Urinary Symptoms Change and Quality of Life After Robotic Radical Prostatectomy: A Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVE: To present the patient-reported quality of life (QoL) outcomes from a prospective, randomized controlled trial comparing the use of pelvic floor muscle training (PFMT) and duloxetine after robot-assisted radical prostatectomy (RARP). METHODS: We identified 213 men with organ-confined disease having post-RARP urinary incontinence who were randomly assigned to received PFMT, duloxetine, combined PFMT-duloxetine and pelvic floor muscle home exercises. Urinary symptoms burden was measured by marked clinical important difference improvement (MCID) defined by using the International Prostate Symptom Score (IPSS) difference of - 8 points (ΔIPSS ≤-8). QoL was assessed according to Visual Analog Scale (VAS), King's Health Questionnaire (KQH), and International Index of Erectile Function (IIEF-5). Multivariable regression analyses aimed to predict MCID, burden of urinary symptoms (IPSS ≥8), and patients reporting to be satisfied (IPSS QoL ≤2) or comfortable (VAS ≤1) post-RARP. RESULTS: Moderate to severe urinary symptoms decreased from 48% preoperatively to 40%, 34%, and 23% at 3, 6, and 12months post-RARP. After surgery, MCID improvement was observed in 19% of patients, and deterioration in 3.3%. Large prostate was the only factor associated to MCID (OR 1.03 [95%CI 1.01-1.05], P = .005). At 6months, patients reached the same degree of preoperative satisfaction. Neurovascular bundle preservation was the only predictor of being comfortable regarding urinary symptoms postoperatively (OR 12.8 [CI95% 1.47-111.7], P = .02 at 3months) and was also associated to higher median postoperative IIEF-5. CONCLUSION: Despite urinary incontinence following RARP, patients with larger prostates experience a reduction of lower urinary tract symptoms within a year, which subsequently elevates QoL. Furthermore, nerve-sparing surgery augments erectile function and urinary outcomes, shaping postoperative QoL.

Assessing the efficacy of pelvic floor muscle training and duloxetine on urinary continence recovery following radical prostatectomy: A randomized clinical trial.

BACKGROUND: Urinary incontinence (UI) can negatively impact quality of life (QoL) after robot-assisted radical prostatectomy (RARP). Pelvic floor muscle training (PFMT) and duloxetine are used to manage post-RARP UI, but their efficacy remains uncertain. We aimed to investigate the efficacy of PFMT and duloxetine in promoting urinary continence recovery (UCR) after RARP. METHODS: A randomized controlled trial involving patients with urine leakage after RARP from May 2015 to February 2018. Patients were randomized into 1 of 4 arms: (1) PFMT-biofeedback, (2) duloxetine, (3) combined PFMT-biofeedback and duloxetine, (4) control arm. PFMT consisted of pelvic muscle exercises conducted with electromyographic feedback weekly, for 3 months. Oral duloxetine was administered at bedtime for 3 months. The primary outcome was prevalence of continence at 6 months, defined as using ≤1 security pad. Urinary symptoms and QoL were assessed by using a visual analogue scale, and validated questionnaires. RESULTS: From the 240 patients included in the trial, 89% of patients completed 1 year of follow-up. Treatment compliance was observed in 88% (92/105) of patients receiving duloxetine, and in 97% (104/107) of patients scheduled to PFMT-biofeedback sessions. In the control group 96% of patients had achieved continence at 6 months, compared with 90% (p = 0.3) in the PMFT-biofeedback, 73% (p = 0.008) in the duloxetine, and 69% (p = 0.003) in the combined treatment arm. At 6 months, QoL was classified as uncomfortable or worse in 17% of patients in the control group, compared with 44% (p = 0.01), 45% (p = 0.008), and 34% (p = 0.07), respectively. Complete preservation of neurovascular bundles (NVB) (OR: 2.95; p = 0.048) was the only perioperative intervention found to improve early UCR. CONCLUSIONS: PFMT-biofeedback and duloxetine demonstrated limited impact in improving UCR after RP. Diligent NVB preservation, along with preoperative patient and disease characteristics, are the primary determinants for early UCR.

The Cancer of the Bladder Risk Assessment (COBRA) score accurately predicts cancer-specific survival after radical cystectomy: external validation and lymphovascular invasion assessment value to improve its performance.

