MRI/real-time ultrasound image fusion guided high-intensity focused ultrasound: a prospective comparative and functional analysis of different ablative techniques.

BACKGROUND: The aim of this paper was to compare safety and functional outcomes of total, hemi and focal ablation by the latest focal high-intensity focused ultrasound (HIFU) device. METHODS: This is a prospective study including patients with low to intermediate-risk PCa treated with HIFU by Focal One® device from 11/2018 to 3/2020. Before the treatment all patients underwent mp-magnetic resonance imaging (MRI) and subsequent MRI/transrectal ultrasound (TRUS) fusion and standard biopsy. Patients were stratified according to the type of ablation: total, hemi- or focal ablation. Functional data (IPSS, Quality of Life [QoL], IIEF-5, maximum flow [Qmax] and post void residual [PVR] at flowmetry) were assessed preoperatively and at 1, 3, 6 and 12 months after treatment. Moreover, the urinary symptoms reported by patients at IPSS questionnaire were divided in "irritative" and "obstructive" and compared. RESULTS: One hundred patients were enrolled. Median prostate volume and lesion diameter were 46 (IQR 25-75) mL and 10 (IQR 6-13) mm. 15, 50 and 35 patients underwent total, hemi- and focal ablation, respectively. No differences were found between them except for operative time (lower in the focal group, P<0.01). Significant lower incidence of irritative symptoms was identified in the focal group compared to the others (P<0.05 at 1 and 3 months of follow-up). No differences were found among the baseline status and the postoperative assessment in terms of obstructive IPSS items, IIEF-5, QoL, Qmax and PVR (all P value>0.05). CONCLUSIONS: Our study suggests that patients' specific HIFU tailoring with the MRI/real-time TRUS Guidance by Focal One® device is able to minimize the side effects of treatment.

The real-time intraoperative guidance of the new HIFU Focal-One® platform allows to minimize the perioperative adverse events in salvage setting.

PURPOSE: To assess the use of the new Focal-One® HIFU platform in salvage setting to evaluate the occurrence of postoperative complications. METHODS: Patients who underwent salvage HIFU (sHIFU) with Focal-One® platform were enrolled prospectively (Candiolo cancer institute-FPO IRCCS; registry number: 258/2018). Perioperative and postoperative outcomes (in terms of oncological and functional ones) were recorded during the first year of follow-up. In particular postoperative complications were classified according to Clavien-Dindo system. RESULTS: 20 patients were enrolled. No grade 3 complications were recorded. Referring to grade 2 complications, eight patients reported urgency after 3 months of follow-up, and in 4 cases, a low urinary tract infection occurred. Evaluating the impact of sHIFU on patients' sexual potency, micturition and quality of life, no significant deterioration was recorded during the follow-up as proven using the ANOVA analysis for repeated measurements. Only two patient had a biochemical failure after 12 months of follow-up. CONCLUSIONS: The real-time intraoperative guidance with Focal-One® platform, allows a continuous monitoring and tailoring of the treatment, with a minimization of the adverse events even in a salvage setting.

Beyond the Learning Curve of Prostate MRI/TRUS Target Fusion Biopsy after More than 1000 Procedures.

OBJECTIVE: To evaluate the learning curve (LC) of two urology residents in the execution of fusion biopsy (FB) in terms of overall prostate cancer (PCa) and clinically significant (cs) PCa detection rate (DR) and according to different characteristics of the lesions on MRI MATERIAL AND METHODS: We analyzed data from our prospective maintained FB database between January 2015 and December 2019. FB was performed using the BioJet fusion system (D&K Technologies, Barum, Germany) with a transrectal or transperineal approach. An ANOVA test was used to evaluate the homogeneity of our cohort. Multivariable linear and logistic regression analysis were used to evaluate the relationship between operator experience and DR for PCa and csPCa. Then, the postprocedural complication rate trend was evaluated. RESULTS: 1005 patients were included. The overall DR of PCa was 61.2% (615/1005) [IC 0.58 - 0.64]; whilst DR for csPCA was 54.6% (549/1005) [IC 0.51 - 0.57]. Operator experience does not seem to influence the DR of overall PCa and csPCa; whilst for lesions <8 mm in diameter, PCa and csPCa DR increased significantly with operator experience (P = 0.048 and P = 0.038, respectively). Postprocedural complications remained stable during the whole study period (P = 0.75). CONCLUSION: A standardized FB approach turned out to be feasible, safe, and effective since the beginning of the residents' LC. PCa and csPCa DR remained stable, at 60% and 55% respectively, after more than 1,000 biopsies. However, for lesions smaller than 8 mm, at least 100 FB of experience is needed to correctly sample the area.

