopsies for detecting intraprostatic cancer recurrence and planning for salvage focal ablation., Design, Setting, and Participants: FOcal RECurrent Assessment and Salvage Treatment (FORECAST; NCT01883128) was a prospective cohort diagnostic study that recruited 181 patients with suspected radiorecurrence at six UK centres (2014 to 2018); 144 were included here., Intervention: All patients underwent MRI with 5 mm transperineal template mapping biopsies; 84 had additional MRI-targeted biopsies. MRI scans with Likert scores of 3 to 5 were deemed suspicious., Outcome Measurements and Statistical Analysis: First, the diagnostic accuracy of MRI was calculated. Second, the pathological characteristics of MRI-detected and MRI-undetected tumours were compared using the Wilcoxon rank sum test and chi-square test for trend. Third, four biopsy strategies involving an MRI-targeted biopsy alone and with systematic biopsies of one to two other quadrants were studied. Fisher's exact test was used to compare MRI-targeted biopsy alone with the best other strategy for the number of patients with missed cancer and the number of patients with cancer harbouring additional tumours in unsampled quadrants. Analyses focused primarily on detecting cancer of any grade or length. Last, eligibility for focal therapy was evaluated for men with localised (≤T3bN0M0) radiorecurrent disease., Results and Limitations: Of 144 patients, 111 (77%) had cancer detected on biopsy. MRI sensitivity and specificity at the patient level were 0.95 (95% confidence interval [CI] 0.92 to 0.99) and 0.21 (95% CI 0.07 to 0.35), respectively. At the prostate quadrant level, 258/576 (45%) quadrants had cancer detected on biopsy. Sensitivity and specificity were 0.66 (95% CI 0.59 to 0.73) and 0.54 (95% CI 0.46 to 0.62), respectively. At the quadrant level, compared with MRI-undetected tumours, MRI-detected tumours had longer maximum cancer core length (median difference 3 mm [7 vs 4 mm]; 95% CI 1 to 4 mm, p < 0.001) and a higher grade group (p = 0.002). Of the 84 men who also underwent an MRI-targeted biopsy, 73 (87%) had recurrent cancer diagnosed. Performing an MRI-targeted biopsy alone missed cancer in 5/73 patients (7%; 95% CI 3 to 15%); with additional systematic sampling of the other ipsilateral and contralateral posterior quadrants (strategy 4), 2/73 patients (3%; 95% CI 0 to 10%) would have had cancer missed (difference 4%; 95% CI -3 to 11%, p = 0.4). If an MRI-targeted biopsy alone was performed, 43/73 (59%; 95% CI 47 to 69%) patients with cancer would have harboured undetected additional tumours in unsampled quadrants. This reduced but only to 7/73 patients (10%; 95% CI 4 to 19%) with strategy 4 (difference 49%; 95% CI 36 to 62%, p < 0.0001). Of 73 patients, 43 (59%; 95% CI 47 to 69%) had localised radiorecurrent cancer suitable for a form of focal ablation., Conclusions: For patients with recurrent prostate cancer after radiotherapy, MRI and MRI-targeted biopsy, with or without perilesional sampling, will diagnose cancer in the majority where present. MRI-undetected cancers, defined as Likert scores of 1 to 2, were found to be smaller and of lower grade. However, if salvage focal ablation is planned, an MRI-targeted biopsy alone is insufficient for prostate mapping; approximately three of five patients with recurrent cancer found on an MRI-targeted biopsy alone harboured further tumours in unsampled quadrants. Systematic sampling of the whole gland should be considered in addition to an MRI-targeted biopsy to capture both MRI-detected and MRI-undetected disease., Patient Summary: After radiotherapy, magnetic resonance imaging (MRI) is accurate for detecting recurrent prostate cancer, with missed cancer being smaller and of lower grade. Targeting a biopsy to suspicious areas on MRI results in a diagnosis of cancer in most patients. However, for every five men who have recurrent cancer, this targeted approach would miss cancers elsewhere in the prostate in three of these men. If further focal treatment of the prostate is planned, random biopsies covering the whole prostate in addition to targeted biopsies should be considered so that tumours are not missed., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

At present there is no standardised system for scoring the appearance of the prostate on multiparametric magnetic resonance imaging (MRI) after focal ablation for localised prostate cancer. We propose a novel scoring system, the Prostate Imaging after Focal Ablation (PI-FAB) score, to fill this gap. PI-FAB involves a 3-point scale for rating MRI sequences in sequential order: (1) dynamic contrast-enhanced sequences; (2) diffusion-weighted imaging, split into assessment of the high-b-value sequence first and then the apparent diffusion coefficient map; and (3) T2-weighted imaging. It is essential that the pretreatment scan is also available to help with this assessment. We designed PI-FAB using our experience of reading postablation scans over the past 15 years and include details for four representative patients initially treated with high-intensity focus ultrasound at our institution to demonstrate the scoring system. We propose PI-FAB as a standardised method for evaluating prostate MRI scans after treatment with focal ablation. The next step is to evaluate its performance across multiple experienced readers of MRI after focal therapy in a clinical data set. PATIENT SUMMARY: We propose a scoring system called PI-FAB for assessing the appearance of magnetic resonance imaging scans of the prostate after focal treatment for localised prostate cancer. This will help clinicians in deciding on further follow-up., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Purpose: This study aimed to assess the image quality of apparent diffusion coefficient (ADC) maps derived from conventional diffusion-weighted MRI and fractional intracellular volume maps (FIC) from VERDICT MRI (Vascular, Extracellular, Restricted Diffusion for Cytometry in Tumours) in patients from the INNOVATE trial. The inter-reader agreement was also assessed., Methods: Two readers analysed both ADC and FIC maps from 57 patients enrolled in the INNOVATE prospective trial. Image quality was assessed using the Prostate Imaging Quality (PI-QUAL) score and a subjective image quality Likert score (Likert-IQ). The image quality of FIC and ADC were compared using a Wilcoxon Signed Ranks test. The inter-reader agreement was assessed with Cohen's kappa., Results: There was no statistically significant difference between the PI-QUAL score for FIC datasets compared to ADC datasets for either reader (p = 0.240 and p = 0.614). Using the Likert-IQ score, FIC image quality was higher compared to ADC (p = 0.021) as assessed by reader-1 but not for reader-2 (p = 0.663). The inter-reader agreement was 'fair' for PI-QUAL scoring of datasets with FIC maps at 0.27 (95% confidence interval; 0.08-0.46) and ADC datasets at 0.39 (95% confidence interval 0.22-0.57). For Likert scoring, the inter-reader agreement was also 'fair' for FIC maps at 0.38 (95% confidence interval; 0.10-0.65) and substantial for ADC maps at 0.62 (95% confidence interval; 0.39-0.86)., Conclusion: Image quality was comparable for FIC and ADC. The inter-reader agreement was similar when using PIQUAL for both FIC and ADC datasets but higher for ADC maps compared to FIC maps using the image quality Likert score., 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., (Crown Copyright © 2023. Published by Elsevier B.V. All rights reserved.)

Objectives: To externally validate a published model predicting failure within 2 years after salvage focal ablation in men with localised radiorecurrent prostate cancer using a prospective, UK multicentre dataset., Patients and Methods: Patients with biopsy-confirmed ≤T3bN0M0 cancer after previous external beam radiotherapy or brachytherapy were included from the FOcal RECurrent Assessment and Salvage Treatment (FORECAST) trial (NCT01883128; 2014-2018; six centres), and from the high-intensity focussed ultrasound (HIFU) Evaluation and Assessment of Treatment (HEAT) and International Cryotherapy Evaluation (ICE) UK-based registries (2006-2022; nine centres). Eligible patients underwent either salvage focal HIFU or cryotherapy, with the choice based predominantly on anatomical factors. Per the original multivariable Cox regression model, the predicted outcome was a composite failure outcome. Model performance was assessed at 2 years post-salvage with discrimination (concordance index [C-index]), calibration (calibration curve and slope), and decision curve analysis. For the latter, two clinically-reasonable risk threshold ranges of 0.14-0.52 and 0.26-0.36 were considered, corresponding to previously published pooled 2-year recurrence-free survival rates for salvage local treatments., Results: A total of 168 patients were included, of whom 84/168 (50%) experienced the primary outcome in all follow-ups, and 72/168 (43%) within 2 years. The C-index was 0.65 (95% confidence interval 0.58-0.71). On graphical inspection, there was close agreement between predicted and observed failure. The calibration slope was 1.01. In decision curve analysis, there was incremental net benefit vs a 'treat all' strategy at risk thresholds of ≥0.23. The net benefit was therefore higher across the majority of the 0.14-0.52 risk threshold range, and all of the 0.26-0.36 range., Conclusion: In external validation using prospective, multicentre data, this model demonstrated modest discrimination but good calibration and clinical utility for predicting failure of salvage focal ablation within 2 years. This model could be reasonably used to improve selection of appropriate treatment candidates for salvage focal ablation, and its use should be considered when discussing salvage options with patients. Further validation in larger, international cohorts with longer follow-up is recommended., (© 2023 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)

