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This work aims to investigate the utility of positron emission tomography/computed tomography (PET/CT) with fibroblast activation protein inhibitors (FAPI) in urological neoplasms, including prostate cancer, urothelial carcinoma, and renal cell carcinoma. Although the available data are very preliminary, FAPI PET showed potential for detecting primary prostate cancer with low prostate-specific membrane antigen expression, while prostate-specific membrane antigen PET/CT outperformed FAPI PET/CT in detecting biochemical recurrence. In urothelial carcinoma, FAPI PET/CT demonstrated increased detection rates compared with deoxy-2-[18F]fluoro-D-glucose PET/CT, in particular in small lymph node metastases, whose identification is still an unmet clinical need. Limited data are available for renal cell carcinoma. In conclusion, FAPI PET emerges as a promising imaging modality for urological neoplasms, in particular bladder cancer. Further research is warranted to establish its role in guiding therapeutic decisions and as a potential novel theranostic agent.
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Several randomized control trials (RCTs) have been published comparing open (ORC) with robot-assisted radical cystectomy (RARC). However, uncertainty persists regarding this issue, as evidences and recommendations on RARC are still lacking. In this systematic review and metaanalysis, we summarized evidence in this context. A literature search was conducted according to PRISMA criteria, using PubMed/Medline, Web Of Science and Embase, up to March 2024. Only randomized controlled trials (RCTs) were selected. The primary endpoint was to investigate health-related quality of life (QoL) both at 3 and 6 months after surgery. Secondary endpoints include pathological and perioperative outcomes, postoperative complications and oncological outcomes. Furthermore, we conducted a cost evaluation based on the available evidence. Eight RCTs were included, encompassing 1024 patients (515 RARC versus 509 ORC). QoL appeared similar among the two groups both after 3 and 6 months. No significant differences in overall and major complications at 30 days (p = 0.11 and p > 0.9, respectively) and 90 days (p = 0.28 and p = 0.57, respectively) were observed, as well as in oncological, pathological and perioperative outcomes, excepting from operative time, which was longer in RARC (MD 92.34 min, 95% CI 83.83-100.84, p < 0.001) and transfusion rate, which was lower in RARC (OR 0.43, 95% CI 0.30-0.61, p < 0.001). Both ORC and RARC are viable options for bladder cancer, having comparable complication rates and oncological outcomes. RARC provides transfusion rate advantages, however, it has longer operative time and higher costs. QoL outcomes appear similar between the two groups, both after 3 and 6 months.
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Cistectomía , Complicaciones Posoperatorias , Calidad de Vida , Procedimientos Quirúrgicos Robotizados , Neoplasias de la Vejiga Urinaria , Cistectomía/métodos , Humanos , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/economía , Neoplasias de la Vejiga Urinaria/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Resultado del Tratamiento , Tempo Operativo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
INTRODUCTION: We aimed to compare the detection rate of prostate cancer (PCa) and clinically significant (cs)PCa by magnetic resonance imaging-guided targeted biopsy (MTBx) alone and MTBx plus systematic biopsy (SBx) using an outpatient transperineal (TP) approach under local anesthesia. METHODS: A retrospective study of patients who underwent outpatient TP prostate biopsy under local anesthesia at our tertiary institution between 2019 and 2022 was performed. To compare the proportions of PCa and csPCa in both pathways, McNemar's tests were used. Multivariable logistic regression model was fitted to determine the predictors of csPCa. RESULTS: Of 255 men included, 177 (69%) underwent MTBx alone. MTBx had similar detection rate for PCa (56%) and csPCa (47%) compared to the combination of MTBx and SBx (PCa, 61%; csPCa, 49%; p=0.1 and p=0.3, respectively). MTBx had lower median number of biopsy cores compared to the combination of MTBx and SBx (6 vs. 11, p<0.001). At multivariable logistic regression analysis, age (odds ratio [OR] 1.08 [1.04-1.13], p<0.001), prior negative biopsy (OR 0.19 [0.09-0.44], p<0.001), prostate-specific antigen density cutoff ≥ 0.15 (OR 3.17 [1.67-6.01], p<0.001), and prostate imaging reporting and data system ≥4 (OR 12.2 [4.21-35.6], p<0.001) were independent predictors of csPCa. CONCLUSIONS: MTBx showed similar diagnostic performance to the combination of MTBx and SBx in patients undergoing outpatient TP prostate biopsy. Future studies are needed to evaluate the role of MTBx in avoiding unnecessary biopsies.
