Eric V Li, Anna M Busza, Mohammad R Siddiqui, Jonathan A Aguiar, Mary-Kate Keeter, Clayton Neill, Sai K Kumar, Xinlei Mi, Edward M Schaeffer, Hiten D Patel, Ashley E Ross
{"title":"Detection of clinically significant prostate cancer following initial omission of biopsy in multiparametric MRI era.","authors":"Eric V Li, Anna M Busza, Mohammad R Siddiqui, Jonathan A Aguiar, Mary-Kate Keeter, Clayton Neill, Sai K Kumar, Xinlei Mi, Edward M Schaeffer, Hiten D Patel, Ashley E Ross","doi":"10.1038/s41391-024-00853-9","DOIUrl":"https://doi.org/10.1038/s41391-024-00853-9","url":null,"abstract":"<p><strong>Background: </strong>Multiparametric prostate MRI (mpMRI) is being increasingly adopted for work-up of prostate cancer. For patients selected to omit biopsy, we identified factors associated with repeat MRI, eventual prostate biopsy, and subsequent detection of clinically significant prostate cancer (csPCa, Grade Group ≥2).</p><p><strong>Methods: </strong>We identified biopsy-naïve men presenting with PSA 2-20 ng/mL (March 2018-June 2021) undergoing initial mpMRI with PIRADS 1-3 lesions who were not selected for biopsy with ≥6 months follow-up. We examined factors associated with repeat mpMRI, progression to biopsy, and subsequent detection of csPCa with univariable and multivariable logistic regression.</p><p><strong>Results: </strong>Of 1494 men, 31% (463/1494) did not pursue biopsy. PSA density (PSAD) ≤ 0.1, prostate health index (PHI) < 55, and PIRADS 1-2 were associated with omission of prostate biopsy. csPCa diagnosis-free survival was 97.6% (326/334) with median follow up of 23.1 months (IQR 15.1-34.6 months). Black race, PSA, PHI, PSA density, and PSA and PHI velocity were significant predictors of undergoing repeat mpMRI (15.6%, 52/334) and subsequent biopsy (8.4%, 28/334). 8 men were subsequently diagnosed with csPCa (N = 7 on prostate biopsy; N = 1 incidentally on holmium enucleation of prostate). All patients diagnosed with csPCa had PIRADS 4-5 on repeat mpMRI.</p><p><strong>Conclusions: </strong>The subsequent detection rate of csPCa among patients not initially biopsied after mpMRI was low at 2.4%. Decisions to omit biopsy after initial reassuring PHI, PSAD, and mpMRI appear safe with subsequent reassuring serum biomarkers and for cause mpMRI during follow-up.</p>","PeriodicalId":20727,"journal":{"name":"Prostate Cancer and Prostatic Diseases","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141301442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Frederique B. Denijs, Meike J. van Harten, Jonas J. L. Meenderink, Renée C. A. Leenen, Sebastiaan Remmers, Lionne D. F. Venderbos, Roderick C. N. van den Bergh, Katharina Beyer, Monique J. Roobol
{"title":"Risk calculators for the detection of prostate cancer: a systematic review","authors":"Frederique B. Denijs, Meike J. van Harten, Jonas J. L. Meenderink, Renée C. A. Leenen, Sebastiaan Remmers, Lionne D. F. Venderbos, Roderick C. N. van den Bergh, Katharina Beyer, Monique J. Roobol","doi":"10.1038/s41391-024-00852-w","DOIUrl":"10.1038/s41391-024-00852-w","url":null,"abstract":"Prostate cancer (PCa) (early) detection poses significant challenges, including unnecessary testing and the risk of potential overdiagnosis. The European Association of Urology therefore suggests an individual risk-adapted approach, incorporating risk calculators (RCs) into the PCa detection pathway. In the context of ‘The PRostate Cancer Awareness and Initiative for Screening in the European Union’ (PRAISE-U) project ( https://uroweb.org/praise-u ), we aim to provide an overview of the currently available clinical RCs applicable in an early PCa detection algorithm. We performed a systematic review to identify RCs predicting detection of clinically significant PCa at biopsy. A search was performed in the databases Medline ALL, Embase, Web of Science Core Collection, Cochrane Central Register of Controlled Trials and Google Scholar for publications between January 2010 and July 2023. We retrieved relevant literature by using the terms “prostate cancer”, “screening/diagnosis” and “predictive model”. Inclusion criteria included systematic reviews, meta-analyses, and clinical trials. Exclusion criteria applied to studies involving