INTRODUCTION AND OBJECTIVE:Robotic-assisted laparoscopic prostatectomy (PLAR) seems to improve functional outcomes, however there is not a consensus of a standard procedure. The aim of this study was to identify the PLAR "state of art" in Catalonia, Spain. MATERIAL AND METHODS:This was a cross-sectional survey-based study conducted among urologists across Catalonia, Spain. The survey was distributed through online platforms and the professional urology society. All statistical analyses were performed using Stata software, v20. RESULTS:59 urologists completed the survey, revealing PLAR as the most commonly used technique (79.7%). Most urologist (70%) create the pneumoperitoneum using a controlled incision with direct access and 78.3% use the Airseal technology. The intraperitoneal approach is performed in >90% of cases. Endopelvic fascia preservation is not routinely performed. 34.5% of the survey not perform the dorsal vein complex suture. All preserves the bladder neck when oncologically safe. Nerve-vascular bundles bleeding control is performed using standard coagulation or suturing. 34% performed posterior reconstruction. Only use hemostatic devices when evident bleeding and 70% does not routinely left a drainage. Multivariable analysis showed that center volume had a significant independent association with dorsal venous complex suturing (OR 0.073, 95%CI 0.07-0.826), nerve-vascular bundles suturing hemostasis (OR 11.67, 95%CI 1.07-127.60) and endopelvic fascia preservation (OR 13.64, 95%CI 1.087-201.27), but there was no correlation with time the bladder catheter or days hospitalized. CONCLUSIONS:The study provides an overview of the state of PLAR in Catalonia, Spain, showing significant variability and reflecting a commitment to advancing surgical technology and patient care.
Introducción y Objetivo: La prostatectomía laparoscópica asistida por robot (PLAR) mejora los resultados funcionales. No existe consenso sobre su estandarización. El objetivo del estudio fue identificar el estado actual de la PLAR en Cataluña, España.Material y Métodos: Estudio basado en encuestas transversales distribuidas online y por la sociedad profesional de urología entre urólogos de Cataluña. Todos los análisis estadísticos se realizaron utilizando el software Stata, v20.Resultados: 59 urólogos completaron la encuesta. La PLAR es la técnica más utilizada (79.7%). La mayoría (70%) crean el neumoperitoneo mediante una incisión controlada con acceso directo, el 78.3% utiliza AirSeal. El >90% se realiza un abordaje intraperitoneal. La preservación de la fascia endopélvica no es rutinaria. El 34.5% no suturan el complejo venoso dorsal CVD). Todos preservan el cuello vesical cuando es oncológicamente seguro. El control del sangrado de haces neuro-vasculares fue mediante coagulación o sutura. El 34% realizó reconstrucción posterior. Solo usan dispositivos hemostáticos cuando hay sangrado evidente y el 70% no deja drenaje. El análisis multivariable mostró que el volumen del centro tenía asociación significativa con suturar el complejo venoso dorsal (OR 0.073, IC95% 0.07-0.826), la sutura de los haces neuro-vasculares (OR 11.67, IC95% 1.07-127.60) y la preservación endopélvica (OR 13.64, IC95% 1.087-201.27). No hubo correlación con el tiempo de sonda vesical ni días de hospitalización.Conclusiones: El estudio proporciona una visión general del estado de la PLAR en Cataluña, España, mostrando una variabilidad significativa y reflejando un compromiso con el avance de la tecnología quirúrgica y la atención al paciente.
PURPOSE:To analyze the reduction in multiparametric magnetic resonance imaging (mpMRI) demand and prostate biopsies after the hypothetical implementation of the Barcelona risk-stratified pathway (BCN-RSP) in a population of the clinically significant prostate cancer (csCaP) early detection program in Catalonia.MATERIALS AND METHODS:A retrospective comparation between the hypothetical application of the BCN-RSP and the current pathway, which relied on pre-biopsy mpMRI and targeted and/or systematic biopsies, was conducted. The BCN-RSP stratify men with suspected CaP based on a prostate specific antigen (PSA) level >10 ng/ml and a suspicious rectal examination (DRE), and the Barcelona-risk calculator 1 (BCN-RC1) to avoid mpMRI scans. Subsequently, candidates for prostate biopsy following mpMRI are selected based on the BCN-RC2. This comparison involved 3,557 men with serum PSA levels > 3.0 ng/ml and/or suspicious DRE. The population was recruited prospectively in 10 centers from January 2021 and December 2022. CsCaP was defined when grade group ≥ 2.RESULTS:CsCaP was detected in 1,249 men (35.1%) and insignificant CaP was overdeteced in 498 (14%). The BCN-RSP would have avoid 705 mpMRI scans (19.8%), and 697 prostate biopsies (19.6%), while 61 csCaP (4.9%) would have been undetected. The overdetection of insignificant CaP would have decrease in 130 cases (26.1%), and the performance of prostate biopsy for csCaP detection would have increase to 41.5%.CONCLUSION:The application of the BCN-RSP would reduce the demand for mpMRI scans and prostate biopsies by one fifth while less than 5% of csCaP would remain undetected. The overdetection of insignificant CaP would decrease by more than one quarter and the performance of prostate biopsy for csCaP detection would increase to higher than 40%.