The Cancer of the Bladder Risk Assessment (COBRA) score is a predictive tool for estimating Cancer Specific Survival (CSS) after Radical Cystectomy (RC) for urothelial carcinoma. COBRA score variables are: age at RC, Tumor stage and Lymph Node Density (LND). We sought to externally validate the COBRA score and to improve its performance in estimating CSS adding Lymphovascular Invasion (LVI) as a further variable (Modified COBRA score). Clinicopathological and survival data from 789 patients who underwent RC and Pelvic Lymph Node Dissection (PLND) between January 2007 and December 2020 in two European referral centers (Paris, France and Badalona, Spain) were analyzed. COBRA score was applied to our cohort and CSS Kaplan-Meier curves were performed. Univariable and Multivariable analysis was performed in order to identify risk factors for Cancer Specific Mortality (CSM) and a score was assigned for any statistically significant risk factor; afterward, c-index calculation was performed and CCS curves have been plotted for the model after having integrated LVI variable to the COBRA score. Finally, we compared both COBRA score and Modified COBRA score models with the established AJCC model. A total of 789 patients underwent RC during the observation period. Complete data were available for 731 patients with a median follow-up of 32 months (8-47). CSM was 27.6% (no. 218 patients) at follow-up. When COBRA score was applied to our cohort, c-index was 0.76. Regression COX analysis has shown HR 0.36, CI 95% (0.16-0.83), P = .016 for patients with COBRA score 1; HR 0, CI 95% (0-1.77), P =.94 for score 2; HR 0.51, CI 95% (0.39 -0.67), P =.001 for score 3; HR 1.67, CI 95% (1.23-2.27), P =.001 for score 4; HR 2.45, CI 95% (1.51-3.99), P =.001 for score 5; HR 2.01, CI 95% (1.42-2.85), P =.001 for score 6 and HR 0.66, CI 95% (0.09-4.73), P =.682 for score 7. When the LVI variable was added to the CSS predictive model the discriminatory power increased to a c-index of 0.78. COBRA score adequately identifies those patients with a higher risk of CSM, with a c-index of 0.76. Moreover, LVI variable further improves its predictive accuracy from c-index of 0.76 to c-index of 0.78. LVI variable could be integrated in the COBRA score to optimizing prognosis stratification for patients who undergo RC.

Optimal Surgical Outcome of Minimally Invasive Partial Nephrectomy (MIPN) Based on an Early Postoperative Estimated Glomerular Filtration Rate (eGFR).

PURPOSE OF REVIEW: To compare laparoscopic partial nephrectomy (LPN) and robot-assisted partial nephrectomy (RAPN) performed in two European tertiary centers using the classic optimal surgical definition - "MIC" - and a new optimal surgical definition: the "Novel TRIFECTA" (NT) concept. We sought to strengthen the PN evidence and to test the NT's performance. RECENT FINDINGS: The study population comprehended 505 cases of localized kidney cancer from two tertiary centers between 2012 and 2019. The NT achievement was higher in the RAPN group when compared to LPN (70.5 vs. 87.4%; p = 0.004), while no differences were found when considering the MIC criteria. Also, a similar high-grade complications rate (Clavien-Dindo > III) and operative time (105 min vs. 100 min; p = NS) were found. In the multivariable regression, the RAPN approach was a predictor of NT achievement (OR 2.45; p = 0.008). NT achievement was higher in the RAPN group, while similar results were found when evaluating the MIC criteria. The NT definition could be more sensitive to the individual-specific responses related to the PN.

Association between Lesion Location and Oncologic Outcomes after Focal Therapy for Localized Prostate Cancer Using Either High Intensity Focused Ultrasound or Cryotherapy.

PURPOSE: We assessed whether prostate cancer (PCa) location might affect oncologic outcomes after focal therapy (FT) for PCa. MATERIALS AND METHODS: We identified 274 men receiving FT for PCa using either high intensity focused ultrasound (HIFU) or cryotherapy at a high volume center between 2009 and 2018. Survival analyses using Kaplan-Meier method were used to assess any additional treatment and radical treatment rates according to PCa location. Propensity-score match analysis was used to compare oncologic outcomes of HIFU vs cryotherapy according to PCa location. Covariates were prostate specific antigen, clinical stage, prostate volume, Gleason score, maximum cancer core length, percentage of positive cores and treatment modality. RESULTS: A total of 166 and 108 men received FT with HIFU and cryotherapy, respectively. Overall, 39% (106) and 31% (85) received at least an additional treatment and a radical treatment after FT, respectively, with a median followup of 51 months. At 36 months' followup, the rates of any additional treatment-free survival were 71%, 75%, and 69% for patients with basal, mid-prostate and apical disease, respectively (p=0.7). At multivariable logistic regression analysis, PCa location was not significantly associated with higher risk of either any additional treatment or radical treatment (all p >0.4). After matching, there was no difference between HIFU vs cryotherapy in terms of any additional treatment rates according to PCa location. CONCLUSIONS: The PCa location does not significantly affect the rate of failure after FT. The presence of an apical lesion should not be considered an exclusion criteria for FT. Both HIFU and cryotherapy likely achieve similar medium-term oncologic results regardless of PCa location.

Focal Brachytherapy for Localized Prostate Cancer: Midterm Outcomes.

