To investigate the diagnostic performance and interreader agreement of intraprostatic prostate cancer (PCa) detection, local extension and staging using [18F]PSMA-1007 PET in primary PCa, with whole-mount radical prostatectomy specimens as the reference standard. This prospective study included 66 patients with biopsy-proven PCa who underwent [18F]PSMA-1007 PET/MRI prior to radical prostatectomy. Four nuclear medicine physicians independently evaluated intraprostatic lesions, T stage, extracapsular extension (ECE), seminal vesicle invasion (SVI) and bilaterality, based on PROMISE V2 criteria and a standardized scoring template. Diagnostic accuracy was calculated using whole-mount histopathology as reference. Interreader agreement was assessed using Fleiss’ and weighted kappa statistics. Accurate lesion-level detection of dominant intraprostatic malignant lesions was achieved across readers with mean sensitivity of 96

Preoperative chemotherapy (POC) combined with radical cystectomy (RC) is the standard treatment for clinically node-negative (cN0) bladder cancer (BC), but its role in clinically node-positive (cN+) disease remains uncertain. We investigated whether POC + RC improves outcomes in cN+ patients by assessing whether the survival gap between cN0 and cN+ patients is smaller than that historically observed in RC-only cohorts. We also evaluated whether radiographic nodal response predicts prognosis. We retrospectively analyzed patients with T2-4N0M0 or T1-4N + M0 BC who underwent POC + RC at our institution between 1999 and 2019. Recurrence-free survival (RFS) and cancer-specific survival (CSS) were compared between the cN0 and cN+ groups using Cox regression analysis. The hazard ratios (HRs) for cN+/cN0 survival in our cohort were then compared to published HRs from the largest RC-only series, adjusted for clinical rather than pathological nodal staging (non-inferiority margins: HR 2.19 for RFS, HR 2.39 for CSS). Among 142 patients (73 cN0, 69 cN+), 5-year RFS was 68

PURPOSE:To investigate the reliability, concurrent validity, and clinical feasibility of a structured light scanner (SLS) for measuring leg volume in patients with lymphedema. MATERIALS AND METHODS:Leg volume was measured using the SLS, circumference measurements, and optoelectronic volumetry. Intra-and inter-rater reliability were assessed using intraclass correlation coefficients (ICCs), standard error of measurement (SEM), and smallest real difference (SRD). Concurrent validity was determined by calculating correlation coefficients. Clinical feasibility was evaluated through timing of procedures and a purpose-designed questionnaire. RESULTS:This cross-sectional study was conducted at the Center for Lymphedema, University Hospital Leuven, involving 33 patients (66 legs) with predominantly secondary (70%) and stage 2a (73%) lymphedema (NCT07017166). All three methods showed excellent reliability. Circumference measurements had the highest intra-rater (ICC: 0.999) and inter-rater (ICC: 0.999) reliability, followed by optoelectronic volumetry (intra-rater ICC: 0.988; inter-rater ICC: 0.994) and the SLS (intra-rater ICC: 0.986; inter-rater ICC: 0.982). SLS showed a strong correlation with circumference measurements and with optoelectronic volumetry. The SLS was the most clinically feasible. CONCLUSION:The SLS demonstrates good reliability and concurrent validity for assessing leg volume and appears to have fewer practical limitations than conventional methods, although further research is needed to reduce measurement error and confirm clinical implementation.