OBJECTIVES:To assess of the clinical performance of Proclarix® (a novel Conformité Européenne [CE]-marked biomarker test aiding in the identification of clinically significant prostate cancer [csPCa]) alone or in combination with multiparametric magnetic resonance imaging (mpMRI) to predict csPCa (International Society of Urological Pathology Grade Group ≥2).PATIENTS AND METHODS:The study included blood samples from 721 men undergoing mpMRI followed by biopsy at University College London, London, and Vall d'Hebron University Hospital, Barcelona. Samples were tested blindly. The Proclarix-MRI model combining prostate volume, Proclarix and mpMRI results was trained using the UCL cohort (n = 159) and validated in the Vall d'Hebron cohort (n = 562). Its diagnostic performance was established in correlation to biopsy outcome and compared to available clinical parameters and risk calculators.RESULTS:Clinical performance of the Proclarix-MRI model in the validation cohort did not significantly differ from the training cohort and resulted in a sensitivity for csPCa of 90%, 90% negative predictive value and 66% positive predictive value. The Proclarix-MRI score's specificity (68%) was significantly (P < 0.001) better than the MRI-European Randomized study of Screening for Prostate Cancer risk score (51%), Proclarix (27%) or mpMRI (28%) alone. In addition, Proclarix by itself was found to be useful in the MRI Prostate Imaging-Reporting and Data System (PI-RADS) score 3 subgroup by outperforming prostate-specific antigen density in terms of specificity (25% vs 13%, P = 0.004) at 100% sensitivity.CONCLUSION:When combined with mpMRI and prostate volume, Proclarix reliably predicted csPCa and ruled out men with no or indolent cancer. A large reduction of two thirds of unneeded biopsies was achieved. Proclarix can further be used with high confidence to reliably detect csPCa in men with an indeterminate PI-RADS score 3 mpMRI. Despite these encouraging results, further validation is needed.
Background and Objective: Prostate cancer (PC) is the malignant neoplasm with the highest incidence after lung cancer worldwide. The objective of this study is to review the literature on the methods that improve the efficacy of the current strategy for the early diagnosis of clinically significant PC (csPC), based on the performance of magnetic resonance imaging (RM) and targeted biopsies when suspicious lesions are detected, in addition to systematic biopsy. Evidence acquisition: A systematic literature review was performed in PubMed, Web of Science and Cochrane according to the PRISMA criteria (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), using the search terms: multiparametric magnetic resonance ima-ging, biparametric magnetic resonance imaging, biomarkers in prostate cancer, prostate cancer y early diagnosis. A total of 297 references were identified and, using the PICO selection criteria, 21 publications were finally selected to synthesize the evidence. Evidence synthesis: With the consolidation of MRI as the test of choice for the diagnosis of prostate cancer, the role of PSA density (PSAD) becomes relevant as a predictive tool included in prediction nomograms, without added cost. PSAD and diagnostic markers, combined with MRI, offer a high diagnostic power with an area under curve (AUC) above 0,7. Only the SHTLM3 model integrates markers in the creation of a nomogram. Prediction models also offer consistent efficacy with an AUC greater than 0,8 when associating MRI. Conclusions: The efficacy of MRI in clinically significant prostate cancer detection can be impro-ved with different parameters in order to generate predictive models that support decision making. (c) 2022 AEU. Published by Elsevier Espana, S.L.U. All rights reserved.