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Recurrencia Local de Neoplasia , Neoplasias de la Vejiga Urinaria , Humanos , Neoplasias de la Vejiga Urinaria/terapia , Neoplasias de la Vejiga Urinaria/patología , Medición de Riesgo , Clasificación del Tumor , Invasividad Neoplásica , Cistectomía/métodos , Neoplasias Vesicales sin Invasión MuscularRESUMEN
PURPOSE: Small intestinal submucosa (SIS) graft urethroplasty has been employed to decrease buccal mucosa morbidity and facilitate the procedure. The first published series had a short follow-up, inhomogeneous patient selection, and a lack of a control group. Our purpose is to report treatment outcomes at 13 years in a propensity score-matched cohort comparing bulbar urethroplasty with SIS (SISU) or buccal mucosa (BMU). METHODS: From our institutional database of 1132 bulbar urethroplasties, we used propensity score matching with the nearest-neighbor method without replacement to generate a study sample of 25 BMU and 25 SISU. Failure was defined as any treatment after urethroplasty. Survival analyses were used to analyze treatment failure occurrence with data censored at 156mo. RESULTS: Matching resulted in a complete correction of bias between the two samples except for the follow-up duration, which was slightly longer in the SIS group. The cumulative treatment success probability of BMU and SISU at 156mo was 83.4% and 68%, respectively. At multivariable Cox regression, SIS graft, previous urethrotomy, stricture length, and lower postoperative Qmax (within 2mo after catheter removal) were predictors of failure. Stricture length had a more remarkable effect in SISU, with estimated survival probabilities from the Cox model lower than 80% in strictures > = 3 cm. CONCLUSION: SIS has poorer outcomes compared to BM but may still be useful when BM grafting is not possible. The best candidates for SISU, with similar success to BMU, are patients with strictures shorter than 3 cm, preferably without a history of DVIU.
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Estrechez Uretral , Masculino , Humanos , Constricción Patológica/cirugía , Estrechez Uretral/cirugía , Mucosa Bucal/trasplante , Puntaje de Propensión , Procedimientos Quirúrgicos Urológicos Masculinos/métodos , Uretra/cirugía , Resultado del TratamientoRESUMEN
RATIONALE AND OBJECTIVES: To compare urethral stricture shear wave elastography (SWE) with normal areas and assess its association with other explanatory variables. SUBJECTS AND METHODS: we recruited all men with urethral stricture disease referred to our center between December 2021 and July 2023. Patients underwent SWE and elasticity in the stricture area, and one and three centimeters distant from the stricture were measured. Gathered data were analyzed using Freidman and post hoc analysis, correlation methods, student t-tests, and one-way ANOVA. RESULTS: 22 patients were recruited for our study. Spongiofibrosis was significantly higher in the stricture area relative to the one-centimeter-distant adjacent area (p < .0005), in the one-centimeter-distant compared to the three-centimeter-distant area (p = .002), and in the stricture area relative to the three-centimeter-distant area (p < .0005). There was no association between elasticity ratio and patient age or stricture location. Likewise, there was no difference in elasticity ratios between bulbar and pendulous strictures (p = 0.19) or among different etiologies of urethral strictures (p = 0.76). CONCLUSION: There is a significant difference in elasticity between the urethral stricture area and other parts of the corpus spongiosum. Normal areas closer to strictures are stiffer. The elasticity ratio is unrelated to patient age or prior internal urethromies. Neither stricture locations nor distinct urethral stricture etiologies differed in elasticity ratios.
