European Urology Open Science最新文献

{"title":"Impact of Surgical Margin Status and Tumor Volume on Mortality After Robotic Radical Prostatectomy","authors":"Zaki Zeidan ,&nbsp;Joshua Tran ,&nbsp;Yeagyeong Hwang ,&nbsp;Linda My Huynh ,&nbsp;Mai Xuan Nguyen ,&nbsp;Erica Huang ,&nbsp;Whitney Zhang ,&nbsp;Thomas Ahlering","doi":"10.1016/j.euros.2024.12.004","DOIUrl":"10.1016/j.euros.2024.12.004","url":null,"abstract":"<div><h3>Background and objective</h3><div>Positive surgical margins (PSMs) following radical prostatectomy (RP) have been seen as inherently unfavorable. However, a large international multi-institutional study recently revealed that unifocal PSMs (UPSMs) had no impact on prostate cancer–specific mortality (PCSM), whereas multifocal PSMs (MPSMs) did. Our aim was to assess the relative impact of PSMs versus percentage tumor volume (PTV) on PCSM.</div></div><div><h3>Methods</h3><div>We analyzed data for 1552 patients who underwent robot-assisted RP performed by a single surgeon between 2002 and 2018 at a tertiary referral center with up to 15-yr follow-up. Patients were divided into negative surgical margin (NSM), UPSM, and MPSM groups, with PTV stratification using a cutoff of 40%. The primary outcome was stepwise multivariate regression analysis of predictors of PCSM (pT stage, pathological Gleason grade group, PTV, UPSM, and MPSM). The secondary outcome was the risk of 15-yr PCSM via Kaplan-Meier analysis.</div></div><div><h3>Key findings and limitations</h3><div>The group with 40–100% PTV was older and presented with more advanced grade and stage. High PTV was significantly associated with greater risk of PSM, biochemical recurrence, PCSM, and overall mortality at 15 yr (<em>p</em> &lt; 0.001). In addition to high stage and grade, MPSM predicted PCSM in multivariate analysis, but lost predictive significance when PTV was included. Limitations of the study include the retrospective nature and the single-center setting.</div></div><div><h3>Conclusions and clinical implications</h3><div>Our study further challenges the belief that MPSMs inherently have an adverse impact on PCSM. Instead, MPSMs appear to signify more aggressive underlying disease that predominantly drives oncological outcomes. We recommend considering PTV as a more reliable predictor of PCSM. While avoidance of PSMs remains a critical surgical principle, this goal in prostate cancer needs to be weighed against urinary and sexual function outcomes.</div></div><div><h3>Patient summary</h3><div>After surgery to remove the prostate in men with prostate cancer, samples from the edge of the prostate that are positive for tumor cells are called positive surgical margins (PSMs). Results from our study show that a PSM on its own is not necessarily an adverse factor. However, PSMs may be a sign of higher severity of prostate cancer. We found that men with a high tumor volume have a higher risk of dying from their prostate cancer.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 187-192"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751535/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Cross-sectional Survey of Physicians to Understand Biomarker Testing and Treatment Patterns in Patients with Prostate Cancer in the USA, EU5, Japan, and China","authors":"Christian Gratzke ,&nbsp;Himani Aggarwal ,&nbsp;Jeri Kim ,&nbsp;Holly Chaignaud ,&nbsp;Sabine Oskar","doi":"10.1016/j.euros.2024.07.113","DOIUrl":"10.1016/j.euros.2024.07.113","url":null,"abstract":"<div><h3>Background and objective</h3><div>Treatment landscape in advanced prostate cancer (PC) is evolving. There is limited understanding of the factors influencing decision-making for genetic/genomic testing and the barriers to recommending testing and treatment in international real-world clinical practice following the approval of poly-adenosine diphosphate-ribose polymerase inhibitors (PARPi) for metastatic castration-resistant PC (mCRPC). This work aims to assess genetic/genomic testing patterns and methods, including for homologous recombination repair mutation (HRRm), and treatment decisions among physicians caring for patients with PC across the USA, Europe, and Asia.</div></div><div><h3>Methods</h3><div>A cross-sectional online survey of physicians treating patients with advanced PC was administered in the USA, France, Germany, Italy, Spain, UK, Japan, and China. Physicians were recruited (from August to December 2022) via clinical panels and provided informed consent. Survey questions covered factors influencing HRRm testing and treatment decision-making.