Background: The optimal radiological follow-up of prostate lesions negative on magnetic resonance imaging (MRI)-targeted biopsy (MRI-TB) is yet to be optimised., Objective: To present medium-term radiological and clinical follow-up of biopsy-negative lesions., Design, Setting, and Participants: The records for men who underwent multiparametric MRI at the UCLH one-stop clinic for suspected prostate cancer between September 2017 and March 2020 were reviewed (n = 1199). Patients with Likert 4 or 5 lesions were considered (n = 495), and those with a subsequent negative MRI-TB comprised the final study population (n = 91)., Outcome Measurements and Statistical Analysis: Baseline and follow-up MRI and biopsy data (including prostate-specific antigen [PSA], prostate volume, radiological scores, and presence of any noncancerous pathology) were extracted from reports. The last follow-up date was the date of the last test or review in clinic., Results and Limitations: Median follow-up was 1.8 yr (656 d, interquartile range [IQR] 359-1008). At baseline, the median age was 65.4 yr (IQR 60.7-70.0), median PSA was 7.1 ng/ml (IQR 4.7-10.0), median prostate volume was 54 ml (IQR 39.5-75.0), and median PSA density (PSAD) was 0.13 ng/ml 2 (IQR 0.09-0.18). Eighty-six men (95%) had Likert 4 lesions, while the remaining five (5%) had Likert 5 lesions. Only 21 men (23%) had a single lesion; most had at least two. Atrophy was the most prevalent pathology on MRI-TB, present in 64 men (74%), and followed by acute inflammation in 42 (46%), prostatic intraepithelial neoplasia in 33 (36%), chronic inflammation in 18 (20%), atypia in 13 (14%), and granulomatous inflammation in three (3%). Fifty-eight men had a second MRI study (median 376 d, IQR 361-412). At the second MRI, median PSAD decreased to 0.11 ng/ml 2 (IQR 0.08-0.18). A Likert 4 or 5 score persisted only in five men (9%); 40 men (69%) were scored Likert 3, while the remaining 13 (22%) were scored Likert 2 (no lesion). Of 45 men with a Likert ≥3 score, most only had one lesion at the second MRI (28 men; 62%). Of six men with repeat MRI-TB during the study period, two were subsequently diagnosed with prostate cancer and both had persistent Likert 4 scores (at baseline and at least one follow-up MRI)., Conclusions: Most biopsy-negative MRI lesions in the prostate resolve over time, but any persistent lesions should be closely monitored., Patient Summary: Lesions in the prostate detected via magnetic resonance imaging (MRI) scans that are negative for cancer on biopsy usually resolve. Repeat MRI can indicate persistent lesions that might need a second biopsy., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Purpose: In older patients who do not wish to undergo watchful waiting, focal therapy could be an alternative to the more morbid radical treatment. We evaluated the role of focal therapy in patients 70 years and older as an alternative management modality., Materials and Methods: A total of 649 patients across 11 UK sites receiving focal high-intensity focused ultrasound or cryotherapy between June 2006 and July 2020 reported within the UK-based HEAT (HIFU Evaluation and Assessment of Treatment) and ICE (International Cryotherapy Evaluation) registries were evaluated. Primary outcome was failure-free survival, defined by need for more than 1 focal reablation, progression to radical treatment, development of metastases, need for systemic treatment, or prostate cancer-specific death. This was compared to the failure-free survival in patients undergoing radical treatment via a propensity score weighted analysis., Results: Median age was 74 years (IQR: 72, 77) and median follow-up 24 months (IQR: 12, 41). Sixty percent had intermediate-risk disease and 35% high-risk disease. A total of 113 patients (17%) required further treatment. Sixteen had radical treatment and 44 required systemic treatment. Failure-free survival was 82% (95% CI: 76%-87%) at 5 years. Comparing patients who had radical therapy to those who had focal therapy, 5-year failure-free survival was 96% (95% CI: 93%-100%) and 82% (95% CI: 75%-91%) respectively ( P < .001). Ninety-three percent of those in the radical treatment arm had received radiotherapy as their primary treatment with its associated use of androgen deprivation therapy, thereby leading to potential overestimation of treatment success in the radical treatment arm, especially given the similar metastases-free and overall survival rates seen., Conclusions: We propose focal therapy to be an effective management option for the older or comorbid patient who is unsuitable for or not willing to undergo radical treatment.

Purpose: To investigate the utility of a prostate magnetic resonance imaging (MRI) second read using a semi-automated software program in the one-stop clinic, where patients undergo multiparametric MRI, review and biopsy planning in one visit. We looked at concordance between readers for patients with equivocal scans and the possibility for biopsy deferral in this group., Methods: We present data from 664 consecutive patients. Scans were reported by seven different expert genitourinary radiologists using dedicated software (MIM®) and a Likert scale. All scans were rescored by another expert genitourinary radiologist using a customised workflow for second reads that includes annotated biopsy contours for accurate visual targeting. The number of scans in which a biopsy could have been deferred using biopsy results and prostate specific antigen density was assessed. Gleason score ≥ 3 + 4 was considered clinically significant disease. Concordance between first and second reads for equivocal scans (Likert 3) was evaluated., Results: A total of 209/664 (31%) patients scored Likert 3 on first read, 128 of which (61%) were concordant after second read. 103/209 (49%) of patients with Likert 3 scans were biopsied, with clinically significant disease in 31 (30%) cases. Considering Likert 3 scans that were both downgraded and biopsied using the workflow-generated biopsy contours, 25/103 (24%) biopsies could have been deferred., Conclusions: Implementing a semi-automated workflow for accurate lesion contouring and targeting biopsies is helpful during the one-stop clinic. We observed a reduction of indeterminate scans after second reading and almost a quarter of biopsies could have been deferred, reducing the potential biopsy-related side effects., 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 © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