Prospective evaluation of urinary steroids and prostate carcinoma-induced deviation: preliminary results.

BACKGROUND: The serum prostate-specific antigen is the most widespread biomarker for prostate disease. Its low specificity for prostatic malignancies is a matter of concern and the reason why new biomarkers for screening purposes are needed. The correlation between altered production of the main steroids and prostate carcinoma (PCa) occurrence is historically known. The purpose of this study is to evaluate the modifications of a comprehensive urinary endogenous steroidal profile (USP) induced by PCa, by multivariate statistical methods. METHODS: A total of 283 Italian subjects were included in the study, 139 controls and 144 PCa-affected patients. The USP, including 17 steroids and five urinary steroidal ratios, was quantitatively evaluated using gas chromatography coupled with single quadrupole mass spectrometry (GC-MS). The data were interpreted using a chemometric, multivariate approach (intrinsically more sensible to alterations with respect to traditional statistics) and a model for the discrimination of cancer-affected profiles was built. RESULTS: Two multivariate classification models were calculated, the former including three steroids with the highest statistical significance (e.g. testosterone, etiocholanolone and 7ß-OH-DHEA) and PSA values, the latter considering the three steroids' levels only. Both models yielded high sensitivity and specificity scores near to 70%, resulting significantly higher than PSA alone. CONCLUSIONS: Three USP steroids resulted significantly altered in our PCa population. These preliminary results, combined with the simplicity and low-cost of the analysis, open to further investigation of the potential role of this restricted USP in PCa diagnosis.

Risk of Gleason Score 3+4=7 prostate cancer upgrading at radical prostatectomy is significantly reduced by targeted versus standard biopsy.

BACKGROUND: The aim of this study is to evaluate if multiparametric magnetic resonance (mpMRI)-transrectal ultrasound (TRUS) fusion targeted biopsy (TBx) versus untargeted standard biopsy (SBx) may decrease the rate of pathological upgrading of Gleason Score (GS) 3+4 prostate cancer (PCa) at radical prostatectomy (RP). We also evaluated the impact of percent pattern 4 and cribriform glands at biopsy in the risk of GS 3+4=7 upgrading. METHODS: A total of 301 patients with GS 3+4 PCa on biopsy (159 SBx and 142 TBx) who underwent laparoscopic robot-assisted RP were sequentially enrolled. Histological data from RP sections were used as reference standard. The concordance of biopsy with pathological GS, as well as the GS 3+4 upgrading at RP were evaluated in different univariate and multivariate binary logistic regression models, testing age, PSA, fPSA%, tumor volume, PI-RADS, clinical stage, percentage of Gleason pattern 4 (GP) and/or presence of cribriform sub-type at biopsy. RESULTS: Of the 301 biopsies, the median of GP 4 was 16% of the tissue. Minimal GP 4 (≤16%) cancers had a significant lower median volume (1.7 mL) than those with GP4 >16% (2.9 mL), (P<0.001). Pathological GS 3+4 was confirmed for 58.8% and 82.2% for SBx and TBx patients, respectively. The rate of upgraded and downgraded GS on SBx versus TBx was 38.8% vis. 16.7% and 1.8% and 2.1%, respectively. The rate of upgrading was significantly associated with the presence of GP4 >16% versus ≤16% (OR 4.4, 95% CI 1.4-12.0; P=0.021) and with the presence of cribriform sub-type at biopsy specimens (OR 6.2, 95% CI 2.2-18.7; P<0.001). CONCLUSIONS: We demonstrated that TBx technique significantly reduced the risk of GS 3+4 upgrading at RP, compared to SBx one. The rate of upgrading was significantly associated with GP4>16%, mostly when cribriform sub-type was present at biopsy specimens.

