The diagnostic roles of serum percentage α2,3-linked sialylated prostate-specific antigen (S2,3PSA%) and the Prostate Health Index (PHI) in predicting clinically significant prostate cancer (csPC) remain unclear in the context of magnetic resonance imaging (MRI)-guided biopsy. Our aim was to evaluate the associations of S2,3PSA% and PHI with csPC and to develop an internally validated nomogram that integrates these biomarkers with prostate MRI.
Methods
This retrospective single-center study included 248 consecutive men who underwent both S2,3PSA% and PHI testing, followed by MRI-ultrasound fusion targeted biopsy between October 2018 and July 2025. We used multivariable logistic regression models to identify predictors of csPC (Gleason ≥7). Internal validation was conducted with 1000 bootstrap resamples to estimate optimism and calculate the optimism-corrected area under the receiver operating characteristic curve (AUC), calibration slope, and Brier score. Decision curve analysis (DCA) was used to assess the clinical net benefit of the nomogram.
Key findings and limitations
Among 248 patients, csPC was detected in 111 (45%). Age, S2,3PSA%, and Prostate Imaging-Reporting and Data System (PI-RADS) score were independent predictors of csPC. The nomogram achieved an apparent AUC of 0.857. Internal bootstrap validation yielded an optimism-corrected AUC of 0.783, calibration slope of 0.911, and Brier score of 0.139, which confirm good model discrimination and calibration. DCA demonstrated a clear net benefit for the nomogram across clinically relevant threshold probabilities. The single-center design and lack of external validation limit the generalizability of our results.
Conclusions and clinical implications
Integration of S2,3PSA%, PHI, and PI-RADS scores provides incremental diagnostic utility for csPC detection. Internally validated models suggested better discrimination on integration of these biomarkers with MRI. However, these findings are exploratory and require external validation.
Patient summary
We found that combining blood biomarkers called S2,3PSA% and the Prostate Health Index with MRI (magnetic resonance imaging) scan findings improved prediction of whether a patient has prostate cancer. Larger studies are needed to confirm our results.
{"title":"Integrated Assessment of Percentage α2,3-Linked Sialylated Prostate-specific Antigen and the Prostate Health Index with Magnetic Resonance Imaging for Detection of Clinically Significant Prostate Cancer","authors":"Takuya Oishi , Tohru Yoneyama , Yuki Miura , Tomoko Hamaya , Hirotake Kodama , Takuma Narita , Jotaro Mikami , Naoki Fujita , Teppei Okamoto , Hayato Yamamoto , Atsushi Imai , Chikara Ohyama , Shingo Hatakeyama","doi":"10.1016/j.euros.2025.12.012","DOIUrl":"10.1016/j.euros.2025.12.012","url":null,"abstract":"<div><h3>Background and objective</h3><div>The diagnostic roles of serum percentage α2,3-linked sialylated prostate-specific antigen (S2,3PSA%) and the Prostate Health Index (PHI) in predicting clinically significant prostate cancer (csPC) remain unclear in the context of magnetic resonance imaging (MRI)-guided biopsy. Our aim was to evaluate the associations of S2,3PSA% and PHI with csPC and to develop an internally validated nomogram that integrates these biomarkers with prostate MRI.</div></div><div><h3>Methods</h3><div>This retrospective single-center study included 248 consecutive men who underwent both S2,3PSA% and PHI testing, followed by MRI-ultrasound fusion targeted biopsy between October 2018 and July 2025. We used multivariable logistic regression models to identify predictors of csPC (Gleason ≥7). Internal validation was conducted with 1000 bootstrap resamples to estimate optimism and calculate the optimism-corrected area under the receiver operating characteristic curve (AUC), calibration slope, and Brier score. Decision curve analysis (DCA) was used to assess the clinical net benefit of the nomogram.</div></div><div><h3>Key findings and limitations</h3><div>Among 248 patients, csPC was detected in 111 (45%). Age, S2,3PSA%, and Prostate Imaging-Reporting and Data System (PI-RADS) score were independent predictors of csPC. The nomogram achieved an apparent AUC of 0.857. Internal bootstrap validation yielded an optimism-corrected AUC of 0.783, calibration slope of 0.911, and Brier score of 0.139, which confirm good model discrimination and calibration. DCA demonstrated a clear net benefit for the nomogram across clinically relevant threshold probabilities. The single-center design and lack of external validation limit the generalizability of our results.</div></div><div><h3>Conclusions and clinical implications</h3><div>Integration of S2,3PSA%, PHI, and PI-RADS scores provides incremental diagnostic utility for csPC detection. Internally validated models suggested better discrimination on integration of these biomarkers with MRI. However, these findings are exploratory and require external validation.</div></div><div><h3>Patient summary</h3><div>We found that combining blood biomarkers called S2,3PSA% and the Prostate Health Index with MRI (magnetic resonance imaging) scan findings improved prediction of whether a patient has prostate cancer. Larger studies are needed to confirm our results.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"83 ","pages":"Pages 158-165"},"PeriodicalIF":4.5,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145836773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-26DOI: 10.1016/j.euros.2025.12.006
Ingunn Roth , Christian Beisland , Karin M. Hjelle , Christian Arvei Moen , Elisabeth Grov Beisland , Patrick Juliebø-Jones
Background and objective
Insertion of an artificial urinary sphincter (AUS) is the reference treatment for stress urinary incontinence (SUI) after radical prostatectomy (RP). Although long-term outcomes have been characterised, data on decisional regret remain limited. Our aim was to evaluate decisional regret, quality of life, and the symptom burden among men with an AUS in this setting.
Methods
After ethics approval for the study, all men who had undergone RP and subsequent AUS implantation at a tertiary centre between 2012 and 2023 were identified and contacted by post. The men were invited to complete a series of validated questionnaires: Expanded Prostate Cancer Index Composite (EPIC-26), Decisional Regret Scale (DRS), and Hospital Anxiety and Depression Scale (HADS). The overall response rate was 87.5% (n = 91), with median follow-up of 82 mo (interquartile range 49–100).
Key findings and limitations
Pad use significantly improved postoperatively but worsened over time; however, it remained better than at baseline. Higher pad counts correlated with higher depression scores. Overall, 35% of men reported no decisional regret, 34% mild regret, 30% moderate regret, and 1.3% severe regret. Reoperation was the only independent predictor of regret (+18 points on DRS; p = 0.001). Better continence scores correlated with lower anxiety and depression, while scores for bowel and hormonal domains also influenced psychological wellbeing.
