Publications by authors named "Mario Falsaperla"

28 Publications

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J Urol 2021 03 23;205(3):685. Epub 2020 Dec 23.

Unit of Urology, Spedali Civili Hospital, University of Brescia, Brescia, Italy.

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http://dx.doi.org/10.1097/JU.0000000000001417.02DOI Listing
March 2021

Holmium laser enucleation of prostate versus minimally invasive simple prostatectomy for large volume (≥ 120 ml) prostate glands: a prospective multicenter randomized study.

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

Urology Unit, Department of Medico - Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy -

Background: The aim of this study was to compare the perioperative and functional results between laparoscopic and robot-assisted simple prostatectomy (LSP and RASP) and Holmium laser enucleation of prostate (HoLEP) in prostate volumes ≥ 120 ml. The primary endpoint was to investigate and compare minimally invasive techniques in the management of large prostate gland volume, and the secondary endpoint was to evaluate the frequency and type of postoperative complications according to Clavien Dindo classification.

Methods: This multicentre study was conducted on male patients with LUTS associated with BPO candidates for surgical treatment. The surgery approach choice in relation to the prostatic volume ≥ 120 ml was HoLEP or minimally invasive simple prostatectomy (LSP or RASP). All patients were prospectively randomized into three groups, according to a simple computed randomization: HoLEP, LSP and RASP groups. During the follow-up, all patients underwent post-operative control at 1, 3, 6, 12 and 24 months from the surgical procedure.

Results: 110 male patients were randomized in three homogeneous groups: 36 in LSP, 32 in RASP and 42 in HoLEP group. During the follow-up (mean 26.15 months), despite the significant improvement compared to baseline results, no significant differences were shown, between the groups in terms of functional and perioperative outcomes. The only statistically significant data was reported for catheterization time, that resulted longer in the LSP group than RASP and HoLEP groups (p value: 0.002). Furthermore, MISP resulted in longer hospitalization, and lower rate of patients with new-onset irritative symptoms.

Conclusions: This prospective randomized study is the first to compare extraperitoneal LSP, RASP and HoLEP in the treatment of LUTS secondary to benign prostatic hyperplasia for prostate volumes ≥ 120 ml. Our findings confirm the safety and efficacy of MISP, demonstrating its equivalence in functional outcomes and perioperative morbidity in comparison to HoLEP.
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http://dx.doi.org/10.23736/S0393-2249.20.04043-6DOI Listing
November 2020

Deviation from the Protocol of a Randomized Clinical Trial Comparing On-Clamp versus Off-Clamp Laparoscopic Partial Nephrectomy (CLOCK II Laparoscopic Study): A Real-Life Analysis.

J Urol 2021 Mar 9;205(3):678-685. Epub 2020 Oct 9.

Unit of Urology, Spedali Civili Hospital, University of Brescia, Brescia, Italy.

Purpose: We assess factors/additional morbidities related to the conversion of clamping approach during off-clamp vs on-clamp laparoscopic partial nephrectomy in the setting of a randomized study.

Materials And Methods: Consecutive candidates for laparoscopic partial nephrectomy from 6 institutions were randomized to on-clamp or off-clamp surgery. The present study analyzed 1) off-clamp arm patients, comparing the procedures finalized per protocol without artery clamping (off-clamp) to those needing renal artery clamping (shift-on-clamp) and 2) on-clamp arm patients, comparing the procedures finalized with artery clamping (on-clamp) to those completed without clamping (shift-off-clamp).

Results: A total of 123 patients were randomized to on-clamp and 126 to off-clamp surgery. Of the off-clamp patients 41 (32.5%) converted to on-clamp. Of the on-clamp patients 70 (56.9%) completed surgery without clamping the renal artery due to subjective intraoperative decision of the surgeon. Tumor size was greater in shift-on-clamp vs off-clamp cases (4 vs 3, p=0.002). Conversely, tumor size (3.7 vs 3 cm, p=0.002) and R.E.N.A.L. nephrometry score (6 vs 5, p=0.038) were lower in shift-off-clamp cases. Shift-on-clamp cases had longer operative times and greater changes in estimated glomerular filtration rate on postoperative day 1. Shift-off-clamp cases had shorter operative times. A higher proportion of patients who completed on-clamp surgery per protocol had a greater than 25% drop in estimated glomerular filtration rate on postoperative day 1 (29.4%) compared to smaller changes (10.3%, p=0.009) in estimated glomerular filtration rate. Increasing tumor size and complete endophytic growth pattern predicted shift-on-clamp while preventing shift-off-clamp. Body mass index above 28 predicted shift-off-clamp.