pre-targeted high-risk populations, diagnosed PCa patients, or a sample sizes under 50 men. We identified 6474 articles, of which 140 were included after screening abstracts and full texts. In total, we identified 96 unique RCs. Among these, 45 underwent external validation, with 28 validated in multiple cohorts. Of the externally validated RCs, 17 are based on clinical factors, 19 incorporate clinical factors along with MRI details, 4 were based on blood biomarkers alone or in combination with clinical factors, and 5 included urinary biomarkers. The median AUC of externally validated RCs ranged from 0.63 to 0.93. This systematic review offers an extensive analysis of currently available RCs, their variable utilization, and performance within validation cohorts. RCs have consistently demonstrated their capacity to mitigate the limitations associated with early detection and have been integrated into modern practice and screening trials. Nevertheless, the lack of external validation data raises concerns about numerous RCs, and it is crucial to factor in this omission when evaluating whether a specific RC is applicable to one’s target population.","PeriodicalId":20727,"journal":{"name":"Prostate Cancer and Prostatic Diseases","volume":"27 3","pages":"544-557"},"PeriodicalIF":5.1,"publicationDate":"2024-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41391-024-00852-w.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141236990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrea Mari, Anna Cadenar, Sofia Giudici, Gemma Cianchi, Simone Albisinni, Riccardo Autorino, Fabrizio Di Maida, Giorgio Gandaglia, M Carmen Mir, Massimo Valerio, Giancarlo Marra, Fabio Zattoni, Lorenzo Bianchi, Riccardo Lombardo, Shahrokh F Shariat, Morgan Roupret, Matteo Bauckneht, Luca Vaggelli, Cosimo De Nunzio, Andrea Minervini
{"title":"A systematic review and meta-analysis to evaluate the diagnostic accuracy of PSMA PET/CT in the initial staging of prostate cancer.","authors":"Andrea Mari, Anna Cadenar, Sofia Giudici, Gemma Cianchi, Simone Albisinni, Riccardo Autorino, Fabrizio Di Maida, Giorgio Gandaglia, M Carmen Mir, Massimo Valerio, Giancarlo Marra, Fabio Zattoni, Lorenzo Bianchi, Riccardo Lombardo, Shahrokh F Shariat, Morgan Roupret, Matteo Bauckneht, Luca Vaggelli, Cosimo De Nunzio, Andrea Minervini","doi":"10.1038/s41391-024-00850-y","DOIUrl":"https://doi.org/10.1038/s41391-024-00850-y","url":null,"abstract":"<p><strong>Background: </strong>Positron Emission Tomography-Computed Tomography using Prostate-Specific Membrane Antigen (PSMA PET/CT) is notable for its superior sensitivity and specificity in detecting recurrent PCa and is under investigation for its potential in pre-treatment staging. Despite its established efficacy in nodal and metastasis staging in trial setting, its role in primary staging awaits fuller validation due to limited evidence on oncologic outcomes. This systematic review and meta-analysis aims to appraise the diagnostic accuracy of PSMA PET/CT compared to CI for comprehensive PCa staging.</p><p><strong>Methods: </strong>Medline, Scopus and Web of science databases were searched till March 2023. Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines were followed to identify eligible studies. Primary outcomes were specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV) of PSMA PET/CT for local, nodal and metastatic staging in PCa patients. Due to the unavailability of data, a meta-analysis was feasible only for detection of seminal vesicles invasion (SVI) and LNI.</p><p><strong>Results: </strong>A total of 49 studies, comprising 3876 patients, were included. Of these, 6 investigated accuracy of PSMA PET/CT in detection of SVI. Pooled sensitivity, specificity, PPV and NPV were 42.29% (95%CI: 29.85-55.78%), 87.59% (95%CI: 77.10%-93.67%), 93.39% (95%CI: 74.95%-98.52%) and 86.60% (95%CI: 58.83%-96.69%), respectively. Heterogeneity analysis revealed significant variability for PPV and NPV. 18 studies investigated PSMA PET/CT accuracy in detection of LNI. Aggregate sensitivity, specificity, PPV and NPV were 43.63% (95%CI: 34.19-53.56%), 85.55% (95%CI: 75.95%-91.74%), 67.47% (95%CI: 52.42%-79.6%) and 83.61% (95%CI: 79.19%-87.24%). No significant heterogeneity was found between studies.