Conclusions and clinical implications
AUS implantation provides a durable improvement in continence and psychological health for men with post-RP SUI. However, outcomes may deteriorate over time, and the need for reoperation is a significant driver of decisional regret.
Patient summary
We asked men who received an artificial urinary sphincter to treat urinary leakage after prostate surgery to complete questionnaires on their quality of life. Most men reported lasting improvements. Repeat sphincter surgery was linked to more regret, which shows the importance of long-term follow-up and counselling.
{"title":"Decisional Regret and Long-term Quality of Life After Artificial Urinary Sphincter Implantation Following Radical Prostatectomy","authors":"Ingunn Roth , Christian Beisland , Karin M. Hjelle , Christian Arvei Moen , Elisabeth Grov Beisland , Patrick Juliebø-Jones","doi":"10.1016/j.euros.2025.12.006","DOIUrl":"10.1016/j.euros.2025.12.006","url":null,"abstract":"<div><h3>Background and objective</h3><div>Insertion of an artificial urinary sphincter (AUS) is the reference treatment for stress urinary incontinence (SUI) after radical prostatectomy (RP). Although long-term outcomes have been characterised, data on decisional regret remain limited. Our aim was to evaluate decisional regret, quality of life, and the symptom burden among men with an AUS in this setting.</div></div><div><h3>Methods</h3><div>After ethics approval for the study, all men who had undergone RP and subsequent AUS implantation at a tertiary centre between 2012 and 2023 were identified and contacted by post. The men were invited to complete a series of validated questionnaires: Expanded Prostate Cancer Index Composite (EPIC-26), Decisional Regret Scale (DRS), and Hospital Anxiety and Depression Scale (HADS). The overall response rate was 87.5% (<em>n</em> = 91), with median follow-up of 82 mo (interquartile range 49–100).</div></div><div><h3>Key findings and limitations</h3><div>Pad use significantly improved postoperatively but worsened over time; however, it remained better than at baseline. Higher pad counts correlated with higher depression scores. Overall, 35% of men reported no decisional regret, 34% mild regret, 30% moderate regret, and 1.3% severe regret. Reoperation was the only independent predictor of regret (+18 points on DRS; <em>p</em> = 0.001). Better continence scores correlated with lower anxiety and depression, while scores for bowel and hormonal domains also influenced psychological wellbeing.</div></div><div><h3>Conclusions and clinical implications</h3><div>AUS implantation provides a durable improvement in continence and psychological health for men with post-RP SUI. However, outcomes may deteriorate over time, and the need for reoperation is a significant driver of decisional regret.</div></div><div><h3>Patient summary</h3><div>We asked men who received an artificial urinary sphincter to treat urinary leakage after prostate surgery to complete questionnaires on their quality of life. Most men reported lasting improvements. Repeat sphincter surgery was linked to more regret, which shows the importance of long-term follow-up and counselling.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"83 ","pages":"Pages 185-190"},"PeriodicalIF":4.5,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145836768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-26DOI: 10.1016/j.euros.2025.12.010
Mathieu Fourel , Nicolas Morel-Journel , Lionel Badet , Alain Ruffion , Damien Carnicelli , Philippe Chaffanjon , Gaelle Fiard , Samuel Airoldi , Fabien Boucher , Paul Neuville
Background and objective
Our aim was to assess the reproducibility of en bloc penile harvesting with a focus on the vascular structures to determine whether the procedure could be performed while preserving critical vascular supply.
Methods
A single-center, prospective cadaver study was conducted from November 2023 to October 2024 using 15 male cadavers, a number determined a priori. The main outcome criterion was successful harvesting and transplantation. This was defined as a harvest that included the entire corpora cavernosa, the urethra up to the subprostatic region, the pudendal nerves, the external pudendal arteries to their origin, the external pudendal veins to their termination, and the internal pudendal arteries to their origin, the deep dorsal vein. Transplantation was considered successful if arterial, venous, urethral, and nerve anastomoses were possible.
Key findings and limitations
Thirteen harvests were deemed successful and were associated with 13 transplantations. The external pudendal vessels were anastomosed to the superficial femoral artery, the great saphenous vein, or one of its accessory branches. The internal pudendal artery was anastomosed to either the external iliac artery or the deep inferior epigastric artery. The urethra, pudendal nerves, and deep dorsal vein were anastomosed with their respective counterparts in the recipient. The main study limitation is the cadaver setting.
Conclusions and clinical implications
Our study confirms that harvesting of the entire penile structure—including the external pudendal vessels, deep dorsal vein, pudendal nerves, internal pudendal arteries, and urethra—is both feasible and reproducible in a cadaver model. Furthermore, use of such a graft appears to be anatomically achievable.
Patient summary
In a cadaver study, we demonstrated that our technique for harvesting the entire penis is feasible and reproducible. This could expand the range of conditions for which a penis transplant is possible.