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BACKGROUND: The diagnostic process for prostate cancer after a negative biopsy is challenging. This study compares the diagnostic accuracy of micro-ultrasound (mUS) with multiparametric magnetic resonance imaging (mpMRI) for such cases. METHODS: A retrospective cohort study was performed, targeting men with previous negative biopsies and using mUS and mpMRI to detect prostate cancer and clinically significant prostate cancer (csPCa). RESULTS: In our cohort of 1397 men, 304 had a history of negative biopsies. mUS was more sensitive than mpMRI, with better predictive value for negative results. Importantly, mUS was significantly associated with csPCa detection (adjusted odds ratio [aOR]: 6.58; 95% confidence interval [CI]: 1.15-37.8; p = 0.035). CONCLUSIONS: mUS may be preferable for diagnosing prostate cancer in previously biopsy-negative patients. However, the retrospective design of this study at a single institution suggests that further research across multiple centers is warranted.
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OBJECTIVES: To develop a microultrasound-based nomogram including clinicopathological parameters and microultrasound findings to predict the presence of extra-prostatic extension and guide the grade of nerve-sparing. MATERIAL AND METHODS: All patients underwent microultrasound the day before robot-assisted radical prostatectomy. Variables significantly associated with extra-prostatic extension at univariable analysis were used to build the multivariable logistic model, and the regression coefficients were used to develop the nomogram. The model was subjected to 1000 bootstrap resamples for internal validation. The performance of the microultrasound-based model was evaluated using the area under the curve (AUC) of the receiver operating characteristic (ROC) curve, calibration plot, and decision curve analysis (DCA). RESULTS: Overall, 122/295 (41.4%) patients had a diagnosis of extra-prostatic extension on definitive pathology. Microultrasound correctly identify extra-prostatic extension in 84/122 (68.9%) cases showing a sensitivity and a specificity of 68.9% and 84.4%, with an AUC of 76.6%. After 1000 bootstrap resamples, the predictive accuracy of the microultrasound-based model was 85.9%. The calibration plot showed a satisfactory concordance between predicted probabilities and observed frequencies of extra-prostatic extension. The DCA showed a higher clinical net-benefit compared to the model including only clinical parameters. Considering a 4% cut-off, nerve-sparing was recommended in 173 (58.6%) patients and extra-prostatic extension was detected in 32 (18.5%) of them. CONCLUSION: We developed a microultrasound-based nomogram for the prediction of extra-prostatic extension that could aid in the decision whether to preserve or not neurovascular bundles. External validation and a direct comparison with mpMRI-based nomogram is crucial to corroborate our results.
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Neoplasias de la Próstata , Robótica , Masculino , Humanos , Nomogramas , Neoplasias de la Próstata/diagnóstico por imagen , Neoplasias de la Próstata/cirugía , Neoplasias de la Próstata/patología , Próstata/diagnóstico por imagen , Próstata/cirugía , Próstata/patología , Prostatectomía/métodos , Estudios RetrospectivosRESUMEN
PURPOSE: To assess the diagnostic performance of microultrasound-targeted biopsy (microUSTBx) and systematic biopsy (SBx) in detecting clinically significant prostate cancer (csPCa) among men with abnormal digital rectal examination (DRE) and suspicious lesions at multiparametric magnetic resonance imaging (mpMRI), and to compare the diagnostic performance of this approach with a mpMRI-guided targeted biopsy (MTBx) plus SBx-based strategy. METHODS: Biopsy-naïve men with suspicious lesions at mpMRI and abnormal DRE were prospectively evaluated between October 2017 and January 2023. csPCa detection rate by microUSTBx plus SBx and MTBx plus SBx was assessed and then compared by McNemar's test. The added value of prostate-specific antigen density (PSAd) was also evaluated. RESULTS: Overall, 182 biopsy naïve men were included. MicroUSTBx plus SBx achieved comparable detection rate to MTBx plus SBx in diagnosis of ciPCa and csPCa (ciPCa: 9.3% [17/182] vs 10% [19/182]; csPCa: 63% [114/182] vs 62% [113/182]). MicroUSTBx outperformed MTBx (ciPCa: 5.5% [10/182] vs 6.0% [11/182]; csPCa: 57% [103/182] vs 54% [99/182]). Using microUSTBx plus SBx would have avoided 68/182 (37%) unnecessary mpMRI, while missing only 2/116 (1.7%) csPCa. The decision curve analysis of suspicious microUS plus PSAd ≥ 0.15 ng/ml showed higher net benefit in the ability to identify true positives and reduce the number of unnecessary prostate biopsy in this subcategory of patients. CONCLUSIONS: The combination of microUSTBx and SBx showed equal diagnostic performance to an mpMRI-based approach in biopsy-naïve patients with an abnormal DRE. The combination of this approach with PSAd maximize the diagnostic accuracy while lowering the need for unnecessary biopsies.