Laparoscopic simple prostatectomy: complications and functional results after five years of follow-up.

BACKGROUND: The aim of this study was to investigate complications and functional results in a cohort of patients who underwent extraperitoneoscopic transcapsular laparoscopic simple prostatectomy (LSP) for large prostate adenomas with a minimum follow-up of 5 years. METHODS: We retrospectively reviewed data obtained from our prospectively maintained database of patients treated with LSP at our institution between January 2004 and June 2012, with at least 5 years of reported follow-up data. Demographics, perioperative results, early and late complications, and functional results were evaluated. The various impacts of the independent variables on the development of complications was evaluated performing logistic regression models. Follow-up was planned at 1, 3, 6 and 12 months, then yearly up to a minimum of 5 years. RESULTS: One-hundred patients were included in our analysis. Median follow-up was 135 (IQR 24) months (11 years and 3 months). Grade III complications were recorded in 2 cases. Five cases of late postoperative complications were recorded. Logistic regression models showed a statistically significant correlation between the adenoma volume and the risk of developing early postoperative complications (OR 1.014). International Prostate Symptom Score (I-PSS), I-PSS quality of life (QoL) index, and maximum urine flow (Qmax) significantly improved when comparing preoperative and postoperative results. No significant differences were recorded in the I-PSS and I-PSS QoL index during follow-up. A low but significant worsening in Qmax was observed starting the 48th month after surgery. CONCLUSIONS: The present findings confirm that LSP carries a low rate of early and late complications, and it offers good functional outcomes at 5 years.

Total anatomical reconstruction during robot-assisted radical prostatectomy in patients with previous prostate surgery.

BACKGROUND: In the literature there are conflicting conclusions for radical prostatectomy (RP) after previous surgery for benign prostatic hyperplasia (BPH). The advent of robot-assisted radical prostatectomy (RARP) has allowed technical advances in preservation and reconstruction of the anatomical structures. Despite the robotic approach, the discordant oncological and functional results between different series did not permit final conclusions. METHODS: In our Department, starting from June 2013, we performed a total anatomical reconstruction (TAR) technique during robot-assisted RP for early recovery of urinary continence. We have retrospectively reviewed all the patients who underwent RARP with TAR procedure with a previous history of prostate surgery for BPH from June 2013 to April 2017 at our Department with a minimum follow-up period of 12 months. All the procedures considered were performed by a single surgeon (F.P.). Preoperative, intraoperative events, complications and functional and oncological results have all been collected. We found 40 patients with previous BPH surgery with adequate preoperative information and postoperative follow-up. RESULTS: RARP was performed successfully in all patients without need for open conversion. No major intraoperative complications were encountered. In no cases blood transfusion was needed. All the complications recorded are Clavien grade I (20%). Continence rate at one, four, 12, 24, and 52 weeks from catheter removal was 77.5%, 82.5%, 90%, 92.5%, and 95%, respectively. CONCLUSIONS: In our experience patients with prostate cancer and a previous surgery for BPH should be managed as naïve patients. RARP is a safe and feasible procedure with no major risks of complications, provided that it is performed by a skilled robotic surgeon.

Total anatomical reconstruction during robot-assisted radical prostatectomy: focus on urinary continence recovery and related complications after 1000 procedures.

