Publications by authors named "Luca Cindolo"

192 Publications

Can Medical Therapy Fix Sexual Dysfunction after Major Pelvic and Prostate Surgery and does it Work for Kidney Stones? Chemotherapy before Cystectomy, New Schemes for which Patients?

Curr Drug Targets 2021 ;22(1):2-3

Department of Urology, Faculty of Medicine School of Health Sciences, Aristotle University of Thessaloniki Thessaloniki, Greece.

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http://dx.doi.org/10.2174/138945012201201231123209DOI Listing
January 2021

Protocol of the Italian Radical Cystectomy Registry (RIC): a non-randomized, 24-month, multicenter study comparing robotic-assisted, laparoscopic, and open surgery for radical cystectomy in bladder cancer.

BMC Cancer 2021 Jan 11;21(1):51. Epub 2021 Jan 11.

Department of Urology, Policlinico Abano Terme, Abano Terme, PD, Italy.

Background: Bladder cancer is the ninth most common type of cancer worldwide. In the past, radical cystectomy via open surgery has been considered the gold-standard treatment for muscle invasive bladder cancer. However, in recent years there has been a progressive increase in the use of robot-assisted laparoscopic radical cystectomy. The aim of the current project is to investigate the surgical, oncological, and functional outcomes of patients with bladder cancer who undergo radical cystectomy comparing three different surgical techniques (robotic-assisted, laparoscopic, and open surgery). Pre-, peri- and post-operative factors will be examined, and participants will be followed for a period of up to 24 months to identify risks of mortality, oncological outcomes, hospital readmission, sexual performance, and continence.

Methods: We describe a protocol for an observational, prospective, multicenter, cohort study to assess patients affected by bladder neoplasms undergoing radical cystectomy and urinary diversion. The Italian Radical Cystectomy Registry is an electronic registry to prospectively collect the data of patients undergoing radical cystectomy conducted with any technique (open, laparoscopic, robotic-assisted). Twenty-eight urology departments across Italy will provide data for the study, with the recruitment phase between 1st January 2017-31st October 2020. Information is collected from the patients at the moment of surgical intervention and during follow-up (3, 6, 12, and 24 months after radical cystectomy). Peri-operative variables include surgery time, type of urinary diversion, conversion to open surgery, bleeding, nerve sparing and lymphadenectomy. Follow-up data collection includes histological information (e.g., post-op staging, grading, and tumor histology), short- and long-term outcomes (e.g., mortality, post-op complications, hospital readmission, sexual potency, continence etc).

Discussion: The current protocol aims to contribute additional data to the field concerning the short- and long-term outcomes of three different radical cystectomy surgical techniques for patients with bladder cancer, including open, laparoscopic, and robot-assisted. This is a comparative-effectiveness trial that takes into account a complex range of factors and decision making by both physicians and patients that affect their choice of surgical technique.

Trial Registration: ClinicalTrials.gov , NCT04228198 . Registered 14th January 2020- Retrospectively registered.
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http://dx.doi.org/10.1186/s12885-020-07748-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802145PMC
January 2021

Impact of the presence of a median lobe on functional outcomes of greenlight photovaporization of the prostate (PVP): an analysis of the Global Greenlight Group (GGG) Database.

World J Urol 2021 Jan 3. Epub 2021 Jan 3.

Division of Urology, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, QC, Canada.

Objectives: Previous analyses of the impact of median lobe presence on Greenlight photoselective vaporization of the prostate (PVP) outcomes were limited by their small sample size and the ability to adjust for important confounders. As such, we sought to investigate the impact of prostate median lobe presence on the operative outcomes of 180 W XPS GreenLight PVP using a large international database.

Methods: Data were obtained from the Global GreenLight Group (GGG) database which pools data of eight high-volume, experienced surgeons, from a total of seven international centers. All men with established benign prostatic hyperplasia who underwent GreenLight PVP using the XPS-180 W system between 2011 and 2019 were eligible for the study. Patients were assigned to two groups based on presence or absence of median lobes. Analyses were adjusted for patient age, prostate volume, body mass index, and American Society of Anesthesia (ASA) score.

Results: A total of 1650 men met the inclusion criteria. A median lobe was identified in 621 (37.6%) patients. Baseline prostate volume, patient age, and ASA score varied considerably between the two groups. In adjusted analyses, the operative and lasing time of patients with median lobes was 6.72 (95% CI 3.22-10.23; p < 0.01) minutes and 2.90 (95% CI 1.02-4.78; p < 0.01) minutes longer than the control group. Men with median lobes had similar postoperative functional outcomes to those without a median lobe except for a 1.59-point greater drop in the 12-month IPSS score compared to baseline (95% CI 0.11-3.08; p = 0.04) in the median lobe group, and a decrease in PVR after 6 months which was 46.51 ml (95% CI 4.65-88.36; p = 0.03) greater in patients with median lobes compared to men without median lobes.

Conclusions: Our findings suggest that the presence of a median lobe has no clinically significant impact on procedural or postoperative outcomes for patients undergoing Greenlight PVP using the XPS-180 W system.
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http://dx.doi.org/10.1007/s00345-020-03529-wDOI Listing
January 2021

The safety and feasibility of the simultaneous use of 180-W GreenLight laser for prostate vaporization during concomitant surgery.

Arch Ital Urol Androl 2020 Dec 17;92(4). Epub 2020 Dec 17.

Department of Urology, Private Hospital Villa Stuart, Rome.

Objectives: To explore the safety and feasibility of photo-selective vaporization of the prostate (PVP) with GreenLight XPS 180 Watt laser (GL-180- W XPS) combined with other surgical procedures.

Material And Methods: Data on patients in whom GL-180-W XPS was performed to relieve lower urinary tract symptoms/ benign prostatic hyperplasia (LUTS/BPH) symptoms were extracted from a multi-institutional database (2011-2016). Patients were stratified into two groups. In the first all patients who had GL-180-W XPS with a concomitant procedure during the same surgical session were included as cases while those who underwent GL-180-W XPS PVP only were included as control.

Results: A total of 487 patients were included. Fifty-eight (11.9%) patients underwent concomitant procedures. Multivariable linear regression models failed to find an association between concomitant procedures and longer laser time (p = 0.4). Similarly, multivariable linear regression models failed to find an association between concomitant procedures and laser time even when the analyses were repeated and stratified into endoscopic (p = 0.6) and open/laparoscopic (p = 0.4) procedures. Multivariable logistic regression models failed to demonstrate any association between concomitant procedures and early complications (OR:1.39, CI: 0.379-2.44, p = 0.2), late complications (OR:1.84, CI:0.78-3.98; p = 0.1) and acute urinary retention (OR:1.84, CI:0.78-3.98; p = 0.1). When the analyses were repeated and the concomitant procedures stratified into endoscopic and open/laparoscopic ones, they yielded virtually the same results.

Conclusions: GL-180-W XPS PVP could be safely performed in concomitant endoscopic or open/laparoscopic surgery. These results should be taken into consideration in the counseling of the patient who might choose to undergo simultaneous procedures.
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http://dx.doi.org/10.4081/aiua.2020.4.297DOI Listing
December 2020

Interactions between Drugs and Surgery in the Treatment of LUTS and Advanced Renal Cancer.

Curr Drug Targets 2020 ;21(15):1512-1514

Department of Urology, Villa Stuart Private Hospital, Rome, Italy.

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http://dx.doi.org/10.2174/138945012115201102115645DOI Listing
January 2020

Ultrasound prostate parameters as predictors of successful trial without catheter after acute urinary retention in patients ongoing medical treatment for benign prostatic hyperplasia: a prospective multicenter study.