{"title":"Penis “En Bloc”: From Reproducible Harvesting to Transplantation in a Cadaver study","authors":"Mathieu Fourel , Nicolas Morel-Journel , Lionel Badet , Alain Ruffion , Damien Carnicelli , Philippe Chaffanjon , Gaelle Fiard , Samuel Airoldi , Fabien Boucher , Paul Neuville","doi":"10.1016/j.euros.2025.12.010","DOIUrl":"10.1016/j.euros.2025.12.010","url":null,"abstract":"<div><h3>Background and objective</h3><div>Our aim was to assess the reproducibility of en bloc penile harvesting with a focus on the vascular structures to determine whether the procedure could be performed while preserving critical vascular supply.</div></div><div><h3>Methods</h3><div>A single-center, prospective cadaver study was conducted from November 2023 to October 2024 using 15 male cadavers, a number determined a priori. The main outcome criterion was successful harvesting and transplantation. This was defined as a harvest that included the entire corpora cavernosa, the urethra up to the subprostatic region, the pudendal nerves, the external pudendal arteries to their origin, the external pudendal veins to their termination, and the internal pudendal arteries to their origin, the deep dorsal vein. Transplantation was considered successful if arterial, venous, urethral, and nerve anastomoses were possible.</div></div><div><h3>Key findings and limitations</h3><div>Thirteen harvests were deemed successful and were associated with 13 transplantations. The external pudendal vessels were anastomosed to the superficial femoral artery, the great saphenous vein, or one of its accessory branches. The internal pudendal artery was anastomosed to either the external iliac artery or the deep inferior epigastric artery. The urethra, pudendal nerves, and deep dorsal vein were anastomosed with their respective counterparts in the recipient. The main study limitation is the cadaver setting.</div></div><div><h3>Conclusions and clinical implications</h3><div>Our study confirms that harvesting of the entire penile structure—including the external pudendal vessels, deep dorsal vein, pudendal nerves, internal pudendal arteries, and urethra—is both feasible and reproducible in a cadaver model. Furthermore, use of such a graft appears to be anatomically achievable.</div></div><div><h3>Patient summary</h3><div>In a cadaver study, we demonstrated that our technique for harvesting the entire penis is feasible and reproducible. This could expand the range of conditions for which a penis transplant is possible.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"83 ","pages":"Pages 152-157"},"PeriodicalIF":4.5,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145836775","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-22DOI: 10.1016/j.euros.2025.12.003
Fabio Zattoni , Pawel Rajwa , Veeru Kasivisvanathan , Lara Rodriguez Sanchez , Tamás Fazekas , Felix Preisser , Claudia Kesch , Alberto Martini , Giuseppe Reitano , August Sigle , Jonathan Olivier , Rossella Nicoletti , Rui Bernardino , Isabel Heidegger , Lorenzo Bianchi , Matteo Bauckneht , Francesco Giganti , Alexander Giesen , Timo Soeterik , Roderick van den Bergh , Giancarlo Marra
<div><h3>Background and objective</h3><div>Pelvic lymph node dissection (PLND) is considered the most reliable method for managing prostate cancer (PCa). However, the role of PLND remains controversial in both clinical practice and guideline recommendations. This study aims to characterize contemporary practices and attitudes related to extended and/or limited PLND in PCa management during radical prostatectomy (RP).</div></div><div><h3>Methods</h3><div>A cross-sectional survey was conducted from February to May 2025. The survey was disseminated through the official mailing lists of several prominent urological societies worldwide. Multivariable logistic regression models were used to identify the predictors of the performance and perceived benefits of PLND in high-risk PCa patients, considering clinical, institutional, and practitioner-related factors.</div></div><div><h3>Key findings and limitations</h3><div>Our survey of 438 urologists revealed that 80% always perform PLND in European Association of Urology (EAU) high-risk patients during RP, while 18% do so selectively and only 2.6% never do. Among high-risk, prostate-specific membrane antigen (PSMA) positron emission tomography (PET)–negative patients, 53% opt for extended PLND and 39% for standard PLND. The remaining 7.6% either undergo limited/unilateral PLND or do not receive it at all. Notably, only 22% believe in the therapeutic benefit of extended PLND in high-risk PSMA-PET–negative patients, with this proportion increasing to 47% for PSMA-PET–positive cases. The primary rationale for PLND was staging (43%), followed by detecting micrometastases (31%). Multivariable analyses showed that PLND for EAU high-risk patients during RP was independently associated with treatments performed in university/referral centers structured risk stratification following the National Comprehensive Cancer Network guidelines ,and the use of nomograms. Resource limitations, particularly concerns about hospital stays due to complications (58.9%), and reimbursement policy for PLND (30%) impacted PLND practices significantly. Key limitations of the study include a potential selection bias and mainly European responses.</div></div><div><h3>Conclusions and clinical implications</h3><div>Significant variability persists in PLND practices despite evolving guidelines and imaging.</div></div><div><h3>Patient summary</h3><div>Pelvic lymph node dissection (PLND) is a procedure in which lymph nodes are removed and examined during prostate cancer surgery (prostatectomy) to determine whether the cancer has spread. We surveyed urologists worldwide about their current use of this procedure during prostatectomy. The introduction of prostate-specific membrane antigen positron emission tomography scans has changed how doctors decide when to perform PLND. Our findings show considerable variation in practice and persistent uncertainty about its benefits, underscoring the need for further research to guide treatment decisions.</
{"title":"Impact of Negative Prostate-specific Membrane Antigen Positron Emission Tomography on the Decision to Perform a Pelvic Lymph Node Dissection During Radical Prostatectomy for Intermediate- to High-risk Prostate Cancer Patients: Results of an International Survey","authors":"Fabio Zattoni , Pawel Rajwa , Veeru Kasivisvanathan , Lara Rodriguez Sanchez , Tamás Fazekas , Felix Preisser , Claudia Kesch , Alberto Martini , Giuseppe Reitano , August Sigle , Jonathan Olivier , Rossella Nicoletti , Rui Bernardino , Isabel Heidegger , Lorenzo Bianchi , Matteo Bauckneht , Francesco Giganti , Alexander Giesen , Timo Soeterik , Roderick van den Bergh , Giancarlo Marra","doi":"10.1016/j.euros.2025.12.003","DOIUrl":"10.1016/j.euros.2025.12.003","url":null,"abstract":"<div><h3>Background and objective</h3><div>Pelvic lymph node dissection (PLND) is considered the most reliable method for managing prostate cancer (PCa). However, the role of PLND remains controversial in both clinical practice and guideline recommendations. This study aims to characterize contemporary practices and attitudes related to extended and/or limited PLND in PCa management during radical prostatectomy (RP).</div></div><div><h3>Methods</h3><div>A cross-sectional survey was conducted from February to May 2025. The survey was disseminated through the official mailing lists of several prominent urological societies worldwide. Multivariable logistic regression models were used to identify the predictors of the performance and perceived benefits of PLND in high-risk PCa patients, considering clinical, institutional, and practitioner-related factors.