Purpose: To describe the national-level patterns of care for local ablative therapy among men with PCa and identify patient- and hospital-level factors associated with the receipt of these techniques., Methods: We retrospectively interrogated the National Cancer Database (NCDB) for men with clinically localized PCa between 2010 and 2017. The main outcome was receipt of local tumor ablation with either cryo- or laser-ablation, and "other method of local tumor destruction including high-intensity focused ultrasound (HIFU)". Patient level, hospital level, and demographic variables were collected. Mixed effect logistic regression models were fitted to identify separately patient- and hospital-level predictors of receipt of local ablative therapy., Results: Overall, 11,278 patients received ablative therapy, of whom 78.8% had cryotherapy, 15.6% had laser, and 5.7% had another method including HIFU. At the patient level, men with intermediate-risk PCa were more likely to be treated with local ablative therapy (OR 1.05; 95% CI 1.00-1.11; p = 0.05), as were men with Charlson Comorbidity Index > 1 (OR 1.36; 95% CI 1.29-1.43; p < 0.01), men between 71 and 80 years (OR 3.70; 95% CI 3.43-3.99; p < 0.01), men with Medicare insurance (OR 1.38; 95% 1.31-1.46; p < 0.01), and an income < $47,999 (OR 1.16; 95% CI 1.06-1.21; p < 0.01). At the hospital-level, local ablative therapy was less likely to be performed in academic/research facilities (OR 0.45; 95% CI 0.32-0.64; p < 0.01)., Conclusions: Local ablative therapy for PCa treatment is more commonly offered among older and comorbid patients. Future studies should investigate the uptake of these technologies in non-hospital-based settings and in light of recent changes in insurance coverage., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction: Prostate MRI is a well-established tool for the diagnostic work-up for men with suspected prostate cancer (PCa). Current recommendations advocate the use of multiparametric MRI (mpMRI), which is composed of three sequences: T2-weighted sequence (T2W), diffusion-weighted sequence (DWI) and dynamic contrast-enhanced sequence (DCE). Prior studies suggest that a biparametric MRI (bpMRI) approach, omitting the DCE sequences, may not compromise clinically significant cancer detection, though there are limitations to these studies, and it is not known how this may affect treatment eligibility. A bpMRI approach will reduce scanning time, may be more cost-effective and, at a population level, will allow more men to gain access to an MRI than an mpMRI approach., Methods: Prostate Imaging Using MRI±Contrast Enhancement (PRIME) is a prospective, international, multicentre, within-patient diagnostic yield trial assessing whether bpMRI is non-inferior to mpMRI in the diagnosis of clinically significant PCa. Patients will undergo the full mpMRI scan. Radiologists will be blinded to the DCE and will initially report the MRI using only the bpMRI (T2W and DWI) sequences. They will then be unblinded to the DCE sequence and will then re-report the MRI using the mpMRI sequences (T2W, DWI and DCE). Men with suspicious lesions on either bpMRI or mpMRI will undergo prostate biopsy. The main inclusion criteria are men with suspected PCa, with a serum PSA of ≤20 ng/mL and without prior prostate biopsy. The primary outcome is the proportion of men with clinically significant PCa detected (Gleason score ≥3+4 or Gleason grade group ≥2). A sample size of at least 500 patients is required. Key secondary outcomes include the proportion of clinically insignificant PCa detected and treatment decision., Ethics and Dissemination: Ethical approval was obtained from the National Research Ethics Committee West Midlands, Nottingham (21/WM/0091). Results of this trial will be disseminated through peer-reviewed publications. Participants and relevant patient support groups will be informed about the results of the trial., Trial Registration Number: NCT04571840., Competing Interests: Competing interests: AN is an academic clinical fellow funded by the National Institute for Health and Care Research. PK is an academic clinical fellow funded by the National Institute for Health and Care Research and The Urology Foundation. FG is a recipient of the 2020 Young Investigator Award (20YOUN15) funded by the Prostate Cancer Foundation / CRIS Cancer Foundation. SP is supported by the National Institute of Health and Care Research (NIHR), UCLH and UCL Biomedical Research Centre. ME receives research support from the National Institute of Health and Care Research (NIHR), UCLH and UCL Biomedical Research Centre. YT is funded by a UK NIHR Postdoctoral Fellowship and supported by the NIHR Birmingham Biomedical Research Centre. CMM is an NIHR Research Professor, and receives grants from MRC, CRUK, Movember, and Prostate Cancer UK. VK is funded by Prostate Cancer UK and The John Black Charitable Foundation. He receives speaker fees from the European Association of Urology, Singapore Urology Association, The Clinical Comms Group and Got IT consulting SL. All authors declare that there are no conflicts of interest. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, NIHR, or the Department of Health and Social Care., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background: Active surveillance (AS) is recommended for low-risk and some intermediate-risk prostate cancer. Uptake and practice of AS vary significantly across different settings, as does the experience of surveillance-from which tests are offered, and to the levels of psychological support., Objective: To explore the current best practice and determine the most important research priorities in AS for prostate cancer., Design, Setting, and Participants: A formal consensus process was followed, with an international expert panel of purposively sampled participants across a range of health care professionals and researchers, and those with lived experience of prostate cancer. Statements regarding the practice of AS and potential research priorities spanning the patient journey from surveillance to initiating treatment were developed., Outcome Measurements and Statistical Analysis: Panel members scored each statement on a Likert scale. The group median score and measure of consensus were presented to participants prior to discussion and rescoring at panel meetings. Current best practice and future research priorities were identified, agreed upon, and finally ranked by panel members., Results and Limitations: There was consensus agreement that best practice includes the use of high-quality magnetic resonance imaging (MRI), which allows digital rectal examination (DRE) to be omitted, that repeat standard biopsy can be omitted when MRI and prostate-specific antigen (PSA) kinetics are stable, and that changes in PSA or DRE should prompt MRI ± biopsy rather than immediate active treatment. The highest ranked research priority was a dynamic, risk-adjusted AS approach, reducing testing for those at the least risk of progression. Improving the tests used in surveillance, ensuring equity of access and experience across different patients and settings, and improving information and communication between and within clinicians and patients were also high priorities. Limitations include the use of a limited number of panel members for practical reasons., Conclusions: The current best practice in AS includes the use of high-quality MRI to avoid DRE and as the first assessment for changes in PSA, with omission of repeat standard biopsy when PSA and MRI are stable. Development of a robust, dynamic, risk-adapted approach to surveillance is the highest research priority in AS for prostate cancer., Patient Summary: A diverse group of experts in active surveillance, including a broad range of health care professionals and researchers and those with lived experience of prostate cancer, agreed that best practice includes the use of high-quality magnetic resonance imaging, which can allow digital rectal examination and some biopsies to be omitted. The highest research priority in active surveillance research was identified as the development of a dynamic, risk-adjusted approach., (Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.)

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., (Copyright © 2022. Published by Elsevier Inc.)

Aims: Focal therapy treats individual areas of tumour in non-metastatic prostate cancer in patients unsuitable for active surveillance. The aim of this work was to evaluate the cost-effectiveness of focal therapy versus prostatectomy and external beam radiotherapy (EBRT)., Materials and Methods: A Markov cohort health state transition model with four health states (stable disease, local recurrence, metastatic disease and death) was created, evaluating costs and utilities over a 10-year time horizon for patients diagnosed with non-metastatic prostate cancer. National Health Service (NHS) for England perspective was used, based on direct healthcare costs. Clinical transition probabilities were derived from prostate cancer registries in patients undergoing radical prostatectomy, EBRT and focal therapy using cryotherapy (Boston Scientific) or high-intensity focused ultrasound (HIFU) (Sonablate). Propensity score matching was used to ensure that at-risk populations were comparable. Variables included age, prostate-specific antigen (PSA), International Society of Urological Pathology (ISUP) grade group, maximum cancer core length (mm), T-stage and year of treatment., Results: Focal therapy was associated with a lower overall cost and higher quality-adjusted life year (QALY) gains than either prostatectomy or EBRT, dominating both treatment strategies. Positive incremental net monetary benefit (NMB) values confirm focal therapy as cost-effective versus the alternatives at a willingness to pay (WTP) threshold of £30,000/QALY. One-way deterministic sensitivity analyses revealed consistent results., Limitations: Data used to calculate the transition probabilities were derived from a limited number of hospitals meaning that other potential treatment options were excluded. Limited data were available on later outcomes and none on quality of life data, therefore, literature-based estimates were used., Conclusions: Cost-effectiveness modelling demonstrates use of focal therapy (cryotherapy or HIFU) is associated with greater QALY gains at a lower overall cost than either radical prostatectomy or EBRT, representing good value for money in the NHS.

Objectives: The Prostate Imaging Quality (PI-QUAL) score is a new metric to evaluate the diagnostic quality of multiparametric magnetic resonance imaging (MRI) of the prostate. This study assesses the impact of an intervention, namely a prostate MRI quality training lecture, on the participant's ability to apply PI-QUAL., Methods: Sixteen participants (radiologists, urologists, physicists, and computer scientists) of varying experience in reviewing diagnostic prostate MRI all assessed the image quality of ten examinations from different vendors and machines. Then, they attended a dedicated lecture followed by a hands-on workshop on MRI quality assessment using the PI-QUAL score. Five scans assessed by the participants were evaluated in the workshop using the PI-QUAL score for teaching purposes. After the course, the same participants evaluated the image quality of a new set of ten scans applying the PI-QUAL score. Results were assessed using receiver operating characteristic analysis. The reference standard was the PI-QUAL score assessed by one of the developers of PI-QUAL., Results: There was a significant improvement in average area under the curve for the evaluation of image quality from baseline (0.59 [95 % confidence intervals: 0.50-0.66]) to post-teaching (0.96 [0.92-0.98]), an improvement of 0.37 [0.21-0.41] (p < 0.001)., Conclusions: A teaching course (dedicated lecture + hands-on workshop) on PI-QUAL significantly improved the application of this scoring system to assess the quality of prostate MRI examinations., Key Points: • A significant improvement in the application of PI-QUAL for the assessment of prostate MR image quality was observed after an educational intervention. • Appropriate training on image quality can be delivered to those involved in the acquisition and interpretation of prostate MRI. • Further investigation will be needed to understand the impact on improving the acquisition of high-quality diagnostic prostate MR examinations., (© 2022. The Author(s).)