</div></div><div><h3>Key findings and limitations</h3><div>Physicians reported that 50% of patients with mCRPC are recommended for HRRm testing, and among those recommended for testing, 60% are recommended for <em>BRCA1/2</em> mutation testing and 65% go on to receive HRRm testing. Overall proportions of patients recommended for testing increased following PARPi approval (from 20% to 50%) and following updated practice guidelines (from 25% to 50%). Perceived barriers to the use of genetic/genomic testing included patient refusal, lack of insurance/reimbursement, and lack of availability of adequate tissue for testing.</div></div><div><h3>Conclusions and clinical implications</h3><div>Overall, testing rates increased following PARPi approval and updated clinical practice guidelines; yet, there was a wide variation in the proportions of patients with mCRPC recommended for testing, and perceived barriers to testing remain, suggesting unmet needs for patients and physicians.</div></div><div><h3>Patient summary</h3><div>We surveyed physicians globally about their experience in treating patients with advanced prostate cancer and genetic testing. Physicians reported that half of patients are recommended for genetic testing, which varied across countries. We conclude that barriers to testing remain for patients and physicians.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 148-155"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751505/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a Novel Clinical Classification for Radiation-induced Cystitis: The Portuguese Navy Radiation-induced Cystitis (PNRC) Scale","authors":"Tiago Ribeiro de Oliveira ,&nbsp;Carla D’Espiney Amaro ,&nbsp;Sérgio Henriques Pereira ,&nbsp;Afonso Sousa Castro ,&nbsp;Pedro Gomes Monteiro ,&nbsp;João Cardoso Felício ,&nbsp;Guilherme Bernardo ,&nbsp;João Chambino ,&nbsp;José Palma dos Reis ,&nbsp;Chandra Shekhar Biyani","doi":"10.1016/j.euros.2024.12.006","DOIUrl":"10.1016/j.euros.2024.12.006","url":null,"abstract":"<div><h3>Background and objective</h3><div>Radiation-induced cystitis (RIC) is an important consequence of pelvic radiotherapy that can cause high morbidity and, in extreme cases, mortality. The lack of a widely accepted classification system makes it difficult to compare treatment regimens. Our aim was to develop a new classification system covering the RIC spectrum to improve treatment comparisons and accurate incidence estimates for systematic use in clinical and research settings.</div></div><div><h3>Methods</h3><div>A three-phase project was planned. Phase 1 involved a literature review and development of the Portuguese Navy Radiation-induced Cystitis (PNRC) scale. In phase 2 the scale was applied to 20 clinical cases. Phase 3 involved assessment of the applicability, relevance, inter-rater reliability, and usability of the scale using numerical and graphical methods to achieve consensus among international experts.</div></div><div><h3>Key findings and limitations</h3><div>In phase 1, the panel analysed 13 existing classification systems and developed the PNRC scale, a comprehensive system encompassing five clinical domains: haematuria, other lower urinary tract symptoms, functional impairment, endoscopic findings, and therapeutic interventions. In phase 2, 114 experts from 30 countries completed the first validation round. Consensus was reached for 85% of cases. In phase 3, consensus was reached among 61 experts on the relevance and appropriateness of each domain, and on the exhaustiveness, hierarchy, clarity, mutual exclusivity, and clinical utility of the PNRC scale. Study limitations are the inclusion of only Medline-indexed manuscripts in the review and minor dispersion of responses, indicating subjectivity in the analysis of clinical case scenarios.</div></div><div><h3>Conclusions and clinical implications</h3><div>The PNRC scale showed reliability and face and construct validity in the stratification of RIC severity for clinical cases.</div></div><div><h3>Patient summary</h3><div>Radiation-induced cystitis is a debilitating complication of pelvic radiotherapy. A uniform classification system is needed to assess the incidence of this disease and to compare the results for different treatment options. We developed the Portuguese Navy Radiation-induced Cystitis (PNRC) scale, which was validated by an independent group of experts from 30 different countries.