BACKGROUND:This study aimed to compare existing nomograms and identify which models best predict long-term survival outcomes, namely disease-free survival (DFS) or recurrence-free survival (RFS), and cancer-specific survival (CSS), in patients undergoing radical cystectomy (RC) for bladder cancer (BC). METHODS:Six nomograms (three for DFS, three for CSS) were selected from 20 studies and evaluated using data from 730 RC patients treated at University Hospitals Leuven. Discriminatory performance was assessed using area under the curve (AUC) of receiver operating characteristics (ROC) curve, along with sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy. Calibration was analyzed using the Hosmer-Lemeshow (HL) test and calibration plots, while clinical utility was assessed through decision curve analysis (DCA). Statistical significance was set at P<0.05. RESULTS:All nomograms effectively predicted 5-year DFS and CSS. The AUC values for DFS nomograms were 0.74 (95% Confidence interval [CI]: 0.70-0.78) for Simone et al., 0.74 (95% CI: 0.70-0.77) for Cicione et al., and 0.73 (95% CI: 0.69-0.77) for Karakiewicz et al. For CSS nomograms, the AUC values were 0.78 (95% CI: 0.74-0.82) for Simone et al., 0.78 (95% CI: 0.74-0.82) for Cicione et al., and 0.77 (95% CI: 0.74-0.81) for Shariat et al. Among DFS nomograms, Simone et al. showed the highest sensitivity (0.64, 95% CI: 0.58-0.69), while Karakiewicz et al. had the highest specificity (0.81, 95% CI: 0.78-0.88). Among CSS nomograms, sensitivity was highest for Shariat et al. (0.84, 95% CI: 0.81-0.88), while specificity was highest for Simone et al. (0.72, 95% CI: 0.67-0.78). Accuracy, PPV, NPV, and Brier scores were comparable across all DFS and CSS nomograms. The Cicione et al. nomogram demonstrated the best calibration for DFS, while the Simone et al. nomogram had the least systematic bias in absolute calibration. For CSS, all three nomograms exhibited similar discrimination and predictive accuracy, with the Cicione et al. and Shariat et al. models showing slightly better calibration than the Simone et al. nomogram. DCA confirmed the clinical usefulness of all DFS and CSS nomograms. CONCLUSIONS:All evaluated nomograms showed comparable accuracy in predicting 5-year DFS or CSS, supporting their use in clinical practice. Nonetheless, their limitations should be considered when applying them to individual patient-specific decision-making.

The understanding of oligometastatic prostate cancer has advanced substantially in the past two decades, reshaping both diagnostic and therapeutic paradigms. The advent of next-generation imaging, particularly prostate-specific membrane antigen PET-CT, has improved staging accuracy, enabling patients with limited metastatic burden who might benefit from intensified local and metastasis-directed approaches to be identified. Results from randomized phase II trials support the use of metastasis-directed therapy in patients with metachronous oligometastatic prostate cancer. However, evidence for metastasis-directed therapy in de novo presentations remains preliminary but encouraging. In parallel, prostate-directed treatments such as radiotherapy and cytoreductive radical prostatectomy are under active investigation, although the role of these approaches in the era of intensified systemic therapy is yet to be fully defined. Although interest around oligometastatic prostate cancer is growing, several issues are currently unsettled, including a unified definition of oligometastatic prostate cancer; the inclusion of biological information in patient selection; optimal treatment sequencing, including the integration and duration of systemic therapy; and appropriate clinical end points.

For prostate cancer patients with metachronous nodal oligorecurrences detected by positron emission tomography, the randomized phase 2 PEACE V-STORM trial (NCT03569241) demonstrated that, compared with metastasis-directed therapy (MDT), elective nodal pelvic radiotherapy (ENRT) in combination with 6 mo of androgen deprivation therapy (ADT) improved locoregional disease control and metastasis-free survival. In the 190 evaluable patients (MDT: 97 and ENRT: 93) of the 196 randomized in the study, health-related quality of life (HRQoL) was assessed by European Organization for Research and Treatment of Cancer QLQ-C-30 and QLQ-PR-25 questionnaires over a 4-yr period as a part of a statistically defined quality of life analysis. During a median follow-up of 50 mo (interquartile range 42-58), QLQ-C30 scores showed no significant differences between MDT and ENRT, except for worse physical functioning at month 24 in the ENRT group (mean decline -7.7 vs -1.3) and worse emotional functioning at month 12 in the MDT group (mean decline 5.8 vs -0.4, p = 0.034). No significant differences in QLQ-PR25 scores were observed, except slightly better bowel symptoms at 18 mo for ENRT, but with no difference before or after. The decline in sexual activity and increase in ADT-related symptoms during the first 6 mo were comparable between arms, returning to baseline by month 12. Consistent with physician-reported treatment-related adverse events, HRQoL analyses show no significant differences between ENRT and MDT.