Minerva Urol Nefrol 2020 Nov 17. Epub 2020 Nov 17.

Department of Urology, Università La Sapienza, Ospedale Sant'Andrea, Rome, Italy.

Background: Alpha-blockers (ABs) are considered the standard treatment after initial management of acute urinary retention (AUR). However, no data are available on the predictors of a successful trial without catheter (TWOC) in patients previously on treatment with ABs and 5alpha reductase inhibitors (5ARI). Aim of our study was to investigate prostate ultrasound parameters as predictors of TWOC outcome.

Methods: A consecutive series of patients, on treatment with ABs alone or in combination with 5ARI, experiencing AUR were prospectively enrolled. Clinical data (i.e.age, body mass index (BMI) and IPSS), urinary ultrasound features including hydronephrosis, prostate volume-TRUS, bladder wall thickness (BWT), intravesical prostatic protrusion more than 10mm (IPP≥10) were related to TWOC outcome performed seven days after AUR. A binary logistic regression analysis was computed to detect predictors of successful TWOC.

Results: Overall,143 patients with a median age of 72 years (IQR 64-77) were enrolled. Seventy-mine patients (54%) with smaller prostate volume (59(IQR 52-74) Vs 99 (IQR 74-125) ml, p=0.008) and a thinner BWT (5(IQR 4.8-5.2) Vs 5.2 (4.7-5.5) mm p=0.001) recovered voiding at TWOC. IPP≥10 was less common in patients with successful TWOC 11(14%) vs 33(52%), p=0.001. On multivariate analysis, IPP<10mm (OR 6.10 (95%CI 2.61-14.20), p=0.001), lower IPSS (OR 0.95 (95%CI 0.89-0.99), p= 0.045), smaller TRUS (OR 0.96 (95%CI 0.95-0.97), p=0.001), thinner BWT OR 1.23 (95%CI 0.73-0,92) p=0.001were the independent predictors of voiding recovery.

Conclusions: Patients receiving medical treatment for BPH and experiencing AUR still present a 54% probability of a successful TWOC. Ultrasound may help to identify patients with successful TWOC.
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http://dx.doi.org/10.23736/S0393-2249.20.04088-6DOI Listing
November 2020

Evaluating the utility of antibiotic prophylaxis prior to ESWL in patients with sterile urine: a systematic review and meta-analysis.

Minerva Urol Nefrol 2020 Nov 17. Epub 2020 Nov 17.

Department of Urology, University of Patras, Patras, Greece.

Introduction: To evaluate the effect of antibiotic prophylaxis (AP) on asymptomatic bacteriuria (AB) and urinary tract infection (UTI) in patients with sterile urine undergoing ESWL.

Evidence Acquisition: PubMed, Scopus, Web of Science and Cochrane Registry were searched systematically for randomized clinical trials assessing the effect of AP in patients with sterile urine undergoing SWL up to May 2020. Risk ratios were used to compare dichotomous outcomes. A stratified analysis was performed depending on the risk of bias assessment of the included studies. Subgroup analysis was performed in patients that underwent instrumentation of the urinary tract.

Evidence Synthesis: 16 studies were evaluated including 2442 patients. When evaluating all the included studies (regardless of the risk of bias assessment), the risk of AB was RR: 0.88, 95% CI:0.64-1.21, p=0.42 and the risk of UTI was RR: 0.55 95% CI: 0.22-1.36, p=0.19. When excluding the high risk of bias studies the risk for AB was RR: 0.9, 95% CI: 0.63-1.28, p=0.55 and for UTI RR: 1.18, 95% CI: 0.38-3.72, p=0.77. When evaluating patients that underwent instrumentation of the urinary tract the risk for AB was RR:0.92, 95% CI: 0.66-1.27, p=0.6 and for UTI was RR: 0.69, 95% CI: 0.22-2.22, p-0.54.

Conclusions: AP is not necessary for patients with sterile urine prior to ESWL for the prevention of UTI. Also, patients that undergo instrumentation of the urinary tract prior to or during ESWL do not benefit from antibiotic prophylaxis but further research is required.
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http://dx.doi.org/10.23736/S0393-2249.20.04061-8DOI Listing
November 2020

Overall survival in mCPRC patients treated with Radium-223 in association with bone health agents: a national multicenter study.

Int J Radiat Biol 2020 Dec 3;96(12):1608-1613. Epub 2020 Nov 3.

Department of Radiological Sciences, Oncology and Anatomical Pathology, Sapienza University of Rome, Rome, Italy.

Purpose: Radium-223 has demonstrated efficacy in improving overall survival (OS) and in delaying symptomatic skeletal-related events (SREs). Bone Health Agents (BHA), i.e. RANK ligand inhibitor (Denosumab) and bisphosphonate such as zoledronic acid, are indicated to prevent SREs without a clear survival benefit. SREs on patient health have a high impact and it is, therefore, important to consider the role of new therapies with BHA to better understand the involvement of combination therapy. The primary aim of this multicentric study is to assess OS in mCRPC patients treated with Radium-223 in combination with BHA.

Materials And Methods: 430 consecutive patients treated with Radium-223 alone or in combination with BHA, affected by mCRPC, from January 2015 to July 2019 in six Italian Nuclear Medicine Units, were included. Furthermore, data were collected at baseline, after every Radium-223 administration, and during follow-up, at 3 and 6 months and 1 year after the 6th cycle. Clinical data have been evaluated before starting treatment with Radium-223 and at the end of treatment and/or at progression. Patients who received target bone therapy with BHA before Radium-223 treatment together with patients who did not receive this therapy at all (NO BHA GROUP), were compared to patients treated with concomitant Radium-223 and BHA (BHA GROUP).

Results: In univariate models ( < .05) several clinical aspects have an impact on OS: concomitant BHA ( = .018), BMI ( .001), ECOG PS ( = .000), Baseline Hb ( = .000), Baseline PSA ( = .000), Baseline tALP ( = .000), Baseline LDH ( = .000), and Baseline neutrophils ( = .009). Baseline Hb, Baseline tALP, and Baseline LDH have been confirmed as statistically significant parameters in multivariate models. Indeed, concomitant BHA has not a significant impact on OS ( = .244) in multivariate models.

Conclusions: At univariate analysis, our data showed that NO BHA GROUP and BHA GROUP differ in OS by 7 months (95%CI: (1-16.4),  = .02). This is not confirmed at multivariate analysis where after adjusting for other baseline factors, BHA is not significant anymore. This is clearly explained as bias by indication: patients with the same levels of tALP, Hb, and LDH receiving or not receiving BHA are expected to have a similar survival. Our results support and confirm the role of Radium-223 therapy on OS and, furthermore, appear to confirm that BHA treatment has not a survival benefit.
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http://dx.doi.org/10.1080/09553002.2020.1838655DOI Listing
December 2020

Predictive Ability for Disease-Free Survival of the GRade, Age, Nodes, and Tumor (GRANT) Score in Patients with Resected Renal Cell Carcinoma.

Curr Urol 2020 Jun 23;14(2):98-104. Epub 2020 Jun 23.

Medical Oncology Unit, St. Salvatore Hospital, L'Aquila.

Background: Recently, the GRANT (GRade, Age, Nodes, and Tumor) score was validated through an adjuvant trial population.

Methods: This retrospective study evaluated the performance of the GRANT score as a prognostic model for disease-free survival (DFS), compared to the University of California Los Angeles Integrated Staging System (UISS) score, in a "real-life" population of early renal cell carcinoma patients. A uni-/multivariate analysis of DFS was also performed, to weigh the roles of baseline clinical factors.