El cáncer de próstata (CP) es la neoplasia maligna con mayor incidencia a nivel mundial después del cáncer de pulmón. El objetivo de este estudio es revisar la literatura para conocer qué métodos permiten mejorar la eficacia de la estrategia actual de diagnóstico precoz del CP clínicamente significativo (csCP), basada en la realización de la resonancia magnética (RM) y biopsias dirigidas cuando se detectan lesiones sospechosas, además de la biopsia sistemática. Se realizó una revisión sistemática de la literatura en PubMed, Web of Science y Cochrane según los criterios Preferred reporting items for systematic reviews and meta-analyses (PRISMA), utilizando los términos de búsqueda: RM multiparamétrica, RM biparamétrica, densidad de antígeno prostático específico (PSA), prostate cancer antigen 3 (PCA3), Prostate Health Index (PHI), 4 K score, cáncer de próstata, diagnóstico precoz. Se identificaron 297 referencias y, a través de los criterios de selección Participants, Interventions, Comparisons and Outcomes (PICO), se seleccionaron 21 publicaciones para sintetizar la evidencia. Con la consolidación de la RM como prueba de elección el diagnóstico del CP, la densidad de PSA (DPSA) es una herramienta de gran importancia incluyéndose en nomogramas predictores, sin coste añadido. La PSAD y los biomarcadores, en asociación con la RM, ofrecen un poder diagnóstico elevado con un área bajo la curva (ABC) por encima del 0,7. Únicamente, el modelo SHTLM3 integra biomarcadores en la elaboración de un nomograma. Los modelos predictores ofrecen una eficacia constante en las diferentes series, con un ABC superior a 0,8 en asociación con la RM. La eficacia de la RM, para diagnosticar el csCP, se puede mejorar con diferentes parámetros con el objetivo de generar modelos predictivos que apoyen la toma de decisiones. Prostate cancer (PC) is the malignant neoplasm with the highest incidence after lung cancer worldwide. The objective of this study is to review the literature on the methods that improve the efficacy of the current strategy for the early diagnosis of clinically significant PC (csPC), based on the performance of magnetic resonance imaging (RM) and targeted biopsies when suspicious lesions are detected, in addition to systematic biopsy. A systematic literature review was performed in PubMed, Web of Science and Cochrane according to the PRISMA criteria (Preferred Reporting Items for Systematic Reviews and Meta-Analyses), using the search terms: multiparametric magnetic resonance imaging, biparametric magnetic resonance imaging, biomarkers in prostate cancer, prostate cancer y early diagnosis. A total of 297 references were identified and, using the PICO selection criteria, 21 publications were finally selected to synthesize the evidence. With the consolidation of MRI as the test of choice for the diagnosis of prostate cancer, the role of PSA density (PSAD) becomes relevant as a predictive tool included in prediction nomograms, without added cost. PSAD and diagnostic markers, combined with MRI, offer a high diagnostic power with an area under curve (AUC) above 0,7. Only the SHTLM3 model integrates markers in the creation of a nomogram. Prediction models also offer consistent efficacy with an AUC greater than 0,8 when associating MRI. The efficacy of MRI in clinically significant prostate cancer detection can be improved with different parameters in order to generate predictive models that support decision making.
The European Association of Urology currently recommends the use of risk-organized models to decrease the demand of prebiopsy magnetic resonance imaging (MRI) and unnecessary prostate biopsies in men with suspected prostate cancer (CaP). Low evidence suggests that men with prostate-specific antigen >10 ng/ml and an abnormal digital rectal examination (DRE) do not benefit from prebiopsy MRI and targeted biopsies. We aim to validate this low evidence in a sizable cohort and knowing how many clinically significant CaP (csCaP) would go undetected if only random biopsies were performed in these cases. We analyze a subset of 545 men with PSA >10 ng/ml and an abnormal DRE who met the previous criteria among 5,329 participants in a prospective trial in whom random biopsy was always performed and targeted biopsies of PI-RADS ≥3 lesions (10.2%). CsCaP (grade group ≥2) was detected in 370 men (67.9%), with 11 of 49 with negative MRI (22.5%) and 359 of 496 (72.4%) having PI-RADS ≥3. CsCaP was identified in random and targeted biopsies in 317 (88.7%) men, in targeted biopsies only in 23 (6.4%), and in random biopsies only in 19 (5.3%). If only random biopsies were performed in these men, 23 of overall 1,914 csCaP (1.2%) would go undetected in this population. Prebiopsy MRI can be saved in men with serum PSA >10 ng/ml and an abnormal DRE and only random biopsy performed. However, a close follow-up of men with negative random biopsy seems appropriate due to the high-risk of csCaP in these men.
