Pub Date : 2025-12-15DOI: 10.1097/ju.0000000000004896
Steven A Kaplan,Sijo J Parekattil,Ning Z Wu,Brian Mazzarella,Michael Trotter,Sheldon Freedman,Samuel Lawindy,Raviender Bukkapatnam,Bradley F Schwartz,Barry Jones,Prithipal Sethi,Mark Jalkut,John S Liu,Dean Elterman,Edward Gheiler,Ricardo R Gonzalez,Jed Kaminetsky,Jay A Motola,Alexis Te,Christopher Chapple,Lori Lerner,Thomas Lynch
PURPOSEThe ProVee System for BPH is a new generation permanent prostatic urethral stent for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. ProVIDE is a prospective, randomized, double-blind, sham controlled study evaluating the safety and effectiveness of ProVee against a sham procedure.MATERIALS AND METHODSMen at least 45 years of age were eligible for the study if they had International Prostate Symptom Score ≥13, peak urinary flow rate <12ml/s, prostate volume 30-80 cc, and prostatic urethral length ≥3.75cm. Primary effectiveness endpoints were a mean improvement in International Prostate Symptom Score at 3 months and 12 months. Symptomatic improvement, uroflowmetry, quality of life and sexual function were assessed at follow-up.RESULTSA total of 221 participants were randomized 2:1 (150 ProVee, 71 sham) at 15 centers in the US and 2 centers outside the US. Treatments were performed in an ambulatory surgery center or office setting and required no catheterization post-procedure. Intention-to-treat analyses showed a >25% mean improvement in International Prostate Symptom Score over sham at 3 months (9.5 versus 5.6, p=0.001) and a >30% mean improvement from baseline to 12 months in the ProVee arm (37.8%, p=0.002). There were no device or procedure related serious adverse events through 12 months and no incidence of de novo sustained retrograde ejaculation or erectile dysfunction.CONCLUSIONSTreatment with ProVee was reliably performed and resulted in a statistically superior improvement in IPSS at 3 months compared to a sham procedure with sustained response at 12 months.
目的ProVee System for BPH是新一代永久性前列腺尿道支架用于治疗良性前列腺增生继发的下尿路症状。提供是一项前瞻性、随机、双盲、假对照研究，评估ProVee对假手术的安全性和有效性。材料和方法至少45岁的男性符合研究条件，如果他们的国际前列腺症状评分≥13,3个月时国际前列腺症状评分的峰值尿流率比sham平均改善25%(9.5比5.6,p=0.001)，并且ProVee组从基线到12个月的平均改善bbb30 % （37.8%, p=0.002）。在12个月内，没有器械或手术相关的严重不良事件，也没有新发持续性逆行射精或勃起功能障碍的发生率。结论ProVee治疗是可靠的，在3个月时IPSS的改善在统计学上优于假手术，在12个月时持续缓解。
{"title":"12-Month Outcomes from a Randomized, Sham Controlled Trial Evaluating a Novel Prostatic Urethral Stent for the Treatment of Benign Prostatic Hyperplasia.","authors":"Steven A Kaplan,Sijo J Parekattil,Ning Z Wu,Brian Mazzarella,Michael Trotter,Sheldon Freedman,Samuel Lawindy,Raviender Bukkapatnam,Bradley F Schwartz,Barry Jones,Prithipal Sethi,Mark Jalkut,John S Liu,Dean Elterman,Edward Gheiler,Ricardo R Gonzalez,Jed Kaminetsky,Jay A Motola,Alexis Te,Christopher Chapple,Lori Lerner,Thomas Lynch","doi":"10.1097/ju.0000000000004896","DOIUrl":"https://doi.org/10.1097/ju.0000000000004896","url":null,"abstract":"PURPOSEThe ProVee System for BPH is a new generation permanent prostatic urethral stent for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. ProVIDE is a prospective, randomized, double-blind, sham controlled study evaluating the safety and effectiveness of ProVee against a sham procedure.MATERIALS AND METHODSMen at least 45 years of age were eligible for the study if they had International Prostate Symptom Score ≥13, peak urinary flow rate <12ml/s, prostate volume 30-80 cc, and prostatic urethral length ≥3.75cm. Primary effectiveness endpoints were a mean improvement in International Prostate Symptom Score at 3 months and 12 months. Symptomatic improvement, uroflowmetry, quality of life and sexual function were assessed at follow-up.RESULTSA total of 221 participants were randomized 2:1 (150 ProVee, 71 sham) at 15 centers in the US and 2 centers outside the US. Treatments were performed in an ambulatory surgery center or office setting and required no catheterization post-procedure. Intention-to-treat analyses showed a >25% mean improvement in International Prostate Symptom Score over sham at 3 months (9.5 versus 5.6, p=0.001) and a >30% mean improvement from baseline to 12 months in the ProVee arm (37.8%, p=0.002). There were no device or procedure related serious adverse events through 12 months and no incidence of de novo sustained retrograde ejaculation or erectile dysfunction.CONCLUSIONSTreatment with ProVee was reliably performed and resulted in a statistically superior improvement in IPSS at 3 months compared to a sham procedure with sustained response at 12 months.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"77 1","pages":"101097JU0000000000004896"},"PeriodicalIF":0.0,"publicationDate":"2025-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145752577","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-09DOI: 10.1097/ju.0000000000004862
Peter N Schlegel,Joseph Y Clark,R Matthew Coward,Steven J Hirshberg,Stanton Honig,Wayland Hsiao,Erin Kirkby,Michel Labrecque,Richard Lee,Jonathan Stack,Cigdem Tanrikut,Peter Tiffany,Jonathan R Treadwell,Sarah C Vij,Akanksha Mehta