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Imágenes de Resonancia Magnética Multiparamétrica , Neoplasias de la Próstata , Masculino , Humanos , Próstata/diagnóstico por imagen , Tacto Rectal , Neoplasias de la Próstata/diagnóstico por imagen , Biopsia , UltrasonografíaRESUMEN
PURPOSE: Micro-UltraSound (microUS) is a new imaging modality capable of identifying and targeting suspicious areas, which might further increase the diagnostic yield of prostate biopsy (PBx). Aim of this review is to provide insights into the usefulness of microUS for the sub-stratification of prostate cancer (PCa), clinically significant PCa (i.e., any Gleason score ≥ 7 PCa; csPCa) along with non-organ-confined disease in patients undergoing PBx. METHODS: A PubMed literature search was performed using keywords: prostate cancer diagnosis, prostate cancer diagnosis surveillance, systematic biopsy, target biopsy, micro-ultrasound, and prostate risk identification using micro-ultrasound. RESULTS: MicroUS could significantly improve multiparametric magnetic resonance imaging (mpMRI) findings by adding valuable anatomical and pathological information provided by real-time examination. Furthermore, microUS target biopsy could replace systematic biopsy in clinical practice by reducing the detection of clinically insignificant (ciPCa) and increasing that of csPCa. Finally, microUS may be useful in predicting the presence of non-organ confined PCa before radical prostatectomy and it could also be an effective add-on tool for patient monitoring within the active surveillance program. CONCLUSION: MicroUS may represent an attractive step forward for the management of csPCa as a complementary or alternative tool to mpMRI. Nevertheless, further longitudinal studies are warranted, and the strength of the evidence is still suboptimal to provide clear recommendations for daily clinical practice.
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Imagen por Resonancia Magnética , Neoplasias de la Próstata , Masculino , Humanos , Imagen por Resonancia Magnética/métodos , Neoplasias de la Próstata/patología , Biopsia , Antígeno Prostático Específico , Próstata/diagnóstico por imagen , Próstata/patología , Biopsia Guiada por Imagen/métodosRESUMEN
PURPOSE: We sought to determine if the International Bladder Cancer Group IR-NMIBC (Intermediate-risk Nonmuscle-invasive Bladder Cancer) scoring system can predict the requirement of delayed transurethral resection of bladder tumor in low-grade nonmuscle-invasive bladder cancer managed by active surveillance. MATERIALS AND METHODS: We prospectively studied recurrent low-grade Ta/T1 nonmuscle-invasive bladder cancer patients managed with active surveillance with the following characteristics: low-grade papillary nonmuscle-invasive bladder cancer, ≤5 apparent low-grade nonmuscle-invasive bladder tumors, tumor diameter ≤1 cm, absence of gross hematuria, and negative urinary cytology. Subsequent transurethral resection of bladder tumor was offered to patients who no longer met the inclusion criteria or patient choice. The ability of the International Bladder Cancer Group IR-NMIBC scoring system to predict receipt of subsequent transurethral resection of bladder tumor was determined. Multivariable Cox proportional hazards analysis was used to determine factors associated with subsequent transurethral resection of bladder tumor. RESULTS: A total of 163 patients with low-grade Ta/T1 nonmuscle-invasive bladder cancer were included for analysis. After a median follow-up of 33 months (IQR: 21-46), transurethral resection of bladder tumor was performed on 109 patients. At landmark time point of 24 months, patients with 0 risk factors were over 2-fold more likely to continue active surveillance compared to patients with ≥3 risk factors (59% vs 24%). Multivariable Cox regression suggested that the International Bladder Cancer Group IR-NMIBC scoring system was associated with subsequent transurethral resection of bladder tumor (1-2 risk factors [HR: 1.66, 95% CI: 0.96-2.90, P = .072], ≥3 risk factors [HR: 3.21, 95% CI: 1.70-6.09, P < .001]) after adjusting for age, T stage, and sex. CONCLUSIONS: The International Bladder Cancer Group IR-NMIBC scoring system can predict the risk of subsequent transurethral resection of bladder tumor in patients with low-grade nonmuscle-invasive bladder cancer on active surveillance.