</div></div><div><h3>Key findings and limitations</h3><div>Our survey of 438 urologists revealed that 80% always perform PLND in European Association of Urology (EAU) high-risk patients during RP, while 18% do so selectively and only 2.6% never do. Among high-risk, prostate-specific membrane antigen (PSMA) positron emission tomography (PET)–negative patients, 53% opt for extended PLND and 39% for standard PLND. The remaining 7.6% either undergo limited/unilateral PLND or do not receive it at all. Notably, only 22% believe in the therapeutic benefit of extended PLND in high-risk PSMA-PET–negative patients, with this proportion increasing to 47% for PSMA-PET–positive cases. The primary rationale for PLND was staging (43%), followed by detecting micrometastases (31%). Multivariable analyses showed that PLND for EAU high-risk patients during RP was independently associated with treatments performed in university/referral centers structured risk stratification following the National Comprehensive Cancer Network guidelines ,and the use of nomograms. Resource limitations, particularly concerns about hospital stays due to complications (58.9%), and reimbursement policy for PLND (30%) impacted PLND practices significantly. Key limitations of the study include a potential selection bias and mainly European responses.</div></div><div><h3>Conclusions and clinical implications</h3><div>Significant variability persists in PLND practices despite evolving guidelines and imaging.</div></div><div><h3>Patient summary</h3><div>Pelvic lymph node dissection (PLND) is a procedure in which lymph nodes are removed and examined during prostate cancer surgery (prostatectomy) to determine whether the cancer has spread. We surveyed urologists worldwide about their current use of this procedure during prostatectomy. The introduction of prostate-specific membrane antigen positron emission tomography scans has changed how doctors decide when to perform PLND. Our findings show considerable variation in practice and persistent uncertainty about its benefits, underscoring the need for further research to guide treatment decisions.</","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"83 ","pages":"Pages 142-151"},"PeriodicalIF":4.5,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145836777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-19DOI: 10.1016/j.euros.2025.12.004
Leo Bickley , Elisabeth E. Fransen van de Putte , Luna van den Brink , Laura Marandino , Johannes C. van der Mijn , Sofie Wilgenhof , Johannes V. van Thienen , John B.A.G. Haanen , Ekaterini Boleti , Thomas Powles , Patricia J. Zondervan , Niels M. Graafland , Zayd Tippu , Samra Turajlic , Axel Bex
Background and objective
Patients with synchronous metastatic renal cell carcinoma (s-mRCC) increasingly undergo systemic therapy with their primary tumour in situ. We report long-term survival outcomes and deferred cytoreductive nephrectromy (dCN) rates in an unselected real-world s-mRCC cohort of patients treated with nivolumab + ipilimumab.
Methods
This was a retrospective cohort study of 287 patients with s-mRCC treated with nivolumab + ipilimumab between 2018 and 2024 at five European institutions. Data were collected for International mRCC Database Consortium (IMDC) risk, overall survival (OS), progression-free survival (PFS), treatment responses, and dCN rates.
Key findings and limitations
At median follow-up of 23.5 mo, median OS was 29.0 mo (95% confidence interval [CI] 20.1–36.2) for the overall cohort (n = 287), and 49.8 mo (95% CI 33.1–not reached) for the intermediate-risk group (n = 144, 50%) versus 16.3 mo (95% CI 13.5–26.3) for the poor-risk group (n = 143, 50%; hazard ratio [HR] 0.50, 95% CI 0.35–0.71; p < 0.001). IMDC risk was the only significant baseline multivariable predictor for both OS and PFS. Among patients with a complete or near-complete response (CR/nCR) at metastatic sites, there was no significant difference in OS between subgroups with dCN owing to the depth of response (n = 27) and without dCN (n = 23; HR 1.00, 95% CI 0.29–3.47; p > 0.9).
Conclusions and clinical implications
Real-world treatment of s-mRCC with nivolumab + ipilimumab yields encouraging OS, especially in patients with intermediate IMDC risk and CR/nCR at metastatic sites. Trials investigating dCN following immunotherapy may be impacted by this lower-than-expected event rate, which could potentially affect their estimated sample sizes.
Patient summary
We looked at outcomes for patients with metastatic kidney cancer who were treated with immunotherapy while their kidney tumour was still in place. Patients who responded well to immunotherapy were likely to survive for a long time, whether or not they then had surgery to remove their kidney tumour. Our results will help in the design of analyses for clinical trials that are already testing the role of delayed surgery for metastatic kidney tumours.
{"title":"Long-term Real-world Survival Outcomes with Dual Immune Checkpoint Blockade in Synchronous Metastatic Renal Cell Carcinoma: Implications for the Design of Prospective Cytoreductive Nephrectomy Trials","authors":"Leo Bickley , Elisabeth E. Fransen van de Putte , Luna van den Brink , Laura Marandino , Johannes C. van der Mijn , Sofie Wilgenhof , Johannes V. van Thienen , John B.A.G. Haanen , Ekaterini Boleti , Thomas Powles , Patricia J. Zondervan , Niels M. Graafland , Zayd Tippu , Samra Turajlic , Axel Bex","doi":"10.1016/j.euros.2025.12.004","DOIUrl":"10.1016/j.euros.2025.12.004","url":null,"abstract":"<div><h3>Background and objective</h3><div>Patients with synchronous metastatic renal cell carcinoma (s-mRCC) increasingly undergo systemic therapy with their primary tumour in situ. We report long-term survival outcomes and deferred cytoreductive nephrectromy (dCN) rates in an unselected real-world s-mRCC cohort of patients treated with nivolumab + ipilimumab.</div></div><div><h3>Methods</h3><div>This was a retrospective cohort study of 287 patients with s-mRCC treated with nivolumab + ipilimumab between 2018 and 2024 at five European institutions. Data were collected for International mRCC Database Consortium (IMDC) risk, overall survival (OS), progression-free survival (PFS), treatment responses, and dCN rates.</div></div><div><h3>Key findings and limitations</h3><div>At median follow-up of 23.5 mo, median OS was 29.0 mo (95% confidence interval [CI] 20.1–36.2) for the overall cohort (<em>n</em> = 287), and 49.8 mo (95% CI 33.1–not reached) for the intermediate-risk group (<em>n</em> = 144, 50%) versus 16.3 mo (95% CI 13.5–26.3) for the poor-risk group (<em>n</em> = 143, 50%; hazard ratio [HR] 0.50, 95% CI 0.35–0.71; <em>p</em> < 0.001). IMDC risk was the only significant baseline multivariable predictor for both OS and PFS. Among patients with a complete or near-complete response (CR/nCR) at metastatic sites, there was no significant difference in OS between subgroups with dCN owing to the depth of response (<em>n</em> = 27) and without dCN (<em>n</em> = 23; HR 1.00, 95% CI 0.29–3.47; <em>p</em> > 0.9).</div></div><div><h3>Conclusions and clinical implications</h3><div>Real-world treatment of s-mRCC with nivolumab + ipilimumab yields encouraging OS, especially in patients with intermediate IMDC risk and CR/nCR at metastatic sites. Trials investigating dCN following immunotherapy may be impacted by this lower-than-expected event rate, which could potentially affect their estimated sample sizes.</div></div><div><h3>Patient summary</h3><div>We looked at outcomes for patients with metastatic kidney cancer who were treated with immunotherapy while their kidney tumour was still in place. Patients who responded well to immunotherapy were likely to survive for a long time, whether or not they then had surgery to remove their kidney tumour. Our results will help in the design of analyses for clinical trials that are already testing the role of delayed surgery for metastatic kidney tumours.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"83 ","pages":"Pages 133-141"},"PeriodicalIF":4.5,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145786863","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-18DOI: 10.1016/j.euros.2025.12.002
Rosanne van Ee , Chris A. Suijker , Antoinette D.I. van Asselt , Inge M. van Oort , Riemer A. Kingma , Stijn Roemeling
Background and objective
Residual fragments (RFs) after percutaneous nephrolithotomy (PCNL) increase the risk of stone-related events (SREs) such as reinterventions and emergency department (ED) visits. Intraoperative cone-beam computed tomography (CBCT) facilitates detection and removal of RFs to improve stone-free rates and potentially reduce SREs. To determine whether the initial increase in surgical costs for CBCT in a hybrid operating room (OR) is offset by a reduction in overall expenses by minimizing SREs, we compared the total in-hospital health care costs of standard PCNL versus CBCT-PCNL over an 18-mo period.