Conclusions: The likelihood of shift-on/off-clamp relies on tumor size/complexity. The intraoperative need to convert the planned strategy seemed harmless on postoperative course. An advantage in terms of early functional outcomes does exist when avoiding artery clamping.
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http://dx.doi.org/10.1097/JU.0000000000001417DOI Listing
March 2021

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

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

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

Possible role of 5-alpha reductase inhibitors in non-invasive bladder urothelial neoplasm: multicentre study.

Minerva Urol Nefrol 2019 Dec 12. Epub 2019 Dec 12.

Urology Unit, Department of Medico- Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Latina, Italy.

Background: About 75% of urothelial bladder cancers are non-muscle invasive (NMIBC), and limited to mucosa (Ta or CIS) or sub-mucosa (T1). An increase of androgen expression and androgen receptors has a positive effect on oncogenic expression. We aimed to evaluate whether 5-alpha reductase inhibitors (5-ARI) have a role in NMIBC.

Methods: We retrospectively evaluated the clinical and pathological data of 423 patients with NMIBC who underwent transurethral bladder resection. We analysed the number of resections, number of total recurrences, time of recurrences, and histopathology details. The population was classified into two groups: treated and untreated with 5-ARIs. The enrolled patients were in treatment with 5ARIs for symptomatic prostatic hyperplasia for at least 12 months. Mean follow-up time was 30.43 months.

Results: Patients treated with 5-ARIs had a lower rate of recurrence (14%) than the untreated group (37%). There was a significant difference in the mean number of recurrences between the untreated and the treated group (p value: 0.006). Furthermore, the treated group showed a significantly greater number of low than high grade tumours, compared to the untreated group (p value ≤ 0.05). There was a significant decrease in the number of muscle invasive tumours in treated patients (p value = 0.032). The recurrence- free survival rate of patients treated with 5-ARIs was significantly higher (p value: 0.0001).

Conclusions: Long-term treatment with 5- ARIs might reduce the risk of bladder tumour recurrence, extension of lesions and increase the recurrence-free survival rate. A long-term, randomized prospective study could definitively assess the possible role of these drugs.
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http://dx.doi.org/10.23736/S0393-2249.19.03563-XDOI Listing
December 2019

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

Sexual and functional outcomes of prostate artery embolisation: A prospective long-term follow-up, large cohort study.

Int J Clin Pract 2020 Mar 10;74(3):e13454. Epub 2019 Dec 10.

Department of Medico-Surgical Biotechnologies, Department of Urology, Sapienza University of Rome, Latina, Italy.

Aim Of The Study: Among minimally invasive procedures for treating benign prostate hyperplasia (BPH) prostate artery embolisation (PAE) is described as safe and effective. Aim of this study is to report our results, focusing on sexual outcomes (erectile and ejaculatory functions sparing) of PAE in patients suffering from bladder outlet obstruction (BOO) secondary to BPH.

Methods: We prospectively enrolled and submitted to PAE subjects suffering from BOO secondary to BPH. All patients were not suitable for surgery or declined invasive approaches. All subjects were preoperatively and postoperatively (3, 6, 12 and 18 months after) evaluated by urinary flowmetry, post voiding residual volume, prostate volume, serum PSA levels, International Index of Erectile Function, International Prostate Symptom Score and QoL scores.

Results: PAE was performed in 147 patients (mean age 72.5 y.o.). PAE was technically successful in all patients. The procedure lasted a mean time of 94.3 minutes, with a mean fluoroscopic time of 42.5 minutes. Twelve months follow-up data were available for all patients, while 126 patients (85%) completed the 18 months follow up. At 12 months follow up, the mean IPSS and QoL scores significantly decreased, and all the objective parameters (mean Qmax, PVR and prostate volume) reported a significant improvement. A total of 130 patients (88.5%) at 12 months reported the antegrade ejaculation preserved, and a slight not significant improvement of IIEF scores. The 18 months after PAE outcomes confirmed the significant improvement of all the variables evaluated (even for PSA values and IIEF scores). No major complications occurred.

Conclusions: Our results evidence prostate artery embolisation as highly feasible and safe procedure with interesting outcomes. In particular, in our study PAE reported promising results in preserving antegrade ejaculation and erectile function. Our data are in line with the literature, confirming how PAE reduces obstructive symptoms in BPH patients not suitable or refusing standard surgical approaches.
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http://dx.doi.org/10.1111/ijcp.13454DOI Listing
March 2020

Hydroperitoneum: A Rare Complication Performing Endoscopic Combined Intrarenal Surgery.