BJU InternationalEarly View Research Letter Does surgical skill rely on surgical specialty or training method? A randomised controlled trial Ruben De Groote, Corresponding Author Ruben De Groote [email protected] orcid.org/0000-0003-4081-8221 ORSI Academy, Melle, Belgium Department of Urology, OLV, Aalst, Belgium Department of Development and Regeneration, KU Leuven, Leuven, Belgium Correspondence: Ruben De Groote, Consultant Urological Surgeon, Uro-oncology and Robotics, Department of Urology, Onze Lieve Vrouw Ziekenhuis Aalst, Moorselbaan 164, 9300 Aalst, Belgium. e-mail: [email protected]Search for more papers by this authorStefano Puliatti, Stefano Puliatti ORSI Academy, Melle, Belgium Department of Urology, University of Modena and Reggio Emilia, Modena, ItalySearch for more papers by this authorMarco Amato, Marco Amato ORSI Academy, Melle, Belgium Department of Urology, University of Modena and Reggio Emilia, Modena, ItalySearch for more papers by this authorElio Mazzone, Elio Mazzone orcid.org/0000-0003-1932-1800 Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy Vita-Salute San Raffaele University, Milan, ItalySearch for more papers by this authorGiuseppe Rosiello, Giuseppe Rosiello orcid.org/0000-0002-4354-1582 Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy Vita-Salute San Raffaele University, Milan, ItalySearch for more papers by this authorRui Farinha, Rui Farinha orcid.org/0000-0002-1286-1399 ORSI Academy, Melle, Belgium Centro Hospitalar Universitário de Lisboa Central EPE, Lisbon, PortugalSearch for more papers by this authorArtur Paludo, Artur Paludo orcid.org/0000-0002-0701-3301 ORSI Academy, Melle, Belgium Urology, Clinic Hospital of Porto Alegre, Porto Alegre, BrazilSearch for more papers by this authorLiesbeth Desender, Liesbeth Desender Department of Thoracovascular Surgery, University Hospital Ghent, Ghent, BelgiumSearch for more papers by this authorBen Van Cleynenbreugel, Ben Van Cleynenbreugel orcid.org/0000-0001-9517-3673 Department of Development and Regeneration, KU Leuven, Leuven, BelgiumSearch for more papers by this authorWouter Everaerts, Wouter Everaerts Department of Cellular and Molecular Medicine, KU Leuven, Leuven, BelgiumSearch for more papers by this authorBrendan P. Bunting, Brendan P. Bunting School of Psychology, Ulster University, Coleraine, Northern Ireland, UKSearch for more papers by this authorAlexandre Mottrie, Alexandre Mottrie ORSI Academy, Melle, Belgium Department of Urology, OLV, Aalst, BelgiumSearch for more papers by this authorAnthony G. Gallagher, Anthony G. Gallagher ORSI Academy, Melle, Belgium Department of Development and Regeneration, KU Leuven, Leuven, Belgium School of Medicine, Faculty of Life and Health Sciences, Ulster University, Coleraine, Northern Ireland, UKSearch for more papers by this authoron behalf of the European Association of Urology and the ERUS Education Working Group, the European Association of Urology and the ERUS Education Working GroupSearch for more papers by this author Ruben De Groote, Corresponding Author Ruben De Groote [email protected] orcid.org/0000-0003-4081-8221 ORSI Academy, Melle, Belgium Department of Urology, OLV, Aalst, Belgium Department of Development and Regeneration, KU Leuven, Leuven, Belgium Correspondence: Ruben De Groote, Consultant Urological Surgeon, Uro-oncology and Robotics, Department of Urology, Onze Lieve Vrouw Ziekenhuis Aalst, Moorselbaan 164, 9300 Aalst, Belgium. e-mail: [email protected]Search for more papers by this authorStefano Puliatti, Stefano Puliatti ORSI Academy, Melle, Belgium Department of Urology, University of Modena and Reggio Emilia, Modena, ItalySearch for more papers by this authorMarco Amato, Marco Amato ORSI Academy, Melle, Belgium Department of Urology, University of Modena and Reggio Emilia, Modena, ItalySearch for more papers by this authorElio Mazzone, Elio Mazzone orcid.org/0000-0003-1932-1800 Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy Vita-Salute San Raffaele University, Milan, ItalySearch for more papers by this authorGiuseppe Rosiello, Giuseppe Rosiello orcid.org/0000-0002-4354-1582 Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy Vita-Salute San Raffaele University, Milan, ItalySearch for more papers by this authorRui Farinha, Rui Farinha orcid.org/0000-0002-1286-1399 ORSI Academy, Melle, Belgium Centro Hospitalar Universitário de Lisboa Central EPE, Lisbon, PortugalSearch for more papers by this authorArtur Paludo, Artur Paludo orcid.org/0000-0002-0701-3301 ORSI Academy, Melle, Belgium Urology, Clinic Hospital of Porto Alegre, Porto Alegre, BrazilSearch for more papers by this authorLiesbeth Desender, Liesbeth Desender Department of Thoracovascular Surgery, University Hospital Ghent, Ghent, BelgiumSearch for more papers by this authorBen Van Cleynenbreugel, Ben Van Cleynenbreugel orcid.org/0000-0001-9517-3673 Department of Development and Regeneration, KU Leuven, Leuven, BelgiumSearch for more papers by this authorWouter Everaerts, Wouter Everaerts Department of Cellular and Molecular Medicine, KU