</p><p><strong>Conclusions: </strong>The present systematic review and meta-analysis highlights PSMA PET-CT effectiveness in detecting SVI and its good accuracy in LNI compared to CI. Nonetheless, it also reveals a lack of high-quality research on its performance in clinical T staging, extraprostatic extension and distant metastasis evaluation, emphasizing the need for further rigorous studies.</p>","PeriodicalId":20727,"journal":{"name":"Prostate Cancer and Prostatic Diseases","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141184394","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andrew W Hahn, Efstratios Koutroumpakis, Vivek Narayan, Ana Aparicio
{"title":"The need for precision medicine in managing cardiovascular risk for men receiving ADT.","authors":"Andrew W Hahn, Efstratios Koutroumpakis, Vivek Narayan, Ana Aparicio","doi":"10.1038/s41391-024-00848-6","DOIUrl":"https://doi.org/10.1038/s41391-024-00848-6","url":null,"abstract":"","PeriodicalId":20727,"journal":{"name":"Prostate Cancer and Prostatic Diseases","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141154159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Letter to the editor: \"Incidence of prostate cancer in transgender women in the US: a large database analysis.\"","authors":"Wayne R Lawrence, Carl G Streed","doi":"10.1038/s41391-024-00846-8","DOIUrl":"10.1038/s41391-024-00846-8","url":null,"abstract":"","PeriodicalId":20727,"journal":{"name":"Prostate Cancer and Prostatic Diseases","volume":" ","pages":""},"PeriodicalIF":5.1,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11576484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141071857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jacob S Hershenhouse, Daniel Mokhtar, Michael B Eppler, Severin Rodler, Lorenzo Storino Ramacciotti, Conner Ganjavi, Brian Hom, Ryan J Davis, John Tran, Giorgio Ivan Russo, Andrea Cocci, Andre Abreu, Inderbir Gill, Mihir Desai, Giovanni E Cacciamani
{"title":"Accuracy, readability, and understandability of large language models for prostate cancer information to the public.","authors":"Jacob S Hershenhouse, Daniel Mokhtar, Michael B Eppler, Severin Rodler, Lorenzo Storino Ramacciotti, Conner Ganjavi, Brian Hom, Ryan J Davis, John Tran, Giorgio Ivan Russo, Andrea Cocci, Andre Abreu, Inderbir Gill, Mihir Desai, Giovanni E Cacciamani","doi":"10.1038/s41391-024-00826-y","DOIUrl":"https://doi.org/10.1038/s41391-024-00826-y","url":null,"abstract":"<p><strong>Background: </strong>Generative Pretrained Model (GPT) chatbots have gained popularity since the public release of ChatGPT. Studies have evaluated the ability of different GPT models to provide information about medical conditions. To date, no study has assessed the quality of ChatGPT outputs to prostate cancer related questions from both the physician and public perspective while optimizing outputs for patient consumption.</p><p><strong>Methods: </strong>Nine prostate cancer-related questions, identified through Google Trends (Global), were categorized into diagnosis, treatment, and postoperative follow-up. These questions were processed using ChatGPT 3.5, and the responses were recorded. Subsequently, these responses were re-inputted into ChatGPT to create simplified summaries understandable at a sixth-grade level. Readability of both the original ChatGPT responses and the layperson summaries was evaluated using validated readability tools. A survey was conducted among urology providers (urologists and urologists in training) to rate the original ChatGPT responses for accuracy, completeness, and clarity using a 5-point Likert scale. Furthermore, two independent reviewers evaluated the layperson summaries on correctness trifecta: accuracy, completeness, and decision-making sufficiency. Public assessment of the simplified summaries' clarity and understandability was carried out through Amazon Mechanical Turk (MTurk). Participants rated the clarity and demonstrated their understanding through a multiple-choice question.