J Endourol Case Rep 2016 1;2(1):55-8. Epub 2016 Mar 1.

Department of Urology, Vittorio Emanuele Hospital , Catania, Italy .

Background: Recently endoscopic combined intrarenal surgery (ECIRS) has been introduced as an innovative approach for the treatment of complex single, multiple, and staghorn urolithiasis, which reveals to be a viable alternative to standard percutaneous nephrolithotomy. Although considered to be a versatile, safe, and efficient endoscopic procedure, it is not free from complications. We would like to report two rare cases of hydroperitoneum that occurred during ECIRS and their management.

Case Presentation: Two female patients, respectively, of 75 and 41 years of age, underwent ECIRS procedure for the treatment of complex staghorn kidney urolithiasis, previously evaluated by noncontrast computed tomography (CT) scan. A combined retrograde-percutaneous access to the intrarenal collecting system, under fluoroscopic and ultrasound guidance with the additional assistance of Endovision technique, was performed. At the end of the procedures, both patients revealed a taut and globous abdomen, and a perioperative CT and ultrasonography revealed the presence of intraperitoneal liquid. Both patients were effectively treated with immediate positioning of abdominal drain with rapid improvement of the clinical presentation.

Conclusion: To our knowledge these are the first two cases of hydroperitoneum occurring during ECIRS and reported in the literature. An early detection of the complication and its prompt treatment revealed to be crucial to effectively prevent morbidity.
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http://dx.doi.org/10.1089/cren.2016.0024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4996594PMC
August 2016

Laparoscopic and robotic ureteral stenosis repair: a multi-institutional experience with a long-term follow-up.

J Robot Surg 2016 Dec 21;10(4):323-330. Epub 2016 May 21.

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

The treatment of ureteral strictures represents a challenge due to the variability of aetiology, site and extension of the stricture; it ranges from an end-to-end anastomosis or reimplantation into the bladder with a Boari flap or Psoas Hitch. Traditionally, these procedures have been done using an open access, but minimally invasive approaches have gained acceptance. The aim of this study is to evaluate the safety and feasibility and perioperative results of minimally invasive surgery for the treatment of ureteral stenosis with a long-term follow-up. Data of 62 laparoscopic (n = 36) and robotic (n = 26) treatments for ureteral stenosis in 9 Italian centers were reviewed. Patients were followed according to the referring center's protocol. Laparoscopic and robotic approaches were compared. All the procedures were completed successfully without open conversion. Average estimated blood loss in the two groups was 91.2 ± 71.9 cc for the laparoscopic and 47.2 ± 32.3 cc for the robotic, respectively (p = 0.004). Mean days of hospitalization were 5.9 ± 2.4 for the laparoscopic group and 7.6 ± 3.4 for the robotic group (p = 0.006). No differences were found in terms of operative time and post-operative complications. After a median follow-up of 27 months, the robotic group yielded 2 stenosis recurrence, instead the laparoscopic group shows no cases of recurrence (p = 0.091). Minimally invasive approach for ureteral stenosis is safe and feasible. Both robotic and pure laparoscopic approaches may offer good results in terms of perioperative outcomes, low incidence of complications and recurrence.
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http://dx.doi.org/10.1007/s11701-016-0601-0DOI Listing
December 2016

[Positive surgical margin status after minimally invasive radical prostatectomy: a multicenter study].

Urologia 2015 Oct-Dec;82(4):229-37. Epub 2015 Oct 1.

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano - Italy.

Unlabelled: UNLABELLED: The aim of our study is to evaluate the status of positive margins (PSMs) comparing their incidence between aparoscopic radical prostatectomy (LRP) and robot assisted radical prostatectomy (RARP) in centers with medium case-load (50-150 cases/year). We also analyzed the correlations between surgical technique, nerve-sparing approach (NS), and incidence of PSMs, stratifying our results by pathological stage.

Materials And Methods: We analyzed 1992 patients who underwent RP in various urologic centers. We evaluated the incidence of PSMs, and then we compared the stage-related incidence of PSMs, for both the techniques.

Results: We did not find a statistically significant difference between the two surgical modalities in the study regarding the overall incidence of PSMs.

Conclusions: In our retrospective study, we did not find any difference in terms of PSMs in RARP versus LRP. Our PSMs were not negligible, particularly in pT3 stages, compared with high-volume centers; surgical experience and patients' selection can be a possible explanation.
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http://dx.doi.org/10.5301/uro.5000125DOI Listing
April 2017

Multicenter analysis of pathological outcomes of patients eligible for active surveillance according to PRIAS criteria.