OBJECTIVES: To present the functional and oncological outcomes after ≥1 year of follow-up, following an experience of >1000 robot-assisted radical prostatectomies (RARPs) with our standardised total anatomical reconstruction (TAR) technique. To evaluate which factors influence postoperative continence recovery in order to obtain a nomogram to predict the risk of postoperative urinary incontinence (UI). PATIENTS AND METHODS: The enrolment phase began in June 2013 and ended in May 2017. Patients were prospectively included in the study with the following inclusion criteria: (i) localised prostate cancer (clinical stages cT1-3, cN0, cM0); (ii) indication for RP; and (iii) preoperative multiparametric prostate magnetic resonance imaging. All patients underwent RARP with the TAR technique done at the end of the demolitive phase. The continence rates were assessed at 24 h, and 1, 4, 12, 24 and 48 weeks after catheter removal. Patients were defined as continent if they answered 'zero pad' or 'one safety pad' per day. A logistic regression model was used to evaluate the potential impact of some pre- and intraoperative factors on postoperative urinary continence recovery. Model discrimination was assessed using an area under (AUC) the receiver operating characteristic (ROC) curve. A nomogram to predict the risk of postoperative UI after RARP with the TAR technique was generated based on the logistic model. RESULTS: In all, 1008 patients were enrolled in our study. At 24 h, and 1, 4, 12, 24 and 48 weeks after catheter removal, 621 (61.61%), 594 (58.93%), 803 (79.66%), 912 (90.48%), 950 (94.25%) and 956 (94.84%) patients were continent, respectively. In the logistic regression model, the variables analysed had a higher impact on continence recovery at 4 and 12 weeks. At 4 weeks, the postoperative odds of urinary continence recovery increased with the absence of diabetes [odds ratio (OR) 2.76, 95% confidence interval (CI) 1.41-5.41] and D'Amico low vs high risk (OR 2.01, 95% CI 1.01-3.99). At 12 weeks, urinary continence increased with the absence of diabetes (OR 3.01, 95% CI 1.23-7.35), D'Amico low vs high risk (OR 4.04, 95% CI 1.56-10.47), and D'Amico intermediate vs high risk (OR 3.33, 95% CI 1.66-6.70). ROC curves were drawn and an AUC value of 61.9% (95% CI 57.49-66.36) at 4 weeks and 63.8% (95% CI 58.03-69.65) at 12 weeks were computed. Based on these parameters, two nomograms (at 4 and 12 weeks postoperatively) were generated. CONCLUSION: The TAR technique conferred excellent results in the early recovery of urinary continence. Two nomograms were created, to predict preoperatively the postoperative odds of urinary continence recovery at 4 and 12 weeks after RARP by integrating the presence of diabetes and D'Amico risk classification.

The role of side-specific biopsy and dominant tumor location at radical prostatectomy in predicting the side of nodal metastases in organ confined prostate cancer: is lymphatic spread really unpredictable?

BACKGROUND: The aim of this study was to evaluate the correlation between the location of prostate cancer (PCa) either at biopsy or at radical prostatectomy (RP) specimens and the side of positive lymph nodes (LNs). Furthermore, we assessed the risk of contralateral LN metastasis (LNMs) in patients with unilateral positive biopsy and/or dominant lesion at RP. METHODS: We reviewed retrospectively our prospectively maintained database of patients with LNM treated with robot-assisted RP and bilateral robot-assisted extended pelvic lymph node dissection (EPLND) for PCa from January 2014 to May 2018 at a surgical high-volume center. All men with a suspicion for PCa underwent a 12-cores prostate biopsy. In case of a first negative biopsy but the persistence of suspicion, all the patients underwent prostate multiparametric magnetic resonance imaging (mpMRI) and subsequently either fusion targeted biopsy (TBx) or systematic standard biopsy (SBx), in case of positive or negative mpMRI, respectively. All patients underwent a robot-assisted RP. Whole-mount histological sections resected from the RP specimens were used as reference standards. RESULTS: Eighty-seven patients were enrolled for the study. Median number of LNs retrieved per patient was 26, specifically 13 and 12, on the left and right side, respectively. Seven of 24 (29.1%) right lobe positive biopsy showed positive LNs on the left side (one exclusively left, 6 bilateral LNMs). Again, 12 of 26 (46.1%) left lobe positive biopsy showed positive LNs on the right side (one exclusively right, 11 bilateral LNMs). No significant differences of performance to predict the side of LNMs were recorded in the SBx and TBx groups. Concerning RP specimens, only five of 22 (22.7%) right lobe dominant cases showed positive LNs on the left side (two exclusively left, 3 bilateral LN metastases). Again, none of 16 left lobe dominant cases showed positive LNs on the contralateral side (15 exclusively right, 1 bilateral LNMs). CONCLUSIONS: Our results suggest confirmed that a unilateral LN dissection limited to the tumor-bearing side of the gland evaluated by biopsy specimens should not be recommended due to the substantial risk of missing contralateral LNMs.

Use of chitosan membranes after nerve-sparing radical prostatectomy improves early recovery of sexual potency: results of a comparative study.