Methods
Data from a previous randomized controlled trial including 80 patients undergoing CBCT-PCNL and 80 undergoing conventional PCNL were analyzed. Procedural costs were calculated by multiplying operative duration by the Dutch reference price per minute, and adding disposable costs. Follow-up costs included costs for complications, SREs (reinterventions, ED visits, drainage, admissions), imaging, and consultations during 18 mo.
Key findings and limitations
Assuming utilization rates of 42% for a hybrid OR and 92% for a conventional OR and following reference prices, we calculated mean total costs per patient of €8725 for the CBCT group and €8564 for the control group, with a difference of €167. The 40.2% higher procedural costs for hybrid-OR PCNL were nearly offset by 38.3% lower follow-up, complication, and SRE costs. Limitations include the single-center design, incomplete cost standardization, and the exclusion of non-hospital costs such as productivity loss.
Conclusions and clinical implications
While PCNL with CBCT in a hybrid OR increases operative costs, it lowers SREs and unplanned care expenses. Even at a significantly lower hybrid OR utilization rate, total health care costs remain comparable, so PCNL-CBCT can facilitate predictable resource use and efficient care, with potential benefits for patients and health care systems.
Patient summary
A new technique using CT (computed tomography) scans during surgery may help in more complete extraction of kidney stone fragments. Our study shows that even though this procedure is more expensive, it reduces the need for postoperative appointments, scans, emergency department visits and additional operations.
{"title":"Cost Comparison of Percutaneous Nephrolithotomy With and Without Intraoperative Cone-beam Computed Tomography: 18-month Postoperative Analysis","authors":"Rosanne van Ee , Chris A. Suijker , Antoinette D.I. van Asselt , Inge M. van Oort , Riemer A. Kingma , Stijn Roemeling","doi":"10.1016/j.euros.2025.12.002","DOIUrl":"10.1016/j.euros.2025.12.002","url":null,"abstract":"<div><h3>Background and objective</h3><div>Residual fragments (RFs) after percutaneous nephrolithotomy (PCNL) increase the risk of stone-related events (SREs) such as reinterventions and emergency department (ED) visits. Intraoperative cone-beam computed tomography (CBCT) facilitates detection and removal of RFs to improve stone-free rates and potentially reduce SREs. To determine whether the initial increase in surgical costs for CBCT in a hybrid operating room (OR) is offset by a reduction in overall expenses by minimizing SREs, we compared the total in-hospital health care costs of standard PCNL versus CBCT-PCNL over an 18-mo period.</div></div><div><h3>Methods</h3><div>Data from a previous randomized controlled trial including 80 patients undergoing CBCT-PCNL and 80 undergoing conventional PCNL were analyzed. Procedural costs were calculated by multiplying operative duration by the Dutch reference price per minute, and adding disposable costs. Follow-up costs included costs for complications, SREs (reinterventions, ED visits, drainage, admissions), imaging, and consultations during 18 mo.</div></div><div><h3>Key findings and limitations</h3><div>Assuming utilization rates of 42% for a hybrid OR and 92% for a conventional OR and following reference prices, we calculated mean total costs per patient of €8725 for the CBCT group and €8564 for the control group, with a difference of €167. The 40.2% higher procedural costs for hybrid-OR PCNL were nearly offset by 38.3% lower follow-up, complication, and SRE costs. Limitations include the single-center design, incomplete cost standardization, and the exclusion of non-hospital costs such as productivity loss.</div></div><div><h3>Conclusions and clinical implications</h3><div>While PCNL with CBCT in a hybrid OR increases operative costs, it lowers SREs and unplanned care expenses. Even at a significantly lower hybrid OR utilization rate, total health care costs remain comparable, so PCNL-CBCT can facilitate predictable resource use and efficient care, with potential benefits for patients and health care systems.</div></div><div><h3>Patient summary</h3><div>A new technique using CT (computed tomography) scans during surgery may help in more complete extraction of kidney stone fragments. Our study shows that even though this procedure is more expensive, it reduces the need for postoperative appointments, scans, emergency department visits and additional operations.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"83 ","pages":"Pages 125-132"},"PeriodicalIF":4.5,"publicationDate":"2025-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145786864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-15DOI: 10.1016/j.euros.2025.11.008
Guglielmo Mantica , Wesley Verla , Mikołaj Frankiewicz , Andrea Cocci , Francesco Chierigo , Łukasz Białek , François-Xavier Madec , Maciej Oszczudłowski , Felix Campos-Juanatey , Paul Neuville , Clemens M. Rosenbaum , Elaine J. Redmond , Marjan Waterloos , Malte W. Vetterlein
Treatment success after urethral reconstruction remains poorly standardized, resulting in heterogeneous outcome reporting and limited comparability across studies. To address this gap, we aimed to establish a consensus-based, reproducible definition of surgical success through the development of a novel outcome framework: the stricture-fecta. A two-round Delphi process was conducted under the auspices of the European Association of Urology (EAU) Young Academic Urologists—Trauma and Reconstructive Urology Working Party. A total of 113 international experts in urethral reconstruction were invited to assess the potential outcome criteria using a 9-point Likert scale. Consensus was defined as a rating of 7–9 by ≥70% and 1–3 by ≤15% of respondents. Eighty-seven (77%) experts completed round 1, and 65 (75%) participated in round 2. The final consensus identified three core criteria: (1) freedom from stricture retreatment; (2) no significant impact on continence or sexual function, assessed with validated instruments; and (3) patient satisfaction. The stricture-fecta represents a step toward standardized outcome reporting in urethral reconstruction, akin to the trifecta metrics in urological oncology. Its adoption may improve data quality, facilitate multicenter collaboration, and support more transparent, patient-centered evaluations of surgical success.