Minerva Urol Nefrol 2016 Jun 3;68(3):237-41. Epub 2015 Mar 3.

Clinica Urologica I, Universita` degli Studi di Milano, IRCCS Ca' Granda Foundation, Ospedale Maggiore Policlinic, Milan, Italy -

Background: The aim of this study was to retrospectively analyze the pathological outcomes of patients meeting the Prostate Cancer Research International Active Surveillance (PRIAS) criteria who had undergone radical prostatectomy (RP).

Methods: Out of 2014 patients recruited for minimally invasive RP between 2008 and 2014 in 7 centers, 226 (11.2%) met the modified PRIAS criteria (clinical stage T1c/T2, PSA<10 ng/mL, 1-2 positive biopsy cores and Gleason Score<6).

Results: At pathological evaluation, Gleason Score upgrade was reported in 47.3% of patients; 74 (32.7%), 10 (4.4%), 9 (3.9%) patients showed RP Gleason sum 7, 8 and 9, respectively. Upstaging was reported in 135 patients (59.7%). Twelve (5.3%) and 4 (1.7%) patients had T3a and T3b pathological stage respectively.

Conclusions: Notwithstanding the PRIAS criteria can identify some PCa patients as low-risk, at pathological evaluation some of them harbored intermediate- or high-risk disease. According to our data, patients eligible for AS should be carefully counseled about possible disease understaging.
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June 2016

Contemporary urologic minilaparoscopy: indications, techniques, and surgical outcomes in a multi-institutional European cohort.

J Endourol 2014 Aug 19;28(8):951-7. Epub 2014 May 19.

1 Department of Urology, San Luigi Gonzaga Hospital , Orbassano, Italy .

Objectives: To provide an analytical overview of contemporary indications, techniques, and outcomes of urologic minilaparoscopy (ML) in multiple European centers.

Methods: Data of patients who had undergone a minilaparoscopic urologic procedure at nine European institutions between 2009 and 2012 were retrospectively gathered. Surgical procedures were classified as upper or lower urinary tract and as ablative or extirpative and reconstructive. The main surgical outcome parameters were analyzed and relevant operative data related to the surgical technique were recorded.

Results: Overall, 192 patients (mean age 45.25±17.8 years) were included in the analysis. Most of them were nonobese (mean body mass index [BMI] 24.7±3.6 kg/m(2)) at low estimated surgical risk (mean American Society of Anesthesiologists [ASA] 1.69±0.68). Indications for surgery were mostly nononcologic (132 cases, 68.8%). Most of the procedures were done in the upper urinary tract (133 cases, 69.2%) and were mostly with a reconstructive intent (109 cases, 56.7%). Overall operative time was 132.7±52.3 minutes with an estimated blood loss of 60.9±47.6 mL while the mean hospital stay was 5±2.1 days. Most of the postoperative complications were low Clavien grade (1 and 2), with only one (0.5%) grade 3 and one (0.5%) grade 4 complications recorded.

Conclusions: A broad range of common procedures can be safely and effectively performed with ML techniques. By duplicating the principles of standard laparoscopy, but potentially offering less surgical scar and trauma, ML can be regarded as a viable option when looking for a virtually "scarless" surgery.
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http://dx.doi.org/10.1089/end.2014.0134DOI Listing
August 2014

Contemporary monopolar and bipolar transurethral resection of the prostate: prospective assessment of complications using the Clavien system.

Int Urol Nephrol 2013 Aug 31;45(4):951-9. Epub 2013 May 31.

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

Purpose: A modified version of the Clavien system has been recently suggested to allow a standardized assessment of complications associated with transurethral resection of the prostate (TURP). Aim of this multicentre study was to validate the use of this assessment tool in a contemporary cohort of patients undergoing monopolar or bipolar TURP.

Methods: Consecutive patients undergoing TURP in five Italian institutions from April 2011 to March 2012 were prospectively included in this study. Complications occurring within first postoperative month were recorded and graded according to the modified Clavien system. Univariate and binary logistic regression analysis were used for statistical analysis.