Leuven, Leuven, BelgiumSearch for more papers by this authorBrendan P. Bunting, Brendan P. Bunting School of Psychology, Ulster University, Coleraine, Northern Ireland, UKSearch for more papers by this authorAlexandre Mottrie, Alexandre Mottrie ORSI Academy, Melle, Belgium Department of Urology, OLV, Aalst, BelgiumSearch for more papers by this authorAnthony G. Gallagher, Anthony G. Gallagher ORSI Academy, Melle, Belgium Department of Development and Regeneration, KU Leuven, Leuven, Belgium School of Medicine, Faculty of Life and Health Sciences, Ulster University, Coleraine, Northern Ireland, UKSearch for more papers by this authoron behalf of the European Association of Urology and the ERUS Education Working Group, the European Association of Urology and the ERUS Education Working GroupSearch for more papers by this author First published: 03 March 2025 https://doi.org/10.1111/bju.16689Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookxLinkedInRedditWechat No abstract is available for this article. References 1Pellegrini CA. Surgical education in the United States: navigating the white waters. Ann Surg 2006; 244: 335–342 10.1097/01.sla.0000234800.08200.6c PubMedWeb of Science®Google Scholar 2Gallagher AG. Metric-based simulation training to proficiency in medical education: what it is and how to do it. Ulster Med J 2012; 81: 107–113 PubMedGoogle Scholar 3Gallagher AG, De Groote R, Paciotti M, Mottrie A. Proficiency-based progression training: a scientific approach to learning surgical skills. Eur Urol 2022; 81: 394–395 10.1016/j.eururo.2022.01.004 PubMedWeb of Science®Google Scholar 4De Groote R, Puliatti S, Amato M et al. Proficiency-based progression training for robotic surgery skills training: a randomized clinical trial. BJU Int 2022; 130: 528–535 10.1111/bju.15811 PubMedWeb of Science®Google Scholar 5Ericsson KA, Krampe RT, Tesch-Römer C. 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BACKGROUND:Various locoregional treatments exist for PET-CT-detected pelvic nodal oligorecurrences in patients with prostate cancer. We aimed to assess whether elective nodal radiotherapy (ENRT) to the pelvis would be superior to metastasis-directed therapy (MDT). METHODS:PEACE V-STORM is a phase 2, open-label, randomised, controlled trial conducted in 21 hospitals in Australia, Belgium, Italy, Norway, Spain, and Switzerland. Eligible participants were aged 18 years or older, with WHO performance status 0-1 and a histologically confirmed initial diagnosis of adenocarcinoma of the prostate, with a PET-detected pelvic nodal oligorecurrence (up to five nodes) following radical local treatment. Patients were randomly assigned (1:1) to MDT or ENRT. Randomisation was done online by minimisation with randomisation factor 0·80 and was stratified by type of PET tracer (choline vs prostate-specific membrane antigen) and type of MDT used (salvage lymph node dissection vs stereotactic body radiotherapy or simultaneous integrated boost). Participants and researchers were not masked to treatment assignment. Patients in the MDT group had salvage lymph node dissection or stereotactic body radiotherapy (30 Gy in three fractions every other day), with 6 months of androgen deprivation therapy. Patients in the ENRT group received a 45 Gy dose in 25 fractions to the pelvis with a simultaneous integrated boost of 65 Gy to the PET-positive nodes or salvage lymph node dissection, with 6 months of androgen deprivation therapy. The primary endpoint was metastasis-free survival, defined as the time between randomisation and the appearance of a metastatic recurrence (any M1) on PET imaging or death due to any cause, and was analysed per modified intention to treat. This study is registered with ClinicalTrials.gov, NCT03569241, and the Swiss National Clinical Trials Portal, SNCTP000002947, and is active, not recruiting. FINDINGS:Between June 11, 2018, and April 30, 2021, 198 patients were screened for eligibility, 196 of whom were randomly assigned to MDT (n=99) or ENRT (n=97), with 190 evaluable patients (MDT n=97 and ENRT n=93). All patients were male. Data on race and ethnicity were not collected. Median follow-up was 50 months (IQR 42-58). 4-year metastasis-free survival was 63% (80% CI 56-69) in the MDT group and 76% (69-81) in the ENRT group (HR 0·62 [80% CI 0·44-0·86]; p=0·063). The most common grade 3 adverse events were urinary incontinence (six [6%] of 97 in the MDT group vs nine [10%] in the ENRT group) and diarrhoea (one [1%] in the MDT group vs two [2%] in the ENRT group). No treatment-related deaths occurred. INTERPRETATION:To our knowledge, this is the first randomised trial for metachronous PET-detected nodal recurrences comparing two local treatment approaches (MDT and ENRT) in combination with 6 months of androgen deprivation therapy. By showing an improved metastasis-free survival with ENRT, this trial establishes ENRT as a potential standard treatment approach, awaiting a phase 3 trial confirming these results. FUNDING:Movember Foundation, Kom Op Tegen Kanker, Stichting tegen Kanker.