The primary objective of this study was to analyse the current accuracy of targeted and systematic prostate biopsies in detecting csPCa. A secondary objective was to determine whether there are factors predicting the finding of csPCa in targeted biopsies and, if so, to explore the utility of a predictive model for csPCa detection only in targeted biopsies. We analysed 2122 men with suspected PCa, serum PSA > 3 ng/mL, and/or a suspicious digital rectal examination (DRE), who underwent targeted and systematic biopsies between 2021 and 2022. CsPCa (grade group 2 or higher) was detected in 1026 men (48.4%). Discrepancies in csPCa detection in targeted and systematic biopsies were observed in 49.6%, with 13.9% of csPCa cases being detected only in systematic biopsies and 35.7% only in targeted biopsies. A predictive model for csPCa detection only in targeted biopsies was developed from the independent predictors age (years), prostate volume (mL), PI-RADS score (3 to 5), mpMRI Tesla (1.5 vs. 3.0), TRUS-MRI fusion image technique (cognitive vs. software), and prostate biopsy route (transrectal vs. transperineal). The csPCa discrimination ability of targeted biopsies showed an AUC of 0.741 (95% CI 0.721-0.762). The avoidance rate of systematic prostate biopsies went from 0.5% without missing csPCa to 18.3% missing 4.6% of csPCa cases. We conclude that the csPCa diagnostic accuracy of targeted biopsies is higher than that of systematic biopsies. However, a significant rate of csPCa remains detected only in systematic biopsies. A predictive model for the partial omission of systematic biopsies was developed.
We sought to find further evidence showing the increase in PCa aggressiveness as PI-RADS score increases from four surrogates of PCa aggressiveness: i. prostate biopsy GG (≤3 vs. >3), ii. type of pathology in surgical specimens (favourable vs. unfavourable), iii. clinical stage (localised vs. advanced), and risk of recurrence of localised PCa after primary treatment (low-intermediate vs. high). A group of 692 PCa patients were diagnosed after 3-T multiparametric MRI (mpMRI) and guided and/or systematic biopsies, showing csPCa (GG ≥ 2) in 547 patients (79%) and insignificant PCa (iPCa) in 145 (21%). The csPCa rate increased from 32.4% in PI-RADS < 3 to 95.5% in PI-RADS 5 (p < 0.001). GG ≥ 3 was observed in 7.6% of PCa with PI-RADS < 3 and 32.6% in those with PI-RADS > 3 (p < 0.001). Unfavourable pathology was observed in 38.9% of PCa with PI-RAD < 3 and 68.3% in those with PI-RADS > 3 (p = 0.030). Advanced disease was not observed in PCa with PI-RADS ≤ 3, while it existed in 12.7% of those with PI-RADS > 3 (p < 0.001). High-risk recurrence localised PCa was observed in 9.5% of PCa with PI-RADS < 3 and 35% in those with PI-RADS > 3 (p = 0.001). The PI-RADS score was an independent predictor of all surrogates of PCa aggressiveness as PSA density. We confirmed that mpMRI grades PCa aggressiveness.
A new and externally validated MRI-PM for csPCa was developed in the metropolitan area of Barcelona, and a web-RC designed with the new option of selecting the csPCa probability threshold. The development cohort comprised 1486 men scheduled to undergo a 3-tesla multiparametric MRI (mpMRI) and guided and/or systematic biopsies in one academic institution of Barcelona. The external validation cohort comprised 946 men in whom the same diagnostic approach was carried out as in the development cohort, in two other academic institutions of the same metropolitan area. CsPCa was detected in 36.9% of men in the development cohort and 40.8% in the external validation cohort (p = 0.054). The area under the curve of mpMRI increased from 0.842 to 0.897 in the developed MRI-PM (p < 0.001), and from 0.743 to 0.858 in the external validation cohort (p < 0.001). A selected 15% threshold avoided 40.1% of prostate biopsies and missed 5.4% of the 36.9% csPCa detected in the development cohort. In men with PI-RADS <3, 4.3% would be biopsied and 32.3% of all existing 4.2% of csPCa would be detected. In men with PI-RADS 3, 62% of prostate biopsies would be avoided and 28% of all existing 12.4% of csPCa would be undetected. In men with PI-RADS 4, 4% of prostate biopsies would be avoided and 0.6% of all existing 43.1% of csPCa would be undetected. In men with PI-RADS 5, 0.6% of prostate biopsies would be avoided and none of the existing 42.0% of csPCa would be undetected. The Barcelona MRI-PM presented good performance on the overall population; however, its clinical usefulness varied regarding the PI-RADS category. The selection of csPCa probability thresholds in the designed RC may facilitate external validation and outperformance of MRI-PMs in specific PI-RADS categories.