OBJECTIVES: To evaluate the 1-year efficacy of chitosan membrane (ChiMe) application on the neurovascular bundles (NVBs) after nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) in potency recovery rate. To compare the results with those of a contemporary cohort of patients who did not benefit from chitosan use. PATIENTS AND METHODS: Patients in the ChiMe group were enrolled at our institution from July 2015 to September 2016 in a preliminary phase II study. All of them underwent NS-RARP with ChiMe applied on the NVBs and were followed over time to complete a 1-year follow-up. The control group was composed of patients who underwent NS-RARP at our institution without the application of ChiMe from January 2015. The patients were further classified into two groups based on the amount of nerves spared: Group A, comprised patients who underwent a monolateral or bilateral full NS; Group B, comprised patients in which a full NS was not performed. The demographics, peri- and postoperative data, and complications were recorded and compared. Potency recovery was recorded for Group A vs Group B in both the ChiMe and the control groups. RESULTS: In all, 136 patients were enrolled in the ChiMe group and 334 patients in the control group. There were no differences between groups in terms of baseline variables. Based on the amount of nerves preserved, 183 patients were included in Group A and 287 in Group B. Odds ratios at different time points showed that the only two factors influencing potency recovery were the amount of nerves preserved (Group A vs Group B) and the application or not of ChiMe on the NVBs spared. Comparing the ChiMe vs control groups at different time points, we found a statistically significant improvement in the potency recovery rate in the ChiMe group at 1 month (36.76% vs 25.88%; P = 0.02) and 2 months (52.2% vs 39.22%; P = 0.01) after surgery, showing a favourable trend at every time point of the entire follow-up period, even if not significant after the second postoperative month. In Group A, the log-rank test showed a statistically significant difference between the ChiMe vs control groups (P = 0.02), in particular at 1 and 2 months after surgery (P = 0.02 and P = 0.01, respectively). CONCLUSION: The application of ChiMe on the NVBs resulted in a higher potency recovery rate at 1 and 2 months after a bilateral or monolateral full NS-RARP. A trend of a higher and shorter potency recovery rate showed it to be favourable to use ChiMe, even in the cohort of patients who did not undergo a full NS procedure.

Comparing Image-guided targeted Biopsies to Radical Prostatectomy Specimens for Accurate Characterization of the Index Tumor in Prostate Cancer.

AIM: To evaluate the accuracy of multiparametric magnetic resonance-transrectal ultrasound fusion targeted biopsy (TBx) in the characterization of the index tumor, as confirmed by association with radical prostatectomy (RP) specimens. PATIENTS AND METHODS: A total of 152 patients with TBx-confirmed prostate cancer (PCa) underwent robot-assisted RP. Stained whole-mount histological sections were used as the reference standard. All lesions with a volume >0.5 ml and/or pathological Gleason score (GS) >6 were defined as clinically significant PCa. The index lesion was defined as the largest tumor focus within the prostate gland. RESULTS: The pathological index tumours included: 147 lesions (96.7%) with a volume >0.5 ml and five (3.3%) with a volume ≤0.5 ml, but with a pathological GS ≥7; 135 (88.8%) were located in the peripheral zone. TBx accuracy in the detection of the correct site of the index lesion by reference standard was 82.2%. Sensitivity, specificity, positive and negative predictive value were: 82.3%, 50.4%, 82.8% and 49.7%, respectively. The primary/secondary Gleason grade and GS of the 152 index tumors were properly estimated in 130 (85.5%), 115 (75.6%) and 127 (83.6%) cases, respectively. The concordance of TBx with pathological GS was 83.6%. The rate of up-grading and down-grading of TBx Gleason sum was 12.2% and 4.2%, respectively. CONCLUSION: TBx has a high sensitivity for characterization of index lesions, with a good concordance for topographic and Gleason grading accuracy between biopsy and surgical specimens.

3-Year follow-up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction.