To investigate the relationship between [18F]PSMA-1007 PET parameters and biochemical recurrence-free survival (BCR-FS) in high-risk primary prostate cancer patients receiving neoadjuvant hormonal treatment. This prospective randomized, double-blind, placebo-controlled phase II trial included 89 high-risk primary prostate cancer patients who received a pelvic [18F]PSMA-1007 PET/MRI prior to and following neoadjuvant hormonal treatment. Patients were randomly assigned to neoadjuvant hormonal treatment with degarelix + apalutamide (n = 45) or degarelix + matching placebo (n = 44) for 3 months followed by radical prostatectomy and extended pelvic lymph node dissection. The following [18F]PSMA-1007 PET parameters were determined on the pre- and posttreatment [18F]PSMA-1007 PET: (i) semi-quantitative [18F]PSMA-1007 PET parameters such as SUVmax, SUVmean, PSMA-expressing volume and total lesion activity, and their absolute and relative differences; (ii) number of pelvic lymph node, distant and extraprostatic (i.e. pelvic lymph node and distant) metastases determined on [18F]PSMA-1007 PET; (iii) [18F]PSMA-1007 PET-based response criteria (aPERCIST and RECIP 1.0); (iv) molecular imaging TNM-stage as determined by PROMISE V2. 35

Bladder pain and dysfunction are common symptoms in patients with urinary tract infections (UTIs), including catheter-associated UTIs (CAUTIs). Underlying mechanisms of chronic bladder pain and recurrent UTIs remain poorly understood, and good translational mice models are sparse. Here, we developed a female mouse suprapubic CAUTI model, and combined in vivo and ex vivo imaging techniques and behavioral assays to longitudinally evaluate the consequences for bladder function, inflammation, abdominal pain, bacterial colonization, and biofilm. Catheter-associated urinary tract infection animals, with an implanted suprapubic bladder catheter infected with the bioluminescent uropathogenic Escherichia coli (UPEC) UTI89-Lux strain, were compared with sham-operated mice (SHAM), mice with a sterile catheter (CACON), and mice infected via transurethral instillation (UTI). Compared to transient infections in UTI mice, CAUTI mice exhibited sustained bacterial infection during >2 weeks, which was associated with bacterial biofilm formation on the catheter inner surface. Compared to CACON mice, CAUTI mice showed a more pronounced increase in suprapubic sensitivity, which was sensitive to antibiotic treatment. Void spot assays and fluoroscopic volumetry further revealed a smaller bladder capacity in both CAUTI and CACON mice, but only in CAUTI mice this was associated with reduced voiding efficiency. This model successfully recapitulates clinically relevant symptoms of CAUTI in patients and demonstrates that sustained bacterial colonization of the catheter directly contributes to bladder hypersensitivity and voiding dysfunction. This novel in vivo research model may be instrumental in the search for new therapies aimed at disrupting biofilms and treatments of bladder-related pain, infections, and dysfunction.

Background PSMA PET is the standard imaging modality for biochemically recurrent prostate cancer (BCR PCa). How-ever, the role of whole-body MRI (wb-MRI) remains unclear. This study presents an intra-individual comparison of PSMA PET and wb-MRI in patients with BCR PCa.Materials and methods This post-hoc analysis of a prospective, single-center trial included patients with BCR PCa, who underwent hybrid [68Ga]Ga-PSMA-11 or [18F]PSMA-1007 PET/MRI. Inclusion required at least two years of follow-up data after the PET/MRI, including histopathological results, imaging, and post-treatment serum PSA response. PSMA PET and wb-MRI scans were independently assessed for suspicious malignant lesions at patient and region level. Lesion verifica-tion was based on follow-up data to classify true positive (TP) and false positive findings. We compared the TP detection rate, positive predictive value (PPV), and number of TP malignant lesions between PSMA PET and wb-MRI.Results A total of 82 patients were included. At patient level, PSMA PET had significantly higher TP detection rate than wb-MRI (100% vs. 66%, p = 0.0005) and detected more TP lesions (mean 2.2 vs. 1.3, p = 0.0021). At overall region level, PSMA PET outperformed wb-MRI in TP detection rate (90% vs. 60%, p = 0.0042) and number of TP lesions (mean 2.0 vs. 1.0, p = < 0.0001). Organ-specific analysis revealed significantly higher number of TP lesions on PSMA PET for pelvic lymph nodes (mean 2.0 vs. 1.2, p = 0.016) and all lymph nodes (mean 2.9 vs. 1.2, p = 0.028). For all distant regions, PSMA PET showed higher TP detection rate (95% vs. 60%, p = 0.039). No significant differences were observed in PPV between PSMA PET and wb-MRI at patient level and all region levels.Conclusion In patients with BCR PCa, wb-MRI (i) demonstrates a significantly lower TP detection rate than PSMA PET, (ii) shows equivalent PPV and (iii) detects significantly fewer TP lesions.Trial registration ClinicalTrials.gov identifier NCT03327675