Results: From February 1998 to January 2018, 134 consecutive patients were enrolled, of which 85 patients (63.4%) had a favorable GRANT score, 49 (36.6%) an unfavorable GRANT score, and 21 (15.7%), 84 (62.6%), and 29 (21.6%) patients had a low, intermediate, or high risk of recurrence according to the UISS score, respectively. The median follow-up was 96 months. The median DFS of the overall study population was 53.7 months (95% CI: 38.4-87.8). Only bilateral renal cell carcinoma (p = 0.0041), Fuhrman grade 3/4 (p = 0.0008), pT3b- 4 (p = 0.0324), and pN1-2 (p = 0.0303) pathological status were confirmed as independent predictors of a shorter DFS by the multivariate analysis. The median DFS of patients with favorable and unfavorable GRANT scores were 84.9 (95% CI: 49.8-129) and 38.4 months (95% CI: 24.4-87.8), respectively, with a statistically significant difference (p = 0.0147). The median DFS of patients with low, intermediate, and high risk of recurrence according to the UISS score were 92.3 (95% CI: 18.1-153.9), 51.7 (95% CI: 36.2-87.8), and 49.8 months (95% CI: 31.3-129), respectively, without statistically significant differences (p = 0.4728). DFS c-statistic values were 0.59 (95% CI: 0.51-0.67) and 0.51 (95% CI: 0.42-0.60) for the GRANT and the UISS scores, respectively.

Conclusion: The GRANT score might be a useful tool that is user-friendly and easy to perform in clinical practice.
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http://dx.doi.org/10.1159/000499252DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7390980PMC
June 2020

The combination cytology/epichek test in non muscle invasive bladder carcinoma follow-up: Effective tool or useless expence?

Urol Oncol 2021 Feb 7;39(2):131.e17-131.e21. Epub 2020 Aug 7.

Institute of Urology, Università Cattolica del S. Cuore, Fondazione Policlinico "A. Gemelli", Rome, Italy.

Objective: To identify in which cases after cytological diagnosis, the Bladder EpiCheck test could represent an effective tool in non-muscle invasive bladder carcinoma or an useless expence.

Materials And Methods: 375 patients diagnosed with non-muscle invasive bladder cancer, 269 with high grade urothelial carcinoma and 106 with carcinoma in situ, were treated and followed for 1 year. The treatment was an intravesical instillation of Bacillus Calmette-Guerin in 305 patients and Mitomycin-C in 70 patients. During the follow-up patients were evaluated by voided urine cytology and white-light cystoscopy, according to the European Association of Urology Guidelines. Bladder EpiCheck test was performed together with cytology in all cases.

Results: Analyzing Bladder Epicheck results for each category defined by the Paris System for Reporting Urinary Cytology, we found that the Episcore >60 correlates with histological diagnosis of high grade urothelial carcinoma (HGUC) in atypical urothelial cells and Suspicious for High Grade Urothelial Carcinoma (P = 0.0002 Odds Ratio 0.05926 95% Confidence Interval from 0.01127 to 0.3116 and P = 0.0009 Odds Ratio 0.03155 95% Confidence Interval from 0.001683 to 0.5914, Fisher's exact test, respectively), while in Negative for high grade urothelial carcinoma and HGUC patients Episcore is not helpful to identify cases with histological diagnosis of HGUC (P = 0.101 and P = 0.58 Fisher's exact test, respectively). Considering an Episcore ≥ 90 in the HGUC cytological group, this seems not to be correlated with a histological diagnosis of HGUC (P = 0.090 Fisher's exact test).

Conclusions: Cytology and Bladder EpiCheck test in combination may have the potential to reduce cystoscopies in the follow-up of non-muscle invasive bladder cancer only for cytological diagnoses of atypical urothelial cells and Suspicious for High Grade Urothelial Carcinoma . Moreover, in patients with a cytological diagnosis of Negative for high grade urothelial carcinoma or HGUC, cytology alone seems to be safe and cost-effective.
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http://dx.doi.org/10.1016/j.urolonc.2020.06.018DOI Listing
February 2021

Radium-223 in mCPRC patients: a large real-life Italian multicenter study.

Minerva Urol Nefrol 2020 Aug 4. Epub 2020 Aug 4.

Department of Radiological Sciences, Oncology and Anatomical Pathology, "Sapienza" University of Rome, Rome, Italy.

Background: Radium-223 is a targeted alpha-particles therapy approved for the treatment of mCRPC patients with symptomatic bone metastases. To our knowledge we account for the largest cohort of mCRPC patients subjected to Radium-223 treatment in our country. We aim to describe in a real-life setting the largest cohort of mCRPC patients treated with Radium-223 ever taken into consideration.

Methods: 430 consecutive mCRPC patients were enrolled. Clinical data have been collected at baseline and at the end of the Radium-223 treatment. Furthermore, the overall survival(OS) of our population has been provided.

Results: 157 patients (36.5%) were still alive at the time of data analysis. A mean number of 4.95±1.6 cycles of Radium-223 was reached by our cohort. 265 patients (61.6%) completed the whole six cycles regimen. The mean follow-up period from the first cycle of Radium-223 to the date of the analysis was 12.7 months. The analysis of patients Annual Incidence Rate (AIR) in relation to the number of Radium-223 cycles received depicting a clear advantage for those patients who completed the whole six administrations planned, with an AIR (AIR=0.32) of much lesser value compared to those that have performed five cycles (AIR =0.98). 165 patients (38.4%) dropped out of treatment for death or disease progression.

Conclusions: This study offers a cross-section of the clinical performance of Radium-223 treatment in a real-world context, confirming on a large scale the effectiveness of Radium-223 in improving the OS and quality of life, along with the preservation of an excellent safety profile.
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http://dx.doi.org/10.23736/S0393-2249.20.03808-4DOI Listing
August 2020

Enzalutamide in patients with castration-resistant prostate cancer: retrospective, multicenter, real life study.

Minerva Urol Nefrol 2020 Aug 4. Epub 2020 Aug 4.

Department of Urology, ASL Abruzzo2, Chieti, Italy -

Background: Metastatic castration-resistant prostate cancer (mCRPC) is the final stage of pCa history and represents a clinically relevant phenotype with an elevated burden of mortality. The aim of the present study is to evaluate the efficacy and safety of enzalutamide in a "real-life" setting in mCRPC patients.

Methods: Data about all mCRPC patients treated with enzalutamide from September 2017 to September 2018 were collected. Demographics, comorbidities, clinical parameters, outcomes, toxicity, overall survival and progression free survival were analyzed.

Results: Overall 158 patients were enrolled. Mean age was 75.8 (±8.7) years with a baseline median PSA of 16.5 (IQR 7.4-47.8) ng/mL. The median follow-up lasted 7.7 (IQR 4-14.1) months. Of all the 10.1% of patients reported grade 3-4 adverse events. 43.7% of patients experienced a progression. Overall the 6 and 12 months PFS rates were 69.5% (95% CI: 61.7-78.3%) and the 45.6% (95% CI: 36.5-57.1%); a median baseline PSA >16 ng/mL (HR:2.0, 95% CI: 1.2-3.3, p=0.005), the use of opioid (HR:3.1, 95% CI 1.9-5.0, p<0.001), a previous treatment (abiraterone, docetaxel or abiraterone + docetaxel) were significantly associated with higher rates of cancer progression. Conversely, a brief pain questionnaire of 0-1 (HR: 0.4, 95% CI: 0.2-0.7, p<0.001), a 12 weeks 50% PSA reduction (HR: 0.4, 95% CI: 0.2-0.8, p=0.006) and a longer time to mCRPC (HR: 0.4, 95% CI: 0.3-0.7, p=0.002) were related to lower cancer progression rates.