Background In men suspected of having prostate cancer (PCa), up to 50% of men with positive multiparametric MRI (mpMRI) findings (Prostate Imaging Reporting and Data System [PI-RADS] or Likert score of 3 or higher) have no clinically significant (Gleason score ≤3+3, benign) biopsy findings. Vascular, Extracellular, and Restricted Diffusion for Cytometry in Tumor (VERDICT) MRI analysis could improve the stratification of positive mpMRI findings. Purpose To evaluate VERDICT MRI, mpMRI-derived apparent diffusion coefficient (ADC), and prostate-specific antigen density (PSAD) as determinants of clinically significant PCa (csPCa). Materials and Methods Between April 2016 and December 2019, men suspected of having PCa were prospectively recruited from two centers and underwent VERDICT MRI and mpMRI at one center before undergoing targeted biopsy. Biopsied lesion ADC, lesion-derived fractional intracellular volume (FIC), and PSAD were compared between men with csPCa and those without csPCa, using nonparametric tests subdivided by Likert scores. Area under the receiver operating characteristic curve (AUC) was calculated to test diagnostic performance. Results Among 303 biopsy-naive men, 165 study participants (mean age, 65 years ± 7 [SD]) underwent targeted biopsy; of these, 73 had csPCa. Median lesion FIC was higher in men with csPCa (FIC, 0.53) than in those without csPCa (FIC, 0.18) for Likert 3 ( P = .002) and Likert 4 (0.60 vs 0.28, P < .001) lesions. Median lesion ADC was lower for Likert 4 lesions with csPCa (0.86 × 10 -3 mm 2 /sec) compared with lesions without csPCa (1.12 × 10 -3 mm 2 /sec, P = .03), but there was no evidence of a difference for Likert 3 lesions (0.97 × 10 -3 mm 2 /sec vs 1.20 × 10 -3 mm 2 /sec, P = .09). PSAD also showed no difference for Likert 3 (0.17 ng/mL 2 vs 0.12 ng/mL 2 , P = .07) or Likert 4 (0.14 ng/mL 2 vs 0.12 ng/mL 2 , P = .47) lesions. The diagnostic performance of FIC (AUC, 0.96; 95% CI: 0.93, 1.00) was higher ( P = .02) than that of ADC (AUC, 0.85; 95% CI: 0.79, 0.91) and PSAD (AUC, 0.74; 95% CI: 0.66, 0.82) for the presence of csPCa in biopsied lesions. Conclusion Lesion fractional intracellular volume enabled better classification of clinically significant prostate cancer than did apparent diffusion coefficient and prostate-specific antigen density. Clinical trial registration no. NCT02689271 © RSNA, 2022 Online supplemental material is available for this article.

Purpose: Our goal was to assess patterns of adoption and population-level outcomes of prostate magnetic resonance imaging (MRI) and association with surgical outcomes across a sample of U.S. elderly., Materials and Methods: This population-based retrospective study used Surveillance Epidemiology, and End Results-Medicare linked data from 2003-2016 to identify men receiving prostatectomy for prostate cancer. We characterized the proportion of men receiving preoperative MRI in each year and in each hospital referral region (HRR). A 2-stage instrumental variable analysis was performed to assess the association of preoperative MRI with margin status, surgical complications and further cancer-directed therapies., Results: A total of 19,369 men received prostatectomy in 72 HRRs; the mean age was 70.2 years (SD 3.2). The proportion of men receiving a preoperative MRI increased from 2.9% to 28.2% over the study period and ranged from 0.0% to 28.8% in the different HRRs. In our instrumental variable analysis, preoperative MRI was associated with lower odds of positive surgical margin (OR 0.84, 95% CI 0.72-0.97, p=0.01) lower odds of blood transfusions at 30 and 90 days (OR 0.56, 95% CI 0.38-0.83, p=0.003 and OR 0.58, 95% CI 0.41-0.84, p=0.004) but higher odds of further treatments (OR 1.49, 95% CI 1.32-1.70, p <0.001)., Conclusions: Given that a minority of men receive presurgical MRIs with marked geographic variability, the association of MRI with lower odds of positive surgical margin suggests that efforts to support the dissemination of prostate MRI may improve surgical outcomes-but may come with a tendency for more resource-intensive cancer care overall.

Background: Recurrent prostate cancer after radiotherapy occurs in one in five patients. The efficacy of prostate magnetic resonance imaging (MRI) in recurrent cancer has not been established. Furthermore, high-quality data on new minimally invasive salvage focal ablative treatments are needed., Objective: To evaluate the role of prostate MRI in detection of prostate cancer recurring after radiotherapy and the role of salvage focal ablation in treating recurrent disease., Design, Setting, and Participants: The FORECAST trial was both a paired-cohort diagnostic study evaluating prostate multiparametric MRI (mpMRI) and MRI-targeted biopsies in the detection of recurrent cancer and a cohort study evaluating focal ablation at six UK centres. A total of 181 patients were recruited, with 155 included in the MRI analysis and 93 in the focal ablation analysis., Intervention: Patients underwent choline positron emission tomography/computed tomography and a bone scan, followed by prostate mpMRI and MRI-targeted and transperineal template-mapping (TTPM) biopsies. MRI was reported blind to other tests. Those eligible underwent subsequent focal ablation. An amendment in December 2014 permitted focal ablation in patients with metastases., Outcome Measurements and Statistical Analysis: Primary outcomes were the sensitivity of MRI and MRI-targeted biopsies for cancer detection, and urinary incontinence after focal ablation. A key secondary outcome was progression-free survival (PFS)., Results and Limitations: Staging whole-body imaging revealed localised cancer in 128 patients (71%), with involvement of pelvic nodes only in 13 (7%) and metastases in 38 (21%). The sensitivity of MRI-targeted biopsy was 92% (95% confidence interval [CI] 83-97%). The specificity and positive and negative predictive values were 75% (95% CI 45-92%), 94% (95% CI 86-98%), and 65% (95% CI 38-86%), respectively. Four cancer (6%) were missed by TTPM biopsy and six (8%) were missed by MRI-targeted biopsy. The overall MRI sensitivity for detection of any cancer was 94% (95% CI 88-98%). The specificity and positive and negative predictive values were 18% (95% CI 7-35%), 80% (95% CI 73-87%), and 46% (95% CI 19-75%), respectively. Among 93 patients undergoing focal ablation, urinary incontinence occurred in 15 (16%) and five (5%) had a grade ≥3 adverse event, with no rectal injuries. Median follow-up was 27 mo (interquartile range 18-36); overall PFS was 66% (interquartile range 54-75%) at 24 mo., Conclusions: Patients should undergo prostate MRI with both systematic and targeted biopsies to optimise cancer detection. Focal ablation for areas of intraprostatic recurrence preserves continence in the majority, with good early cancer control., Patient Summary: We investigated the role of magnetic resonance imaging (MRI) scans of the prostate and MRI-targeted biopsies in outcomes after cancer-targeted high-intensity ultrasound or cryotherapy in patients with recurrent cancer after radiotherapy. Our findings show that these patients should undergo prostate MRI with both systematic and targeted biopsies and then ablative treatment focused on areas of recurrent cancer to preserve their quality of life. This trial is registered at ClinicalTrials.gov as NCT01883128., (Copyright © 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Introduction: Multiparametric MRI (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. However, the technique has modest specificity and a high false-positive rate, especially in men with mpMRI scored as indeterminate (3/5) or likely (4/5) to have clinically significant cancer (csPCa) (Gleason ≥3+4). Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively. Before these techniques are translated clinically, robust histological and clinical validation is required., Methods and Analysis: This study aims to clinically validate two advanced MRI techniques in a prospectively recruited cohort of men suspected of prostate cancer. Histological analysis of men undergoing biopsy or prostatectomy will be used for biological validation of biomarkers derived from Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging. In particular, prostatectomy specimens will be processed using three-dimension printed patient-specific moulds to allow for accurate MRI and histology mapping. The index tests will be compared with the histological reference standard to derive false positive rate and true positive rate for men with mpMRI scores which are indeterminate (3/5) or likely (4/5) to have clinically significant prostate cancer (csPCa). Histopathological validation from both biopsy and prostatectomy samples will provide the best ground truth in validating promising MRI techniques which could predict biopsy results and help avoid unnecessary biopsies in men suspected of prostate cancer., Ethics and Dissemination: Ethical approval was granted by the London-Queen Square Research Ethics Committee (19/LO/1803) on 23 January 2020. Results from the study will be presented at conferences and submitted to peer-reviewed journals for publication. Results will also be available on ClinicalTrials.gov., Trial Registration Number: NCT04792138., Competing Interests: Competing interests: The work of SP and DA is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre. Veeru Kasivisvanathan is an Academic Clinical Lecturer funded by the UK National Institute for Health Research (NIHR). CMM is supported by an NIHR Research Professorship, and has additional study funding from the Medical Research Council, Cancer Research UK, PCUK, Movember, and the European Association of Urology Research Board. FG is currently supported by PREdICT, an investigator-initiated study at the Vall d’Hebron Hospital campus (Barcelona, Spain), funded by AstraZeneca., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Background: Focal therapy aims to treat areas of cancer to confer oncological control whilst reducing treatment-related functional detriment., Objective: To report oncological outcomes and adverse events following focal high-intensity focused ultrasound (HIFU) for treating nonmetastatic prostate cancer., Design, Setting, and Participants: An analysis of 1379 patients with ≥6 mo of follow-up prospectively recorded in the HIFU Evaluation and Assessment of Treatment (HEAT) registry from 13 UK centres (2005-2020) was conducted. Five or more years of follow-up was available for 325 (24%) patients. Focal HIFU therapy used a transrectal ultrasound-guided device (Sonablate; Sonacare Inc., Charlotte, NC, USA)., Outcome Measurements and Statistical Analysis: Failure-free survival (FFS) was primarily defined as avoidance of no evidence of disease to require salvage whole-gland or systemic treatment, or metastases or prostate cancer-specific mortality. Differences in FFS between D'Amico risk groups were determined using a log-rank analysis. Adverse events were reported using Clavien-Dindo classification., Results and Limitations: The median (interquartile range) age was 66 (60-71) yr and prostate-specific antigen was 6.9 (4.9-9.4) ng/ml with D'Amico intermediate risk in 65% (896/1379) and high risk in 28% (386/1379). The overall median follow-up was 32 (17-58) mo; for those with ≥5 yr of follow-up, it was 82 (72-94). A total of 252 patients had repeat focal treatment due to residual or recurrent cancer; overall 92 patients required salvage whole-gland treatment. Kaplan-Meier 7-yr FFS was 69% (64-74%). Seven-year FFS in intermediate- and high-risk cancers was 68% (95% confidence interval [CI] 62-75%) and 65% (95% CI 56-74%; p = 0.3). Clavien-Dindo >2 adverse events occurred in 0.5% (7/1379). The median 10-yr follow-up is lacking., Conclusions: Focal HIFU in carefully selected patients with clinically significant prostate cancer, with six and three of ten patients having, respectively, intermediate- and high-risk cancer, has good cancer control in the medium term., Patient Summary: Focal high-intensity focused ultrasound treatment to areas of prostate with cancer can provide an alternative to treating the whole prostate. This treatment modality has good medium-term cancer control over 7 yr, although 10-yr data are not yet available., (Copyright © 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