OBJECTIVES: To report 3-year follow-up results of the first implantations with a temporary implantable nitinol device (TIND® ; Medi-Tate Ltd., Or Akiva, Israel) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: In all, 32 patients with LUTS were enrolled in this prospective study. The study was approved by the local Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) ≥10, peak urinary flow (Qmax ) <12 mL/s, and prostate volume <60 mL. The TIND was implanted within the bladder neck and the prostatic urethra under light sedation, and removed 5 days later in an outpatient setting. Demographics, perioperative results, complications (according to Clavien-Dindo classification), functional results, and quality of life (QoL) were evaluated. Follow-up assessments were made at 3 and 6 weeks, and 3, 6, 12, 24 and 36 months after the implantation. The Student's t-test, one-way analysis of variance and Kruskal-Wallis tests were used for statistical analyses. RESULTS: At baseline, the mean (standard deviation, sd) patient age was 69.4 (8.2) years, prostate volume was 29.5 (7.4) mL, and Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14-23) and the QoL score was 3 (3-4). All the implantations were successful, with a mean total operative time of 5.8 min. No intraoperative complications were recorded. The change from baseline in IPSS, QoL score and Qmax was significant at every follow-up time point. After 36 months of follow-up, a 41% rise in Qmax was achieved (mean 10.1 mL/s), the median (IQR) IPSS was 12 (6-24) and the IPSS QoL was 2 (1-4). Four early complications (12.5%) were recorded, including one case of urinary retention (3.1%), one case of transient incontinence due to device displacement (3.1%), and two cases of infection (6.2%). No further complications were recorded during the 36-month follow-up. CONCLUSIONS: The extended follow-up period corroborated our previous findings and suggests that TIND implantation is safe, effective and well-tolerated, for at least 36 months after treatment.

Multiparametric prostate MRI: technical conduct, standardized report and clinical use.

Multiparametric prostate MRI (mp-MRI) is an emerging imaging modality for diagnosis, characterization, staging, and treatment planning of prostate cancer (PCa). The technique, results reporting, and its role in clinical practice have been the subject of significant development over the last decade. Although mp-MRI is not yet routinely used in the diagnostic pathway, almost all urological guidelines have emphasized the potential role of mp-MRI in several aspects of PCa management. Moreover, new MRI sequences and scanning techniques are currently under evaluation to improve the diagnostic accuracy of mp-MRI. This review presents an overview of mp-MRI, summarizing the technical applications, the standardized reporting systems used, and their current roles in various stages of PCa management. Finally, this critical review also reports the main limitations and future perspectives of the technique.

Multiparametric Magnetic Resonance/Ultrasound Fusion Prostate Biopsy: Number and Spatial Distribution of Cores for Better Index Tumor Detection and Characterization.

PURPOSE: We evaluated the minimum core number for better index tumor detection to determine the best core site as well as biopsy Gleason score heterogeneity in the same index lesion. The aim was to optimize the highest Gleason score detection. MATERIALS AND METHODS: A total of 327 patients with negative digital rectal examination underwent magnetic resonance imaging/transrectal ultrasound fusion targeted biopsy for elevated/rising prostate specific antigen and/or 1 or more detectable lesions on multiparametric magnetic resonance imaging after a previous negative standard biopsy. Depending on the diameter of each index lesion (8 or less, or greater than 8 mm) 4 or 6 cores, respectively, were taken according to a well determined sequence. RESULTS: Of the patients 166 (50.7%) had prostate cancer, including 79 (47.6%) with an 8 mm or less index lesion and 87 (52.4%) with a greater than 8 mm index lesion. Of patients with an index tumor 8 mm or less 7 (8.9%) had 1, 31 (39.2%) had 2, 27 (34.2%) had 3 and 14 (17.7%) had 4 positive cores. Similarly, of patients with a lesion greater than 8 mm 8 (9.2%) had 1, 30 (34.5%) had 2, 13 (14.9%) had 3, 14 (16.1%) had 4, 12 (13.8%) had 5 and 10 (11.5%) had 6 positive cores. The major prevalence of positive cores was observed in the center of the target. Gleason score heterogeneity was found in 12.6% of those with an 8 mm or less target vs 26.4% with a target greater than 8 mm. In the center of the target there was a slight prevalence of Gleason pattern 4 or greater, or a lesser pattern. CONCLUSIONS: Approaching magnetic resonance imaging/transrectal ultrasound fusion targeted biopsy with a single core might be inadequate. Rather, taking 2 cores in the center of the index lesion may provide more accurate cancer detection and optimize the chances of finding the highest Gleason pattern.