PURPOSE: Focal brachytherapy (F-BT) is a suitable technique for focal therapy in localized prostate cancer. It has the ability to adapt the seed implantation to the volume and location of the tumor. The aim of this study was to assess F-BT oncologic, functional, and toxicity midterm outcomes in men who underwent prostate cancer treatment. METHODS AND MATERIALS: The study included 39 men with low- to intermediate-risk prostate cancer treated with F-BT between 2010 and 2015. The dose prescription was 145 Gy. Failure was defined as the presence of any residual prostate cancer in the treated area. The primary and secondary endpoints were the F-BT oncologic and functional outcomes, respectively. A 2-sided P value < .05 indicated statistical significance. RESULTS: The mean follow-up time was 65 months (range, 43-104 months). After 24 months, 34 patients underwent control biopsies and 5 patients refused. The biopsies were negative in 27 cases (79%) and positive in 7 cases (21%), all outside the volume treated. Biochemical relapse-free survival at 5 years, disease-free survival, and overall survival were 96.8% ± 0.032%, 79.5% ± 0.076%, and 100%, respectively. The mean International Prostate Symptom Score at 2 months was significantly higher than initially (P = .0003), with no significant difference later. No late urinary, sexual, or rectal toxicity was observed. Salvage treatment was possible with good tolerance at 3.4 years of follow-up. Limitations of this study include the retrospective nature and lack of randomization. CONCLUSIONS: F-BT is a safe and effective treatment for selected patients presenting with low- or intermediate-risk localized prostate cancer.

Impact of Focal Versus Whole Gland Ablation for Prostate Cancer on Sexual Function and Urinary Continence.

PURPOSE: Focal instead of whole gland ablation for prostate cancer has been proposed to decrease treatment morbidity. We sought to determine differences in erectile function and urinary continence after focal and whole gland ablation for prostate cancer. MATERIALS AND METHODS: From 2009 to 2018, 346 patients underwent high intensity focused ultrasound or cryotherapy for prostate cancer. Urinary continence was defined as use of no pads and sexual potency as enough erection for sexual penetration. Logistic regressions to treatment groups and covariates age, prostate specific antigen, International Society of Urological Pathology grading, prostate volume and energy modality were performed to access the effect of focal therapy in sexual potency and urinary continence after 3 and 12 months. IIEF-5 (International Index of Erectile Function) and I-PSS (International Prostate Symptom Score) questionnaires were evaluated. Propensity score matching was performed to adjust for potential baseline differences between groups. RESULTS: After exclusion, 195 post-focal therapy and 105 post-whole gland therapy patients were included in analysis. No significant difference was seen in baseline I-PSS and IIEF-5 scores. In multivariate models focal therapy was the most important factor related to sexual potency at 3 (OR 7.7) and 12 months (OR 3.9). Median IIEF-5 score at 3 months was 12 and 5 (p <0.001), and at 12 months was 13 and 9 (p=0.04) in focal therapy and whole gland therapy groups, respectively. Focal therapy was the only factor related to continence (OR 0.7, p <0.001). Results remained significant after propensity score matching. CONCLUSIONS: Focal ablation instead of whole gland therapy is the most important factor related to better sexual and urinary continence recovery after high intensity focused ultrasound and cryotherapy for prostate cancer.

Does mpMRI guidance improve HIFU partial gland ablation compared to conventional ultrasound guidance? Early functional outcomes and complications from a single center

ABSTRACT Background Focal therapy (FT) for localized prostate cancer (PCa) treatment is raising interest. New technological mpMRI-US guided FT devices have never been compared with the previous generation of ultrasound-only guided devices. Materials and Methods We retrospectively analyzed prospectively recorded data of men undergoing FT for localized low- or intermediate-risk PCa with US- (Ablatherm®-2009 to 2014) or mpMRI-US (Focal One®-from 2014) guided HIFU. Follow-up visits and data were collected using internationally validated questionnaires at 1, 2, 3, 6 and 12 months. Results We included n=88 US-guided FT HIFU and n=52 mpMRI-US guided FT HIFU respectively. No major baseline differences were present except higher rates of Gleason 3+4 for the mpMRI-US group. No major differences were present in hospital stay (p=0.1), catheterization time (p=0.5) and complications (p=0.2) although these tended to be lower in the mpMRI-US group (6.8% versus 13.2% US FT group). At 3 months mpMRI-US guided HIFU had significantly lower urine leak (5.1% vs. 15.9%, p=0.04) and a lower drop in IIEF scores (2 vs. 4.2, p=0.07). Of those undergoing 12-months control biopsy in the mpMRI-US-guided HIFU group, 26% had residual cancer in the treated lobe. Conclusion HIFU FT guided by MRI-US fusion may allow improved functional outcomes and fewer complications compared to US- guided HIFU FT alone. Further analysis is needed to confirm benefits of mpMRI implementation at a longer follow-up and on a larger cohort of patients.