Results: Two hundred and ninety-five patients were included in the study. Overall, 47 complications were recorded in 44 patients. There was no difference in terms of postoperative complications between those who underwent monopolar TURP (27 pts; 9.2 %) versus those who underwent bipolar TURP (17 pts; 5.2 %, p = 0.142). Overall perioperative morbidity rate was 15.5 %. Most of the complications were Clavien type I (37 cases; 78 %) and II (6 cases; 12 %). High-grade complications were few as follows: Clavien type IIIb in two cases (4 %) and IV in two cases (4 %). No TURP-related deaths were reported. In the monopolar TURP group, a longer-operative time (OR 1.024; 95 % CI 1.007-1.040, p = 0.004) is an independent predictors of postoperative complications.

Conclusions: A modified Clavien system can be considered a practical and easily applicable tool in grading postoperative complications in patients undergoing TURP. Our findings confirm that TURP is a safe procedure associated with minimal perioperative morbidity.
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http://dx.doi.org/10.1007/s11255-013-0476-1DOI Listing
August 2013

A complex renal cyst: it is time to call the oncologist?

Int J Nephrol 2011 10;2011:893985. Epub 2011 May 10.

Departments of Nephrology, Dialysis, Urology, and Radiology, AOU "Policlinico-Vittorio Emanuele", Catania, Italy.

Introduction. Hydatid disease is a cyclozoonotic parasitic infestation caused by the cestode Echinococcus granulosus. The cysts mainly arise in the liver (50 to 70%) or lung (20 to 30%), but any other organ can be involved, in abdominal and pelvic locations, as well as in other less common sites, which may make both diagnosis and treatment more complex. Isolated renal involvement is extremely rare. Case Presentation. We report a rare case of isolated renal hydatid disease in a 71-year-old man with a history of vague abdominal pain, anemia, fever, and microhematuria. Ultrasonographic examination revealed a complex cyst in the right kidney, including multiple smaller cysts with internal echoes. A magnetic resonance scan of the abdomen confirmed the findings, and hydatid cyst disease was diagnosed. Right nephrectomy was performed, and microscopic examination confirmed the diagnosis of hydatid cyst. Albendazole, 10 mg/kg per day, was given for 4 weeks (2 weeks preoperatively and 2 weeks postoperatively). Conclusion. Isolated primary hydatidosis of the kidney should always be considered in the differential diagnosis of any cystic renal mass, even in the absence of accompanying involvement of liver or other visceral organs.
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http://dx.doi.org/10.4061/2011/893985DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3108175PMC
July 2011

Differential role of CD133 and CXCR4 in renal cell carcinoma.

Cell Cycle 2010 Nov;9(22):4492-4500

Department of Oncological Immunology, S Pio da Pietrelcina Hospital Vasto, Italy.

The chemokine receptor CXCR4 and CD133, putative stem cell markers, were previously described in renal cancer (RCC). To evaluate the biological and prognostic role of CD133 and CXCR4 in RCC the expression was evaluated through qPCR and immunoblotting in human renal cancer cell lines (786-O, A498, ACHN, CAKI-1, SN12C, TK10, UO31) and patients biopsies. Renal cancer cells and surgical biopsies expressed functional CXCR4 while CD133 was not detectable. CXCR4 and CD133 expression was then evaluated in 240 renal cancer patients through immunohistochemistry. CXCR4 and CD133 were low in 19.1% and 59.6%; intermediate in 20% and 17.9%; high in 60.8% and 22.5% of the cases, respectively. CXCR4 was overexpressed in tumours (p= 0.02), while CD133 was over expressed in healthy tissues (p= 0.04). Disease free survival Kaplan Meier plots suggest that prognosis is unfavourable for patients whose primary tumours express CXCR4 (p= 0.0199) but nor CD133 (p= 0.151) neither the concomitant CXCR4-CD133 (p=0.848) high expression affected prognosis. Analysis of prognostic factors suggests that age, clinical presentation, AJCC stage and CXCR4 had a significant prognostic value at the univariate analysis. The CXCR4 predictive ability was confirmed at the multivariate analysis while no prognostic role was identified for CD133.Thus concomitant CD133 and CXCR4 evaluation is not worth in RCC patient while the CXCR4 prognostic role encourage CXCR4 antagonists as promising therapeutic option.
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http://dx.doi.org/10.4161/cc.9.22.13680DOI Listing
November 2010

A 1-year maintenance after early adjuvant intravesical chemotherapy has a limited efficacy in preventing recurrence of intermediate risk non-muscle-invasive bladder cancer.

BJU Int 2010 Jul 11;106(2):212-7. Epub 2010 Jan 11.

Institute of Urology, University of Palermo, Palermo, Italy.

Objective: To evaluate the efficacy of 1-year maintenance after a 6-week cycle of early intravesical chemotherapy, as the role of maintenance in intravesical chemotherapy is debated.