</p><p><strong>Results: </strong>GPT-generated output was deemed correct by 71.7% to 94.3% of raters (36 urologists, 17 urology residents) across 9 scenarios. GPT-generated simplified layperson summaries of this output was rated as accurate in 8 of 9 (88.9%) scenarios and sufficient for a patient to make a decision in 8 of 9 (88.9%) scenarios. Mean readability of layperson summaries was higher than original GPT outputs ([original ChatGPT v. simplified ChatGPT, mean (SD), p-value] Flesch Reading Ease: 36.5(9.1) v. 70.2(11.2), <0.0001; Gunning Fog: 15.8(1.7) v. 9.5(2.0), p < 0.0001; Flesch Grade Level: 12.8(1.2) v. 7.4(1.7), p < 0.0001; Coleman Liau: 13.7(2.1) v. 8.6(2.4), 0.0002; Smog index: 11.8(1.2) v. 6.7(1.8), <0.0001; Automated Readability Index: 13.1(1.4) v. 7.5(2.1), p < 0.0001). MTurk workers (n = 514) rated the layperson summaries as correct (89.5-95.7%) and correctly understood the content (63.0-87.4%).</p><p><strong>Conclusion: </strong>GPT shows promise for correct patient education for prostate cancer-related contents, but the technology is not designed for delivering patients information. Prompting the model to respond with accuracy, completeness, clarity and readability may enhance its utility when used for GPT-powered medical chatbots.</p>","PeriodicalId":20727,"journal":{"name":"Prostate Cancer and Prostatic Diseases","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140922930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mayuko Kanayama, Hua-Ling Tsai, Hao Wang, Emmanuel S Antonarakis, Samuel R Denmeade, Jun Luo
{"title":"Baseline serum testosterone and differential efficacy of bipolar androgen therapy and enzalutamide in the randomized TRANSFORMER trial.","authors":"Mayuko Kanayama, Hua-Ling Tsai, Hao Wang, Emmanuel S Antonarakis, Samuel R Denmeade, Jun Luo","doi":"10.1038/s41391-024-00844-w","DOIUrl":"https://doi.org/10.1038/s41391-024-00844-w","url":null,"abstract":"<p><p>Bipolar androgen therapy (BAT) is effective in a subset of metastatic castration-resistant prostate cancer (mCRPC) patients. Treatment selection biomarkers are needed due to other therapies that can be equally efficacious. We performed post-hoc analysis to determine whether baseline serum testosterone (T) is a treatment selection marker in the TRANSFORMER study, a randomized trial of abiraterone-pretreated mCRPC patients assigned to BAT (n = 94) or enzalutamide (n = 101). The findings suggest that patients with poor outcomes to abiraterone and serum T ≥ 20 ng/dL may benefit preferentially from BAT over enzalutamide. Baseline testosterone could be considered in the treatment selection process when BAT is an option.</p>","PeriodicalId":20727,"journal":{"name":"Prostate Cancer and Prostatic Diseases","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140877183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Leslie Claire Licari, Eugenio Bologna, Celeste Manfredi, Antonio Franco, Francesco Ditonno, Cosimo De Nunzio, Alessandro Antonelli, Giuseppe Simone, Marco De Sio, Luca Cindolo, Ephrem O. Olweny, Edward E. Cherullo, Costantino Leonardo, Riccardo Autorino
{"title":"Incidence and management of BPH surgery-related urethral stricture: results from a large U.S. database","authors":"Leslie Claire Licari, Eugenio Bologna, Celeste Manfredi, Antonio Franco, Francesco Ditonno, Cosimo De Nunzio, Alessandro Antonelli, Giuseppe Simone, Marco De Sio, Luca Cindolo, Ephrem O. Olweny, Edward E. Cherullo, Costantino Leonardo, Riccardo Autorino","doi":"10.1038/s41391-024-00841-z","DOIUrl":"10.1038/s41391-024-00841-z","url":null,"abstract":"Urethral stricture (US) is a well-known complication after surgical treatment of benign prostatic hyperplasia (BPH). This study aimed to evaluate the contemporary incidence of the US after different types of BPH surgery, to identify associated risk factors and to assess its management. A retrospective analysis was conducted using the PearlDiver™ Mariner database, containing de-identified patient records compiled between 2011 and 2022. Specific International Classification of Diseases (ICD) and Current Procedural Terminology (CPT) codes were employed to identify population characteristics and outcomes. All the most employed surgical procedures for BPH treatment were considered. Multivariable logistic regression was employed to evaluate factors associated with diagnosis of post-operative US. Among 274,808 patients who underwent BPH