Publications by authors named "Marco Giampaoli"

26 Publications

  • Page 1 of 1

Adding systematic biopsy to magnetic resonance ultrasound fusion targeted biopsy of the prostate in men with previous negative biopsy or enrolled in active surveillance programs: A prospective single center, randomized study.

Medicine (Baltimore) 2020 Sep;99(37):e22059

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

Magnetic resonance imaging (MRI) targeted biopsy (TBx) of the prostate demonstrated to improve detection rate (DR) of clinically significant prostate cancer (csPCa) in biopsy-naive patients achieving strong level of evidence. Nevertheless, the csPCa yield for TBx alone versus TBx plus systematic biopsy (SBx) after accounting for overlapping of SBx cores with TBx cores, in prior-negative or active surveillance (AS) patients has not been well established.The objective of the study was to investigate benefits in terms of detection rate and pathological stratification of prostate cancer (PCa) using contextual SBx during MRI-TBx.Patients previously submitted to negative-SBx (cohort A) and those enrolled in an AS program (cohort B) who showed at least 1 suspicious area with a PIRADSv2 score ≥ 3 were prospectively and randomly assigned to only TBx strategy versus TBx plus SBx strategy. SBx locations could not encompass the TBx sites, so that the results of each type of biopsy were independent and did not overlap.A total of 312 patients were included in the 2 cohorts (cohort A: 213 cases; cohort B: 99 cases). No significant differences were found in terms of overall PCa-DR (77.6% vs 69.6% respectively; P = .36) and csPCa-DR (48.2% vs 60.9 respectively; P = .12). The MRI-TBx alone cohort showed higher csPCa/PCa ratio (87.5% vs 62.2%; P = .03). The MRI-TBx plus SBx group subanalysis showed significantly higher csPCa-DR obtained at the MRI-TBx cores when compared with the SBx cores (43.7% vs 24.1%, respectively; P = .01). Independently to age, prostatic-specific antigen and prostate imaging-reporting and data system score, either in rebiopsy (OR 0.43, 0.21-0.97) or AS (OR 0.46, 0.32-0.89) setting, SBx cores were negatively associated with the csPCa-DR when combined to TBx cores.MRI-TBx should be considered the elective method to perform prostate biopsy in patients with previous negative SBx and those considered for an AS program. Adding SBx samples to MRI-TBx did not improve detection rate of csPCa.
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http://dx.doi.org/10.1097/MD.0000000000022059DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489582PMC
September 2020

Prognostic performance of magnetic resonance imaging-guided biopsy in defining prostate cancer anterior lesions.

World J Urol 2020 Jul 3. Epub 2020 Jul 3.

Department of Urology, Sapienza Rome University Policlinico Umberto I, P.le Aldo Moro, 5, Rome, Italy.

Purpose: Diagnosis of anterior prostate cancer (PCa) can be quite challenging, often leading to delay in treatment. mpMRI-guided biopsy (GB) has been introduced aiming to increase the number of diagnoses of clinically significant PCa with fewer cores. The aim of our study is to compare pathological findings of prostate biopsy, In-bore or Fusion technique, with histopathological evaluation of radical prostatectomy.

Methods: We prospectively collected data from 90 consecutive patients who underwent either In-bore or Fusion biopsy following the detection of an index suspicious lesion at mpMRI in the anterior part of the prostatic gland. Bioptical pathological findings were compared with pathological findings reported after robot-assisted radical prostatectomy.

Results: Patients who underwent In-bore GB had a higher rate of previous negative prostate biopsies (19% vs 44%, p = 0.02). Median number of bioptic cores taken (13 vs 2) and number of positive cores (3 vs 2) were significantly superior in the Fusion group compared to the In-bore group (p < 0.001 and p = 0.002, respectively), whilst clinical International Society of Urological Pathology (ISUP) grade was homogeneous within groups. The concordance between anterior lesions detected at biopsy and those reported in the histopathological finding of radical prostatectomy was very high, without statistically significant difference between groups.

Conclusion: Both Fusion and In-bore GB are accurate in detecting anterior PCa, with enhanced precision detecting clinically significant tumours, as evidenced by pathologic examinations which confirmed the presence of index anterior PCa in > 50% of patients overall. Additional sextant biopsy is still required, especially among biopsy-näive patients, to avoid missing clinically significant PCa.
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http://dx.doi.org/10.1007/s00345-020-03335-4DOI Listing
July 2020

The pathological and clinical features of anterior lesions of prostate cancer: Evaluation in a single cohort of patients.

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

Department of Urology, Abano Terme Hospital, Abano Terme (PD).

Introduction: The aim of our work is to evaluate the principal differences of the pathological features in prostate cancer (PCa) lesions comparing those in the anterior region of the gland (APCa) to those in the posterior zone (PPCa) among patients who underwent to robotic-assisted radical prostatectomy (RP).