Patients And Methods: Between May 2002 and August 2003, 577 patients with non-muscle-invasive bladder cancer (NMI-BC) underwent transurethral resection (TUR) and early intravesical chemotherapy (epirubicin, 80 mg/50 mL). They were randomized between a 6-week induction cycle and the induction cycle plus maintenance with 10 monthly instillations. In all, 95 patients with T1G3, Tis or single and primary Ta-T1 G1-G2 tumours were excluded; 482 patients at intermediate risk of recurrence continued the study. All patients had cytology and cystoscopy at 3-monthly intervals for the first 2-years and 6-monthly thereafter.

Results: The tumours' characteristics were equally distributed between the two arms. Treatment interruption for toxicity was required in 39 patients. One death due to toxicity of early instillation occurred. The median follow-up was 48 months. Ten patients (2.5%) progressed and 117 patients (29.6%) recurred. No statistically significant difference in the recurrence-free rate (RFS) was detected between the two arms (P = 0.43). An advantage in favour of the maintenance arm was evident only at 18 months after TUR (P = 0.03). A trend for a higher benefit from maintenance in primary and multiple tumours was detected.

Conclusions: In patients with intermediate risk NMI-BC treated by TUR and early adjuvant chemotherapy, adding a maintenance regimen with monthly instillations for 1 year is of limited efficacy in preventing recurrence.
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http://dx.doi.org/10.1111/j.1464-410X.2009.09153.xDOI Listing
July 2010

Oral chemotherapy in hormone-refractory prostate carcinoma patients unwilling to be admitted to hospital.

Urol Int 2009 8;83(4):452-7. Epub 2009 Dec 8.

Department of Urology, University of Palermo, Palermo, Italy.

Objectives: To investigate the safety and efficacy in terms of PSA response of a low-dose oral combination of estramustine phosphate (EMP) and etoposide (VP16) in hormone- refractory prostate cancer (HRPC) patients. Well-tolerated outpatient chemotherapy regimens for patients unfit and/or unwilling to be admitted to hospital are needed.

Methods: Fifty-six HRPC patients with metastatic disease (median age 75 years) were randomized between arm A (daily oral EMP 10 mg/kg, in 3 doses) and arm B (28-day cycle with low-dose EMP 3 mg/kg once daily plus VP16 25 mg/m(2) once daily on days 1 through 14). Baseline characteristics between the two groups were similar. LHRH therapy was maintained. Anti- androgen was stopped 1 month before entry.

Results: The low-dose combination was better tolerated, with a significant advantage in terms of time to treatment interruption for any reason (p = 0.01) or toxicity (6 vs. 12 months, p = 0.02). A trend in favour of arm B was evident in terms of PSA reduction (41.4 vs. 15%), performance status and pain improvement. Hospital admission due to toxicity was never required for arm B patients and there were no treatment-related deaths.

Conclusions: Low-dose oral combination of EMP and VP16 might represent a treatment option for patients unfit for i.v. chemotherapy. This regimen requires minimal toxicity monitoring when administered at home for prolonged periods.
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http://dx.doi.org/10.1159/000251187DOI Listing
May 2010

NeuroD1 expression in human prostate cancer: can it contribute to neuroendocrine differentiation comprehension?

Eur Urol 2007 Nov 20;52(5):1365-73. Epub 2006 Nov 20.

Urology Unit, "G. Rummo" Hospital, Benevento, Italy.

Objectives: Neuroendocrine differentiation is a common feature of prostate cancer (pCA). NeuroD1 is a neuronal transcription factor able to convert epithelial cells into neurons. The aim of the study is to investigate NeuroD1 expression and compare it with chromogranin-A, synaptophysin, and CD56 staining in human prostate cell lines and surgical specimens.

Methods: We detected NeuroD1 gene expression, by duplex reverse transcriptase-polymerase chain reaction, in primary human prostate fibroblasts, in EPN, LNCaP, DU145, and PC3 cell lines before and after cAMP exposure, in 6 BPH and 11 pCA samples. Thereafter 166 paraffin sections from normal and neoplastic prostates were stained with NeuroD1, chromogranin-A, synaptophysin, and CD56 antibodies. The relationships between chromogranin-A and NeuroD1 and clinicopathologic parameters were evaluated by multivariate logistic regression analysis.