PURPOSEThis Guideline aims to provide a contemporary overview of options for future fertility following vasectomy. See Part I of this series for information on indications for vasectomy, pre-operative counseling and preparation, peri-operative considerations, procedural techniques, potential risks and complications, and post-operative care.MATERIALS AND METHODOLOGYA comprehensive search of the literature was performed and covered articles published between January 1, 1990 and January 30, 2024. Relevant study designs included randomized controlled trials, controlled clinical trials, and observational studies (cohort with and without comparison group, case-control). Systematic reviews were searched for as an additional resource to identify any relevant studies with the designs noted above that may not have been captured in the literature search.RESULTSThe Panel developed evidence- and consensus-based statements based on a comprehensive systematic review of the literature. Recommendations for restoration of fertility following vasectomy are detailed herein.CONCLUSIONWhile this Guideline provides a summary of the current evidence related to vasectomy reversal and other fertility options after vasectomy, future review will be required as knowledge in this space continues to evolve. The unabridged version of this Guideline is available at auanet.org.
{"title":"Fertility Restoration After Vasectomy: AUA Guideline Part II.","authors":"Peter N Schlegel,Joseph Y Clark,R Matthew Coward,Steven J Hirshberg,Stanton Honig,Wayland Hsiao,Erin Kirkby,Michel Labrecque,Richard Lee,Jonathan Stack,Cigdem Tanrikut,Peter Tiffany,Jonathan R Treadwell,Sarah C Vij,Akanksha Mehta","doi":"10.1097/ju.0000000000004862","DOIUrl":"https://doi.org/10.1097/ju.0000000000004862","url":null,"abstract":"PURPOSEThis Guideline aims to provide a contemporary overview of options for future fertility following vasectomy. See Part I of this series for information on indications for vasectomy, pre-operative counseling and preparation, peri-operative considerations, procedural techniques, potential risks and complications, and post-operative care.MATERIALS AND METHODOLOGYA comprehensive search of the literature was performed and covered articles published between January 1, 1990 and January 30, 2024. Relevant study designs included randomized controlled trials, controlled clinical trials, and observational studies (cohort with and without comparison group, case-control). Systematic reviews were searched for as an additional resource to identify any relevant studies with the designs noted above that may not have been captured in the literature search.RESULTSThe Panel developed evidence- and consensus-based statements based on a comprehensive systematic review of the literature. Recommendations for restoration of fertility following vasectomy are detailed herein.CONCLUSIONWhile this Guideline provides a summary of the current evidence related to vasectomy reversal and other fertility options after vasectomy, future review will be required as knowledge in this space continues to evolve. The unabridged version of this Guideline is available at auanet.org.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"30 1","pages":"101097JU0000000000004862"},"PeriodicalIF":0.0,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145704415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-09DOI: 10.1097/ju.0000000000004890
Neal D Shore,Martin Gleave,Ugo De Giorgi,Antti Rannikko,Christopher M Pieczonka,Swetha Sridharan,Klaus Brasso,Henry H Woo,Antonio Gómez Caamaño,Jeff W Saranchuk,Luke T Nordquist,Ubirajara Ferreira,Yiyun Tang,Brad Rosbrook,Gabriel P Haas,Matt Rosales,Fabian Zohren,Jamal Tarazi,Stephen J Freedland
PURPOSEThe primary analysis of EMBARK reported improved metastasis-free survival for enzalutamide plus leuprolide (enzalutamide combination) vs leuprolide plus placebo (leuprolide alone) in patients with high-risk biochemical recurrence (BCR) while maintaining quality of life. Here, we present secondary efficacy endpoints for enzalutamide combination vs leuprolide alone.MATERIALS AND METHODSEMBARK is a global, multicenter, randomized, controlled, phase 3 trial. Patients were randomized (1:1:1) to enzalutamide combination, leuprolide alone, or enzalutamide monotherapy. Non-key secondary endpoints reported herein include time to: distant metastasis, resumption of any hormonal therapy, castration resistance, symptomatic progression, and first symptomatic skeletal event. Hormonal treatment-related symptoms were assessed using the Quality of Life Questionnaire-Prostate 25. Time-to-event endpoints were summarized using the Kaplan-Meier method, with nominal P-values.RESULTSEnzalutamide combination vs leuprolide alone was associated with increased 5-year probabilities (95% CI) for remaining free of: distant metastasis (91.0% [87.1‒93.7] vs 81.5% [76.3-85.7]), resumption of any hormonal therapy after treatment suspension (14.9% [10.8-19.6] vs 7.8% [4.4-12.3]), castration resistance (96.6% [93.9-98.1] vs 67.8% [62.4-72.6]), symptomatic progression (70.9% [65.5-75.6] vs 53.3% [47.6-58.6]), and first symptomatic skeletal event (97.8% [95.4-98.9] vs 91.5% [87.8-94.1]). Time to confirmed clinically meaningful deterioration of hormonal treatment-related symptoms favored leuprolide alone vs enzalutamide combination, although the median difference was small (0.03 months).CONCLUSIONSCombined with the primary findings from EMBARK, data from non-key secondary efficacy endpoints strengthen support for enzalutamide combination as a new standard of care for patients with high-risk BCR.CLINICAL TRIAL REGISTRATION NUMBERNCT02319837.