Patient summary
This study developed a clear and simple way to measure success after surgery to fix narrowing of the urethra, a condition that affects urination and quality of life. Experts agreed that success means no need for further treatment, and no negative effects on bladder control or sexual function, and that patients feel satisfied with the results. The use of this approach will help doctors compare outcomes better and improve care for patients undergoing urethral surgery.
{"title":"Toward Standardized Outcome Reporting in Urethral Reconstruction: Development of the “Stricture-fecta” Through an International Modified Delphi Consensus","authors":"Guglielmo Mantica , Wesley Verla , Mikołaj Frankiewicz , Andrea Cocci , Francesco Chierigo , Łukasz Białek , François-Xavier Madec , Maciej Oszczudłowski , Felix Campos-Juanatey , Paul Neuville , Clemens M. Rosenbaum , Elaine J. Redmond , Marjan Waterloos , Malte W. Vetterlein","doi":"10.1016/j.euros.2025.11.008","DOIUrl":"10.1016/j.euros.2025.11.008","url":null,"abstract":"<div><div>Treatment success after urethral reconstruction remains poorly standardized, resulting in heterogeneous outcome reporting and limited comparability across studies. To address this gap, we aimed to establish a consensus-based, reproducible definition of surgical success through the development of a novel outcome framework: the stricture-fecta. A two-round Delphi process was conducted under the auspices of the European Association of Urology (EAU) Young Academic Urologists—Trauma and Reconstructive Urology Working Party. A total of 113 international experts in urethral reconstruction were invited to assess the potential outcome criteria using a 9-point Likert scale. Consensus was defined as a rating of 7–9 by ≥70% and 1–3 by ≤15% of respondents. Eighty-seven (77%) experts completed round 1, and 65 (75%) participated in round 2. The final consensus identified three core criteria: (1) freedom from stricture retreatment; (2) no significant impact on continence or sexual function, assessed with validated instruments; and (3) patient satisfaction. The stricture-fecta represents a step toward standardized outcome reporting in urethral reconstruction, akin to the trifecta metrics in urological oncology. Its adoption may improve data quality, facilitate multicenter collaboration, and support more transparent, patient-centered evaluations of surgical success.</div></div><div><h3>Patient summary</h3><div>This study developed a clear and simple way to measure success after surgery to fix narrowing of the urethra, a condition that affects urination and quality of life. Experts agreed that success means no need for further treatment, and no negative effects on bladder control or sexual function, and that patients feel satisfied with the results. The use of this approach will help doctors compare outcomes better and improve care for patients undergoing urethral surgery.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"83 ","pages":"Pages 120-124"},"PeriodicalIF":4.5,"publicationDate":"2025-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145786861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-12DOI: 10.1016/j.euros.2025.11.014
Asim Armagan Aydin , Erkan Kayikcioglu , Ramazan Oguz Yuceer
{"title":"Re: Muhammet Demirbilek, Göktuğ Kalender, Said Bıyıkoglu, et al. External Validation of Nomograms for Predicting Pelvic Lymph Node Metastases in Patients with Prostate Cancer and the Added Value of the Prostate-specific Membrane Antigen Positron Emission Tomography–based PRIMARY Score. Eur Urol Open Sci 2025;82:170–7","authors":"Asim Armagan Aydin , Erkan Kayikcioglu , Ramazan Oguz Yuceer","doi":"10.1016/j.euros.2025.11.014","DOIUrl":"10.1016/j.euros.2025.11.014","url":null,"abstract":"","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"83 ","pages":"Page 119"},"PeriodicalIF":4.5,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145733036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-10DOI: 10.1016/j.euros.2025.11.010
Changhao Hou , Zhenwei Yu , Ziwen Liu , Tao Liang , Xuxiao Ye , Jiemin Si , Weidong Zhu , Chongrui Jin , Zhenghao Dai , Yinglong Sa , Lujie Song , Qiang Fu
Background and objective
Surgical management of the harvest site for lingual mucosal graft (LMG) urethroplasty remains controversial. Our aim was to compare pain intensity and oral morbidity at the donor site between primary closure (PC) and use of an artificial acellular dermal matrix (ADM) for coverage during suturing.
Methods
We conducted a retrospective study of patients who underwent LMG urethroplasty between October 15, 2015, and December 18, 2022. Follow-up was conducted prospectively in the early postoperative period (7 d after surgery) and retrospectively for the 3-mo time point. Patients completed a postoperative questionnaire regarding LMG harvesting, including questions on pain intensity and oral morbidity. Propensity score matching was used to balance the PC and ADM groups, and generalized linear mixed models were used to evaluate factors influencing lingual pain (primary endpoint) and oral morbidity (secondary endpoint).
Key findings and limitations
A total of 250/448 patients (55.8%) completed the postoperative tongue health questionnaire, including 174 in the PC group and 76 in the ADM group. ADM use for coverage during suturing significantly reduced early-stage pain (60.94% vs 92.80%; p < 0.001) and swelling (64.06% vs 88.80%; p < 0.001). The 3-mo data showed no significant between-group differences in oral morbidity, including pain, bleeding, swelling, numbness, salivary secretion, taste changes, and dietary and speech impairments. The retrospective design is the main study limitation.
Conclusions and clinical implications
ADM use for coverage during suturing reduces early pain and swelling after LMG harvesting for urethroplasty in comparison to PC, with comparable long-term oral morbidity. Patients may benefit from ADM use in terms of faster early recovery.