There is increasing interest in the use of multiparametric magnetic resonance imaging (mpMRI) in the prostate cancer pathway. The European Association of Urology (EAU) and the British Association of Urological Surgeons (BAUS) now advise mpMRI prior to biopsy, and the Prostate Imaging Reporting and Data System (PI-RADS) recommendations set out the minimal technical requirements for the acquisition of mpMRI of the prostate.The widespread and swift adoption of this technique has led to variability in image quality. Suboptimal image acquisition reduces the sensitivity and specificity of mpMRI for the detection and staging of clinically significant prostate cancer.This critical review outlines the studies aimed at improving prostate MR quality that have been published over the last 5 years. These span from the use of specific MR sequences, magnets and coils to patient preparation. The rates of adherence of prostate mpMRI to technical standards in different cohorts across the world are also discussed.Finally, we discuss the first standardised scoring system ( i.e., Prostate Imaging Quality, PI-QUAL) that has been created to evaluate image quality, although further iterations of this score are expected in the future.

Objectives: The aim of this study was to evaluate the changes in lesion volume on serial multiparametric magnetic resonance (mpMRI) during active surveillance for prostate cancer., Methods: A total of 160 patients with a targeted biopsy-confirmed visible lesion on mpMRI, stratified by low- and intermediate-risk disease (Gleason Grade Group 1 vs Gleason Grade Group 2), were analysed. The % change per year was calculated using the formula: [(final volume/initial volume) exp (1/interval between scans in years)]-1 ., Results: There was no significant difference in the annual median percentage change between Gleason Grade Group 1 (18%) and Gleason Grade Group 2 (23%) disease (p = 0.16), and between ≤ 10% (23%) and > 10% (22%) of Gleason pattern 4 (p = 0.78).Assuming a spherical lesion, these changes corresponded to annual increases in mean tumour diameter of 6% and 7% for Gleason Grade Group 1 and Gleason Grade Group 2 respectively, which may be less than the interscan variability of serial mpMRI., Conclusion: In an active surveillance cohort, we did not see a significant difference in the annual growth rate of Gleason Grade Group 1 and 2 tumours., Advances in Knowledge: In patients on active surveillance, the measured growth rates for visible tumours in Gleason Grade Groups 1 and 2 were similar. The annual growth rate was small in most cases and this may have implications for the MRI follow-up interval in active surveillance.