A predictive model including age, PCa family history, biopsy status (initial vs repeat), DRE (normal vs abnormal), serum prostate-specific antigen (PSA), and DRE prostate volume ca-tegory was developed to stratify initial PCa suspicion in 1486 men with PSA > 3 ng/mL and/or abnormal DRE, in whom mpMRI followed; 2- to 4-core TRUS-guided biopsies where Prostate Imaging Report and Data System (PI-RADS) > 3 lesions and/or 12-core TRUS systematic biopsies were performed in one academic institution between 1 January 2016–31 December 2019. The csPCa detection rate, defined as International Society of Uro-Pathology grade group 2 or higher, was 36.9%. An external validation of designed BCN-RC 1 was carried out on 946 men from two other institutions in the same metropolitan area, using the same criteria of PCa suspicion and diagnostic approach, yielded a csPCa detection rate of 40.8%. The areas under the receiver operating characteristic curves of BCN-RC 1 were 0.823 (95% CI: 0.800–0.846) in the development cohort and 0.837 (95% CI: 0.811–0.863) in the validation cohort (p = 0.447). In both cohorts, BCN-RC 1 exhibited net benefit over performing mpMRI in all men from 8 and 12% risk thresholds, respectively. At 0.95 sensitivity of csPCa, the specificities of BCN-RC 1 were 0.24 (95% CI: 0.22–0.26) in the development cohort and 0.34 (95% CI: 0.31–0.37) in the validation cohort (p < 0.001). The percentages of avoided mpMRI scans were 17.2% in the development cohort and 22.3% in the validation cohort, missing between 1.8% and 2% of csPCa among men at risk of PCa. In summary, BCN-RC 1 can stratify initial PCa suspicion, reducing the demand of mpMRI, with an acceptable loss of csPCa.
Urinary incontinence after radical prostatectomy (RP) is an adverse event with high impact on patient’s quality of life. Nowadays there is no standardized method for urinary continence measurement. Posterior rhabdosphincter reconstruction (PRR) is a surgical step that can improve early urinary continence after RP. Our objective was to analyse different continence definitions and predictors of urinary continence recovery after robot-assisted RP (RARP). We conducted a double-blind, randomised controlled trial (NCT03302169) including 152 consecutive patients with localized prostate cancer subjected to RARP. Patients were randomised to single urethrovesical anastomosis (control arm) or PRR before urethrovesical anastomosis (PRR arm). Urinary continence was measured with the EPIC-26 and ICIQ-SF validated questionnaires, and pad use (0-1 pads and no pads), at 7, 15, 30, 90, 180 and 365 days after catheter removal. Prognostic factors for early urinary continence recovery were analysed. 72 patients were included in the control arm and 80 in the PRR arm. Baseline characteristics were similar between arms, except body mass index, which was higher in PRR arm. “No pad” was the only definition assessing the benefit of PRR at 30 days, 33.8% in PRR arm and 18.1% in control arm, p = 0.022; and at 90 days, 58.8 and 43.1% respectively, p = 0.038. Questionnaires did not detect differences in terms of continence recovery. PRR was the only predictor for early continence recovery, p = 0.03. PRR increased early urinary continence recovery after RARP. Continence definition was critical to assess benefit. The only predictive factor for early continence recovery was PRR. La incontinencia urinaria después de la prostatectomía radical es un efecto adverso con gran impacto en la calidad de vida. Actualmente no disponemos de medidas estandarizadas para su evaluación. La reconstrucción posterior del rabdoesfínter (RPR) puede mejorar la incontinencia urinaria precoz. Nuestro objetivo fue analizar diferentes definiciones y factores pronósticos de continencia urinaria precoz después de prostatectomía radical robótica (PRR). Realizamos un ensayo clínico aleatorizado (NCT03302169) incluyendo 152 pacientes con cáncer de próstata localizado sometidos a PRR y aleatorizados en anastomosis uretrovesical simple (grupo control) y RPR previa a la anastomosis (grupo RPR). La continencia urinaria se evaluó mediante cuestionarios específicos (EPIC-26 y ICIQ-SF), y la utilización de compresas (0-1 compresa y 0 compresas) a los 7, 15, 30, 90, 180 y 365 días tras la retirada de la sonda vesical. Se analizaron factores predictores para recuperación de continencia urinaria precoz. Se incluyeron 72 pacientes en el grupo control y 80 en el grupo RPR. Las características basales fueron similares entre grupos excepto el índice de masa corporal, mayor en el grupo RPR. La definición «0 compresas» fue la única que demostró beneficio de la RPR a los 30 días, con continencia del 33,8% en el grupo RPR y 18,1% en el grupo control, p = 0,022, y a los 90 días, 58,8% y 43,1%, respectivamente, p = 0,038. Los cuestionarios no mostraron diferencias entre grupos. La RPR fue el único factor predictor de continencia urinaria precoz. La RPR mejora las tasas de continencia urinaria precoz, pero la definición de continencia es determinante. El único factor predictor de continencia urinaria precoz fue la RPR.