BACKGROUND AND OBJECTIVE:High-risk prostate cancer (PCa) carries a substantial risk of recurrence and progression after radical prostatectomy (RP). The ARNEO trial previously showed that apalutamide (APA) plus degarelix (DEG) improved the rates of minimal residual disease (MRD) and organ-confined pathology (ypT2) compared with matching placebo (PBO). This study aims to assess the oncological and quality-of-life outcomes of neoadjuvant DEG + APA compared with DEG + PBO. METHODS:ARNEO was a double-blind, randomised, PBO-controlled phase 2 trial investigating neoadjuvant DEG + APA in high-risk PCa patients eligible for RP. Patients received 3 mo of neoadjuvant DEG + APA or DEG + PBO. No adjuvant or salvage therapy was given unless biochemical recurrence (BCR) occurred. Quality-of-life data were collected at predefined time points. The prespecified secondary endpoints included a between-arm comparison of testosterone recovery (testosterone ≥150 ng/ml), BCR within 3 yr (prostate-specific antigen ≥0.2 ng/ml), BCR-free survival (BCR-FS), and quality of life according to treatment allocation. Quality of life was assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, International Index of Erectile Function-5 items, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 questionnaires. Exploratory analyses included metastasis-free survival (MFS) and the relation of outcomes according to pathological outcomes. KEY FINDINGS AND LIMITATIONS:With a median follow-up of 54 mo, the 3-yr BCR rate was not significantly different between groups (24% with DEG + APA vs 39% with DEG + PBO; relative risk 0.63 [95% confidence interval {CI} 0.34-1.19], p = 0.18). BCR-FS was not associated with treatment allocation (hazard ratio 0.72 [95% CI 0.37-1.41]; p = 0.34) or MRD achieved (p = 0.93). However, BCR-FS was significantly longer in patients with ypT2 or specimen-confined disease (p ≤ 0.0001). Similar outcomes regarding 3-yr BCR rates and MFS were found. The median testosterone (>150 ng/dl) recovery time was 5 mo in both the groups (p = 0.36). Quality-of-life outcomes were not different at each time point (p > 0.47). Importantly, the ARNEO trial was powered for a difference in MRD rates (primary endpoint) and not for the reported secondary endpoints. CONCLUSIONS AND CLINICAL IMPLICATIONS:At 3-yr follow-up, no differences were seen in the 3-yr BCR rate or BCR-FS between patients treated with neoadjuvant DEG + APA and those treated with DEG + PBO. Achieving MRD was not predictive of better outcomes, whereas ypT2 and specimen-confined disease were strongly associated with improved BCR-FS and MFS. Quality of life remained similar between groups at all time points.

OBJECTIVE:To evaluate the feasibility of randomising patients with newly diagnosed metastatic prostate cancer (mPCa) to cytoreductive radical prostatectomy (cRP) plus systemic standard of care (SOC) vs SOC alone in Belgian centres. PATIENTS AND METHODS:This is a phase II, multicentre, prospective, randomised, open-label feasibility trial. Patients with newly diagnosed mPCa were screened across six centres from August 2018 to August 2024. The aim was to randomise 86 patients to either cRP with pelvic lymphadenectomy plus systemic SOC or SOC alone (including radiotherapy in low-volume disease). Eligible patients had an Eastern Cooperative Oncology Group Performance Status of 0-1 and were considered suitable candidates for local treatment. The primary endpoint was the feasibility of randomisation, assessed by the randomisation rate (randomised/eligible). RESULTS:A total of 325 patients with newly diagnosed mPCa were screened, of whom 170 (52%) were eligible. The main reasons for ineligibility included unresectable tumours (42% [65/155]) and inadequate surgical fitness (37% [58/155]). Among eligible patients, 75% were excluded (127/170), mostly due to patient refusal (68% [86/127]) and inclusion in competing studies (21% [27/127]). A total of 43 patients were randomised: 21 to cRP and 22 to SOC, yielding a randomisation rate of 25% (43/170). Randomisation rates were lower than anticipated, limiting feasibility in the present trial setting. CONCLUSION:Randomising men with newly diagnosed mPCa to RP plus SOC vs SOC alone proved challenging in this Belgian trial. Major barriers to recruitment included limited surgical eligibility and patient refusal. Targeted recruitment strategies or alternative trial designs should be considered.