Does mpMRI guidance improve HIFU partial gland ablation compared to conventional ultrasound guidance? Early functional outcomes and complications from a single center.

BACKGROUND: Focal therapy (FT) for localized prostate cancer (PCa) treatment is raising interest. New technological mpMRI-US guided FT devices have never been compared with the previous generation of ultrasound-only guided devices. MATERIALS AND METHODS: We retrospectively analyzed prospectively recorded data of men undergoing FT for localized low- or intermediate-risk PCa with US- (Ablatherm®-2009 to 2014) or mpMRI-US (Focal One®-from 2014) guided HIFU. Follow-up visits and data were collected using internationally validated questionnaires at 1, 2, 3, 6 and 12 months. RESULTS: We included n=88 US-guided FT HIFU and n=52 mpMRI-US guided FT HIFU respectively. No major baseline differences were present except higher rates of Gleason 3+4 for the mpMRI-US group. No major differences were present in hospital stay (p=0.1), catheterization time (p=0.5) and complications (p=0.2) although these tended to be lower in the mpMRI-US group (6.8% versus 13.2% US FT group). At 3 months mpMRI-US guided HIFU had significantly lower urine leak (5.1% vs. 15.9%, p=0.04) and a lower drop in IIEF scores (2 vs. 4.2, p=0.07). Of those undergoing 12-months control biopsy in the mpMRI-US-guided HIFU group, 26% had residual cancer in the treated lobe. CONCLUSION: HIFU FT guided by MRI-US fusion may allow improved functional outcomes and fewer complications compared to US- guided HIFU FT alone. Further analysis is needed to confirm benefits of mpMRI implementation at a longer follow-up and on a larger cohort of patients.

Comparing Perioperative Complications Between Laparoscopic and Robotic Radical Cystectomy for Bladder Cancer.

Background: Minimally invasive cystectomy is being increasingly performed, however, data comparing laparoscopic radical cystectomy (LRC) and robotic radical cystectomy (RRC) are scarce. We compared 30- and 90-day Clavien-Dindo Classification (CDC) complications between patients undergoing LRC and RRC at our center. Materials and Methods: We retrospectively evaluated 300 patients who underwent minimally invasive radical cystectomy from January 2007 to July 2019 and grouped them into LRC (112 patients) and RRC (188 patients). We compared the two groups for demographic variables, perioperative characteristics, and 30- and 90-day CDC overall, minor, and major complications. Multivariable logistic regression analysis was performed to identify variables that predict perioperative complications. Results: The two groups were comparable for the duration of surgery (270 minutes in LRC vs 265 minutes in RRC) and rate of conversion to open surgery. The RRC cohort had a higher estimated blood loss (EBL) (675 mL vs 500 mL, p = 0.006), but the two groups had a comparable need for intraoperative transfusion. Patients undergoing RRC also had a shorter duration of hospital stay (13 days vs 14 days, p < 0.001). There was no difference between the two groups for 30- and 90-day CDC overall, minor, and major complications. The incidence of rehospitalization within 30 days (p = 0.1) and surgical reintervention (p = 0.5) was also comparable between the two groups. On multivariable logistic regression analysis, approach to cystectomy (RRC vs LRC) was not a significant predictor of 30-day CDC overall and major complications. Conclusion: LRC was associated with lesser EBL, whereas the hospital stay was shorter in patients undergoing RRC. The two approaches were comparable with each other for 30- and 90-day CDC overall, minor, and major complications. The choice between the two approaches should depend on availability and surgeon experience and preference, rather than any specific perioperative parameter.

Long-term functional and oncological outcomes of nerve-sparing and prostate capsule-sparing cystectomy: a single-centre experience.

OBJECTIVES: To evaluate the technical feasibility, oncological and functional outcomes of nerve sparing cystoprostatectomy (NSCP) and prostate capsule-sparing cystectomy (PCSC) for the treatment of organ-confined bladder cancer at a single referral centre. PATIENTS AND METHODS: From April 2001 to June 2012, 60 patients underwent PCSC and 47 were treated with NSCP. Inclusion criteria for PCSC were: fully informed consent for the well-motivated patient; negative transurethral resection of the bladder neck; normal prostatic specific antigen (PSA) level (defined as <4 ng/dL during the first year of the study, which was later lowered to 2.5 ng/dL); and normal transrectal ultrasonography, with biopsy for any suspicious nodule. Patients received a complete oncological and functional follow-up. The Kaplan-Meier method was used to depict survival outcomes after surgery. RESULTS: After a median follow-up of 73 and 62 months for PCSC and NSCP, respectively, the 5-year cancer-specific survival was 90% for the PCSC group and 78% for the NSCP group (P = 0.055). Considering complications within 30 days after surgery, 13% and 21% patients had Clavien ≥III complications in the PCSC and NSCP groups, respectively (P = 0.2). For functional outcomes, at 3 months after surgery, 54 (90%) and 24 (51%) patients reported full recovery of daytime urinary continence in the PCSC and NSCP groups, respectively (P < 0.001); and for erectile function recovery, 32 (53%) and four (9%) patients in the PCSC group and in the NSCP group were respectively potent without any treatment (P < 0.001). CONCLUSIONS: NSCP and PCSC are appropriate for a subset of patients with bladder cancer, with excellent oncological and functional results. These surgical procedures should be proposed to well-motivated patients.