This study is a head-to-head comparison between mPSAD and MRI-PMbdex. The MRI-PMbdex was created from 2432 men with suspected PCa; this cohort comprised the development and external validation cohorts of the Barcelona MRI predictive model. Pre-biopsy 3-Tesla multiparametric MRI (mpMRI) and 2 to 4-core transrectal ultrasound (TRUS)-guided biopsies for suspicious lesions and/or 12-core TRUS systematic biopsies were scheduled. Clinically significant PCa (csPCa), defined as Gleason-based Grade Group 2 or higher, was detected in 934 men (38.4%). The area under the curve was 0.893 (95% confidence interval [CI]: 0.880–0.906) for MRI-PMbdex and 0.764 (95% CI: 0.774–0.783) for mPSAD, with p < 0.001. MRI-PMbdex showed net benefit over biopsy in all men when the probability of csPCa was greater than 2%, while mPSAD did the same when the probability of csPCa was greater than 18%. Thresholds of 13.5% for MRI-PMbdex and 0.628 ng/mL2 for mPSAD had 95% sensitivity for csPCa and presented 51.1% specificity for MRI-PMbdex and 19.6% specificity for mPSAD, with p < 0.001. MRI-PMbdex exhibited net benefit over mPSAD in men with prostate imaging report and data system (PI-RADS) <4, while neither exhibited any benefit in men with PI-RADS 5. Hence, we can conclude that MRI-PMbdex is more accurate than mPSAD for the proper selection of candidates for prostate biopsy among men with suspected PCa, with the exception of men with a PI-RAD S 5 score, for whom neither tool exhibited clinical guidance to determine the need for biopsy.
La incontinencia urinaria después de la prostatectomía radical es un efecto adverso con gran impacto en la calidad de vida. Actualmente no disponemos de medidas estandarizadas para su evaluación. La reconstrucción posterior del rabdoesfínter (RPR) puede mejorar la incontinencia urinaria precoz. Nuestro objetivo fue analizar diferentes definiciones y factores pronósticos de continencia urinaria precoz después de prostatectomía radical robótica (PRR). Realizamos un ensayo clínico aleatorizado (NCT03302169) incluyendo 152 pacientes con cáncer de próstata localizado sometidos a PRR y aleatorizados en anastomosis uretrovesical simple (grupo control) y RPR previa a la anastomosis (grupo RPR). La continencia urinaria se evaluó mediante cuestionarios específicos (EPIC-26 y ICIQ-SF), y la utilización de compresas (0-1 compresa y 0 compresas) a los 7, 15, 30, 90, 180 y 365 días tras la retirada de la sonda vesical. Se analizaron factores predictores para recuperación de continencia urinaria precoz. Se incluyeron 72 pacientes en el grupo control y 80 en el grupo RPR. Las características basales fueron similares entre grupos excepto el índice de masa corporal, mayor en el grupo RPR. La definición «0 compresas» fue la única que demostró beneficio de la RPR a los 30 días, con continencia del 33,8% en el grupo RPR y 18,1% en el grupo control, p = 0,022, y a los 90 días, 58,8% y 43,1%, respectivamente, p = 0,038. Los cuestionarios no mostraron diferencias entre grupos. La RPR fue el único factor predictor de continencia urinaria precoz. La RPR mejora las tasas de continencia urinaria precoz, pero la definición de continencia es determinante. El único factor predictor de continencia urinaria precoz fue la RPR. Urinary incontinence after radical prostatectomy (RP) is an adverse event with high impact on patient's quality of life. Nowadays there is no standardized method for urinary continence measurement. Posterior rhabdosphincter reconstruction (PRR) is a surgical step that can improve early urinary continence after RP. Our objective was to analyse different continence definitions and predictors of urinary continence recovery after robot-assisted RP (RARP). We conducted a double-blind, randomised controlled trial (NCT03302169) including 152 consecutive patients with localized prostate cancer subjected to RARP. Patients were randomised to single urethrovesical anastomosis (control arm) or PRR before urethrovesical anastomosis (PRR arm). Urinary continence was measured with the EPIC-26 and ICIQ-SF validated questionnaires, and pad use (0-1 pads and no pads), at 7, 15, 30, 90, 180 and 365 days after catheter removal. Prognostic factors for early urinary continence recovery were analysed. 