{"title":"Treatment of High-Risk Biochemically Recurrent Prostate Cancer With Enzalutamide in Combination With Leuprolide: Secondary Endpoints From the EMBARK Trial.","authors":"Neal D Shore,Martin Gleave,Ugo De Giorgi,Antti Rannikko,Christopher M Pieczonka,Swetha Sridharan,Klaus Brasso,Henry H Woo,Antonio Gómez Caamaño,Jeff W Saranchuk,Luke T Nordquist,Ubirajara Ferreira,Yiyun Tang,Brad Rosbrook,Gabriel P Haas,Matt Rosales,Fabian Zohren,Jamal Tarazi,Stephen J Freedland","doi":"10.1097/ju.0000000000004890","DOIUrl":"https://doi.org/10.1097/ju.0000000000004890","url":null,"abstract":"PURPOSEThe primary analysis of EMBARK reported improved metastasis-free survival for enzalutamide plus leuprolide (enzalutamide combination) vs leuprolide plus placebo (leuprolide alone) in patients with high-risk biochemical recurrence (BCR) while maintaining quality of life. Here, we present secondary efficacy endpoints for enzalutamide combination vs leuprolide alone.MATERIALS AND METHODSEMBARK is a global, multicenter, randomized, controlled, phase 3 trial. Patients were randomized (1:1:1) to enzalutamide combination, leuprolide alone, or enzalutamide monotherapy. Non-key secondary endpoints reported herein include time to: distant metastasis, resumption of any hormonal therapy, castration resistance, symptomatic progression, and first symptomatic skeletal event. Hormonal treatment-related symptoms were assessed using the Quality of Life Questionnaire-Prostate 25. Time-to-event endpoints were summarized using the Kaplan-Meier method, with nominal P-values.RESULTSEnzalutamide combination vs leuprolide alone was associated with increased 5-year probabilities (95% CI) for remaining free of: distant metastasis (91.0% [87.1‒93.7] vs 81.5% [76.3-85.7]), resumption of any hormonal therapy after treatment suspension (14.9% [10.8-19.6] vs 7.8% [4.4-12.3]), castration resistance (96.6% [93.9-98.1] vs 67.8% [62.4-72.6]), symptomatic progression (70.9% [65.5-75.6] vs 53.3% [47.6-58.6]), and first symptomatic skeletal event (97.8% [95.4-98.9] vs 91.5% [87.8-94.1]). Time to confirmed clinically meaningful deterioration of hormonal treatment-related symptoms favored leuprolide alone vs enzalutamide combination, although the median difference was small (0.03 months).CONCLUSIONSCombined with the primary findings from EMBARK, data from non-key secondary efficacy endpoints strengthen support for enzalutamide combination as a new standard of care for patients with high-risk BCR.CLINICAL TRIAL REGISTRATION NUMBERNCT02319837.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"60 1","pages":"101097JU0000000000004890"},"PeriodicalIF":0.0,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145710874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PURPOSEHemostatic agents (HA) are typically used during robotic-assisted laparoscopic partial nephrectomy (RALPN) to minimize perioperative bleeding. However, high-quality evidence supporting their effectiveness is limited. We aimed to determine whether HA reduce perioperative blood loss in patients undergoing RALPN.METHODSWe conducted a prospective, randomized controlled trial of patients undergoing RALPN. Patients were randomized to HA+, in which HA were assigned, and HA-, no HA. The primary endpoint was mean change in hemoglobin from preoperative baseline to postoperative day 1. Secondary outcomes included major bleeding complications (blood transfusion, reoperation and endovascular intervention), length of stay and 30-day readmission.RESULTSA total of 208 patients were randomized, and 178 patients were included in the final modified intention-to-treat analysis (88 HA-, 90 HA+). Mean hemoglobin decrease was 1.7 g/dL (95% CI: 1.4-2.0) in the HA- group and 1.8 g/dL (95% CI: 1.4-2.1) in the HA+ group (p = 0.5, 95% CI for group difference: (0.26) - 0.48). The mean estimated blood loss in the HA- group was 116 cc (95% CI: 96-136) and in the HA+ group was 114 cc (95% CI: 88-140) (p-value=0.3). We found no significant difference in major bleeding complications (p-value =0.7, 95% CI for group difference: (-5.4%)-9.8%), as four patients (4.5%) in the HA- group and six patients (6.7%) in the HA+ experienced major bleeding complications.CONCLUSIONSRoutine use of hemostatic agents during RALPN does not appear to lower the risk for bleeding following surgery, as measured by the change in hemoglobin levels or major bleeding complications.