Comparison of Initial Experience with Transrectal Magnetic Resonance Imaging Cognitive Guided Micro-Ultrasound Biopsies versus Established Transperineal Robotic Ultrasound Magnetic Resonance Imaging Fusion Biopsies for Prostate Cancer.

PURPOSE: We compared cancer detection rates in patients who underwent magnetic resonance imaging cognitive guided micro-ultrasound biopsy vs robotic ultrasound magnetic resonance imaging fusion biopsy for prostate cancer. MATERIALS AND METHODS: Among 269 targeted biopsy procedures 222 men underwent robotic ultrasound magnetic resonance imaging fusion biopsy and 47 micro-ultrasound biopsy. Robotic ultrasound magnetic resonance imaging fusion biopsy was performed using the transperineal Artemis™ device while micro-ultrasound biopsy was performed transrectally with the high resolution ExactVu™ system. Random biopsies were performed in addition to targeted biopsy in both modalities. Prostate cancer detection rates and concordance between random and target biopsies were also assessed. RESULTS: Groups were comparable in terms of age, prostate specific antigen, prostate volume and magnetic resonance PI-RADS (Prostate Imaging Reporting and Data System) version 2 score. The micro-ultrasound biopsy group presented fewer biopsied cores in random and target approaches. In targeted biopsies micro-ultrasound biopsy cases presented higher detection of clinically significant disease (Gleason score greater than 6) than the robotic ultrasound magnetic resonance imaging fusion biopsy group (38% vs 23%, p=0.02). When considering prostate cancer detection regardless of Gleason score or prostate cancer detection by random+target biopsies, no difference was found between the groups. However, on a per core basis overall prostate cancer detection rates favored micro-ultrasound biopsy in random and targeted scenarios. In addition, the PRI-MUS (Prostate Risk Identification Using Micro-Ultrasound) score yielded by micro-ultrasound visualization was independently associated with improved cancer detection rates of clinically significant prostate cancer. CONCLUSIONS: In our initial experience micro-ultrasound biopsy featured a higher clinically significant prostate cancer detection rate in target cores than robotic ultrasound magnetic resonance imaging fusion biopsy, which was associated with target features in micro-ultrasound (PRI-MUS score). These findings reinforce the role of micro-ultrasound technology in targeted biopsies.

HIFU focal therapy for prostate cancer using intraoperatory contrast enhanced ultrasound.

OBJECTIVE: High-intensity focused ultrasound (HIFU) Focal therapy appears to have encouraging oncologic outcomes and urinary and erectile function. The control of the treated area can be done using contrast enhanced ultrasound with sulfur hexafluoride (Sonovue®) at the end of the procedure. We report oncological and functional outcomes in HIFU focal therapy (FT) for prostate cancer (PCa) management using sonovue. METHODS: A total of 274 HIFU procedures were found in our registry in the period between June 2014 and July 2018. Prospective data of 59 consecutive patients after focal high-intensity focused ultrasound (HIFU) using Sonovue were collected. FT failure was defined as positive biopsy Gleason score (GS) ≥ 7 in- or out-field, local or systemic salvage treatment, PCa-metastasis or PCa-specific death. RESULTS: A total of 59 patients submitted to HIFU with median follow-up of 18 months were included in the analysis. Median age was 66.7 yr (IQR 59.1-74.3). Median preoperative prostate-specific antigen (PSA) was 7.6 ng/ml (IQR 5-10.2) and preoperative biopsies GS 6, 7(3+4), 7(4+3) were found in 26 (44%), 30 (50.8%) and 3 (5%), respectively. Failure was found in 16 (27.1%) patients. Failure-free survival (FFS) in 2 and 4yr was 83% and 74% respectively (Figure 1). No PCa-specific death was registered in the period of study. Median nadir PSA after FT was 2.67 ng/ml. Sexual potency was achieved in 75% of previous potent patients and urinary continence in 93.4% of patients at 3 months. Fourteen (23%) patients presented with complications. Four (6.7%) patients have presented complications grade 1 and 10 (16.9%) patients have presented complications grade 2. Six (10.1%) patients have presented acute urinary retention. CONCLUSIONS: Our study shows that the use of Sonovue after HIFU FT was safe. Patients present a significant proportion of failure after HIFU FT but with good functional outcomes and without incidence of severe complications.