72 patients were included in the control arm and 80 in the PRR arm. Baseline characteristics were similar between arms, except body mass index, which was higher in PRR arm. “No pad” was the only definition assessing the benefit of PRR at 30 days, 33.8% in PRR arm and 18.1% in control arm, p = 0.022; and at 90 days, 58.8 and 43.1% respectively, p = 0.038. Questionnaires did not detect differences in terms of continence recovery. PRR was the only predictor for early continence recovery, p = 0.03. PRR increased early urinary continence recovery after RARP. Continence definition was critical to assess benefit. The only predictive factor for early continence recovery was PRR.
Proclarix is a new blood-based test to assess the likelihood of clinically significant prostate cancer (csPCa) defined as >2 grade group. In this study, we analyzed whether Proclarix and PSA density (PSAD) could improve the selection of candidates for prostate biopsy after multiparametric magnetic resonance imaging (mpMRI). Proclarix and PSAD were assessed in 567 consecutive men with suspected PCa in whom pre-biopsy 3 Tesla mpMRI, scoring with Prostate Imaging-Report and Data System (PI-RADS) v.2, and guided and/or systematic biopsies were performed. Proclarix and PSAD thresholds having csPCa sensitivity over 90% were found at 10% and 0.07 ng/(mL*cm3), respectively. Among 100 men with negative mpMRI (PI-RADS <3), csPCa was detected in 6 cases, which would have been undetected if systematic biopsies were avoided. However, Proclarix suggested performing a biopsy on 70% of men with negative mpMRI. In contrast, PSAD only detected 50% of csPCa and required 71% of prostate biopsies. In 169 men with PI-RADS 3, Proclarix avoided 21.3% of prostate biopsies and detected all 25 cases of csPCa, while PSAD avoided 26.3% of biopsies, but missed 16% of csPCa. In 190 men with PI-RADS 4 and 108 with PI-RADS 5, Proclarix avoided 12.1% and 5.6% of prostate biopsies, but missed 4.8% and 1% of csPCa, respectively. PSAD avoided 18.4% and 9.3% of biopsies, but missed 11.4% and 4.2% csPCa, respectively. We conclude that Proclarix outperformed PSAD in the selection of candidates for prostate biopsy, especially in men with PI-RADS <3.
Purpose Functional and anatomical changes associated with prostate removal coincide with alterations in pelvic structures. Posterior rhabdosphincter reconstruction was designed to improve urinary continence after radical prostatectomy. The aim of this study was to determine magnetic resonance anatomic predictors of urinary recovery after radical prostatectomy, and to assess their relation to the type of reconstruction. Material and Methods Forty patients were randomly selected from a trial (NCT03302169). Two independent radiologists determined the situation of the anastomosis in the pelvis according to MRI performed a month after the radical prostatectomy: vertical situation assessed as the distance to the line coccyx-inferior pubic margin (ACPv) and anteroposterior situation as the distance from the pubis (Distance A), and from the coccyx (Distance B). Results The Pearson correlation of ACPv, Distance A, and B between readers were 0.975, 0.940, and 0.711, p < 0.001. Patients with the reconstruction presented more cephalic situation of the anastomosis (higher ACPv) than patients with standard reconstruction technique. A multivariate analysis was performed including age, BMI, prostate volume, PRRS, and the MRI parameters. ACPv and Distance B were the only two independent predictors of no need for any urinary protection at 6 months after the surgery. Conclusions This is the first study that suggests positional differences according to the type of reconstruction after radical prostatectomy related to early urinary recovery. Magnetic resonance measurements to determine anastomosis positioning are reliable and have a strong correlation between readers. Anatomic MRI features are independent predictors of urinary recovery after robotic radical prostatectomy.