Conclusions: Our data shows an effective and safe profile of enzalutamide in a "realworld" perspective in patients with mcRPC.
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http://dx.doi.org/10.23736/S0393-2249.20.03723-6DOI Listing
August 2020

Radical penectomy, a compromise for life: results from the PECAD study.

Transl Androl Urol 2020 Jun;9(3):1306-1313

Department of Urology, ASL 2 Abruzzo, Hospital "S. Pio da Pietrelcina", Vasto, Italy.

Background: The use of organ sparing strategies to treat penile cancer (PC) is currently supported by evidence that has indicated the safety, efficacy and benefit of this surgery. However, radical penectomy still represents up to 15-20% of primary tumor treatments in PC patients. The aim of the study was to evaluate efficacy in terms of overall survival (OS) and disease-free survival (DFS) of radical penectomy in PC patients.

Methods: Data from a retrospective multicenter study (PEnile Cancer ADherence study, PECAD Study) on PC patients treated at 13 European and American urological centers (Hospital "Sant'Andrea", Sapienza University, Roma, Italy; "G.D'Annunzio" University, Chieti and ASL 2 Abruzzo, Hospital "S. Pio da Pietrelcina", Vasto, Italy; Department of Genitourinary Oncology, Moffitt Cancer Center, Tampa, FL, USA; Hospital of Budapest, Hungary; Department of Emergency and Organ Transplantation, Urology and Andrology Unit II, University of Bari, Italy; Hospital "Spedali Civili", Brescia, Italy; Istituto Europeo di Oncologia, University of Milan, Milan, Italy; University of Modena & Reggio Emilia, Modena, Italy; Hospital Universitario La Paz, Madrid, Spain; Ceara Cancer Institute, Fortaleza, Brazil; Virginia Commonwealth University, Richmond, VA, USA; Aristotle University of Thessaloniki, Thessaloniki, Greece; Maria Skłodowska-Curie Memorial Cancer Center, Warsaw, Poland) between 2010 and 2016 were used. Medical records of patients who specifically underwent radical penectomy were reviewed to identify main clinical and pathological variables. Kaplan-Meier method was used to estimate 1- and 5-year OS and DFS.

Results: Of the entire cohort of 425 patients, 72 patients (16.9%) treated with radical penectomy were extracted and were considered for the analysis. The median age was 64.5 (IQR, 57.5-73.2) years. Of all, 41 (56.9%) patients had pT3/pT4 and 31 (43.1%) pT1/pT2. Moreover, 36 (50.0%) were classified as pN1-3 and 5 (6.9%) M1. Furthermore, 61 (84.7%) had a high grade (G2-G3) with 6 (8.3%) positive surgical margins. The 1- and 5-year OS rates were respectively 73.3% and 59.9%, while the 1- and 5-year DFS rates were respectively 67.3% and 35.1%.

Conclusions: PC is an aggressive cancer particularly in more advanced stage. Overall, more than a third of patients do not survive at 5 years and more than 60% report a disease recurrence, despite the use of a radical treatment.
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http://dx.doi.org/10.21037/tau.2020.04.04DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7354339PMC
June 2020

Validation of the 3-variable prognostic score (3-PS) in mCRPC patients treated with Radium-dichloride: a national multicenter study.

Ann Nucl Med 2020 Oct 11;34(10):772-780. Epub 2020 Jul 11.

Department of Radiological Sciences, Oncology and Anatomical Pathology, "Sapienza" University of Rome, Rome, Italy.

Objective: Radium-223 (Ra) has been approved for treatment in patients with metastatic castration-resistant prostatic cancer (mCRPC) and bone metastasis. This α-emitting radionuclide has a beneficial effect on pain and is also capable to increase overall survival (OS). Several studies evaluated the prognostic value of different biomarkers at baseline, such as serum values, imaging parameters or pain. To date, however, clinicians lack a validated and simple system to assess which patients will most likely benefit from Ra treatment. The 3-variable prognostic score (3-PS), proposed in a single-center study in 2017 classifies patients in five prognostic groups with a specific OS. This study aims to validate the 3-PS in a larger multicenter population.

Methods: Four hundred and thirty mCRPC patients treated with Ra from six different centers were analyzed. The 3-PS score consists of the collection of baseline hemoglobin, prostatic specific antigen and Eastern cooperative oncology group performance status and was initially applied to the whole population (total group). The score was then validated on the 338 patient's subgroup (clean group) obtained by subtracting the 92 patients enrolled for the original study of the 3-PS score. This purified group served as further validation evidence.

Results: Statistical analysis showed that the 3-PS score was valid on the total group as well as in the clean group as the AUC estimated (0.74) falls within the CI of the AUC calculated on the validation sample (95% CI 0.66-0.82).

Conclusion: This study confirms the validity of the 3-PS score for mCRPC patients. This score is simple, noninvasive and affordable and can be easily used to select patients that will most probably complete Ra treatment. In addition, this tool provides an exact estimate of life expectancy in terms of OS.
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http://dx.doi.org/10.1007/s12149-020-01501-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7515961PMC
October 2020

COMMENT ON: Hospital care in Departments defined as COVID-free: A proposal for a safe hospitalization protecting healthcare professionals and patients not affected by COVID-19.

Arch Ital Urol Androl 2020 06 23;92(2). Epub 2020 Jun 23.

Department of Urology, University of Verona, Azienda Ospedaliera Universitaria Integrata Verona, Verona.

The COVID-19 outbreak dramatically changed hospital everyday life, impairing the course of previous routine activity, also in urology. In the next months, together with keeping the focus on the prevention of contagion recrudescence, the health care system will face another stringent issue, i.e. to restore all the services not COVID-related. Leonardi et al. in their paper report an equilibrate overview on the incoming "Phase 2", in order to set up so-called COVID-free hospitals and departments. The authors offer an insight from a practical point of view, detailing protocols for any of the steps of the path of care, from the outpatient visit to surgery.
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http://dx.doi.org/10.4081/aiua.2020.2.80DOI Listing
June 2020

The dramatic COVID 19 outbreak in Italy is responsible of a huge drop of urological surgical activity: a multicenter observational study.

BJU Int 2021 01 19;127(1):56-63. Epub 2020 Oct 19.

Azienda Ospedaliero Universitaria Careggi, Firenze, Italy.

Objective: To describe the trend in surgical volume in urology in Italy during the coronavirus disease 2019 (COVID-19) outbreak, as a result of the abrupt reorganisation of the Italian national health system to augment care provision to symptomatic patients with COVID-19.

Methods: A total of 33 urological units with physicians affiliated to the AGILE consortium (Italian Group for Advanced Laparo-Endoscopic Surgery; www.agilegroup.it) were surveyed. Urologists were asked to report the amount of surgical elective procedures week-by-week, from the beginning of the emergency to the following month.

Results: The 33 hospitals involved in the study account overall for 22 945 beds and are distributed in 13/20 Italian regions. Before the outbreak, the involved urology units performed overall 1213 procedures/week, half of which were oncological. A month later, the number of surgeries had declined by 78%. Lombardy, the first region with positive COVID-19 cases, experienced a 94% reduction. The decrease in oncological and non-oncological surgical activity was 35.9% and 89%, respectively. The trend of the decline showed a delay of roughly 2 weeks for the other regions.