{"title":"Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-Assisted Laparoscopic Partial Nephrectomy.","authors":"Alon Lazarovich,Samuel Tremblay,Charlie Nottingham,Hernan Lescay,David Nusbaum,Caleb Cooper,Craig Labbate,Suki Bristol,Theodore Karrison,Arieh L Shalhav,Scott Eggener","doi":"10.1097/ju.0000000000004889","DOIUrl":"https://doi.org/10.1097/ju.0000000000004889","url":null,"abstract":"PURPOSEHemostatic agents (HA) are typically used during robotic-assisted laparoscopic partial nephrectomy (RALPN) to minimize perioperative bleeding. However, high-quality evidence supporting their effectiveness is limited. We aimed to determine whether HA reduce perioperative blood loss in patients undergoing RALPN.METHODSWe conducted a prospective, randomized controlled trial of patients undergoing RALPN. Patients were randomized to HA+, in which HA were assigned, and HA-, no HA. The primary endpoint was mean change in hemoglobin from preoperative baseline to postoperative day 1. Secondary outcomes included major bleeding complications (blood transfusion, reoperation and endovascular intervention), length of stay and 30-day readmission.RESULTSA total of 208 patients were randomized, and 178 patients were included in the final modified intention-to-treat analysis (88 HA-, 90 HA+). Mean hemoglobin decrease was 1.7 g/dL (95% CI: 1.4-2.0) in the HA- group and 1.8 g/dL (95% CI: 1.4-2.1) in the HA+ group (p = 0.5, 95% CI for group difference: (0.26) - 0.48). The mean estimated blood loss in the HA- group was 116 cc (95% CI: 96-136) and in the HA+ group was 114 cc (95% CI: 88-140) (p-value=0.3). We found no significant difference in major bleeding complications (p-value =0.7, 95% CI for group difference: (-5.4%)-9.8%), as four patients (4.5%) in the HA- group and six patients (6.7%) in the HA+ experienced major bleeding complications.CONCLUSIONSRoutine use of hemostatic agents during RALPN does not appear to lower the risk for bleeding following surgery, as measured by the change in hemoglobin levels or major bleeding complications.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"29 1","pages":"101097JU0000000000004889"},"PeriodicalIF":0.0,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145704360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-05DOI: 10.1097/ju.0000000000004880
Michael Uy,Golena Fernandez Moncaleano,Casey Dauw
{"title":"A Pragmatic Approach to Imaging After Ureteroscopy: Lessons from the MUSIC Statewide Collaborative.","authors":"Michael Uy,Golena Fernandez Moncaleano,Casey Dauw","doi":"10.1097/ju.0000000000004880","DOIUrl":"https://doi.org/10.1097/ju.0000000000004880","url":null,"abstract":"","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"95 Suppl 1","pages":"101097JU0000000000004880"},"PeriodicalIF":0.0,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145680605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-05DOI: 10.1097/ju.0000000000004879
Neal D Shore,Ugo De Giorgi,Ronald F Tutrone,James L Bailen,Erik Pm Roos,Ján Kliment,Gavin Marx,Lawrence I Karsh,Miguel Ramirez-Backhaus,Edward M Uchio,Stéphane Supiot,Yiyun Tang,Brad Rosbrook,Gabriel P Haas,Matt Rosales,Fabian Zohren,Jamal Tarazi,Stephen J Freedland
PURPOSEPrimary analysis of the phase 3 EMBARK trial reported efficacy and safety outcomes for enzalutamide monotherapy in patients with high-risk biochemical recurrence. Here, we report secondary endpoints for enzalutamide monotherapy vs leuprolide alone.MATERIALS AND METHODSPatients were randomized (1:1:1) to enzalutamide plus leuprolide, leuprolide alone, or enzalutamide monotherapy. Overall survival was a key secondary endpoint; non-key secondary endpoints were time to: distant metastasis, symptomatic progression, first symptomatic skeletal event, and resumption of any hormonal therapy. Sexual health was assessed using the Quality of Life Questionnaire-Prostate 25. Time-to-event endpoints were summarized using Kaplan-Meier methods with nominal P-values.RESULTSFive-year probability rates (95% CI) for enzalutamide monotherapy vs leuprolide alone were: overall survival: 89.5% [85.6-92.4] vs 87.2% [83.0-90.4]); time to remaining free from distant metastasis: 86.8% [82.3-90.2] vs 81.5% [76.3-85.7], symptomatic progression: 66.6% [61.2-71.4] vs 53.3% [47.6-58.6], and first symptomatic skeletal event: 95.8% [92.9-97.6] vs 91.5% [87.8-94.1]. Following treatment suspension, the 5-year probability rate (95% CI) of remaining free from resumption of any hormonal therapy for leuprolide alone vs enzalutamide monotherapy was 7.8% [4.4-12.3] vs 5.6% [3.3-8.8]). Sexual health was better preserved in patients treated with enzalutamide monotherapy than leuprolide alone (HR 0.76; 95% CI 0.62-0.94; P=0.008). Following discontinuation, most patients were subsequently treated with hormonal therapies in both groups.CONCLUSIONSSecondary endpoint results support enzalutamide monotherapy as a potential option to improve efficacy and preserve sexual health vs leuprolide alone for patients with high-risk biochemical recurrence.CLINICAL TRIAL REGISTRATION NUMBERNCT02319837.