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PURPOSE: To evaluate the diagnostic accuracy of multiparametric magnetic resonance imaging (MRI)- and microultrasound (microUS)-guided targeted biopsy (TBx) in detecting prostate cancer (PCa) and clinically significant (cs) PCa among men with Prostate Imaging Reporting and Data System (PI-RADS 5) lesions and to compare this combined TBx (CTBx) strategy with CTBx plus systemic biopsy (SBx). METHODS: One hundred and thirty-six biopsy-naïve patients with PI-RADS 5 lesion at multiparametric MRI undergoing CTBx plus SBx were retrospectively evaluated. Analysis of diagnostic performance of microUS-TBx, MRI-TBx, CTBx, SBx and combined CTBx plus SBx was performed. Cost (downgrade, upgrade and biopsy core) to effectiveness (detection rate) was compared. RESULTS: CTBx achieved a comparable detection rate to CTBx plus SBx in diagnosis of PCa and csPCa (PCa: 78.7% [107/136] vs 79.4% [108/136]; csPCa: 67.6% [92/136] vs 67.6% [92/136]; p > 0.05) and outperformed SBx (PCa: 58.8% [80/136]; csPCa: 47.8% [65/136]; p < 0.001). Using CTB would have avoided 41.1% (56/136) unnecessary SBx, without missing any csPCa. The rate of any upgrading or csPCa upgrading was significantly higher by SBx than by CTBx [33/65 (50.8%) vs 17/65 (26.1%) and 20/65 (30.8%) vs 4/65 (6.15%), respectively, p < 0.05]. Considering csPCa detection rate, microUS showed high sensitivity and positive predictive value (94.6%, 87.9%, respectively), with lower specificity and negative predictive value (25.0% and 44.4%, respectively). At multivariable logistic regression models, positive microUS was identified as an independent predictor of csPCa (p = 0.024). CONCLUSIONS: A combined microUS/MRI-TBx approach could be the ideal imaging tool for characterizing primary disease in PI-RADS five patients, allowing SBx to be avoided.
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Imágenes de Resonancia Magnética Multiparamétrica , Neoplasias de la Próstata , Masculino , Humanos , Neoplasias de la Próstata/patología , Imagen por Resonancia Magnética/métodos , Estudios Retrospectivos , Biopsia Guiada por Imagen/métodosRESUMEN
Liquid biopsy (LB) for prostate cancer (PCa) detection could represent an alternative to biopsy. Seminal fluid (SF) is a source of PCa-specific biomarkers, as 40% of ejaculate derives from the prostate. We tested the feasibility of an SF-based LB by evaluating the yield of semen self-sampling in a cohort of >750 patients with clinically localized PCa. The overall SF collection yield was 18.2% (39% when considering only compliant patients), with about a half of the patients (53.15%) not consenting to SF donation. Independent favorable predictors for SF collection were younger age and lower prostate volume. We implemented a protocol to enrich prostate-derived cells by multi-color flow cytometry and applied it on SF and urine samples from 100 patients. The number of prostate-enriched cells (SYTO-16+ PSMA+ CD45-) was variable, with higher numbers of cells isolated from SF than urine (p value < 0.001). Putative cancer cells (EpCAMhigh) were 2% of isolated cells in both specimens. The fraction of EpCAMhigh cells over prostate-enriched cells (PSMA+) significantly correlated with patient age in both semen and urine, but not with other clinical parameters, such as Gleason Score, ISUP, or TNM stage. Hence, enumeration of prostate-derived cells is not sufficient to guide PCa diagnosis; additional molecular analyses to detect patient-specific cancer lesions will be needed.