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 193-199"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751575/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Men’s Attitudes Towards Participation in Organised Prostate Cancer Testing: An Abductive Thematic Analysis","authors":"Markus Arvendell ,&nbsp;Lottie Phillips ,&nbsp;Sara Delilovic ,&nbsp;Moa Backman Enelius ,&nbsp;Karin Olsson ,&nbsp;Anetta Bolejko ,&nbsp;Olof Akre ,&nbsp;Sigrid Carlsson ,&nbsp;Anne Richter ,&nbsp;Anna Lantz","doi":"10.1016/j.euros.2024.12.007","DOIUrl":"10.1016/j.euros.2024.12.007","url":null,"abstract":"<div><h3>Background and objective</h3><div>Organised prostate cancer (PCa) testing (OPT) was introduced in Sweden to gain knowledge in preparation for a potential national PCa screening programme. This study aims to explore men’s opinions regarding the OPT invitation letters and the attitudes influencing their decision to participate in or decline OPT.</div></div><div><h3>Methods</h3><div>We conducted semi-structured telephone interviews with 30 men (nine participants and 21 non-participants) from Stockholm County who received OPT invitations. We employed an abductive thematic analysis, a reflexive process of identifying theoretical explanations of emerging patterns, to identify themes in men’s responses.</div></div><div><h3>Key findings and limitations</h3><div>Informants found the invitation letters informative and appreciated the screening opportunity, but suggested improvements regarding conciseness and clarity about the risks and benefits of testing. Barriers to participation included lack of time or motivation, fear of discovering illness, inaccessibility, and distrust of health care or medical procedures. Facilitators included a desire to confirm or rule out PCa, and taking advantage of the available screening opportunity. Limitations include the study’s single-county focus and a potential recall bias affecting responses.</div></div><div><h3>Conclusions and clinical implications</h3><div>Men’s attitudes towards OPT participation are multifaceted. While men appreciate screening opportunities, practical considerations as well as personal and psychological factors influence their participation decisions. To improve informed decision-making, OPT communication should be clear about the benefits and risks, and accessibility and logistical challenges should be addressed. Enhancing understanding and reducing fears are essential for refining screening practices and aligning these with men’s needs.</div></div><div><h3>Patient summary</h3><div>Men value the option for prostate cancer screening, but face barriers such as low motivation and fear of a cancer diagnosis. Clear communication could improve their understanding of screening and encourage informed decision-making regarding participation in organised prostate cancer testing. Improved accessibility to testing could enhance participant opportunity.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 156-164"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11743549/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002805","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"5 The impact of haemostatic agent used during robot assisted radical prostatectomy on post-op infection and anastomotic leak","authors":"Krishnan J.,&nbsp;Gallagher K.,&nbsp;Sharma A.,&nbsp;Good D.,&nbsp;El-Koubani O.,&nbsp;Brennan R.,&nbsp;Taylor L.,&nbsp;McNeill A.","doi":"10.1016/S2666-1683(25)00036-9","DOIUrl":"10.1016/S2666-1683(25)00036-9","url":null,"abstract":"","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Page S4"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143092300","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment with Autologous Adipose-derived Regenerative Cells for Peyronie’s Disease in Men: The Straight @head Pilot Study","authors":"Majken H. Wiborg ,&nbsp;Rasmus Krøijer ,&nbsp;Birgitte S. Laursen ,&nbsp;Wahida Chakari ,&nbsp;Charlotte Harken Jensen ,&nbsp;Jens Ahm Sørensen ,&nbsp;Lars Lund","doi":"10.1016/j.euros.2024.12.005","DOIUrl":"10.1016/j.euros.2024.12.005","url":null,"abstract":"<div><h3>Background and objective</h3><div>We evaluated the effectiveness of injecting autologous adipose-derived regenerative cells (ADRCs) into plaque in men with chronic Peyronie’s disease (PD).