Patient summary
We compared two methods for suturing the tongue after taking tissue to repair a defect in the urethra. Our results show that use of product called an artificial acellular dermal matrix (ADM) significantly reduces early pain and swelling after surgery in comparison to the traditional method. Long-term results are comparable for the two methods. Patients may benefit from ADM use in terms of faster early recovery.
背景与目的舌粘膜移植尿道成形术的手术处理仍有争议。我们的目的是比较初次缝合（PC）和使用人工脱细胞真皮基质（ADM）进行缝合时供区疼痛强度和口腔发病率。方法对2015年10月15日至2022年12月18日期间行LMG尿道成形术的患者进行回顾性研究。术后早期（术后7 d）前瞻性随访，术后3个月回顾性随访。患者完成了术后关于LMG切除的问卷调查，包括疼痛强度和口腔发病率的问题。使用倾向评分匹配来平衡PC组和ADM组，并使用广义线性混合模型来评估影响舌痛（主要终点）和口腔发病率（次要终点）的因素。448例患者中有250例（55.8%）完成了术后舌健康问卷，其中PC组174例，ADM组76例。在缝合期间使用ADM覆盖可显著减少早期疼痛（60.94% vs 92.80%; p < 0.001）和肿胀（64.06% vs 88.80%; p < 0.001）。3个月的数据显示，两组间口腔发病率无显著差异，包括疼痛、出血、肿胀、麻木、唾液分泌、味觉变化、饮食和语言障碍。回顾性设计是本研究的主要局限性。结论和临床意义与PC相比，在缝合期间使用sadm可以减少尿道成形术中LMG采集后的早期疼痛和肿胀，长期口腔发病率相当。患者可能受益于ADM的使用，在更快的早期恢复。我们比较了两种方法在取组织修复尿道缺损后缝合舌头。我们的研究结果表明，与传统方法相比，使用一种名为人工脱细胞真皮基质（ADM）的产品可显著减少术后早期疼痛和肿胀。两种方法的长期结果具有可比性。患者可能受益于ADM的使用，在更快的早期恢复。
{"title":"Impact of Coverage with an Acellular Dermal Matrix and Suturing Versus Primary Closure on Tongue Pain and Oral Morbidity After Lingual Mucosa Harvesting for Urethroplasty: A Retrospective Cohort Study","authors":"Changhao Hou , Zhenwei Yu , Ziwen Liu , Tao Liang , Xuxiao Ye , Jiemin Si , Weidong Zhu , Chongrui Jin , Zhenghao Dai , Yinglong Sa , Lujie Song , Qiang Fu","doi":"10.1016/j.euros.2025.11.010","DOIUrl":"10.1016/j.euros.2025.11.010","url":null,"abstract":"<div><h3>Background and objective</h3><div>Surgical management of the harvest site for lingual mucosal graft (LMG) urethroplasty remains controversial. Our aim was to compare pain intensity and oral morbidity at the donor site between primary closure (PC) and use of an artificial acellular dermal matrix (ADM) for coverage during suturing.</div></div><div><h3>Methods</h3><div>We conducted a retrospective study of patients who underwent LMG urethroplasty between October 15, 2015, and December 18, 2022. Follow-up was conducted prospectively in the early postoperative period (7 d after surgery) and retrospectively for the 3-mo time point. Patients completed a postoperative questionnaire regarding LMG harvesting, including questions on pain intensity and oral morbidity. Propensity score matching was used to balance the PC and ADM groups, and generalized linear mixed models were used to evaluate factors influencing lingual pain (primary endpoint) and oral morbidity (secondary endpoint).</div></div><div><h3>Key findings and limitations</h3><div>A total of 250/448 patients (55.8%) completed the postoperative tongue health questionnaire, including 174 in the PC group and 76 in the ADM group. ADM use for coverage during suturing significantly reduced early-stage pain (60.94% vs 92.80%; <em>p</em> < 0.001) and swelling (64.06% vs 88.80%; <em>p</em> < 0.001). The 3-mo data showed no significant between-group differences in oral morbidity, including pain, bleeding, swelling, numbness, salivary secretion, taste changes, and dietary and speech impairments. The retrospective design is the main study limitation.</div></div><div><h3>Conclusions and clinical implications</h3><div>ADM use for coverage during suturing reduces early pain and swelling after LMG harvesting for urethroplasty in comparison to PC, with comparable long-term oral morbidity. Patients may benefit from ADM use in terms of faster early recovery.</div></div><div><h3>Patient summary</h3><div>We compared two methods for suturing the tongue after taking tissue to repair a defect in the urethra. Our results show that use of product called an artificial acellular dermal matrix (ADM) significantly reduces early pain and swelling after surgery in comparison to the traditional method. Long-term results are comparable for the two methods. Patients may benefit from ADM use in terms of faster early recovery.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"83 ","pages":"Pages 109-118"},"PeriodicalIF":4.5,"publicationDate":"2025-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145733037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-04DOI: 10.1016/j.euros.2025.11.011
Felix Melchior , Magdalena Koett , Felix Keller , Nastasiia Artamonova , Giulia Giannini , Mona Kafka , Michael Ladurner , Hannes Neuwirt , Jasmin Bektic , Wolfgang Horninger , Isabel Heidegger
Background and objective
Recent advances have led to the introduction of multiple combination treatments for metastatic hormone-sensitive prostate cancer (mHSPC), but their comparative efficacy and toxicity remain uncertain owing to the absence of head-to-head comparisons. We evaluated the efficacy and safety profile of darolutamide plus androgen deprivation therapy (ADT) in comparison to other treatments.
Methods
A systematic search was conducted in the Cochrane Library up to September 30, 2024 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Hazard ratios (HRs) and confidence intervals (CIs) for progression-free survival (PFS) and overall survival (OS) were extracted. Odds ratios (ORs) for treatment-emergent adverse events (TEAEs) were calculated from the events reported.