OBJETIVOS: La terapia focal con HIFU (High-intensity focused ultrasound) parece tener unos resultados oncológicos y de función urinaria y eréctil prometedores. El control del área tratada puede realizarse al final de la intervención utilizando Sonovue®, el contraste de ecografía con hexafluoruro de azufre. Presentamos los resultados oncológicos y funcionales de la terapia focal con HIFU en el tratamiento cáncer de próstata utilizando Sonovue.MÉTODOS: Se encontraron en nuestro registro un total de 274 intervenciones con HIFU entre Junio 2014 y Julio 2018. Se recogieron los datos prospectivamente en 59 pacientes consecutivos después de HIFU utilizando Sonovue. Se define fracaso de la terapia focal como biopsia positiva con puntuación de Gleason (GS) >7 dentro o fuera del campo, tratamiento de salvamento local o sistémico, metástasis del CaP o muerte cáncer específica por CaP. RESULTADOS: Se incluyeron en el análisis un total de 59 pacientes sometidos a HIFU con una mediana de seguimiento de 18 meses. La mediana de edad fue 66,7 años (Rango intercuartílico (RIC) 59,1-74,3). La mediana de PSA preoperatorio fue 7,6 ng/mL (RIC 5-10,2) y las biopsias fueron GS 6, 7 (3+4) y 7 (4+3) en 26 (44%), 30 (50,8%) y 3 (5%) casos, respectivamente. En 16 pacientes (27,1%) fracasó el tratamiento. La supervivencia libre de fracaso del tratamiento a 2 y 4 años fue 83% y 74% respectivamente (Figura 1). No se ha registrado ninguna muerte cáncer específica por el CaP en el periodo de estudio. La mediana del nadir de PSA después de la terapia focal fue 2,67 ng/ml. El 75% de los pacientes previamente potentes consiguieron mantener su potencia sexual y el 93,4% eran continentes a los 3 meses. Catorce pacientes (23%) presentaron complicaciones. Cuatro (6,7%) presentaron complicaciones grado 1 y 10 (16,9%) grado 2. Seis pacientes (10,1%) presentaron retención aguda de orina. CONCLUSIONES: Nuestro estudio muestra que el uso de Sonovue después de terapia focal con HIFU es seguro. Los pacientes presentan una proporción significativa de fracasos después de terapia focal con HIFU aunque tiene buenos resultados funcionales y sin incidencia de complicaciones graves.

Hifu focal therapy for prostate cancer using intraoperatory contrast enhanced ultrasound / Terapia focal con HIFU en cáncer de prostata utilizando ecografia con contraste intraoperatoria

Objective: High-intensity focused ultrasound (HIFU) Focal therapy appears to have encouraging oncologic outcomes and urinary and erectile function. The control of the treated area can be done using contrast enhanced ultrasound with sulfur hexafluoride (Sonovue(R)) at the end of the procedure. We report oncological and functional outcomes in HIFU focal therapy (FT) for prostate cancer (PCa) management using sonovue. Methods: A total of 274 HIFU procedures were found in our registry in the period between June 2014 and July 2018. Prospective data of 59 consecutive patients after focal high-intensity focused ultrasound (HIFU) using Sonovue were collected. FT failure was defined as positive biopsy Gleason score (GS) ≥ 7 in- or out-field, local or systemic salvage treatment, PCa-metastasis or PCa-specific death.Results: A total of 59 patients submitted to HIFU with median follow-up of 18 months were included in the analysis. Median age was 66.7 yr (IQR 59.1-74.3). Median preoperative prostate-specific antigen (PSA) was 7.6 ng/ml (IQR 5-10.2) and preoperative biopsies GS 6, 7(3 + 4), 7(4 + 3) were found in 26 (44%), 30 (50.8%) and 3 (5%), respectively. Failure was found in 16 (27.1%) patients. Failure-free survival (FFS) in 2 and 4yr was 83% and 74% respectively (Figure 1). No PCa-specific death was registered in the period of study. Median nadir PSA after FT was 2.67 ng/ml. Sexual potency was achieved in 75% of previous potent patients and urinary continence in 93.4% of patients at 3 months. Fourteen (23%) patients presented with complications. Four (6.7%) patients have presented complications grade 1 and 10 (16.9%) patients have presented complications grade 2. Six (10.1%) patients have presented acute urinary retention. Conclusions: Our study shows that the use of Sonovue after HIFU FT was safe. Patients present a significant proportion of failure after HIFU FT but with good functional outcomes and without incidence of severe complications