</div></div><div><h3>Methods</h3><div>This pilot safety study recruited 22 Danish men with chronic PD from an outpatient clinic. Patients received one bolus of ADRCs injected into plaque, with follow-ups at 1, 3, 6, and 12 mo. The primary endpoint was a reduction in penile curvature. Secondary endpoints were serious adverse events in relation to treatment, and patient-reported results for improvements, distress, and unhappiness related to PD.</div></div><div><h3>Key findings and limitations</h3><div>There was no significant difference in curvature after treatment. However, the participants reported subjective improvements, less distress, and a decrease in unhappiness. No severe adverse events were observed during 12-mo follow-up.</div></div><div><h3>Conclusions and clinical implications</h3><div>Injections of ADRCs into PD plaque appear to be safe but had no significant measurable effect on penile curvature. Half of the participants reported a subjective improvement.</div></div><div><h3>Patient summary</h3><div>We studied the safety and effectiveness of injections of patient-derived regenerative cells for chronic Peyronie’s disease. While the curvature of the penis did not significantly improve, the treatment was safe and some men reported a decrease in their distress and an improvement in penile shape.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 180-186"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11751568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143022772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"28 Efficacy vs. cost effectiveness, a timely discussion in onco-urology","authors":"Malavaud B.","doi":"10.1016/S2666-1683(25)00032-1","DOIUrl":"10.1016/S2666-1683(25)00032-1","url":null,"abstract":"","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Page S32"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143140657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"21 FBXW7 loss-of-function is associated with worse overall survival and leads to the accumulation of MYC in muscle-invasive bladder cancer","authors":"Black P.,&nbsp;Matsumoto T.,&nbsp;Wang R.,&nbsp;Chen E.,&nbsp;Roberts M.,&nbsp;Reike M.,&nbsp;Ikeda K.,&nbsp;Oo H.Z.,&nbsp;Sano T.,&nbsp;LeBlanc E.,&nbsp;Singh K.,&nbsp;Gao J.,&nbsp;Moskalev I.,Contreras-Sanz A.","doi":"10.1016/S2666-1683(25)00025-4","DOIUrl":"10.1016/S2666-1683(25)00025-4","url":null,"abstract":"","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Page S24"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143092369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Alterations in DNA Damage Repair Genes Before and After Neoadjuvant Cisplatin-based Chemotherapy in Muscle-invasive Bladder Cancer","authors":"Ursula Lemberger ,&nbsp;Büsra Ernhofer ,&nbsp;Sigurd Krieger ,&nbsp;Andreas Bruchbacher ,&nbsp;André Oszwald ,&nbsp;Ekaterina Laukhtina ,&nbsp;Andrea Haitl ,&nbsp;Melanie R. Hassler ,&nbsp;Bernhard Englinger ,&nbsp;Eva Compérat ,&nbsp;Shahrokh F. Shariat","doi":"10.1016/j.euros.2024.10.022","DOIUrl":"10.1016/j.euros.2024.10.022","url":null,"abstract":"<div><h3>Background and objective</h3><div>The role of genetic variants in response to systemic therapy in muscle-invasive bladder cancer (MIBC) is still elusive. We assessed variations in genes involved in DNA damage repair (DDR) before and after cisplatin-based neoadjuvant chemotherapy (NAC) and correlation of alteration patterns with DNA damage and response to therapy.</div></div><div><h3>Methods</h3><div>Matched tissue from 46 patients with MIBC was investigated via Ion Torrent–based next-generation sequencing using a self-designed panel of 30 DDR genes. Phosphorylation of γ-histone 2A.X (H2AX) was analyzed via immunohistochemistry to evaluate DNA damage. Genetic variants were analyzed along with clinical data and quantitative phospho-H2AX data using the Kaplan-Meier method, Cox regression analysis, and factor analysis of mixed data.</div></div><div><h3>Key findings and limitations</h3><div>Twenty-five patients (54%) had a response (&lt;pT2 pN0 cM0) to NAC. Responders had more somatic DDR gene variants in preNAC (53 vs 11; <em>p</em> &lt; 0.001) and postNAC (51 vs 9; <em>p</em> = 0.038) tumor tissue in comparison to nonresponders, as well as significantly greater phosphorylation of H2AX after NAC. <em>ERCC2</em> was significantly co-mutated with <em>REV3L</em> among responders. Owing to the small cohort, no specific mutation was significantly positively associated with therapy response. However, accumulation of <em>CDK12</em>, <em>NBN</em>, <em>MSH3</em>, <em>MLH1</em>, <em>ATR</em>, <em>BRCA1</em>, <em>BRCA2</em>, <em>REVL3L</em>, and <em>SLX4</em> variants was observed for responders.