{"title":"Enzalutamide Monotherapy for the Treatment of Prostate Cancer With High-Risk Biochemical Recurrence: EMBARK Secondary Endpoints.","authors":"Neal D Shore,Ugo De Giorgi,Ronald F Tutrone,James L Bailen,Erik Pm Roos,Ján Kliment,Gavin Marx,Lawrence I Karsh,Miguel Ramirez-Backhaus,Edward M Uchio,Stéphane Supiot,Yiyun Tang,Brad Rosbrook,Gabriel P Haas,Matt Rosales,Fabian Zohren,Jamal Tarazi,Stephen J Freedland","doi":"10.1097/ju.0000000000004879","DOIUrl":"https://doi.org/10.1097/ju.0000000000004879","url":null,"abstract":"PURPOSEPrimary analysis of the phase 3 EMBARK trial reported efficacy and safety outcomes for enzalutamide monotherapy in patients with high-risk biochemical recurrence. Here, we report secondary endpoints for enzalutamide monotherapy vs leuprolide alone.MATERIALS AND METHODSPatients were randomized (1:1:1) to enzalutamide plus leuprolide, leuprolide alone, or enzalutamide monotherapy. Overall survival was a key secondary endpoint; non-key secondary endpoints were time to: distant metastasis, symptomatic progression, first symptomatic skeletal event, and resumption of any hormonal therapy. Sexual health was assessed using the Quality of Life Questionnaire-Prostate 25. Time-to-event endpoints were summarized using Kaplan-Meier methods with nominal P-values.RESULTSFive-year probability rates (95% CI) for enzalutamide monotherapy vs leuprolide alone were: overall survival: 89.5% [85.6-92.4] vs 87.2% [83.0-90.4]); time to remaining free from distant metastasis: 86.8% [82.3-90.2] vs 81.5% [76.3-85.7], symptomatic progression: 66.6% [61.2-71.4] vs 53.3% [47.6-58.6], and first symptomatic skeletal event: 95.8% [92.9-97.6] vs 91.5% [87.8-94.1]. Following treatment suspension, the 5-year probability rate (95% CI) of remaining free from resumption of any hormonal therapy for leuprolide alone vs enzalutamide monotherapy was 7.8% [4.4-12.3] vs 5.6% [3.3-8.8]). Sexual health was better preserved in patients treated with enzalutamide monotherapy than leuprolide alone (HR 0.76; 95% CI 0.62-0.94; P=0.008). Following discontinuation, most patients were subsequently treated with hormonal therapies in both groups.CONCLUSIONSSecondary endpoint results support enzalutamide monotherapy as a potential option to improve efficacy and preserve sexual health vs leuprolide alone for patients with high-risk biochemical recurrence.CLINICAL TRIAL REGISTRATION NUMBERNCT02319837.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"93 1","pages":"101097JU0000000000004879"},"PeriodicalIF":0.0,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145680607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-25DOI: 10.1097/ju.0000000000004864
Daniel A González-Padilla,José Daniel Subiela,Felipe Villacampa-Aubá
{"title":"Immune checkpoint inhibitors for high-risk non-muscle invasive bladder cancer: Lessons learnt from the CREST and POTOMAC trials.","authors":"Daniel A González-Padilla,José Daniel Subiela,Felipe Villacampa-Aubá","doi":"10.1097/ju.0000000000004864","DOIUrl":"https://doi.org/10.1097/ju.0000000000004864","url":null,"abstract":"","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"147 1","pages":"101097JU0000000000004864"},"PeriodicalIF":0.0,"publicationDate":"2025-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145599953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PURPOSEThe combined targeted and systematic biopsy (CTSBx) was the standard scheme for patients with visible suspicious lesions on MRI in recent years. 2024 European Association of Urology (EAU) guideline recommended targeted and perilesional biopsy (TPLBx) for the diagnosis of patients with MRI visible suspicious lesions. This RCT aims to comprehensively evaluate the efficacy and safety profiles of TPLBx and CTSBx schemes.MATERIALS AND METHODSA single-center non-inferiority RCT (NCT06482658) consecutively enrolled 380 biopsy-naïve patients (CTSBx: n=190, TPLBx: n=190) with a single unilateral suspicious lesion on prostate MRI from June 2024 to November 2024. The non-inferiority margin was -15%. All biopsies were undertaken transrectally through the cognitive fusion technique. The primary outcome was Grade Group (GG) ≥2 cancer (GG≥2-PCa) detection rate.RESULTSThe GG≥2-PCa [58% vs 58%, risk difference (RD): 0.53% (95%CI: -9.4%-11%)], and GG≥3-PCa [30% vs 30%, RD: 0.53% (95%CI: -8.7%-9.7%)] detection rates of TPLBx were non-inferior to that of CTSBx (p<0.001). There was no significant difference in PCa and GG1-PCa detection rates between the two groups (p>0.050). The complication rate of TPLBx was significantly lower than that of CTSBx group (Clavien-Dindo scale≥1: 62% vs 74%, p=0.023), especially for bleeding-related complications (rectal bleeding: 34% vs 48%, p=0.003; hematuria, 39% vs 56%, p<0.001) and rectal pain (25% vs 34%, p=0.018). TPLBx could significantly shorten the procedure time and saved the pathological cost (p<0.001).CONCLUSIONSFor patients with a single unilateral suspicious lesion on prostate MRI, TPLBx achieved the non-inferior diagnostic efficacy of csPCa and better safety than the CTSBx scheme.