surgery, 10,918 developed post-operative US (3.97%) within 12 months. Higher incidence of US was observed following TURP (4.48%), Transurethral Incision of the Prostate (TUIP) (3.67%), Photoselective Vaporization of the Prostate (PVP) (3.92%), HoLEP/ThuLEP (3.85%), and open Simple Prostatectomy (SP) (3.21%). Lower incidence rates were observed after laparoscopicrobot-assisted SP (1.76%), Aquablation (1.59%), Prostatic Urethral Lift (PUL) (1.07%), Rezum (1.05%), and Prostatic Artery Embolization (PAE) (0.65%). Multivariable analysis showed that patients undergoing PUL, Rezum, Aquablation, PAE, and PVP were associated with a reduced likelihood of developing US compared to TURP. US required surgical treatment in 18.95% of patients, with direct visual internal urethrotomy (DVIU) and urethroplasty performed in 14.55% and 4.50% of cases, respectively. Urethral dilatation (UD) in an outpatient setting was the primary management in most cases (76.7%). The present analysis from a contemporary large dataset suggests that the incidence of US after BPH surgery is relatively low (<5%) and varies among procedures. Around 94% of US cases following BPH surgery are managed using minimally invasive treatment approaches such as UD and DVIU.","PeriodicalId":20727,"journal":{"name":"Prostate Cancer and Prostatic Diseases","volume":"27 3","pages":"537-543"},"PeriodicalIF":5.1,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140877184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Steven A. Kaplan, Jared L. Moss, Sheldon J. Freedman
{"title":"Two-year long-term follow-up of treatment with the Optilume BPH catheter system in a randomized controlled trial for benign prostatic hyperplasia (The PINNACLE Study)","authors":"Steven A. Kaplan, Jared L. Moss, Sheldon J. Freedman","doi":"10.1038/s41391-024-00833-z","DOIUrl":"10.1038/s41391-024-00833-z","url":null,"abstract":"Patient outcomes were assessed 2 years after treatment with the Optilume BPH Catheter System, a minimally invasive surgical therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). One-hundred forty-eight adult males with symptomatic BPH were enrolled and randomized in a 2:1 fashion to Optilume BPH or Sham (100 Optilume BPH; 48 Sham). Long-term measures include International Prostate Symptom Score (IPSS), peak urinary flow rate (Qmax), Post-Void Residual Urine (PVR), quality of life measures and sexual function. Follow-up beyond one year was limited to those treated with Optilume BPH. At 2 years, 67.5% (56/83 CI 56.3%, 77.4%) of participants in the Optilume BPH arm were symptomatic responders as defined by ≥30% improvement in IPSS without medical or surgical retreatment. IPSS significantly improved from 23.4 ± 5.5 (n = 100) to 11.0 ± 7.0 (n = 74). Qmax improved by 116.8.% (8.9 ± 2.2 (n = 97) to 19.0 ± 16.3 (n = 65)), while PVR showed a slight reduction (83.7 ± 70.3 (n = 99) to 65.9 ± 74.5 (n = 65)). Improvement in uroflowmetry measures was consistent across all prostate volumes. BPH-II improved from 7.0 ± 2.9 (n = 98) to 2.3 ± 2.5 at 1 year (n = 89) and remained consistent at 2.3 ± 2.9 at the 2-years (n = 74), representing a 53.9% improvement. IPSS QoL also improved from 4.6 ± 1.3 (n = 100) at baseline to 2.2 ± 1.5 (n = 74). The most common adverse events reported in the Optilume BPH arm were hematuria and urinary tract infection (UTI). No device and/or treatment related serious adverse events were reported occurring beyond 12 months post-procedure. There was no impact to sexual function. In the PINNACLE study, participants treated with the Optilume BPH Catheter System demonstrated continued and durable results at 2 years, affirming tolerability, safety, and the enduring effectiveness. The Optilume BPH Catheter System provides lasting results that are comparable to the more invasive therapies, while preserving the advantages with being a minimally invasive therapy. ClinicalTrials.gov NCT04131907.","PeriodicalId":20727,"journal":{"name":"Prostate Cancer and Prostatic Diseases","volume":"27 3","pages":"531-536"},"PeriodicalIF":5.1,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41391-024-00833-z.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140812095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}