Background: Prostate Imaging-Reporting and Data System (PI-RADS) category 3 is a challenging scenario for detection of clinically significant prostate cancer (csPCa) and some tools can improve the selection of appropriate candidates for prostate biopsy. Objective: To assess the performance of the European Randomized Study of Screening for Prostate Cancer (ERSPC) magnetic resonance imaging (MRI) model, the new Proclarix test, and prostate-specific antigen density (PSAD) in selecting candidates for prostate biopsy among men in the PI-RADS 3 category. Design, setting, and participants: We conducted a head-to-head prospective analysis of 567 men suspected of having PCa for whom guided and systematic biopsies were scheduled between January 2018 and March 2020 in a single academic institution. A PI-RADS v.2 category 3 lesion was identified in 169 men (29.8%). Outcome measurement and statistical analysis: csPCa, insignificant PCa (iPCa), and unnecessary biopsy rates were analysed. csPCa was defined as grade group >= 2. Receiver operating characteristic (ROC) curves, decision curve analysis curves, and clinical utility curves were plotted. Results and limitations: PCa was detected in 53/169 men (31.4%) with a PI-RADS 3 lesion, identified as csPCa in 25 (14.8%) and iPCa in 28 (16.6%). The area under the ROC curve for csPCa detection was 0.703 (95% confidence interval [CI] 0.621-0.768) for Proclarix, 0.657 (95% CI 0.547-0.766) for the ERSPC MRI model, and 0.612 (95% CI 0.497-0.727) for PSAD (p = 0.027). The threshold with the highest sensitivity was 10% for Proclarix, 1.5% for the ERSPC MRI model, and 0.07 ng/ml/cm(3) for PSAD, which yielded sensitivity of 100%, 91%, and 84%, respectively. Some 21.3%, 26.2%, and 7.1% of biopsies would be avoided with Proclarix, PSAD, and the ERSPC MRI model, respectively. Proclarix showed a net benefit over PSAD and the ERSPC MRI model. Both Proclarix and PSAD reduced iPCa overdetection from 16.6% to 11.3%, while the ERSPC MRI model reduced iPCa overdetection to 15.4%. Conclusions: Proclarix was more accurate in selecting appropriate candidates for prostate biopsy among men in the PI-RADS 3 category when compared to PSAD and the ERSPC MRI model. Proclarix detected 100% of csPCa cases and would reduce prostate biopsies by 21.3% and iPCa overdetection by 5.3%. Patient summary: We compared three methods and found that the Proclarix test can optimise the detection of clinically significant prostate cancer in men with a score of 3 on the Prostate Imaging-Reporting and Data System for magnetic resonance imaging scans. (c) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology.
INTRODUCTION:Urinary incontinence after radical prostatectomy (RP) is an adverse event with high impact on patient's quality of life. Nowadays there is no standardized method for urinary continence measurement. Posterior rhabdosphincter reconstruction (PRR) is a surgical step that can improve early urinary continence after RP. Our objective was to analyse different continence definitions and predictors of urinary continence recovery after robot-assisted RP (RARP).MATERIAL AND METHODS:We conducted a double-blind, randomised controlled trial (NCT03302169) including 152 consecutive patients with localized prostate cancer subjected to RARP. Patients were randomised to single urethrovesical anastomosis (control arm) or PRR before urethrovesical anastomosis (PRR arm). Urinary continence was measured with the EPIC-26 and ICIQ-SF validated questionnaires, and pad use (0-1 pads and no pads), at 7, 15, 30, 90, 180 and 365 days after catheter removal. Prognostic factors for early urinary continence recovery were analysed.RESULTS:72 patients were included in the control arm and 80 in the PRR arm. Baseline characteristics were similar between arms, except body mass index, which was higher in PRR arm. "No pad" was the only definition assessing the benefit of PRR at 30 days, 33.8% in PRR arm and 18.1% in control arm, p = 0.022; and at 90 days, 58.8 and 43.1% respectively, p = 0.038. Questionnaires did not detect differences in terms of continence recovery. PRR was the only predictor for early continence recovery, p = 0.03.CONCLUSIONS:PRR increased early urinary continence recovery after RARP. Continence definition was critical to assess benefit. The only predictive factor for early continence recovery was PRR.