目的靶向与系统联合活检（CTSBx）是近年来MRI上可见可疑病变患者的标准方案。2024年欧洲泌尿外科协会（EAU）指南推荐针对MRI可见可疑病变的患者进行靶向和病灶周围活检（TPLBx）诊断。本随机对照试验旨在综合评价TPLBx和CTSBx方案的疗效和安全性。材料与方法一项单中心非劣劣性随机对照试验（NCT06482658）于2024年6月至2024年11月连续入组380例biopsy-naïve患者（CTSBx: n=190, TPLBx: n=190），均为单侧前列腺MRI可疑病变。非劣效性边际为-15%。所有活检均通过认知融合技术经直肠进行。主要终点为GG≥2级组癌（GG≥2- pca）检出率。结果TPLBx的GG≥2-PCa [58% vs 58%，风险差（RD）： 0.53% (95%CI: -9.4% ~ 11%)]和GG≥3-PCa [30% vs 30%， RD: 0.53% (95%CI: -8.7% ~ 9.7%)]的检出率均不低于CTSBx （p0.050）。TPLBx组的并发症发生率明显低于CTSBx组（Clavien-Dindo量表≥1:62% vs 74%， p=0.023），尤其是出血相关并发症（直肠出血：34% vs 48%， p=0.003；血尿：39% vs 56%， p<0.001）和直肠疼痛（25% vs 34%, p=0.018）。TPLBx可显著缩短手术时间，节约病理费用（p<0.001）。结论对于单侧前列腺MRI可疑病灶患者，TPLBx方案的诊断效果优于csPCa方案，且安全性优于CTSBx方案。
{"title":"Comprehensive evaluation of targeted and perilesional biopsy in biopsy-naïve patients with prostate positive MRI: PERI-PRO non-inferiority randomized controlled trial.","authors":"Ruiyi Deng,Derun Li,Jingyun Wu,Shaojuan Tian,Qi Shen,Shuai Hu,Meixia Shang,Jianhui Qiu,Jiaheng Shang,Jingcheng Zhou,Lin Cai,Yi Liu,Kan Gong","doi":"10.1097/ju.0000000000004863","DOIUrl":"https://doi.org/10.1097/ju.0000000000004863","url":null,"abstract":"PURPOSEThe combined targeted and systematic biopsy (CTSBx) was the standard scheme for patients with visible suspicious lesions on MRI in recent years. 2024 European Association of Urology (EAU) guideline recommended targeted and perilesional biopsy (TPLBx) for the diagnosis of patients with MRI visible suspicious lesions. This RCT aims to comprehensively evaluate the efficacy and safety profiles of TPLBx and CTSBx schemes.MATERIALS AND METHODSA single-center non-inferiority RCT (NCT06482658) consecutively enrolled 380 biopsy-naïve patients (CTSBx: n=190, TPLBx: n=190) with a single unilateral suspicious lesion on prostate MRI from June 2024 to November 2024. The non-inferiority margin was -15%. All biopsies were undertaken transrectally through the cognitive fusion technique. The primary outcome was Grade Group (GG) ≥2 cancer (GG≥2-PCa) detection rate.RESULTSThe GG≥2-PCa [58% vs 58%, risk difference (RD): 0.53% (95%CI: -9.4%-11%)], and GG≥3-PCa [30% vs 30%, RD: 0.53% (95%CI: -8.7%-9.7%)] detection rates of TPLBx were non-inferior to that of CTSBx (p<0.001). There was no significant difference in PCa and GG1-PCa detection rates between the two groups (p>0.050). The complication rate of TPLBx was significantly lower than that of CTSBx group (Clavien-Dindo scale≥1: 62% vs 74%, p=0.023), especially for bleeding-related complications (rectal bleeding: 34% vs 48%, p=0.003; hematuria, 39% vs 56%, p<0.001) and rectal pain (25% vs 34%, p=0.018). TPLBx could significantly shorten the procedure time and saved the pathological cost (p<0.001).CONCLUSIONSFor patients with a single unilateral suspicious lesion on prostate MRI, TPLBx achieved the non-inferior diagnostic efficacy of csPCa and better safety than the CTSBx scheme.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"165 1","pages":"101097JU0000000000004863"},"PeriodicalIF":0.0,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145568148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-21DOI: 10.1097/ju.0000000000004848
Gal Wald,Jacob Lang,Hassan Alkazemi,Ao Zhang,Malik Wahba,Manish Kuchakulla,Gopa Iyer,Eugene Pietzak