Results: NeuroD1 is inactive in baseline prostate cell lines and BPHs, whereas it is actively expressed in cAMP-treated EPN, PC3, and DU145 cells. In our surgical series, positive chromogranin-A, synaptophysin, CD56, and NeuroD1 staining was detected in 26.5%, 4.3%, 3.1%, and 35.5%, respectively (difference between chromogranin-A and NeuroD1: p<0.05). The multivariate analysis showed a strong association between chromogranin-A and microscopic perineural invasion (OR: 2.49; 95%CI, 0.85-7.32; p=0.097) and a high primary Gleason score (OR: 1.96; 95%CI, 1.14-3.39; p=0.015), whereas NeuroD1 expression strictly correlated to microscopic perineural invasion (OR: 2.97; 95%CI, 1.05-8.41; p=0.04).

Conclusions: Expression of NeuroD1 versus chromogranin-A is more frequent in pCA, and correlates to increased indicators of malignancy in moderately to poorly differentiated pCA, and could be involved in the pathophysiology of the neuroendocrine differentiation of pCA.
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http://dx.doi.org/10.1016/j.eururo.2006.11.030DOI Listing
November 2007

Percutaneous lumbar sympathectomy in the treatment of erectile dysfunction secondary to cavernous adrenergic hypertone: initial results of an original technique.

Arch Ital Urol Androl 2005 Mar;77(1):5-9

Department of Urology, Vittorio Emanuele Hospital, University of Catania, Italy.

Corporeal smooth muscle tone is regulated by a delicate balance between contraction and erectile smooth muscle. An abnormal balance in basal conditions, due to an augmented contraction of erectile smooth muscle, defined "dysfunctional antagonism", may be responsible of a particular condition of erectile dysfunction (ED), secondary to cavernous adrenergic hypertone (CAY). In order to investigate the possibility to treat CAY with a definitive inhibition of adrenergic innervation to corpora cavernosa, we evaluated the results of an original technique of percutaneous lumbar sympathectomy (PLS) in a group of patients with clinical signs and symptoms of CAY In our study, 14 patients were selected and treated with PLS. Pre-treatment evaluation was designed to identify patients with ED caused by CAY, eligible for surgical treatment, and consisted of medical history, the self administered International Index of Erectile Function and Doppler sonography evaluation of cavernous arteries. Were considered eligible to the surgical treatment the patients with normal PSV values and abnormal EDV values after first injection of alprostadil, but reduced to zero after redosing with alprostadil and phentolamine. All these patients were treated with percutaneous bilateral lumbar ganglionic block with mepivacaine and, at a successive time, phenol 4% and evaluated after I and 4 months. Each evaluation consisted of a self-administered IIEF questionnaire, physical examination and Doppler sonography evaluation. Among the 14 patients selected and treated with temporary block with mepivacaine, 3 reported significant adverse events, consisting of loss of ejaculation (2 patients) and severe lumbar pain (1 patient). In all the other patients treated, only mild to moderate lumbar pain was reported. 10 patients out of the 14 treated with mepivacaine accepted to undergo the successive step of ganglionic block with phenol. Nine patients reported improved erections at both visits, as assessed by the GEQ. Moreover, the analysis of responses to IIEF questions 2-3 showed a highly significant improvement in erectile function compared to scores at baseline. Doppler sonography showed normal flow parameters at both visits in 8 patients. No significant adverse events were recorded after the procedures, except for mild to moderate lumbar pain. Clinical data collected in this study seem to confirm chemical sympathesctomy as a reliable, effective and safe therapeutic option in ED secondary to CAY.
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March 2005

Support ellagic acid therapy in patients with hormone refractory prostate cancer (HRPC) on standard chemotherapy using vinorelbine and estramustine phosphate.

Eur Urol 2005 Apr 19;47(4):449-54; discussion 454-5. Epub 2005 Jan 19.

Operative Unit of Urology, Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture, Potenza, Italy.

Background: Recent phase III studies in hormone refractory prostate cancer (HRPC) showed an improvement in terms of overall survival (OS), objective response (OR) and biochemical response (BR); however, chemotherapy is usually accompanied by negative side effects that determines poor quality of life (QoL) and only marginally improves individual clinical response (ICR) in terms of pain relief and performance status. Ellagic acid is a polyphenol that is found in many species of flowering plants. It is an antioxidant that determines apoptosis, down regulation of IGF-II, activates p21 (waf1/Cip1), mediates the cumulative effect on G1/S transition phase and prevents destruction of p-53 gene by cancer cells.

Endpoints: The aim of this study was to assess the effects of ellagic acid support therapy on toxicity, OR, ICR and BR in HRPC patients treated with estramustine phosphate and vinorelbine.