Conclusion: Italy, a country with a high fatality rate from COVID-19, experienced a sudden decline in surgical activity. This decline was inversely related to the increase in COVID-19 care, with potential harm particularly in the oncological field. The Italian experience may be helpful for future surgical pre-planning in other countries not so drastically affected by the disease to date.
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http://dx.doi.org/10.1111/bju.15149DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322984PMC
January 2021

Urology in the Time of Coronavirus: Reduced Access to Urgent and Emergent Urological Care during the Coronavirus Disease 2019 Outbreak in Italy.

Urol Int 2020 20;104(7-8):631-636. Epub 2020 May 20.

Department of Urology, University of Florence, Florence, Italy.

Purpose: The coronavirus disease 2019 (COVID-19) pandemic has put a substantial burden on the Italian healthcare system, resulting in the restructuring of hospitals to care for COVID-19 patients. However, this has likely impacted access to care for patients experiencing other conditions. We aimed to quantify the impact of COVID-19 on access to care for patients with urgent/emergent urological conditions throughout Italy.

Materials And Methods: A questionnaire was sent to 33 urological units in the AGILE consortium, asking clinicians to report on the number of urgent/emergent urological patients seen and/or undergoing surgery over a 3-week period during the peak of the COVID-19 outbreak and a reference week prior to the outbreak. ANOVA and linear regression models were used to quantify these changes.

Results: Data from 27 urological centres in Italy showed a decrease from 956 patients/week seen just prior to the outbreak to 291 patients/week seen by the end of the study period. There was a difference in the number of patients with urgent/emergent urological disease seen within/during the different weeks (all p values < 0.05). A significant decrease in the number of patients presenting with haematuria, urinary retention, urinary tract infection, scrotal pain, renal colic, or trauma and urgent/emergent cases that required surgery was reported (all p values < 0.05).

Conclusion: In Italy, during the COVID-19 outbreak there has been a decrease in patients seeking help for urgent/emergent urological conditions. Restructuring of hospitals and clinics is mandatory to cope with the COVID-19 pandemic; however, the healthcare system should continue to provide adequate levels of care also to patients with other conditions.
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http://dx.doi.org/10.1159/000508512DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7360500PMC
August 2020

A National Multicenter Study on overall survival in elderly metastatic castrate-resistant prostate cancer patients treated with Radium-223.

Aging Clin Exp Res 2020 May 1. Epub 2020 May 1.

Department of Radiological Sciences, Oncology and Anatomical Pathology Sapienza, "Sapienza" University of Rome, Rome, Italy.

Background: Radium-223 prolongs overall survival (OS) and delays time to the first symptomatic skeletal events in patients with symptomatic metastatic castration-resistant prostate cancer (mCRPC). There is a lack of evidence on the safety and efficacy of Radium-223 treatment in the very elderly population.

Aims: Aim of this multicentre study is to analyze mCRPC patients treated with Radium-223 in terms of OS and to assess whether there are differences between young and elderly, as well as to verify efficacy and safety in patients ≥ 75 years of age.

Methods: 430 mCRPC patients of six Italian Centres were analyzed in this multicenter retrospective study. At baseline and after each cycle were collected clinical and diagnostic patients' parameters. The whole cohort was divided into two groups based on the age of the patients (< 75 years old and ≥ 75 years old).

Results: 47% of the patients were < 75 years old and 53% were ≥ 75 years old. The primary outcome, OS, does not show significant differences between the two subgroups if other basal parameters are considered. Considering clinical covariates in univariate models (p < 0.05) several clinical aspects have an impact on OS, except for age (p = 0.072). Age continues to have no significant impact on the OS (p = 0.274) even in multivariate models in the two groups. The toxic effects are similar in the two groups.

Conclusions: Radium-223 prolongs survival in both younger and older patients at the same baseline condition and is a good option in the symptomatic mCRPC setting compared to other agents.
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http://dx.doi.org/10.1007/s40520-020-01573-5DOI Listing
May 2020

Operative profile, safety and functional outcomes after GreenLight laser prostate surgery: results from a 12 months follow-up multicenter Italian cohort analyses.

Minerva Urol Nefrol 2020 Oct 10;72(5):622-628. Epub 2020 Apr 10.

Department of Urology, Villa Stuart Private Hospital, Rome, Italy.

Background: Over the two past decades, GreenLight laser therapy has been considered a valid alternative for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia/benign prostatic obstruction (BPH/BPO). However, the debate on the effectiveness of laser therapy compared to conventional techniques is still open. The aim of our study is to analyze and describe the use of GreenLight laser prostate surgery in Italy, with regard to the surgical techniques performed and the surgical and functional outcomes at mid-term follow-up.

Methods: From March 2012 to July 2018, patients who underwent GreenLight laser prostate surgery for LUTS due to BPH/BPO from 19 Italian centers were included. The following parameters were evaluated in the population: age, prostate volume, prostate adenoma volume, PSA tot, Qmax at uroflowmetry (UFM), International Prostatic Symptoms Score (IPSS), previous therapy for LUTS, use of anticoagulants and antiplatelet drugs. We recorded also the kind of anesthesia, mean laser time (min), mean irradiation time (min), TURP conversion/completion rate, postoperative day of catheter removal, postoperative acute urinary retention (AUR), hospital stay, variation of hematocrit (Ht) and hemoglobin levels (Hb). Early complications were classified according to the Clavien-Dindo classification, the re-operation rate within 30 days and after 30 days, the late complications and the Patient Global Impression of Improvement were also collected. Changes over time in terms of blood loss and functional outcomes (IPSS and Qmax at the UFM at 6 and 12 months) were tested with Student's test for paired samples. We assumed P≤0.05 as level of statistical significance.

Results: Overall, 1077 were enrolled in the study, 554 (56.4%) were treated with standard vaporization and 523 (48.6%) with anatomical vaporization. Student's t-test for paired samples showed no statistically significant differences in terms of reduction of Ht preoperative vs. Ht postoperative (42.80±3.91 vs. 39.93±5.35 95% CI P=0.3) and preintervention and postintervention Hb levels (14.28±1.46 vs. 13.72 P=0.35). Compared with the preoperative Qmax (8.60±2.64), the 6- and 12-month UFM showed a significant improvement [19.56±6.29, P<0.01 and 19.99±5.92 P<0.01]. In terms of IPSS variation, compared to the baseline level (22±5.51) the 6- and 12-month follow-up confirmed a significant reduction (8.01±4.41 P<0.01 and 5.81±4.12 P<0.01 respectively). Postoperative complications were CD0, CD1, CD2, CD3, CD4 in 33.0%,35.3%, 2.9%, 0.3%, and 0.6%.

Conclusions: To the best of our knowledge, this is one of the most numerous surgical series of GreenLight laser vaporization and with the longest follow-up. This technique should be considered as a safe and effective alternative in the treatment of secondary LUTS to BPH.
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http://dx.doi.org/10.23736/S0393-2249.20.03597-3DOI Listing
October 2020

Effectiveness of a novel oral combination of D-Mannose, pomegranate extract, prebiotics and probiotics in the treatment of acute cystitis in women.

Arch Ital Urol Androl 2020 Apr 6;92(1):34-38. Epub 2020 Apr 6.

Department of Urology "Villa Stuart" Private Hospital, Rome.

Objective: Urinary tract infections (UTIs) are defined as the symptomatic presence of pathogens in the urinary tract that are typically diagnosed by microscopy and culture of urine samples. Over the long-term antibiotic courses, alternative prophylactic methods as probiotics, cranberry juices and D-mannose have been introduced for recurrence prevention. The present study aimed to determine whether a new combination of D-Mannose, Pomegranate extract, Prebiotics and Probiotics is effective in modifying symptoms reported by women with acute uncomplicated acute cystitis.