PURPOSEBacillus Calmette-Guérin (BCG) is the standard of care therapy for high-risk non-muscle invasive bladder cancer (NMIBC). However, up to half of patients will experience treatment failure, and many face considerable adverse effects which can lead to dose reduction and intolerance. Novel bladder-sparing approaches with favorable risk-to-benefit ratio are thus critical in NMIBC.MATERIALS AND METHODSA narrative review of the literature was performed of English-language MEDLINE indexed articles and abstracts of resistance mechanisms to BCG and combination-based strategies to enhance the efficacy of BCG intravesical therapy in high-risk NMIBC.RESULTSTreatment options for high-risk NMIBC have expanded considerably over the last few years. Combination strategies represent an opportunity to enhance the effectiveness of BCG and promote durable response. Combination therapies that aim to reduce immunosuppressive cellular populations (regulatory T-cells, myeloid derived suppressor cells) and immune checkpoint blockade offer mechanisms to overcome resistance to BCG therapy. Chemoimmunotherapy and immunotherapy-based combinations represent a bladder preservation strategy that needs to be weighed against oncological efficacy, toxicity, and cost-effectiveness.CONCLUSIONSBCG-based combination therapies have emerged as a strategy to overcome BCG resistance and promote durable responses. Despite their promise, combination design is endless, and adoption remains challenging due to overlapping mechanisms of resistance, adverse events associated with systemic therapy and/or additional intravesical therapy, and financial burden. Long term multi-arm trials are needed for direct comparative analyses between combinations of agents to inform oncological efficacy, safety profile and cost-effectiveness.
{"title":"Combination Strategies to Enhance Bacillus Calmette-Guérin Efficacy for Non-Muscle Invasive Bladder Cancer.","authors":"Gal Wald,Jacob Lang,Hassan Alkazemi,Ao Zhang,Malik Wahba,Manish Kuchakulla,Gopa Iyer,Eugene Pietzak","doi":"10.1097/ju.0000000000004848","DOIUrl":"https://doi.org/10.1097/ju.0000000000004848","url":null,"abstract":"PURPOSEBacillus Calmette-Guérin (BCG) is the standard of care therapy for high-risk non-muscle invasive bladder cancer (NMIBC). However, up to half of patients will experience treatment failure, and many face considerable adverse effects which can lead to dose reduction and intolerance. Novel bladder-sparing approaches with favorable risk-to-benefit ratio are thus critical in NMIBC.MATERIALS AND METHODSA narrative review of the literature was performed of English-language MEDLINE indexed articles and abstracts of resistance mechanisms to BCG and combination-based strategies to enhance the efficacy of BCG intravesical therapy in high-risk NMIBC.RESULTSTreatment options for high-risk NMIBC have expanded considerably over the last few years. Combination strategies represent an opportunity to enhance the effectiveness of BCG and promote durable response. Combination therapies that aim to reduce immunosuppressive cellular populations (regulatory T-cells, myeloid derived suppressor cells) and immune checkpoint blockade offer mechanisms to overcome resistance to BCG therapy. Chemoimmunotherapy and immunotherapy-based combinations represent a bladder preservation strategy that needs to be weighed against oncological efficacy, toxicity, and cost-effectiveness.CONCLUSIONSBCG-based combination therapies have emerged as a strategy to overcome BCG resistance and promote durable responses. Despite their promise, combination design is endless, and adoption remains challenging due to overlapping mechanisms of resistance, adverse events associated with systemic therapy and/or additional intravesical therapy, and financial burden. Long term multi-arm trials are needed for direct comparative analyses between combinations of agents to inform oncological efficacy, safety profile and cost-effectiveness.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"42 1","pages":"101097JU0000000000004848"},"PeriodicalIF":0.0,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145568149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-11-21DOI: 10.1097/ju.0000000000004855
Ryan Allen,Vivian Liu,June M Chan,Rebecca Graff,Meir J Stampfer,William J Aronson,Stacey A Kenfield