Introduction: The ReIMAGINE Consortium was conceived to develop risk-stratification models that might incorporate the full range of novel prostate cancer (PCa) diagnostics (both commercial and academic)., Methods: ReIMAGINE Risk is an ethics approved (19/LO/1128) multicentre, prospective, observational cohort study which will recruit 1000 treatment-naive men undergoing a multi-parametric MRI (mpMRI) due to an elevated PSA (≤20ng/ml) or abnormal prostate examination who subsequently had a suspicious mpMRI (score≥3, stage ≤T3bN0M0). Primary outcomes include the detection of ≥Gleason 7 PCa at baseline and time to clinical progression, metastasis and death. Baseline blood, urine, and biopsy cores for fresh prostate tissue samples (2 targeted and 1 non-targeted) will be biobanked for future analysis. High-resolution scanning of pathology whole-slide imaging and MRI-DICOM images will be collected. Consortium partners will be granted access to data and biobanks to develop and validate biomarkers using correlation to mpMRI, biopsy-based disease status and long-term clinical outcomes., Results: Recruitment began in September 2019(n = 533). A first site opened in September 2019 (n = 296), a second in November 2019 (n = 210) and a third in December 2020 (n = 27). Acceptance to the study has been 65% and a mean of 36.5ml(SD+/-10.0), 12.9ml(SD+/-3.7) and 2.8ml(SD+/-0.7) urine, plasma and serum donated for research, respectively. There are currently 4 academic and 15 commercial partners spanning imaging (~9 radiomics, artificial intelligence/machine learning), fluidic (~3 blood-based and ~2urine-based) and tissue-based (~1) biomarkers., Conclusion: The consortium will develop, or adjust, risk models for PCa, and provide a platform for evaluating the role of novel diagnostics in the era of pre-biopsy MRI and targeted biopsy., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Hashim U Ahmed receives grant funding from Sonacare Inc., Sophiris Biocorp and Boston commercial entities. Hashim U Ahmed is awarded academic funds from the MRC, CRUK, The Wellcome Trust, The British Medical Association (BMA), The Urology Foundaiton (TUF), Prostate Cancer U.K. (PCUK) and Imperial Health. Mark Emberton serves as a consultant/educator/trainer to Sonacare Inc., Exact Imaging, Angiodynamics Inc and Profound Medical. Acknowledgements - Mark Emberton receives research support from the United Kingdom’s National Institute of Health Research (NIHR) UCLH/UCL Biomedical Research Centre. Caroline M Moore receives funding from the Prostate Cancer UK, Movember, the Medical Research Council, Cancer Research UK and the NIHR. She receives fees for HIFU proctoring from SonaCare. She has received speaker fees from Astellas, and Jannsen. She carries out research into photodyanamic therapy supported by Spectracure. Shonit Punwani receives research support from the United Kingdom’s National Institute of Health Research (NIHR) UCLH/UCL Biomedical Research Centre Ton Coolen receives funding from Cancer Research UK and is Director of Saddle Point Science Ltd. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Transrectal ultrasound (TRUS) guided biopsy for prostate cancer is prone to random and systemic error and has been shown to have a negative predictive value of 70%. PRECISION and PRECISE are among the first randomised studies to evaluate the new MRI-targeted biopsy (MRI-TB) pathway with a non-paired design to detect clinically significant prostate cancer and avoid unnecessary treatment. The trials' results individually demonstrated non-inferiority of MRI-TB compared to TRUS biopsy. An individual patient data (IPD) meta-analysis was planned from the outset of the two trials in parallel and this IPD meta-analysis aims to further elucidate the utility of MRI-TB as the optimal diagnostic pathway for prostate cancer., Methods and Materials: This study is registered on PROSPERO (CRD42021249263). A search of Medline, Embase, Cochrane Central Register of Registered Trials (CENTRAL), Web of Science, and ClinicalTrials.gov was performed up until 4th February 2021. Only randomised controlled trials (PRECISE, PRECISION and other eligible trials) comparing the MRI-targeted biopsy pathway and traditional TRUS biopsy pathway will be included. The primary outcome of the review is the proportion of men diagnosed with clinically significant prostate cancer in each arm (Gleason ≥ 3+4 = 7). IPD and study-level data and characteristics will be sought from eligible studies. Analyses will be done primarily using an intention-to-treat approach, and a one-step IPD meta-analysis will be performed using generalised linear mixed models. A non-inferiority margin of 5 percentage points will be used. Heterogeneity will be quantified using the variance parameters from the mixed model. If there is sufficient data, we will investigate heterogeneity by exploring the effect of the different conducts of MRIs, learning curves of MRI reporting and MRI targeted biopsies., Trial Registration: This systematic review is registered on PROSPERO (CRD42021249263)., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Veeru Kasivisvanathan is an Academic Clinical Lecturer funded by the United Kingdom National Institute for Health Research (NIHR). Brooke Levis is funded by a Fonds de Recherche du Québec - Santé Postdoctoral Training Fellowship. Yemisi Takwoingi is funded by a UK NIHR Postdoctoral Fellowship and supported by the NIHR Birmingham Biomedical Research Centre. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Objectives: The Prostate Imaging Quality (PI-QUAL) score assesses the quality of multiparametric MRI (mpMRI). A score of 1 means all sequences are below the minimum standard of diagnostic quality, 3 implies that the scan is of sufficient diagnostic quality, and 5 means that all three sequences are of optimal diagnostic quality. We investigated the inter-reader reproducibility of the PI-QUAL score in patients enrolled in the NeuroSAFE PROOF trial., Methods: We analysed the scans of 103 patients on different MR systems and vendors from 12 different hospitals. Two dedicated radiologists highly experienced in prostate mpMRI independently assessed the PI-QUAL score for each scan. Interobserver agreement was assessed using Cohen's kappa with standard quadratic weighting (κw) and percent agreement., Results: The agreement for each single PI-QUAL score was strong (κw = 0.85 and percent agreement = 84%). A similar agreement (κw = 0.82 and percent agreement = 84%) was observed when the scans were clustered into three groups (PI-QUAL 1-2 vs PI-QUAL 3 vs PI-QUAL 4-5). The agreement in terms of diagnostic quality for each single sequence was highest for T2-weighted imaging (92/103 scans; 89%), followed by dynamic contrast-enhanced sequences (91/103; 88%) and diffusion-weighted imaging (80/103; 78%)., Conclusion: We observed strong reproducibility in the assessment of PI-QUAL between two radiologists with high expertise in prostate mpMRI. At present, PI-QUAL offers clinicians the only available tool for evaluating and reporting the quality of prostate mpMRI in a systematic manner but further refinements of this scoring system are warranted., Key Points: • Inter-reader agreement for each single Prostate Imaging Quality (PI-QUAL) score (i.e., PI-QUAL 1 to PI-QUAL 5) was strong, with weighted kappa = 0.85 (95% confidence intervals: 0.51 - 1) and percent agreement = 84%. • Interobserver agreement was strong when the scans were clustered into three groups according to the ability (or not) to rule in and to rule out clinically significant prostate cancer (i.e., PI-QUAL 1-2 vs PI-QUAL 3 vs PI-QUAL 4-5), with weighted kappa = 0.82 (95% confidence intervals: 0.68 - 0.96) and percent agreement = 84%. • T2-weighted acquisitions were the most compliant with the Prostate Imaging Reporting and Data System (PI-RADS) v. 2.0 technical recommendations and were the sequences of highest diagnostic quality for both readers in 95/103 (92%) scans, followed by dynamic contrast enhanced acquisition with 81/103 (79%) scans and lastly by diffusion-weighted imaging with 79/103 (77%) scans., (© 2021. The Author(s).)

Background: Imaging techniques are used to identify local recurrence of prostate cancer (PCa) for salvage therapy and to exclude metastases that should be addressed with systemic therapy. For magnetic resonance imaging (MRI), a reduction in the variability of acquisition, interpretation, and reporting is required to detect local PCa recurrence in men with biochemical relapse after local treatment with curative intent., Objective: To propose a standardised method for image acquisition and assessment of PCa local recurrence using MRI after radiation therapy (RP) and radical prostatectomy (RT)., Evidence Acquisition: Prostate Imaging for Recurrence Reporting (PI-RR) was formulated using the existing literature. An international panel of experts conducted a nonsystematic review of the literature. The PI-RR system was created via consensus through a combination of face-to-face and online discussions., Evidence Synthesis: Similar to with PI-RADS, based on the best available evidence and expert opinion, the minimum acceptable MRI parameters for detection of recurrence after radiation therapy and radical prostatectomy are set. Also, a simplified and standardised terminology and content of the reports that use five assessment categories to summarise the suspicion of local recurrence (PI-RR) are designed. PI-RR scores of 1 and 2 are assigned to lesions with a very low and low likelihood of recurrence, respectively. PI-RR 3 is assigned if the presence of recurrence is uncertain. PI-RR 4 and 5 are assigned for a high and very high likelihood of recurrence, respectively. PI-RR is intended to be used in routine clinical practice and to facilitate data collection and outcome monitoring for research., Conclusions: This paper provides a structured reporting system (PI-RR) for MRI evaluation of local recurrence of PCa after RT and RP., Patient Summary: A new method called PI-RR was developed to promote standardisation and reduce variations in the acquisition, interpretation, and reporting of magnetic resonance imaging for evaluating local recurrence of prostate cancer and guiding therapy., (Copyright © 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Prostate cancer is the second most common malignancy in men worldwide. Systematic transrectal prostate biopsy is commonly used to obtain tissue to establish the diagnosis. In recent years, however, more clinically significant cancer and less clinically insignificant cancer have been detected with MRI targeted biopsy (on the basis of an MRI examination performed before consideration of biopsy) than with systematic biopsy. This approach of performing MRI before biopsy has become, or is becoming, a standard of practice in centers throughout the world. This growing use of an MRI-directed pathway is leading to performance of a larger volume of MRI targeted prostate biopsies. The three common MRI targeted biopsy techniques are cognitive biopsy, MRI-ultrasound software fusion biopsy, and MRI in-bore guided biopsy. These techniques for using MRI information at biopsy can be performed via a transrectal or transperineal approach. The purpose of this review is to describe the three MRI targeted biopsy techniques and their advantages and shortcomings. Comparisons among the techniques are summarized on the basis of the available evidence. Studies to date have had heterogeneous results, and the preferred technique remains debated.