BackgroundRobot-assisted laparoscopic prostatectomy (RALP) is used frequently to treat prostate cancer; yet, prospective data on the quality of life and functional outcomes are lacking.ObjectiveTo assess the quality of life and functional outcomes after radical prostatectomy in different risk groups with or without adjuvant treatments.Design, setting, and participantsThe Be-RALP database is a prospective multicentre database that covers 9235 RALP cases from 2009 until 2016. Of these 9235 patients, 2336 high-risk prostate cancer patients were matched with low/intermediate-risk prostate cancer patients.InterventionPatients were treated with RALP only or followed by radiotherapy and/or hormone treatment.Outcome measurements and statistical analysisWe used a mixed-model analysis to longitudinally analyse quality of life, urinary function, and erectile function between risk groups with or without additional treatments.Results and limitationsRisk group was not significant in predicting quality of life, erectile function, or urinary function after RALP. Postoperative treatment (hormone and/or radiotherapy treatment) was significant in predicting International Index of Erectile Function (IIEF-5), sexual activity, and sexual functioning.ConclusionsRisk group was not linked with clinically relevant declines in functional outcomes after RALP. The observed functional outcomes and quality of life are in favour of considering RALP for high-risk prostate cancer. Postoperative treatment resulted in lower erectile function measures without clinically relevant changes in quality of life and urinary functions. Hormone therapy seems to have the most prominent negative effects on these outcomes.Patient summaryThis study investigated the quality of life, and urinary and erectile function in patients with aggressive and less aggressive prostate cancer after surgery only or in combination with hormones or radiation. We found that quality of life recovers completely, while erectile and urinary function recovers only partially after surgery. Aggressiveness of the disease had a minimal effect on the outcomes; yet, postoperative treatments lowered erectile function further.

Background and objective:Lymph node-positive (pN1) prostate cancer (PCa) is a heterogeneous disease, and a clear definition of prognostic groups is urgently needed. We aimed to assess cancer-related mortality (CRM) in different prognostic groups of pN1 patients, created based on the pathological PCa characteristics and number of positive lymph nodes (LN+). Methods:We conducted a retrospective, multicentre cohort study including 894 patients with pN1 disease treated at 15 European high-volume centres. Independent predictors for CRM were identified and pooled. A prognostic model was constructed for the prediction of CRM, accounting for death from other causes as a competing risk. The 10-yr cumulative risk of mortality was assessed. Key findings and limitations:Our model was based on pT stage (pT2-3a vs pT3b-4), surgical margin (SM) status (positive vs negative), and number of LN+ (1-4 vs >4), and included three prognostic groups. The favourable-prognosis group includes patients with pT2-3a and one to four LN+, or pT3b-4 with negative SM status. The intermediate-prognosis group included patients with pT2-3a disease and more than four LN+, or pT3b-4 disease, one to four LN+, and positive SM status. Patients in the poor-prognosis group had all three high-risk factors present. The C-index of this model was 0.73. The 10-yr cumulative CRM rates were 12% (95% confidence interval: 7.3-16%), 32% (24-40%), and 58% (40-76%), respectively, with significant differences between groups (hazard ratio 2.2-6.4, p < 0.005). Conclusions and clinical implications:The pN1 patient population is extremely heterogeneous, with an increased risk of death from PCa rather than death from other causes. In this group of patients, primary cancer characteristics (pT stage, number of LN+, and SM status) still represent the driving factors of CRM. Patient summary:Men with positive lymph nodes on pathology have an increased risk of dying from prostate cancer, rather than from other causes. Our proposed model stratifies patients into groups with different cancer-related prognosis and may aid in personalised clinical decision-making in a postoperative setting.