OBJECTIVETo determine whether post-diagnosis dietary patterns, lifestyle scores, and related indices are associated with prostate cancer (PCa) clinical outcomes, with the goal of informing evidence-based strategies for survivorship and secondary prevention.PARTICIPANTSAdult men (≥18 years) diagnosed with PCa.OUTCOME MEASURESClinical trials and cohort studies reporting on PCa progression, recurrence, PCa-specific mortality (PCSM), and PSA kinetics. All-cause mortality (ACM) was considered only when accompanied by PCa-specific endpoints.INFORMATION SOURCESPubMed, Embase and the Cochrane Library were searched from January 1, 2005 to May 3, 2025. Eligible studies assessed individual-level post-diagnosis diet or lifestyle exposures using diet or composite indices. Titles and abstracts were screened by two independent reviewers, with full texts of eligible studies assessed in duplicate.RESULTSA total of 21 studies were included.Although not all studies agree, several studies suggest that eating plant foods, adopting healthful diets and lifestyle patterns (as defined herein), and minimizing consumption of inflammatory foods and those with higher insulinemic potential may potentially lower the risk of PCa progression and PCSM. The data also indicate that following Mediterranean, Healthy Eating Index, and Prudent dietary patterns, healthy behaviors, and World Cancer Research Fund/American Institute of Cancer Research recommendations are associated with lower risk of ACM, while the Western dietary pattern and eating foods with higher insulinemic potential are associated with increased risk of ACM.CONCLUSIONCurrent evidence suggests that healthy dietary practices combined with healthy lifestyle behaviors (not smoking, regular physical activity, maintaining a healthy weight) may reduce PCa progression and ACM, with some evidence reported for PCSM. Additional robust cohort and interventional studies with longer follow-up and a greater number of PCSM events are needed. Consideration should be given to incorporating principles of healthy diet and lifestyle as part of PCa survivorship care. A summary Table with diet and lifestyle recommendations is provided for health-care providers.
{"title":"Effect of Post-Diagnosis Diet and Lifestyle on Clinical Outcomes in Prostate Cancer Survivors: A Systematic Review.","authors":"Ryan Allen,Vivian Liu,June M Chan,Rebecca Graff,Meir J Stampfer,William J Aronson,Stacey A Kenfield","doi":"10.1097/ju.0000000000004855","DOIUrl":"https://doi.org/10.1097/ju.0000000000004855","url":null,"abstract":"OBJECTIVETo determine whether post-diagnosis dietary patterns, lifestyle scores, and related indices are associated with prostate cancer (PCa) clinical outcomes, with the goal of informing evidence-based strategies for survivorship and secondary prevention.PARTICIPANTSAdult men (≥18 years) diagnosed with PCa.OUTCOME MEASURESClinical trials and cohort studies reporting on PCa progression, recurrence, PCa-specific mortality (PCSM), and PSA kinetics. All-cause mortality (ACM) was considered only when accompanied by PCa-specific endpoints.INFORMATION SOURCESPubMed, Embase and the Cochrane Library were searched from January 1, 2005 to May 3, 2025. Eligible studies assessed individual-level post-diagnosis diet or lifestyle exposures using diet or composite indices. Titles and abstracts were screened by two independent reviewers, with full texts of eligible studies assessed in duplicate.RESULTSA total of 21 studies were included.Although not all studies agree, several studies suggest that eating plant foods, adopting healthful diets and lifestyle patterns (as defined herein), and minimizing consumption of inflammatory foods and those with higher insulinemic potential may potentially lower the risk of PCa progression and PCSM. The data also indicate that following Mediterranean, Healthy Eating Index, and Prudent dietary patterns, healthy behaviors, and World Cancer Research Fund/American Institute of Cancer Research recommendations are associated with lower risk of ACM, while the Western dietary pattern and eating foods with higher insulinemic potential are associated with increased risk of ACM.CONCLUSIONCurrent evidence suggests that healthy dietary practices combined with healthy lifestyle behaviors (not smoking, regular physical activity, maintaining a healthy weight) may reduce PCa progression and ACM, with some evidence reported for PCSM. Additional robust cohort and interventional studies with longer follow-up and a greater number of PCSM events are needed. Consideration should be given to incorporating principles of healthy diet and lifestyle as part of PCa survivorship care. A summary Table with diet and lifestyle recommendations is provided for health-care providers.","PeriodicalId":501636,"journal":{"name":"The Journal of Urology","volume":"32 1","pages":"101097JU0000000000004855"},"PeriodicalIF":0.0,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145568153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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