Retrospective study testing next generation sequencing of selected cancer-associated genes in resected prostate cancer.

PURPOSE: Prostate cancer (PCa) has a highly heterogeneous outcome. Beyond Gleason Score, Prostate Serum Antigen and tumor stage, nowadays there are no biological prognostic factors to discriminate between indolent and aggressive tumors.The most common known genomic alterations are the TMPRSS-ETS translocation and mutations in the PI3K, MAPK pathways and in p53, RB and c-MYC genes.The aim of this retrospective study was to identify by next generation sequencing the most frequent genetic variations (GVs) in localized and locally advanced PCa underwent prostatectomy and to investigate their correlation with clinical-pathological variables and disease progression. RESULTS: Identified non-synonymous GVs included TP53 p.P72R (78% of tumors), two CSFR1 SNPs, rs2066934 and rs2066933 (70%), KDR p.Q472H (67%), KIT p.M541L (28%), PIK3CA p.I391M (19%), MET p.V378I (10%) and FGFR3 p.F384L/p.F386L (8%). TP53 p.P72R, MET p.V378I and CSFR1 SNPs were significantly associated with the HI risk group, TP53 and MET variations with T≥T2c. FGFR3 p.F384L/p.F386L was correlated with T≤T2b. MET p.V378I mutation, detected in 20% of HI risk patients, was associated with early biochemical recurrence. EXPERIMENTAL DESIGN: Nucleic acids were obtained from tissue samples of 30 high (HI) and 30 low-intermediate (LM) risk patients, according to D'Amico criteria. Genomic DNA was explored with the Ion_AmpliSeq_Cancer_Hotspot_Panel_v.2 including 50 cancer-associated genes. GVs with allelic frequency (AF) ≥10%, affecting protein function or previously associated with cancer, were correlated with clinical-pathological variables. CONCLUSION: Our results confirm a complex mutational profile in PCa, supporting the involvement of TP53, MET, FGFR3, CSF1R GVs in tumor progression and aggressiveness.

Temporary implantable nitinol device (TIND): a novel, minimally invasive treatment for relief of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH): feasibility, safety and functional results at 1 year of follow-up.

OBJECTIVES: To report the first clinical experience with a temporary implantable nitinol device (TIND; Medi-Tate(®) ) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: In all, 32 patients with LUTS were enrolled in this prospective study, which was approved by our Institutional Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) of ≥10, maximum urinary flow rate (Qmax ) of ≤12 mL/s, and prostate volume of <60 mL. The TIND was implanted within the bladder neck and the prostatic urethra under light sedation, using a rigid cystoscope. The device was removed 5 days later in an outpatient setting. Demographics, perioperative results, complications (according to the Clavien system), functional results and quality of life (QoL) were evaluated. Follow-up assessments were made at 3 and 6 weeks, and 3, 6 and 12 months postoperatively. The Student's t-test, analysis of variance (anova), Kruskall-Wallis test, and simple and multiple linear regression models were used in the statistical analyses. RESULTS: The mean patient age was 69.4 years, the mean (standard deviation, sd) prostate volume was 29.5 (7.4) mL and the Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14-23) and QoL score was 3 (3-4). All the implantations were successful, with no intraoperative complications recorded. The mean operative time (sd) was 5.8 (2.5) min and the median (IQR) postoperative stay was 1 (1-2) day. All but one of the devices (96%) was removed 5 days at after implantation in an outpatient setting. Four complications (12.5%) were recorded, including urinary retention (one, 3.1%), transient incontinence due to device displacement (one, 3.1%), prostatic abscess (one, 3.1%), and urinary tract infection (one, 3.1%). Multiple regression analysis failed to identify any independent prognostic factor for complications. There were statistically significant differences in the IPSS, QoL score and Qmax when comparing pre- and postoperative results at every time point. After 12 months, the median (IQR) IPSS and QoL score were 9 (7-13) and 1 (1-2), respectively, and the mean (sd) Qmax was 12 (4.7) mL/s. The mean variations with respect to baseline conditions at the same time points were -45% for the IPSS and +67% for Qmax . At 12 months after surgery (last follow-up visit), no patients required medical therapy or surgical procedures for BPH. CONCLUSION: TIND implantation is a feasible and safe minimally invasive option for the treatment of BPH-related LUTS. The functional results are encouraging and the treatment significantly improved patient QoL. Further studies are required to assess durability of TIND results and to optimise the indications of such a procedure.