Objectives: Focal salvage HIFU is a feasible therapeutic option in some men who have recurrence after primary radiotherapy for prostate cancer. We aimed to determine if multi-parametric quantitative parameters, in addition to clinical factors, might have a role in independently predicting focal salvage HIFU outcomes., Methods: A retrospective registry analysis included 150 consecutive men who underwent focal salvage HIFU (Sonablate500) (2006-2015); 89 had mpMRI available. Metastatic disease was excluded by nodal assessment on pelvic MRI, a radioisotope bone-scan and/or choline or FDG PET/CT scan. All men had mpMRI and either transperineal template prostate mapping biopsy or targeted and systematic TRUS-biopsy. mpMRI included T2-weighted, diffusion-weighted and dynamic contrast-enhancement. Pre-HIFU quantitative mpMRI data was obtained using Horos DICOM Viewer v3.3.5 for general MRI parameters and IB DCE v2.0 plug-in. Progression-free survival (PFS) was defined by biochemical failure and/or positive localized or distant imaging results and/or positive biopsy and/or systemic therapy and/or metastases/prostate cancer-specific death. Potential predictors of PFS were analyzed by univariable and multivariable Cox-regression., Results: Median age at focal salvage HIFU was 71 years (interquartile range [IQR] 65-74.5) and median PSA pre-focal salvage treatment was 5.8ng/ml (3.8-8). Median follow-up was 35 months (23-47) and median time to failure was 15 months (7.8-24.3). D-Amico low, intermediate and high-risk disease was present in 1% (1/89), 40% (36/89) and 43% (38/89) prior to focal salvage HIFU (16% missing data). 56% (50/89) failed by the composite outcome. A total of 22 factors were evaluated on univariable and 8 factors on multivariable analysis. The following quantitative parameters were included: Ktrans, Kep, Ve, Vp, IS, rTTP and TTP. On univariable analysis, PSA, prostate volume at time of radiotherapy failure and Ve (median) value were predictors for failure. Ve represents extracellular fraction of the whole tissue volume. On multivariable analysis, only Ve (median) value remained as an independent predictor., Conclusions: One pharmacokinetic quantitative parameter based on DCE sequences seems to independently predict failure following focal salvage HIFU for radio-recurrent prostate cancer. This likely relates to the tumor microenvironment producing heat-sinks which counter the heating effect of HIFU. Further validation in larger datasets and evaluating mechanisms to reduce heat-sinks are required., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: For localised prostate cancer, focal therapy offers an organ-sparing alternative to radical treatments (radiotherapy or prostatectomy). Currently, there is no randomised comparative effectiveness data evaluating cancer control of both strategies., Methods: Following the eligibility criteria PSA < 20 ng/mL, Gleason score ≤ 7 and T-stage ≤ T2c, we included 830 radical (440 radiotherapy, 390 prostatectomy) and 530 focal therapy (cryotherapy, high-intensity focused ultrasound or high-dose-rate brachytherapy) patients treated between 2005 and 2018 from multicentre registries in the Netherlands and the UK. A propensity score weighted (PSW) analysis was performed to compare failure-free survival (FFS), with failure defined as salvage treatment, metastatic disease, systemic treatment (androgen deprivation therapy or chemotherapy), or progression to watchful waiting. The secondary outcome was overall survival (OS). Median (IQR) follow-up in each cohort was 55 (28-83) and 62 (42-83) months, respectively., Results: At baseline, radical patients had higher PSA (10.3 versus 7.9) and higher-grade disease (31% ISUP 3 versus 11%) compared to focal patients. After PSW, all covariates were balanced (SMD < 0.1). 6-year weighted FFS was higher after radical therapy (80.3%, 95% CI 73.9-87.3) than after focal therapy (72.8%, 95% CI 66.8-79.8) although not statistically significant (p = 0.1). 6-year weighted OS was significantly lower after radical therapy (93.4%, 95% CI 90.1-95.2 versus 97.5%, 95% CI 94-99.9; p = 0.02). When compared in a three-way analysis, focal and LRP patients had a higher risk of treatment failure than EBRT patients (p < 0.001), but EBRT patients had a higher risk of mortality than focal patients (p = 0.008)., Conclusions: Within the limitations of a cohort-based analysis in which residual confounders are likely to exist, we found no clinically relevant difference in cancer control conferred by focal therapy compared to radical therapy at 6 years., (© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)

The technical requirements for the acquisition of multiparametric magnetic resonance imaging (mpMRI) of the prostate have been clearly outlined in the Prostate Imaging Reporting and Data System (PI-RADS) guidelines, but there is still huge variability in image quality among centres across the world. It has been difficult to quantify what constitutes a good-quality image, and a first attempt to address this matter has been the publication of the Prostate Imaging Quality (PI-QUAL) score and its dedicated scoring sheet. This score includes the assessment of technical parameters that can be obtained from the DICOM files along with a visual evaluation of certain features on prostate MRI (e.g., anatomical structures). We retrospectively analysed the image quality of 10 scans from different vendors and magnets using a semiautomated dedicated PI-QUAL software program and compared the time needed for assessing image quality using two methods (semiautomated assessment versus manual filling of the scoring sheet). This semiautomated software is able to assess the technical parameters automatically, but the visual assessment is still performed by the radiologist. There was a significant reduction in the reporting time of prostate mpMRI quality according to PI-QUAL using the dedicated software program compared to manual filling (5'54″ versus 7'59″; p = 0.005). A semiautomated PI-QUAL software program allows the radiologist to assess the technical details related to the image quality of prostate mpMRI in a quick and reliable manner, allowing clinicians to have more confidence that the quality of mpMRI of the prostate is sufficient to determine patient care., (© 2021. The Author(s).)

Background: Multiparametric magnetic resonance imaging (mpMRI) and targeted biopsies (TBs) facilitate accurate detection of significant prostate cancer (sPC). However, it remains unclear how many cores should be applied per target., Objective: To assess sPC detection rates of two different target-dependent magnetic resonance imaging (MRI)/transrectal ultrasonography (TRUS)-fusion biopsy approaches (TB and target saturation [TS]) compared with extended systematic biopsies (SBs)., Design, Setting, and Participants: Retrospective single-centre outcome of transperineal MRI/TRUS-fusion biopsies of 213 men was evaluated. All men underwent TB with a median of four cores per MRI lesion, followed by a median of 24 SBs, performed by experienced urologists. Cancer and sPC (International Society of Urological Pathology grade group ≥2) detection rates were analysed. TB was compared with SB and TS, with nine cores per target, calculated by the Ginsburg scheme and using individual cores of the lesion and its "penumbra"., Outcome Measurements and Statistical Analysis: Cancer detection rates were calculated for TS, TB, and SB at both lesion and patient level. Combination of SB + TB served as a reference. Statistical differences in prostate cancer (PC) detection between groups were calculated using McNemar's tests with confidence intervals., Results and Limitations: TS detected 99% of 134 sPC lesions, which was significantly higher than the detection by TB (87%, p = 0.001) and SB (82%, p < 0.001). SB detected significantly more of the 72 low-risk PC lesions than TB (99% vs 68%, p < 0.001) and 10% (p = 0.15) more than that detected by TS. At a per-patient level, 99% of men harbouring sPC were detected by TS. This was significantly higher than that by TB and SB (89%, p = 0.03 and 81%, p = 0.001, respectively). Limitations include limited generalisability, as a transperineal biopsy route was used., Conclusions: TS detected significantly more cases of sPC than TB and extended SB. Given that both 99% of sPC lesions and men harbouring sPC were identified by TS, the results suggest that this approach allows to omit SB cores without compromising sPC detection., Patient Summary: Target saturation of magnetic resonance imaging-suspicious prostate lesions provides excellent cancer detection and finds fewer low-risk tumours than the current gold standard combination of targeted and systematic biopsies., (Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objectives: To report toxicity of treatment observed in men participating in the Robotic surgery After Focal Therapy (RAFT) clinical trial., Patients and Methods: Men were eligible for this prospective single group interventional study if they had histologically confirmed recurrent/residual prostate adenocarcinoma following primary FT. The short-form Expanded Prostate Cancer Index Composite (EPIC-26) measured prior to salvage robotic prostatectomy (S-RARP) and 3-monthly post-operatively together with Clavien-Dindo complications (I-IV). Secondary outcomes included biochemical recurrence-free survival (BCFS) following surgery and need for salvage treatment after surgery. This study is registered with ClinicalTrials.gov NCT03011606., Results: Twenty-four men were recruited between February 2016 and September 2018. 1 patient withdrew from the trial after consenting and before S-RARP. 23 men completed 12-month post S-RARP follow-up. Median EPIC-26 urinary continence scores initially deteriorated after 3 months (82.4 vs 100) but there was no statistically significant difference from baseline at 12 months (100 vs 100, P = 0.31). Median lower urinary tract symptom scores improved after 12 months compared to baseline (93.8 vs 87.5, P = 0.01). At 12 months, 19/23 (83%) were pad-free and 22/23 (96%) required 0/1 pads. Median sexual function subscale scores deteriorated and remained low at 12 months (22.2 vs 58.3, P < 0.001). Utilising a minimally important difference of nine points, at 12 months after surgery 17/23 (74%) reported urinary continence to be 'better' or 'not different' to pre-operative baseline. The corresponding figure for sexual function (utilising a minimally important difference of 12 points) was 7/23 (30%). There was no statistically significant difference on median bowel/hormonal subscale scores. Only a single patient had a post-operative complication (Clavien-Dindo Grade I). BCFS at 12 months after surgery was 82.6% (95% confidence interval [CI]: 60.1-93.1%) while 4/23 (17%) received salvage radiation., Conclusions: The RAFT clinical trial suggests toxicity of surgery after FT is low, with good urinary function outcomes, albeit sexual function deteriorated overall. Oncological outcomes at 12 months appear acceptable., (© 2021 The Authors. BJU International © 2021 BJU International.)