Objetivos: La terapia focal con HIFU (High-intensity focused ultrasound) parece tener unos resultados oncológicos y de función urinaria y eréctil prometedores. El control del área tratada puede realizarse al final de la intervención utilizando Sonovue(R), el contraste de ecografía con hexafluoruro de azufre. Presentamos los resultados oncológicos y funcionales de la terapia focal con HIFU en el tratamiento cáncer de próstata utilizando Sonovue. Métodos: Se encontraron en nuestro registro un total de 274 intervenciones con HIFU entre Junio 2014 y Julio 2018. Se recogieron los datos prospectivamente en 59 pacientes consecutivos después de HIFU utilizando Sonovue. Se define fracaso de la terapia focal como biopsia positiva con puntuación de Gleason (GS) > 7 dentro o fuera del campo, tratamiento de salvamento local o sistémico, metástasis del CaP o muerte cáncer específica por CaP. Resultados: Se incluyeron en el análisis un total de 59 pacientes sometidos a HIFU con una mediana de seguimiento de 18 meses. La mediana de edad fue 66,7 años (Rango intercuartílico (RIC) 59,1-74,3). La mediana de PSA preoperatorio fue 7,6 ng/mL (RIC 5-10,2) y las biopsias fueron GS 6, 7 (3+4) y 7 (4+3) en 26 (44%), 30 (50,8%) y 3 (5%) casos, respectivamente. En 16 pacientes (27,1%) fracasó el tratamiento. La supervivencia libre de fracaso del tratamiento a 2 y 4 años fue 83% y 74% respectivamente (Figura 1). No se ha registrado ninguna muerte cáncer específica por el CaP en el periodo de estudio. La mediana del nadir de PSA después de la terapia focal fue 2,67 ng/ml. El 75% de los pacientes previamente potentes consiguieron mantener su potencia sexual y el 93,4% eran continentes a los 3 meses. Catorce pacientes (23%) presentaron complicaciones. Cuatro (6,7%) presentaron complicaciones grado 1 y 10 (16,9%) grado 2. Seis pacientes (10,1%) presentaron retención aguda de orina. Conclusiones: Nuestro estudio muestra que el uso de Sonovue después de terapia focal con HIFU es seguro. Los pacientes presentan una proporción significativa de fracasos después de terapia focal con HIFU aunque tiene buenos resultados funcionales y sin incidencia de complicaciones graves

Comprehensive Evaluation of Focal Therapy Complications in Prostate Cancer: A Standardized Methodology.

Purpose: Today, up to one-third of newly diagnosed prostate cancer (PCa) cases may be suitable for focal treatment. The lack of data about the toxicity profiles of lesion-targeting therapies, however, has made it difficult to compare treatment modalities. The aim of the present study was to evaluate comprehensively the incidence, severity, and timing of onset of complications for PCa patients undergoing focal high-intensity focused ultrasound (HIFU) and focal cryosurgical ablation of the prostate (CSAP). Materials and Methods: A total of 336 patients were included who underwent focal HIFU or focal CSAP as a primary treatment for PCa between January 2009 and December 2017. Mean follow-up was 11 months (standard deviation: 3.0). All complications were captured and graded according to severity, and classified by timing of onset. Univariate and multivariate analysis was performed to identify predictors of the most common side effects. Results: There were 98 complications in 79/210 patients (38%) undergoing focal HIFU and 34 complications in 27/126 patients (21%) undergoing focal CSAP. In terms of severity, 95% of the complications of focal HIFU and 91% of the complications of focal CSAP were minor. Most complications presented in the early postoperative period. On multivariate analysis, subtotal HIFU was associated with acute urinary retention (AUR), while a smaller prostate size and longer catheterization time with dysuria. In CSAP patients, longer catheterization time was associated with AUR and urethral sloughing. The main limitation is the nonrandomized and retrospective nature. Conclusions: Focal HIFU and focal CSAP provide a tolerable toxicity, with primarily minor complications presenting in the early postoperative period.

Switch from abiraterone plus prednisone to abiraterone plus dexamethasone at asymptomatic PSA progression in patients with metastatic castration-resistant prostate cancer.