[Ureteroscopy: is it the best?]. / Ureteroscopia: risolve molto di più?

Over the last 40 years the treatment of urolithiasis passed from open surgical therapies to minimally invasive approaches. From the introduction of the first ureteroscopes in '80s many technological improvements allowed to reduce endourological instruments' size, ensuring in the meanwhile an increasingly high success rate in the resolution of the urolithiasis. The purpose of the study is to review the current role of the ureteroscopy(URS) in the treatment of urinary stones. A non-systematic review was performed considering the most recent Guidelines and results from Literature. The results confirm that, considering ureteral calculi, the stone-free rate (SFR) for URS is significantly higher than for ESWL in the treatment of distal ureteral stones <10 mm and >10 mm. Endoscopy has a first-line role also in the treatment of proximal ureteral stones >10 mm, together with ESWL. Retreatment rate and ancillary procedures are also lower in patients treated with URS, despite it is more invasive if compared with ESWL. Recent data are available in Literature about the treatment of nephrolithiasis with Retrograde Intra-Renal Surgery (RIRS). RIRS is the first-line treatment, together with ESWL, for stones <20 mm, and second choice for stones >20 mm. However, for large renal stones the role of RIRS is still being discussed. In conclusion, the majority of urinary stones can be treated by rigid or flexible URS. Further studies are required to clarify the role of endoscopy in the treatment of large stones, especially if compared to percutaneous approaches.

Perioperative and renal functional outcomes of elective robot-assisted partial nephrectomy (RAPN) for renal tumours with high surgical complexity.

OBJECTIVE: To evaluate the perioperative, postoperative and functional outcomes of robot-assisted partial nephrectomy (RAPN) for renal tumours with high surgical complexity at a large volume centre. PATIENTS AND METHODS: Perioperative and functional outcomes of RAPNs for renal tumours with a Preoperative Aspects and Dimensions Used for an Anatomical (PADUA) score of ≥10 performed at our institution between September 2006 and December 2012 were collected in a prospectively maintained database and analysed. Surgical complications were graded according to the Clavien-Dindo classification. Serum creatinine and estimated glomerular filtration rate (eGFR) were assessed at the third postoperative day and 3-6 months after RAPN. RESULTS: In all, 44 RAPNs for renal tumours with PADUA scores of ≥10 were included in the analysis; 23 tumours (52.3%) were cT1b. The median (interquartile range; range) operative time, estimated blood loss and warm ischaemia time (WIT) were 120 (94, 132; 60-230) min, 150 (80, 200; 25-1200) mL and 16 (13.8, 18; 5-35) min, respectively. Two intraoperative complications occurred (4.5%): one inferior vena caval injury and one bleed from the renal bed, which were both managed robotically. There were postoperative complications in 10 patients (22.7%), of whom four (9.1%) were high Clavien grade, including two bleeds that required percutaneous embolisation, one urinoma that resolved with ureteric stenting and one bowel occlusion managed with laparoscopic adhesiolysis. Two patients (4.5%) had positive surgical margins (PSMs) and were followed expectantly with no radiological recurrence at a mean follow-up of 23 months. The mean serum creatinine levels were significantly increased after surgery (121.1 vs 89.3 µmol/L; P = 0.001), but decreased over time, with no significant differences from the preoperative values at the 6-month follow-up (96.4 vs 89.3 µmol/L; P = 0.09). The same trend was seen for eGFR. CONCLUSION: In experienced hands RAPN for renal tumours with a PADUA score of ≥10 is feasible with short WIT, acceptable major complication rate and good long-term renal functional outcomes. A slightly higher risk of PSMs can be expected due to the high surgical complexity of these lesions. The robotic technology allows a safe expansion of the indications of minimally invasive PN to anatomically very challenging renal lesions in referral centres.