Introduction: The primary objective of the ReIMAGINE Prostate Cancer Screening Study is to explore the uptake of an invitation to prostate cancer screening using MRI., Methods and Analysis: The ReIMAGINE Prostate Cancer Screening Study is a prospective single-centre feasibility study. Eligible men aged 50-75 years with no prior prostate cancer diagnosis or treatment will be identified through general practitioner practices and randomly selected for invitation. Those invited will be offered an MRI scan and a prostate-specific antigen (PSA) blood test. The screening MRI scan consists of T2-weighted, diffusion-weighted and research-specific sequences, without the use of intravenous contrast agents. Men who screen positive on either MRI or PSA density will be recommended to have standard of care (National Health Service) tests for prostate cancer assessment, which includes multiparametric MRI. The study will assess the acceptability of an MRI-based prostate screening assessment and the prevalence of cancer detected in MRI-screened men. Summary statistics will be used to explore baseline characteristics in relation to acceptance rates and prevalence of cancer., Ethics and Dissemination: ReIMAGINE Prostate Cancer Screening is a single-site screening study to assess the feasibility of MRI as a screening tool for prostate cancer. Ethical approval was granted by London-Stanmore Research Ethics Committee Heath Research Authority (reference 19/LO/1129). Study results will be published in peer-reviewed journals after completion of data analysis and used to inform the design of a multicentre screening study in the UK., Trial Registration Number: ClinicalTrials.gov Registry (NCT04063566)., Competing Interests: Competing interests: CMM receives funding from the Prostate Cancer UK, Movember, the Medical Research Council, Cancer Research UK and the NIHR. She receives fees for HIFU proctoring from SonaCare. She has received speaker fees from Astellas and Jannsen. She carries out research into photodynamic therapy supported by Spectracure. ME serves as a consultant/educator/trainer to Sonacare, Exact Imaging, Angiodynamics and Profound Medical., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

The management of prostate cancer continues to evolve rapidly, with substantial advances being made in understanding the genomic landscape and biology underpinning both primary and metastatic prostate cancer. Similarly, the emergence of more sensitive imaging methods has improved diagnostic and staging accuracy and refined surveillance strategies. These advances have introduced personalised therapeutics to clinical practice, with treatments targeting genomic alterations in DNA repair pathways now clinically validated. An important shift in the therapeutic framework for metastatic disease has taken place, with metastatic-directed therapies being evaluated for oligometastatic disease, aggressive management of the primary lesion shown to benefit patients with low-volume metastatic disease, and with several novel androgen pathway inhibitors significantly improving survival when used as a first-line therapy for metastatic disease. Research into the molecular characterisation of localised, recurrent, and progressive disease will undoubtedly have an impact on clinical management. Similarly, emerging research into novel therapeutics, such as targeted radioisotopes and immunotherapy, holds much promise for improving the lives of patients with prostate cancer., Competing Interests: Declarations of interests SGW reports grant support from Bristol-Myers Squibb; consultancy fees and travel support from Astellas Pharma, Janssen, Bayer, Amgen, and Noxopharm paid to institution; and chaired the prostate cancer subcommittee of the Australia and New Zealand Urogenital and Prostate clinical trials group, during which time he received scientific grant support from Bayer and Astellas Pharma. SS reports advisory board fees paid to institution and grant support from AstraZeneca, Merck Sharp & Dohme, Amgen, Endocyte, Bristol-Myers Squibb, and Genentech. EC reports speaker honorarium and advisory board fees from Beckman Coulter Singapore, Janssen, Astellas Pharma, Bayer, Ipsen, AstraZeneca, Ferring, Amgen, and grant support from Janssen and Astellas Pharma. HB reports research support from AbbVie, Janssen, Millennium, Eli Lilly, and Astellas Pharma; and has served as advisor or consultant for Janssen, Astellas Pharma, Sanofi Genzyme, Merck Sharp & Dohme, Pfizer, Amgen, and Blue Earth. CMM reports speaker fees from Astellas Pharma, Janssen, and Steba Biotech; and grant support from SpectraCure. RGB reports no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Multiparametric magnetic resonance imaging (mpMRI) is now recommended prebiopsy in numerous healthcare regions based on the findings of high-quality studies from expert centres. Concern remains about reproducibility of mpMRI to rule out clinically significant prostate cancer (csPCa) in real-world settings., Objective: To assess the diagnostic performance of mpMRI for csPCa in a real-world setting., Design, Setting, and Participants: A multicentre, retrospective cohort study, including men referred with raised prostate-specific antigen (PSA) or an abnormal digital rectal examination who had undergone mpMRI followed by transrectal or transperineal biopsy, was conducted. Patients could be biopsy naïve or have had previous negative biopsies., Outcome Measurements and Statistical Analysis: The primary definition for csPCa was International Society of Urological Pathology (ISUP) grade group (GG) ≥2 (any Gleason ≥7); the accuracy for other definitions was also evaluated., Results and Limitations: Across ten sites, 2642 men were included (January 2011-November 2018). Mean age and PSA were 65.3yr (standard deviation [SD] 7.8yr) and 7.5ng/ml (SD 3.3ng/ml), respectively. Of the patients, 35.9% had "negative MRI" (scores 1-2); 51.9% underwent transrectal biopsy and 48.1% had transperineal biopsy, with 43.4% diagnosed with csPCa overall. The sensitivity and negative predictive value (NPV) for ISUP GG≥2 were 87.3% and 87.5%, respectively. The NPVs were 87.4% and 88.1% for men undergoing transrectal and transperineal biopsy, respectively. Specificity and positive predictive value of MRI were 49.8% and 49.2%, respectively. The sensitivity and NPV increased to 96.6% and 90.6%, respectively, when a PSA density threshold of 0.15ng/ml/ml was used in MRI scores 1-2; these metrics increased to 97.5% and 91.2%, respectively, for PSA density 0.12ng/ml/ml. ISUP GG≥3 (Gleason ≥4+3) was found in 2.4% (15/617) of men with MRI scores 1-2. They key limitations of this study are the heterogeneity and retrospective nature of the data., Conclusions: Multiparametric MRI when used in real-world settings is able to rule out csPCa accurately, suggesting that about one-third of men might avoid an immediate biopsy. Men should be counselled about the risk of missing some significant cancers., Patient Summary: Multiparametric magnetic resonance imaging (MRI) is a useful tool for ruling out prostate cancer, especially when combined with prostate-specific antigen density (PSAD). Previous results published from specialist centres can be reproduced at smaller institutions. However, patients and their clinicians must be aware that an early diagnosis of clinically significant prostate cancer could be missed in nearly 10% of patients by relying on MRI and PSAD alone., (Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Competing Interests: CMM reports grants from SpectraCure, the Medical Research Council, Movember, Prostate Cancer UK, National Institute for Health Research, Cancer Research UK, and the EAU Research Foundation; consulting fees from Sonablate; and speaker fees from Astellas and Janssen.