Materials And Methods: Patients with HRPC were randomly distributed in two study groups: a control group (group A) who underwent chemotherapy with vinorelbine and estramustine phosphate, and an experimental group (group B) where chemotherapy regimen was associated with ellagic acid.

Results: The mean number of chemotherapy cycles/patient was 4 (range 3-8 cycles) and 6.5 (range 5-11) in group A and B patients, respectively. A reduction in systemic toxicity, statistically significant for neutropenia, associated with better results in term of OR rate, ICR, and BR were observed in group B compared with group A. On the contrary no significant difference in OS and PFS was detected between groups.

Conclusions: our study suggests that the use of ellagic acid as support therapy reduces chemotherapy induced toxicity, in particular neutropenia, in HRCP patients; however, further studies are required to confirm our results.
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http://dx.doi.org/10.1016/j.eururo.2004.12.001DOI Listing
April 2005

Matrix metalloproteinases as diagnostic (MMP-13) and prognostic (MMP-2, MMP-9) markers of prostate cancer.

Urol Res 2005 Feb 22;33(1):44-50. Epub 2004 Oct 22.

Department of Urology, University of Sassari, Italy.

Previous studies have detected high levels of matrix metalloproteinases (MMPs) in metastatic prostate cancer. In this study, we recruited 40 patients with prostate cancer (PCa): 20 presented organ-confined carcinoma and 20 had metastatic cancer. We also recruited 40 subjects for control groups, 20 with benign prostate hyperplasia (BPH) and 20 healthy males with similar characteristics. All of the patients were monitored at the beginning (time 0) and after 90 days. We analyzed the plasma concentrations of MMP-2, MMP-9, MMP-13, TIMP-1 and the enzyme activity of MMP-2 and MMP-9,using specific ELISA tests. The plasma concentrations of MMP-2, MMP-9 and MMP-13 were higher in PCa patients with metastasis than in the other groups, and in these patients decreased markedly after therapy began. For MMP-2 and MMP-9, greater differences were observed in enzyme activity than in plasma concentrations. TIMP-1 was reduced in PCa patients with metastasis, even if the intergroup differences were not statistically significant. Our results suggest that the plasma concentration and activity of MMPs, in association with PSA determination, could play a role in diagnosis, monitoring therapy and evaluating malignant progression in PCa.
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http://dx.doi.org/10.1007/s00240-004-0440-8DOI Listing
February 2005

Involvement of HSP70 in resveratrol-induced apoptosis of human prostate cancer.

Anticancer Res 2003 Nov-Dec;23(6C):4921-6

Department of Physiological Sciences, University of Catania, Viale Andrea Doria 6, 95125 Catania, Italy.

Background: 70 KDa heat shock proteins (HSPs70), either as a constitutive or inducible form, are expressed at very high levels in malignant human tumors of various origin. In different cell types, they are known to play an antiapoptotic role. Resveratrol (3,5,4'-trihydroxy-trans-stilbene), a polyphenol present in red wine, grapes and other dietary and medicinal plants, has been shown to be active in inhibiting multistage carcinogenesis, inducing apoptotic cell death.

Materials And Methods: With the present study, a possible relationship between HSP70 expression and cell death elicited by resveratrol in DU-145 cells, which mimic the late hormone-refractory stages of prostate carcinoma, was investigated. To this end, we treated DU-145 with different concentrations. (50, 100 and 200 microM) of resveratrol and cell viability, by tetrazolium salts assay (MTT) and membrane breakdown, by lactic dehydrogenase (LDH) release, were measured. The possible induction of oxidative stress was evidenced both by performing a fluorescent analysis of intracellular reactive oxygen species (ROS) production, or evaluating the amount of nitrite/nitrate (NO) in culture medium. In addition, the expression of HSP70 level, evaluated by immunoblotting, was examined and compared with caspase-3 activity (fluorimetrically measured) and DNA damage, determined by Single Cell Gel Electrophoresis or COMET assay.

Results: Our data clearly indicate that the addition of resveratrol to DU-145 reduces cell viability and increases membrane breakdown, in a dose-dependent way, without interfering with ROS production or NO synthesis, unless 200 microM resveratrol was added. Furthermore, at low concentration (50-100 microM) resveratrol is able to raise HSP70 levels but, at high concentration (200 microM), the measured levels of protective HSP70 were unmodified with respect to that of the control values.

Conclusion: Our results confirm the ability of resveratrol to suppress the proliferation of human prostate cancer cells with a typical apoptotic feature, interfering with the expression of HSPs70.
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April 2004