Material And Methods: This is a pilot study, performed between September 2018 and November 2018 at the Department of Urology of Villa Stuart Private Hospital. A dose of a new combination of agents was administered twice daily for 5 days and then once a day for 10 days. Together with the compound, forced hydration (> 2 liters/day) has been strongly suggested. Antibiotics were permitted only in case of clinical worsening. Changes in patients' symptoms, the therapeutic effects and changes in quality of life (QoL) were evaluated clinically and through a validated questionnaire, the Acute Cystitis Symptom Score (ACSS) at the first visit (T0), 15 (T1) and 30 (T2) days later.

Results: Thirty-three patients were enrolled in the study (mean age 38,1 ± 11.2 years) and all completed the treatment protocol. At T1 visit, all symptoms or the majority of symptoms went off in 10 women (30.3%) and at T2 in 30 women (90.9%); some symptoms still remained in 16 women (48.5%) at T1 and in 3 women (9.1%) at T2; the persistence of all symptoms or the worsening of the condition was observed in 7 patients (21.2%) at T1 and in none at T2. The mean score reported at all the ACSS sub-scales significantly decreased between baseline and T1 and T2. Typical symptoms decreased from 11.5 (10.5-12.6) to 4.9 (4.0-5.9) and to 2.7 (2.1-3.3) (p-values < 0.0001); differential symptoms decreased from 3.1 (2.6-3.6) to 0.6 (0.3-0.9) and to 0.3 (0.1-0.5) (p-values 0.009 to < 0.0001); QoL mean score also decrease from 7.2 (6.7- 7.7) to 4.0 (3.3-4.6) and to 1.7 (1.2-2.1) (p-values < 0.0001). Six patients required antibiotics and no adverse events were recorded.

Conclusions: Our study suggests that the action of the compounds, administered in this new combination, could help in an effective management of symptoms of acute cystitis in women, without antibiotics, in a wide majority of the cases. Lack of microbiological assessment is a clear limitation of the study. Moreover, lack of a control group is another important limitation. Finally, hyperhydration could have been a confounding factor in interpretation of results.
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http://dx.doi.org/10.4081/aiua.2020.1.34DOI Listing
April 2020

Primary Radical Prostatectomy or Ablative Radiotherapy as Protective Factors for Patients With mCRPC Treated With Radium-223 Dichloride: An Italian Multicenter Study.

Clin Genitourin Cancer 2020 06 16;18(3):185-191. Epub 2019 Oct 16.

Department of Radiological Sciences, Oncology and Anatomical Pathology, Sapienza University of Rome, Rome, Italy.

Background: We investigated, in a real-life setting, the prognostic relevance of previous primary treatment (radical prostatectomy [RP] or external beam radiotherapy [EBRT]) on overall survival for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra).

Materials And Methods: In the present multicenter retrospective study, we enrolled 275 consecutive patients. The demographic and clinical data and mCRPC characteristics were recorded and evaluated at baseline and at the end of treatment or progression. Ra was administered according to the current label authorization until disease progression or unacceptable toxicity. We divided the whole cohort into 2 groups: those who had undergone primary radical prostatectomy or ablative radiotherapy (RP/EBRT) and those who had not received previous primary treatment (NO).

Results: Of the 275 patients, 128 (46.5%) were alive and undergoing monitoring at the last follow-up examination, 103 (37.4%) had stopped treatment because of disease progression or the onset of comorbidities, and 147 (53.5%) had died during the study period. Of the 275 patients, 132 were in the RP/EBRT group (48%), of whom 93 had undergone RP and 76 had undergone ablative EBRT, and 143 patients were in the NO group (52%). The data showed a clear advantage for the patients in the RP/EBRT group compared with those in the NO group, with an estimated median survival of 18 versus 11 months, respectively (P < .001). The results from the multivariate analysis corroborated this trend, with a hazard ratio of 0.7 (P = .0443), confirming the better outcome for the RP/EBRT group.

Conclusions: Previous radical treatment provides a protective role for patients with mCRPC undergoing Ra treatment.
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http://dx.doi.org/10.1016/j.clgc.2019.10.009DOI Listing
June 2020

Efficacy and safety of Finasteride (5 alpha-reductase inhibitor) monotherapy in patients with benign prostatic hyperplasia: A critical review of the literature.

Arch Ital Urol Androl 2020 Jan 13;91(4):205-210. Epub 2020 Jan 13.

Department of Maternal-Child and Urological Sciences, Sapienza Rome University, Policlinico Umberto I Hospital, Rome.

Background: Combination therapy with 5 alpha-reductase inhibitor (5-ARI) and alpha-blocker can be considered as a gold standard intervention for medical management of lower urinary tract symptoms related to benign prostatic hyperplasia (LUTS/BPH). On the other hand, 5-ARI monotherapy and in particular Finasteride alone is currently getting focus of attention especially due to lack of systematic reviews investigating efficacy outcomes and/or adverse events associated.

Objectives: Aim of the present critical review was to analyze current knowledge of clinical efficacy and incidence of adverse events associated with 5-ARI treatment for LUTS/BPH.

Materials And Methods: A systematic review of clinical trials of the literature of the past 20 years was performed using database from PubMed, Cochrane Collaboration and Embase. A total of 8821 patients were included in this study and inclusion criteria for studies selection were: data from randomized clinical trials (RCTs) focusing their attention on the clinical role of Finasteride monotherapy for symptomatic BPH. Parameters of research included prostate specific antigen (PSA), prostate volume (PV), International Prostate Symptom Score (IPPS), postvoid residual urine (PVR), voiding symptoms of IPSS (voiding IPSS), maximum urinary flow rate (Qmax), and adverse events (AEs).

Results: Overall 12 original articles were included and critically evaluated. Sample sizes of patient actively treated with finasteride varied from 13 to 1524 cases analyzed in a single study. Follow-up after treatments ranged from 3 to 54 months. The effect of finasteride in reducing prostate volume (PV) was moderate (standardized mean difference (SMD) effect between 0.5 to 0.8 for all trials evaluable) while the effect on IPSS score and Qmax was considered significant (SMD in the 0.2 to 0.5 variation range). No severe AEs and/or psychiatric disorders were retrieved among the studies. Sexual health dysfunctions were significantly influenced by finasteride therapy when compared with placebo treated patients.

Conclusions: Although significant clinical benefits of finasteride monotherapy were demonstrated, the effective size of the available reports included in the analysis is limited. Additional head-to-head studies would be needed to re-evaluate clinical efficacy and safety of 5-ARI in combination or not with alpha blockers.
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http://dx.doi.org/10.4081/aiua.2019.4.205DOI Listing
January 2020

External validation of Cormio nomogram for predicting all prostate cancers and clinically significant prostate cancers.

World J Urol 2020 Oct 6;38(10):2555-2561. Epub 2020 Jan 6.

Department of Urology, Ospedale Sant'Andrea-Universitá di Roma "Sapienza", Rome, Italy.

Purpose: Recently, the Cormio et al. nomogram has been developed to predict prostate cancer (PCa) and clinically significant PCa using benign prostatic obstruction parameters. The aim of the present study was to externally validate the nomogram in a multicentric cohort.