OBJECTIVE: To evaluate the effects of switching from prednisone (P) to dexamethasone (D) at asymptomatic prostate-specific antigen (PSA) progression in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate (AA). MATERIALS AND METHODS: Among 93 patients treated with AA between January 2013 and April 2016 in our institution, 48 consecutive asymptomatic patients with mCRPC, who experienced biochemical progression on treatment with AA+P 10 mg/day, were included. A corticosteroid switch to AA+D 0.5 mg/day at PSA increase was administered until radiological and/or clinical progression. The primary endpoint was progression-free-survival (PFS). A prognostic score based on independent prognostic factors was defined. RESULTS: The median time to PSA progression on AA+P was 8.94 months. The median PFS on AA+D and AA+corticosteroids (P then D) was 10.35 and 20.07 months, respectively. A total of 56.25% of patients showed a decrease or stabilization in PSA levels after the switch. In univariate analysis, three markers of switch efficiency were significantly associated with a longer PFS: long hormone-sensitivity duration (≥5 years; median PFS 16.62 vs 4.17 months, hazard ratio [HR] 0.30, 90% confidence interval [CI] 0.16-0.56); low PSA level at the time of switch (<50 ng/mL; median PFS 15.21 vs 3.86 months, HR 0.33, 90% CI 0.18-0.60); and short time to PSA progression on AA+P (<6 months; median PFS 28.02 vs 6.65 months, HR 0.41 (90% CI 0.21-0.81). In multivariate analysis, hormone sensitivity duration and PSA level were independent prognostic factors. CONCLUSION: A steroid switch from P to D appears to be a safe and non-expensive way of obtaining long-term responses to AA in selected patients with mCRPC. A longer PFS has been observed in patients with previous long hormone sensitivity duration, and/or low PSA level and/or short time to PSA progression on AA+P.

Recovery of urinary continence after radical prostatectomy.

INTRODUCTION: In the era of minimally-invasive surgery, urinary incontinence (UI) after radical prostatectomy (RP) still represents a troublesome issue for a considerable rate of patients. Factors associated with the risk of post-RP UI, need to be carefully assessed throughout the overall clinical management process thus including the pre-operative, intra-operative and post-operative setting. AREAS COVERED: This review analyses current published evidences regarding clinical and surgical aspects associated with urinary continence (UC) recovery after RP. A careful evaluation of patient's clinical characteristics should be carried out before surgery in order to properly counsel the patients regarding the risk of UI. In the last two decades, the advent of robotic surgery has led to an overall improvement of functional outcomes after RP, thanks to the development of different surgical strategies based on either the 'preservation' or the 'reconstruction' of the anatomical elements responsible for urinary continence. Finally, several therapeutic strategies including either a conservative approach, or pharmacological and surgical treatments, should be carefully considered for the post-operative management of UI. Expert commentary: A comprehensive pre-operative patient's clinical assessment, along with a proper and well-conducted surgical procedure and an effective post-operative care management are essential element to achieve a high probability of UC recovery.

Focal High-intensity Focused Ultrasound Targeted Hemiablation for Unilateral Prostate Cancer: A Prospective Evaluation of Oncologic and Functional Outcomes.

BACKGROUND: In selected patients with unilateral, organ-confined prostate cancer (PCa), hemiablation of the affected lobe might be feasible to achieve acceptable cancer control with fewer complications. OBJECTIVES: To assess the oncologic and functional outcomes of focal high-intensity focused ultrasound (HIFU) hemiablation in unilateral organ-confined PCa. DESIGN, SETTING AND PATIENTS: Single-center prospective evaluation of HIFU hemiablation for unilateral organ-confined PCa was performed from July 2009 through December 2013. INTERVENTION: Cancer localization was done with transrectal ultrasound-guided biopsy and multiparametric magnetic resonance imaging followed by HIFU hemiablation. OUTCOME MEASUREMENT AND STATISTICAL ANALYSIS: Oncologic outcomes were analyzed with control biopsies and prostate-specific antigen (PSA) measurement. Functional outcomes were assessed with validated questionnaires for genitourinary symptoms. RESULTS AND LIMITATIONS: Of 71 HIFU hemiablation patients, 67 completed the study protocol. The mean age was 70.2 yr (standard deviation: 6.8 yr), and median PSA was 6.1 ng/ml (interquartile range [IQR]: 1.6-15.5 ng/ml). Median maximum cancer-core length was 3 mm (IQR: 2-10 mm), and total cancer length was 6.5 mm (IQR: 2-24 mm). Gleason score was 6 (3+3) in 58 patients (86.6%) and 7 (3+4) in 9 patients (13.4%). Median follow-up was 12 mo (IQR: 6-50 mo), and at 12 mo, 56 of 67 patients had a negative control biopsy in the treated lobe. At 3 mo, all patients were continent, and potency was maintained in 11 of 21 preoperatively potent patients (confidence interval, 0.18-0.69). Complications included 8% Clavien-Dindo grade 2 and 2.8% grade 3 events. CONCLUSIONS: Focal HIFU hemiablation appears to achieve acceptable oncologic outcomes with low morbidity and minimal functional changes. Longer follow-up will establish future considerations. PATIENT SUMMARY: This study showed that high-intensity focused ultrasound hemiablation in selected patients with unilateral organ-confined prostate cancer can be used for satisfactory cancer control with minimal effect on genitourinary functions.