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BACKGROUND: Recent years have seen the development of a new generation of temporary urethral stents as an adjuvant option after direct vision internal urethrotomy (DVIU). Despite some early promising results, large series addressing their safety and outcomes are still lacking. OBJECTIVE: To report complications and outcomes from the largest series of patients receiving a temporary bulbar urethral stent to date. DESIGN, SETTING, AND PARTICIPANTS: We performed a retrospective analysis of bulbar urethral stenting procedures after DVIU in seven centers. Patients either refused urethroplasty or were not fit for surgery. The stents were removed after at least 6 mo in place unless complications requiring earlier removal occurred. SURGICAL PROCEDURE: DVIU with a cold knife or laser is performed, followed by stent placement. At the end of the treatment period, the stent is removed under cystoscopy with gripping forceps. MEASUREMENTS: All patients underwent postoperative follow-up (FU) for assessment of complications while the stent was in place. After removal, the FU schedule consisted of office evaluation at 6 mo and 12 mo, and then annually. Failure was defined as any treatment for urethral stricture after stent removal. RESULTS AND LIMITATIONS: A total of 49% of the patients experienced complications. The most frequent were discomfort (23.8%), stress incontinence (17.5%), and stent dislocation (9.8%). Some 85% of the adverse events observed were Clavien-Dindo grade <3. The overall success rate at median FU of 38.2 mo was 76.9%. The success rate was significantly lower if the stent was removed before 6 mo (53.3% vs 79.7%; p = 0.026). CONCLUSIONS: Temporary urethral stents may be a safe choice with satisfactory results in patients not undergoing urethroplasty. A stent indwelling time shorter than 6 mo provides worse outcomes that are comparable to those with DVIU alone. PATIENT SUMMARY: We assessed complications and outcomes after placement of a temporary narrow tube in the urethra after surgery to widen a narrowing of the urethra. The treatment is safe and easily reproducible with satisfactory results. Further studies are needed to confirm our findings.
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Uretra , Estrechez Uretral , Humanos , Masculino , Uretra/cirugía , Estudios Retrospectivos , Estudios de Factibilidad , Resultado del Tratamiento , Estrechez Uretral/cirugía , Stents , Procedimientos Quirúrgicos Urológicos Masculinos/efectos adversos , Procedimientos Quirúrgicos Urológicos Masculinos/métodosRESUMEN
Segmental ureterectomy (SU) is an alternative to radical nephroureterectomy (RNU) in the treatment of upper-tract urothelial carcinoma (UTUC) of the ureter. SU generally preserves renal function, at the expense of less intensive cancer control. We aim to assess whether SU is associated with inferior survival compared to RNU. Using the National Cancer Database (NCDB), we identified patients diagnosed with localized UTUC of the ureter between 2004-2015. We used a propensity-score-overlap-weighted (PSOW) multivariable survival model to compare survival following SU vs. RNU. PSOW-adjusted Kaplan-Meier curves were generated and we performed a non-inferiority test of overall survival. A population of 13,061 individuals with UTUC of the ureter receiving either SU or RNU was identified; of these, 9016 underwent RNU and 4045 SU. Factors associated with decreased likelihood of receiving SU were female gender (OR, 0.81; 95% CI, 0.75-0.88; p < 0.001), advanced clinical T stage (cT4) (OR, 0.51; 95% CI, 0.30-0.88; p = 0.015), and high-grade tumor (OR, 0.76; 95% CI, 0.67-0.86; p < 0.001). Age greater than 79 years was associated with increased probability of undergoing SU (OR, 1.18; 95% CI, 1.00-1.38; p = 0.047). There was no statistically significant difference in OS between SU and RNU (HR, 0.98; 95% CI, 0.93-1.04; p = 0.538). SU was not inferior to RNU in PSOW-adjusted Cox regression analysis (p < 0.001 for non-inferiority). In weighted cohorts of individuals with UTUC of the ureter, the use of SU was not associated with inferior survival compared to RNU. Urologists should continue to utilize SU in appropriately selected patients.