Methods: Between 2013 and 2019, patients scheduled for ultrasound-guided prostate biopsy were prospectively enrolled at 11 Italian institutions. Demographic, clinical and histological data were collected and analysed. Discrimination and calibration of Cormio nomogram were assessed with the receiver operator characteristics (ROC) curve and calibration plots. The clinical net benefit of the nomogram was assessed with decision curve analysis. Clinically significant PCa was defined as ISUP grade group > 1.

Results: After accounting for inclusion criteria, 1377 patients were analysed. 816/1377 (59%) had cancer at final pathology (574/816, 70%, clinically significant PCa). Multivariable analysis showed age, prostate volume, DRE and post-voided residual volume as independent predictors of any PCa. Discrimination of the nomogram for cancer was 0.70 on ROC analysis. Calibration of the nomogram was excellent (p = 0.94) and the nomogram presented a net benefit in the 40-80% range of probabilities. Multivariable analysis for predictors of clinically significant PCa found age, PSA, prostate volume and DRE as independent variables. Discrimination of the nomogram was 0.73. Calibration was poor (p = 0.001) and the nomogram presented a net benefit in the 25-75% range of probabilities.

Conclusion: We confirmed that the Cormio nomogram can be used to predict the risk of PCa in patients at increased risk. Implementation of the nomogram in clinical practice will better define its role in the patient's counselling before prostate biopsy.
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http://dx.doi.org/10.1007/s00345-019-03058-1DOI Listing
October 2020

Persistence and adherence to androgen deprivation therapy in men with prostate cancer: an administrative database study.

Minerva Urol Nefrol 2020 Oct 12;72(5):615-621. Epub 2019 Dec 12.

Department of Urology, ASL Abruzzo 02, Chieti, Italy.

Background: The aim of this study was to assess adherence to and persistence with androgen deprivation therapy (ADT) in a large cohort of prostate cancer (PCa) patients selected from an administrative database, with special attention to elderly patients.

Methods: Patients treated with LHRH analogues, LHRH antagonists, the novel androgen antagonist enzalutamide, and the CYP17 inhibitor abiraterone were included spanning the years 2011-2017. Descriptive statistics were used to analyze persistence and adherence in older patients stratified by age (46-55, 56-65, 66-75, 76-85, and >85 years). The effect of persistence duration on overall survival in super-elderly patients was analyzed by the Kaplan-Meier method, together with the influence of multiple prescriptions on overall survival.

Results: A total of 1160 male patients were treated with ADT. Of these, 1075 were given LHRH analogues, 80 LHRH antagonists, 14 novel androgen antagonists, and 109 the CYP17 inhibitor. Median adherence values were 0.93, 0.97, 0.95, and 0.99 respectively. The highest persistence was recorded for LHRH analogues/antagonists (24 months), followed enzalutamide and abiraterone (8 months). A total of 107 patients (9.2%) were classified as super-elderly (age range 85-97 years). Median persistence and OS in this group were 13 months and 29 months, respectively. The adherence was 0.92. Overall survival was significantly associated with additional prescriptions for other conditions-indications (P=0.0047) but not with differences in adherence rates (P=0.98).

Conclusions: Our data showed high adherence and persistence rates in men on ADT. The overall survival in the super-elderly is not influenced by persistence and/or adherence but rather by coprescriptions.
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http://dx.doi.org/10.23736/S0393-2249.19.03595-1DOI Listing
October 2020

Role of androgen receptor expression in non-muscle-invasive bladder cancer: a systematic review and meta-analysis.

Histol Histopathol 2020 May 5;35(5):423-432. Epub 2019 Dec 5.

AGILE Group (Italian Group for Advanced Laparoscopic and Robotic Urologic Surgery), Italy.

In order to evaluate the potential prognostic/predictive role of androgen receptor (AR) expression in non-muscle-invasive bladder cancer (NMIBC), and whether it may represent a therapeutic target, we conducted a systematic search of the literature using 'androgen receptor or AR', 'testosterone', 'bladder cancer' and 'non-muscle invasive bladder cancer or NMIBC' as keywords. Eleven studies met the inclusion/exclusion criteria. No significant association was found between AR status and patients' gender (p=0.232), tumor size (p=0.975), tumor stage (p=0.237), tumor grade (p=0.444), tumor multicentricity (p=0.397), concomitant CIS (p=0.316) and progression of disease (p=0.397). On the other hand, relative lack of AR expression was significantly correlated to recurrent disease (p=0.001). Evidence for a direct correlation between AR expression and recurrence-free survival of patients with NMIBC indicate ARs as potential markers of BC behavior; moreover, the finding of a role of androgen blockade therapy in improving survival highlights the potential clinical application of this pathway, which deserves to be further explored.
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http://dx.doi.org/10.14670/HH-18-189DOI Listing
May 2020

New Antiandrogen Compounds Compared to Docetaxel for Metastatic Hormone Sensitive Prostate Cancer: Results from a Network Meta-Analysis.

J Urol 2020 04 5;203(4):751-759. Epub 2019 Nov 5.

Department of Medical, Oral and Biotechnological Sciences, G. d'Annunzio University of Chieti, Chieti, Italy.

Purpose: Docetaxel represent the standard of care in patients with metastatic, hormone sensitive prostate cancer. However, androgen receptor axis targeted therapies have also been shown to be effective. We aimed to analyze findings in randomized controlled trials investigating first-line treatment for hormone sensitive prostate cancer.

Materials And Methods: We systematically reviewed the literature according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria and the PICO (Population, Intervention, Comparator, Outcomes) methodology. Outcomes of interest were overall and progression-free survival, and the rate of high grade adverse events.

Results: No treatment was superior to docetaxel in terms of overall survival. However, abiraterone (HR 0.89, 95% CI 0.76-1.05), enzalutamide (HR 0.90, 95% CI 0.69-1.19) and apalutamide (HR 0.90, 95% CI 0.67-1.22) showed nonstatistically significant lower overall mortality rates than docetaxel. Abiraterone (HR 0.71, 95% CI 0.59-0.86), enzalutamide (HR 0.61, 95% CI 0.49-0.75) and apalutamide (HR 0.74, 95% CI 0.57-0.95) also showed statistically significant lower disease progression rates than docetaxel. Furthermore, abiraterone (OR 0.83, 95% CI 0.56-1.21) showed no statistically significant lower rate of high grade adverse events compared to docetaxel. Finally, enzalutamide (OR 0.56, 95% CI 0.35-0.92) and apalutamide (OR 0.44, 95% CI 0.24-0.79) showed statistically significant lower rates of high grade adverse events compared to docetaxel.

Conclusions: Treatment with androgen receptor axis targeted therapies combined with androgen deprivation therapy in patients with hormone sensitive prostate cancer did not offer a statistically significant advantage in overall survival compared to the standard, docetaxel. However, it was associated with a lower disease progression rate. Moreover, apalutamide and enzalutamide offer a better safety profile.
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http://dx.doi.org/10.1097/JU.0000000000000636DOI Listing
April 2020

What is the standard surgical approach to large volume BPE? Systematic review of existing randomized clinical trials.

Minerva Urol Nefrol 2020 Feb 10;72(1):22-29. Epub 2019 Oct 10.

Department of Urology, University of Florence, Florence, Italy.

Introduction: In the past years several reviews have analysed different aspects of surgical techniques for patients with LUTS due to BPE however none of them have concentrated on large prostates treatment exclusively. Moreover, none of the reviews have focused on level 1 evidence which is essential to avoid bias and wrong conclusions. With this knowledge in mind, aim of the present review is to analyze the available randomized clinical trials assessing the management of patients with big prostates (>80 cc).