Key findings and limitations
Eleven trials involving 11 389 patients were included. Darolutamide triplet therapy was associated with the highest overall PFS (HR 0.24, 95% CI 0.20–0.29) and OS (HR 0.54, 95% CI 0.44–0.66). The highest PFS in low-volume disease was observed with enzalutamide (HR 0.29, 95% CI 0.21–0.38) and darolutamide (HR 0.30, 95% CI 0.15–0.60). All androgen receptor pathway inhibitors (ARPIs) had higher toxicity than ADT, except for darolutamide (OR 0.99, 95% CI 0.71–1.39). In comparison to darolutamide, enzalutamide (OR 2.03, 95% CI 1.08–3.80) and abiraterone (OR 3.18, 95% CI 1.74–5.80) were associated with higher risk of hypertension. Enzalutamide was associated with a higher risk of fatigue (OR 3.22, 95% CI 1.28–8.07). Limited direct comparisons between treatments may affect our conclusions regarding relative efficacy.
Conclusions and clinical implications
Our findings support the role of darolutamide as an effective and well-tolerated ARPI for mHSPC, particularly in low-volume metachronous disease and comorbidity-limited cases. These results may assist clinicians in planning personalized treatment strategies that balance efficacy and safety.
Patient summary
We compared different medical treatment options for metastatic hormone-sensitive prostate cancer, with a special focus on a drug called darolutamide. Darolutamide is well tolerated and is effective, particularly in patients with a low volume of metastasis and patients with other health conditions that may limit their treatment options.
背景和目的最近的进展导致了转移性激素敏感性前列腺癌（mHSPC）的多种联合治疗的引入，但由于缺乏头对头的比较，它们的比较疗效和毒性仍然不确定。我们评估了darolutamide联合雄激素剥夺疗法（ADT）与其他治疗方法的疗效和安全性。方法按照系统评价和meta分析的首选报告项目指南，在Cochrane图书馆进行系统检索，检索时间截止到2024年9月30日。提取无进展生存期（PFS）和总生存期（OS）的风险比（hr）和置信区间（CIs）。治疗中出现的不良事件（teae）的优势比（ORs）根据报道的事件计算。主要发现和局限性纳入了涉及11389例患者的11项even试验。达罗卢胺三联疗法与最高的总PFS （HR 0.24, 95% CI 0.20-0.29）和OS （HR 0.54, 95% CI 0.44-0.66）相关。小体积疾病的PFS最高的是恩杂鲁胺（HR 0.29, 95% CI 0.21-0.38）和达鲁胺（HR 0.30, 95% CI 0.15-0.60）。除darolutamide外，所有雄激素受体途径抑制剂（arpi）的毒性均高于ADT （OR 0.99, 95% CI 0.71-1.39）。与达洛鲁胺相比，恩杂鲁胺（OR 2.03, 95% CI 1.08-3.80）和阿比特龙（OR 3.18, 95% CI 1.74-5.80）与高血压的高风险相关。Enzalutamide与较高的疲劳风险相关（OR 3.22, 95% CI 1.28-8.07）。有限的治疗之间的直接比较可能会影响我们关于相对疗效的结论。研究结果支持darolutamide作为mHSPC有效且耐受性良好的ARPI的作用，特别是在小容量异时性疾病和合并症有限的病例中。这些结果可以帮助临床医生制定平衡疗效和安全性的个性化治疗策略。患者总结：我们比较了转移性激素敏感前列腺癌的不同治疗方案，特别关注了一种叫做达罗卢胺的药物。Darolutamide耐受性良好且有效，特别是对于转移量小的患者和其他可能限制其治疗选择的健康状况的患者。
{"title":"Integration of Darolutamide in the Treatment Landscape for Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis of Efficacy and Safety","authors":"Felix Melchior , Magdalena Koett , Felix Keller , Nastasiia Artamonova , Giulia Giannini , Mona Kafka , Michael Ladurner , Hannes Neuwirt , Jasmin Bektic , Wolfgang Horninger , Isabel Heidegger","doi":"10.1016/j.euros.2025.11.011","DOIUrl":"10.1016/j.euros.2025.11.011","url":null,"abstract":"<div><h3>Background and objective</h3><div>Recent advances have led to the introduction of multiple combination treatments for metastatic hormone-sensitive prostate cancer (mHSPC), but their comparative efficacy and toxicity remain uncertain owing to the absence of head-to-head comparisons. We evaluated the efficacy and safety profile of darolutamide plus androgen deprivation therapy (ADT) in comparison to other treatments.</div></div><div><h3>Methods</h3><div>A systematic search was conducted in the Cochrane Library up to September 30, 2024 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Hazard ratios (HRs) and confidence intervals (CIs) for progression-free survival (PFS) and overall survival (OS) were extracted. Odds ratios (ORs) for treatment-emergent adverse events (TEAEs) were calculated from the events reported.</div></div><div><h3>Key findings and limitations</h3><div>Eleven trials involving 11 389 patients were included. Darolutamide triplet therapy was associated with the highest overall PFS (HR 0.24, 95% CI 0.20–0.29) and OS (HR 0.54, 95% CI 0.44–0.66). The highest PFS in low-volume disease was observed with enzalutamide (HR 0.29, 95% CI 0.21–0.38) and darolutamide (HR 0.30, 95% CI 0.15–0.60). All androgen receptor pathway inhibitors (ARPIs) had higher toxicity than ADT, except for darolutamide (OR 0.99, 95% CI 0.71–1.39). In comparison to darolutamide, enzalutamide (OR 2.03, 95% CI 1.08–3.80) and abiraterone (OR 3.18, 95% CI 1.74–5.80) were associated with higher risk of hypertension. Enzalutamide was associated with a higher risk of fatigue (OR 3.22, 95% CI 1.28–8.07). Limited direct comparisons between treatments may affect our conclusions regarding relative efficacy.</div></div><div><h3>Conclusions and clinical implications</h3><div>Our findings support the role of darolutamide as an effective and well-tolerated ARPI for mHSPC, particularly in low-volume metachronous disease and comorbidity-limited cases. These results may assist clinicians in planning personalized treatment strategies that balance efficacy and safety.</div></div><div><h3>Patient summary</h3><div>We compared different medical treatment options for metastatic hormone-sensitive prostate cancer, with a special focus on a drug called darolutamide. Darolutamide is well tolerated and is effective, particularly in patients with a low volume of metastasis and patients with other health conditions that may limit their treatment options.</div></div>","PeriodicalId":12254,"journal":{"name":"European Urology Open Science","volume":"83 ","pages":"Pages 72-82"},"PeriodicalIF":4.5,"publicationDate":"2025-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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