</div></div><div><h3>Conclusions and clinical implications</h3><div>Patients with MIBC who responded to cisplatin-based NAC had more somatic DDR gene variants than nonresponders. Moreover, responders exhibited significantly greater DNA damage after NAC.</div></div><div><h3>Patient summary</h3><div>Patients with muscle-invasive bladder cancer who have mutations in genes that are involved in repair of DNA damage are more likely to respond to cisplatin-based chemotherapy. Testing to identify these gene mutations could help in selecting the patients who are most likely to benefit from this treatment.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 38-48"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664179/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advanced Restriction Imaging and Reconstruction Technology for Prostate Magnetic Resonance Imaging (ART-Pro): A Study Protocol for a Multicenter, Multinational Trial Evaluating Biparametric Magnetic Resonance Imaging and Advanced, Quantitative Diffusion Magnetic Resonance Imaging for the Detection of Prostate Cancer","authors":"Madison T. Baxter ,&nbsp;Christopher C. Conlin ,&nbsp;Aditya Bagrodia ,&nbsp;Tristan Barrett ,&nbsp;Hauke Bartsch ,&nbsp;Anja Brau ,&nbsp;Matthew Cooperberg ,&nbsp;Anders M. Dale ,&nbsp;Arnaud Guidon ,&nbsp;Michael E. Hahn ,&nbsp;Mukesh G. Harisinghani ,&nbsp;Juan F. Javier-DesLoges ,&nbsp;Sophia C. Kamran ,&nbsp;Christopher J. Kane ,&nbsp;Joshua M. Kuperman ,&nbsp;Daniel J.A. Margolis ,&nbsp;Paul M. Murphy ,&nbsp;Nabih Nakrour ,&nbsp;Michael A. Ohliger ,&nbsp;Rebecca Rakow-Penner ,&nbsp;Tyler M. Seibert","doi":"10.1016/j.euros.2024.12.003","DOIUrl":"10.1016/j.euros.2024.12.003","url":null,"abstract":"<div><div>Multiparametric magnetic resonance imaging (mpMRI) is strongly recommended by current clinical guidelines for improved detection of clinically significant prostate cancer (csPCa). However, the major limitations are the need for intravenous (IV) contrast and dependence on reader expertise. Efforts to address these issues include use of biparametric magnetic resonance imaging (bpMRI) and advanced, quantitative magnetic resonance imaging (MRI) techniques. One such advanced technique is the Restriction Spectrum Imaging restriction score (RSIrs), an imaging biomarker that has been shown to improve quantitative accuracy of patient-level csPCa detection. Advanced Restriction imaging and reconstruction Technology for Prostate MRI (ART-Pro) is a multisite, multinational trial that aims to evaluate whether IV contrast can be avoided in the setting of standardized, state-of-the-art image acquisition, with or without addition of RSIrs. Additionally, RSIrs will be evaluated as a stand-alone, quantitative, objective biomarker. ART-Pro will be conducted in two stages and will include a total of 500 patients referred for multiparametric prostate MRI with a clinical suspicion of prostate cancer at the participating sites. ART-Pro-1 will evaluate bpMRI, mpMRI, and RSIrs on the accuracy of expert radiologists’ detection of csPCa and will evaluate RSIrs as a stand-alone, quantitative, objective biomarker. ART-Pro-2 will evaluate the same MRI techniques on the accuracy of nonexpert radiologists’ detection of csPCa, and findings will be evaluated against the expertly created dataset from ART-Pro-1. The primary endpoint is to evaluate whether bpMRI is noninferior to mpMRI among expert (ART-Pro-1) and nonexpert (ART-Pro-2) radiologists for the detection of grade group ≥2 csPCa. This trial is registered in the US National Library of Medicine Trial Registry (NCT number: NCT06579417) at ClinicalTrials.gov. Patient accrual at the first site (UC San Diego) began in December 2023. Initial results are anticipated by the end of 2026.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"71 ","pages":"Pages 132-143"},"PeriodicalIF":3.2,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11730575/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142983254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}