Evidence Acquisition: A systematic review of the literature using the Medline, Scopus and Web of Science databases for relevant articles published until January 2019 was performed using both the Medical Subjects Heading and free test protocols. The search was conducted by combining the following terms: "Enucleation," "Prostate," "Benign Prostatic Hyperplasia," "Holmium," "laser," "adenomectomy," "Randomized clinical trial," "Big" "large" "prostate," ">80," "≥80," "transurethral resection of prostate," "Thulium," "Diode," "laparoscopy," "robotic," "Plasmakinetic," "green light" "532 nm" "YAG" "Lower Urinary tract symptoms". Only randomized clinical trials were included in the analysis.

Evidence Synthesis: Overall 9 RCTs were retrieved with most of them reporting data at 1 year. The present trials compared enucleation, vaporization and open techniques between each other. In terms of perioperative outcomes all the techniques had similar operative times and resected weight however catheterization time and hospital stay were better in endoscopic techniques when compared to open surgery. In terms of functional outcomes (IPSS, QMAX and PVR) none of the techniques was proven superior to the other. When considering complications open procedures carried a higher risk of transfusions while no technique was proven superior to the others in terms of transient urge urinary incontinence, bladder neck contracture and reintervention. Only one trial was retrieved reporting five years data confirming the safety, efficacy and durability of simple prostatectomy SP and holmium laser enucleation of the prostate at five years.

Conclusions: According to our review no technique may be considered better than the other when treating large adenomas. Studies are still lacking to prove long term efficacy and future studies should clarify the role of prostatic artery embolization and minimally invasive simple prostatectomy in the management of prostates larger than 80 mL.
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http://dx.doi.org/10.23736/S0393-2249.19.03589-6DOI Listing
February 2020

GreenLight Photoselective Vaporization of the Prostate: One Laser for Different Prostate Sizes.

J Endourol 2020 01 20;34(1):54-62. Epub 2019 Nov 20.

Department of Urology, "Villa Stuart" Private Hospital, Rome, Italy.

GreenLight laser vaporization of the prostate (photoselective vaporization of the prostate [PVP]) is a safe and effective procedure for Benign Prostatic Hyperplasia. Long-term results and advantages of PVP in patients with large and symptomatic prostate are still under evaluation. In a multicenter experience, patients who underwent standard or anatomical PVP were retrospectively reviewed. Patients with follow-up >12 months were divided into two groups based on prostate volume (<100 cc ≥100 cc). Pre- and perioperative data, as well as postoperative results and complications, were recorded after 3, 6, and 12 months and then annually. One thousand and thirty-one patients were eligible, 916 of these had a prostate volume of <100 cc and 115 ≥ 100 cc. Median follow-up period was 25.0 months (interquartile range [IQR] 16.5-35.0) and 16.0 months (IQR 12.0-24.0) in ≥100 and <100 groups, respectively. No difference was found in terms of catheterization time, postoperative stay, and postoperative acute urine retention. Patients with prostate ≥100 required longer operative time (75 55 minutes), lasing time (41.7 24.9 minutes), and higher energy used but lower energy density. Patients with prostate ≥100 had a higher incidence of early (50.4% 35.7%) and late complications (21.7% 12.8%) and early urge/incontinence symptoms (40.9% 29.3%). No statistically significant differences were found for the maximum urinary flow (Qmax) and International Prostate Symptom Score (IPSS) results between the two groups. The reintervention rate in ≥100 group was 3.5% 2.3% in <100. In the midterm follow-up, GreenLight PVP guarantees the same results in different prostate volume groups. Early and late complications are more frequent in large prostates.
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http://dx.doi.org/10.1089/end.2019.0478DOI Listing
January 2020

Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort.

World J Urol 2020 Jul 12;38(7):1757-1764. Epub 2019 Oct 12.

Department of Urology, "Regina Elena" National Cancer Institute of Rome, Via Elio Chianesi 53, 00154, Rome, Italy.

Purpose: To provide a snapshot of toxicities and oncologic outcomes of Abiraterone (AA) and Enzalutamide (EZ) in a chemo-naïve metastatic castration-resistant prostate cancer (mCPRC) population from a longitudinal real-life multicenter cohort.

Methods: We prospectively collected data on chemo-naïve mCRPC patients treated with AA or EZ. Primary outcomes were PSA response, oncologic outcomes and toxicity profile. The Kaplan-Meier method was used to compare differences in terms of progression-free survival (PFS) between AA vs EZ and high- vs low-volume disease cohorts. Univariable and multivariable Cox regression analyses were performed to identify predictors of PFS. Toxicity, PSA response rates and oncologic outcomes on second line were compared with those observed on first line.

Results: Out of 137 patients, 88 received AA, and 49 EZ. On first line, patients receiving EZ had significantly higher PSA response compared with AA (95.9% vs 67%, p < 0.001), comparable toxicity rate (10.2% vs 16.3%, p = 0.437) and PFS probabilities (p = 0.145). Baseline PSA and high-volume disease were predictors of lower PFS probabilities at univariable analysis (p = 0.027 and p = 0.007, respectively). Overall, 28 patients shifted to a second-line therapy (EZ or radiometabolic therapy). Toxicity and PSA response rates on second line were comparable to those observed on first line (11.1% vs 12.4%, p = 0.77; 73.1% vs 77.4%, p = 0.62, respectively); 2-year PFS, cancer-specific and overall survival probabilities were comparable to those displayed in first-line cohort (12.1% vs 16.2%, p = 0.07; 85.7% vs 86.4%, p = 0.98; 71% vs 80.3%, p = 0.66, respectively).

Conclusions: Toxicity profile, PSA response rate and oncological outcomes were comparable between first-line and second-line courses in patients treated with either AA or EZ for mCRPC. Our findings showed the tolerability and oncological effectiveness, when feasible, of two lines of therapy other than chemotherapy.
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http://dx.doi.org/10.1007/s00345-019-02974-6DOI Listing
July 2020

External validation of a postoperative nomogram for the prediction of disease-specific survival in patients with papillary renal cell carcinoma using a large multicenter database.

Int J Clin Oncol 2020 Jan 30;25(1):145-150. Epub 2019 Aug 30.

Department of Urology, LMU Munich, Grosshadern, Munich, Germany.

Purpose: Based on data retrieved from a comprehensive multicenter database, we externally validated a published postoperative nomogram for the prediction of disease-specific survival (DSS) in patients with papillary renal cell carcinoma (papRCC).

Methods: A multicenter database containing data of 2325 patients with surgically treated papRCC was used as validation cohort. After exclusion of patients with missing data and patients included in the development cohort, 1372 patients were included in the final analysis. DSS-probabilities according to the nomogram were calculated and compared to actual DSS-probabilities. Subsequently, calibration plots and decision curve analyses were applied.

Results: The median follow-up was 38 months (IQR 11.8-80.7). Median DSS was not reached. The c-index of the nomogram was 0.71 (95% CI 0.60-0.83). A sensitivity analysis including only patients operated after 1998 delivered a c-index of 0.84 (95% CI 0.77-0.92). Calibration plots showed slight underestimation of nomogram-predicted DSS in probability ranges below 90%: median nomogram-predicted 5-year DSS in the range below 90% was 55% (IQR 20-80), but the median actual 5-year DSS in the same group was 58% (95% CI 52-65). Decision-curve analysis showed a positive net-benefit for probability ranges between a DSS probability of 5% and 85%.

Conclusions: The nomogram performance was satisfactory for almost all DSS probabilities; hence it can be recommended for application in clinical routine and for counseling of patients with papRCC.
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http://dx.doi.org/10.1007/s10147-019-01530-xDOI Listing
January 2020