394 Background: High-risk prostate cancer (PCa) patients have a high risk of biochemical recurrence (BCR) and metastatic progression following local therapy. The ARNEO trial is a double-blind, placebo-controlled trial, evaluating the role of neoadjuvant degarelix with or without apalutamide before radical prostatectomy (RP) in men with high-risk PCa. Previously, we demonstrated that patients receiving neoadjuvant degarelix + apalutamide (n=45) had significantly better pathological response in terms of pT2 disease (51% vs. 27%; p=0.022) and minimal residual disease (MRD) (37.8% vs. 9.1%, p=0.002) compared to patients receiving degarelix alone (n=44). However, it was yet unclear if these improved pathological outcomes were also associated with improved oncological outcomes. Methods: High-risk PCa patients were randomly assigned 1:1 to degarelix + apalutamide versus degarelix + placebo for 12 weeks followed by radical prostatectomy. Follow-up of patients included PSA and testosterone testing every 6 months. No adjuvant radiotherapy was given. However, at time of PSA relapse (PSA >0.2 ng/ml) patients received a PSMA PET/CT. In case of negative imaging at time of BCR, patients received salvage radiotherapy to the prostate bed (+/- pelvic region). Results: All patients had a minimum follow-up of 36 months. Median follow-up was 46.5 months (IQR 42-53.5) in the degarelix + placebo arm and 46 months (IQR 42-53) in the degarelix + apalutamide arm. Median time to testosterone recovery (>50 ng/dl) was 6 and 7 months, respectively ( p = 0.15 ). In total, 14 (31%) patients in the degarelix + apalutamide arm developed BCR compared to 18 (41%) patients in the placebo arm (p=0.3). No statistically significant difference in BCR was observed between patients who achieved MRD and patients without MRD at final pathology (35% vs 38%; p = 1 ). However, ypT2 disease at final pathology was highly associated with improved BCR-free survival (11% vs 52%; p < 0.0001 ). Finally, we also looked at the prognostic value of achieving specimen-confined disease (SCD; defined as ypT2-3a AND negative surgical margins AND pN0). Patients with SCD at final pathology also had a significantly better BCR-free survival, compared to those patients without SCD (18% vs 65%; p < 0.0001 ). Conclusions: At 3 years follow-up, no statistically significant difference in terms of BCR was observed between patients treated with neoadjuvant degarelix + apalutamide or degarelix alone. MRD was not associated with improved BCR-free survival. However, ypT2 and SCD disease following neoadjuvant hormonal therapy was highly associated with improved BCR-free survival, suggesting that ypT2 and SCD disease might be used as a surrogate endpoints for improved BCR-free survival. Clinical trial information: NCT03080116 .

OBJECTIVE:To assess the oncological impact of prophylactic urethrectomy (PU) on recurrence, metastasis, and survival outcomes, as PU was historically performed alongside radical cystectomy (RC) in men but has become rare with the increasing use of orthotopic neobladder substitution and uncertain survival benefits. PATIENTS AND METHODS:A total of 1028 patients underwent RC at a single tertiary referral center between 1996 and 2022. Among them, 581 males who received either incontinent urinary diversion or continent cutaneous diversion were identified. A propensity score matching was performed to minimise selection bias, yielding a cohort of 332 patients, of whom 166 underwent PU and 166 did not. Kaplan-Meier survival analysis was conducted to evaluate recurrence-free survival (RFS), urethral recurrence-free survival (URFS), cancer-specific survival (CSS), and overall survival (OS) at multiple time points postoperatively. Differences in survival outcomes between the two groups were assessed using the log-rank test. RESULTS:A trend toward improved CSS was observed in the PU group; however, the difference was not significant, and no notable variation was found in RFS. At 10 years, URFS was higher in the PU group (97.9% vs 90.9%, P = 0.05), but after matching, this difference (98.2% vs 95.9%) was no longer significant. A significant improvement in OS was observed among patients who underwent PU, with a 10-year survival rate of 47.3% compared to 27.5% in those who did not receive the procedure (P = 0.002). Independent predictors of OS included age ≥80 years (P = 0.013), Charlson Comorbidity Index score ≥3 (P = 0.002), pathological N-stage ≥N1 (P < 0.001), positive surgical margins (P < 0.001), and performing PU (P = 0.015). CONCLUSIONS:Patients undergoing PU had significantly improved OS at 2-, 5-, and 10-year follow-up compared to those who did not. No significant differences were found in CSS and RFS. While PU was associated with a reduced risk of urethral recurrence at 10 years, this advantage was no longer significant after adjusting for confounders. The procedure may be most beneficial for select patients, particularly those with prostatic urethral involvement.