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We aim to evaluate the potential protective role of intravesical Bacillus Calmette-Guerin (BCG) against SARS-CoV-2 in patients with non-muscle invasive bladder cancer (NMIBC). Patients treated with intravesical adjuvant therapy for NMIBC between January 2018 and December 2019 at two Italian referral centers were divided into two groups based on the received intravesical treatment regimen (BCG vs. chemotherapy). The study's primary endpoint was evaluating SARS-CoV-2 disease incidence and severity among patients treated with intravesical BCG compared to the control group. The study's secondary endpoint was the evaluation of SARS-CoV-2 infection (estimated with serology testing) in the study groups. Overall, 340 patients treated with BCG and 166 treated with intravesical chemotherapy were included in the study. Among patients treated with BCG, 165 (49%) experienced BCG-related adverse events, and serious adverse events occurred in 33 (10%) patients. Receiving BCG or experiencing systemic BCG-related adverse events were not associated with symptomatic proven SARS-CoV-2 infection (p = 0.9) nor with a positive serology test (p = 0.5). The main limitations are related to the retrospective nature of the study. In this multicenter observational trial, a protective role of intravesical BCG against SARS-CoV-2 could not be demonstrated. These results may be used for decision-making regarding ongoing and future trials.
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BACKGROUND: Active surveillance (AS) represents a standard of care of low-risk prostate cancer (PCa). However, the identification and monitoring of AS candidates remains challenging. Microultrasound (microUS) is a novel high-resolution imaging modality for transrectal ultrasonography (TRUS). We explored the impact of microUS TRUS and targeted biopsies in mpMRI-guided confirmatory biopsies. METHODS: Between October 2017 and September 2021, we prospectively enrolled 100 patients scheduled for MRI-guided confirmatory biopsy at 1 year from diagnosis of ISUP 1 PCa. TRUS was performed using the ExactVu microUS system; PRI-MUS protocol was applied to identify suspicious lesions (i.e., PRIMUS score ≥ 3). All patients received targeted biopsies of any identified microUS and mpMRI lesions and complementary systematic biopsies. The proportion of patients upgraded to clinically significant PCa (defined as ISUP ≥ 2 cancer; csPCa) at confirmatory biopsies was determined, and the diagnostic performance of microUS and mpMRI were compared. RESULTS: Ninety-two patients had a suspicious MRI lesion classified PI-RADS 3, 4, and 5 in respectively 28, 16, and 18 patients. MicroUS identified 82 patients with suspicious lesions, classified as PRI-MUS 3, 4, and 5 in respectively 20, 50, and 12 patients, while 18 individuals had no lesions. Thirty-four patients were upgraded to ISUP ≥ 2 cancer and excluded from AS. MicroUS and mpMRI showed a sensitivity of 94.1% and 100%, and an NPV of 88.9% and 100%, respectively, in detecting ISUP ≥ 2 patients. A microUS-mandated protocol would have avoided confirmatory biopsies in 18 patients with no PRI-MUS ≥ 3 lesions at the cost of missing four upgraded patients. CONCLUSIONS: MicroUS and mpMRI represent valuable imaging modalities showing high sensitivity and NPV in detecting csPCa, thus allowing their use for event-triggered confirmatory biopsies in AS patients. MicroUS offers an alternative imaging modality to mpMRI for the identification and real-time targeting of suspicious lesions in AS patients.