Material And Methods: A total of 85 consecutive patients (mean age 66; IQR 62-71) with clinically suspected PCa were studied with multiparametric magnetic resonance of prostate before prostate biopsies. The prostate biopsies were RM-guided (60 inbore biopsy (MR-GB) and 25 Fusion-biopsy (FB). A total of 72 cases were eligible for robotic RP. An experienced genitourinary pathologist reviewed the histopathology of the tissue specimens of the patients after RP. The exclusion criteria were as follows: previous hormonotherapy, radiotherapy and chemotherapy for others cancers.

Results: Based on the histological diagnosis, after RP, 68 anterior prostate cancer, and 107 posterior lesions were found. We further subcategorized lesions into peripheral and central zones for each the anterior and posterior lesions. The specific distribution of lesions by pathologic stage was: T2 = 74 (42.3%), T3a = 87 (49.7%), T3b = 12 (6.9%), T4 = 2 (1.1%) cases. Tumor volume of posterior neoplasms ranged from 0.04 to 20.35 cm3, with a median of 3.39 cm3. Anterior tumor volume ranged from 0.17 to 15 cm3, with a median volume of 2.54 cm3: PPCa were larger than APCa but the difference in size was not significant. The prostate cancer grade group (GG) I was distributed as 16.6% and 36% in anterior and posterior lesions cases. GG II and III was 43.8% and 31.5% in anterior and posterior cases, respectively. Comparatively, GG IV-V showed 39.6% and 32.5% for anterior and posterior lesions respectively (p < 0.001). Extraprostatic extention of neoplasm (EPE) was found more frequently in anterior cases (31.4%) than in in posterior cases (25.1%), but without significant difference. Lymphovascular invasion was similar in both the groups: 24% and 28.6% in anterior and posterior group, respectively. Anterior lesions showed a significantly higher rate of lymph node metastasis (9.3%) than posterior lesions (3.4%) (p < 0.005).

Conclusion: In our study, we have found EPE, often associated with worse prognosis, more frequently (but not significantly) present in anterior lesions among PCa patients. Although posterior lesions are often related to pT3b stage, in our findings, anterior lesions were more often associated with a more aggressive neoplasm with more frequent nodal involvements.
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http://dx.doi.org/10.4081/aiua.2020.2.102DOI Listing
June 2020

Holmium laser prostatectomy in a tertiary Italian center: A prospective cost analysis in comparison with bipolar TURP and open prostatectomy.

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

Department of Urology, University of Bologna; Department of Experimental, Diagnostic and Specialty Medicine (DIMES), Cardio-Nephro-Thoracic Sciences Doctorate, University of Bologna, Bologna.

Objective: To assess the economic impact of Holmium laser enucleation of prostate (HoLEP) in comparison with transurethral resection of prostate (TURP) and open prostatectomy (OP).

Methods: Between January 2017 and January 2018, we prospectively enrolled 151 men who underwent HoLEP, TURP or OP at tertiary Italian center, due to bladder outflow obstruction symptoms. Patients with prostate volume ≤ 70 cc and those with prostate volume > 70 cc were scheduled for TURP or HoLEP and OP or HoLEP, respectively. Intraoperative and early post-operative functional outcomes were recorded up to 6 months follow up. Cost analysis was carried out considering direct costs (operating room [OR] utilization costs, nurse, surgeons and anesthesiologists' costs, OR disposable products costs and OR products sterilization costs), indirect costs (hospital stay costs and diagnostics costs) and global costs as sum of both direct and indirect plus general costs related to hospitalization. Cost analysis was performed comparing patients referred to TURP and HoLEP with prostate volume ≤ 70 cc and men underwent OP and HoLEP with prostate volume > 70 cc respectively.

Results: Overall, 53 (35.1%), 51 (33.7%) and 47 (31.1%) were scheduled to HoLEP, TURP and OP, respectively. Both TURP, HoLEP and OP proved to effectively improve urinary symptoms related to BPE. Considering patients with prostate volume ≤ 70 cc, median global cost of HoLEP was similar to median global cost of TURP (2151.69 € vs. 2185.61 €, respectively; p = 0.61). Considering patients with prostate volume > 70 cc, median global cost of HoLEP was found to be significantly lower than median global cost of OP (2174.15 € vs. 4064.97 €, respectively; p ≤ 0.001).

Conclusions: Global costs of HoLEP are comparable to those of TURP, offering a cost saving of only 11.4 € in favor of HoLEP. Conversely, HoLEP proved to be a strong competitor of OP because of significant global cost sparing amounting to 1890.82 € in favor of HoLEP.
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http://dx.doi.org/10.4081/aiua.2020.2.82DOI Listing
June 2020

The role of MRI-guided biopsy for diagnosis of prostate cancer; comparison between FUSION and "IN-BORE" approaches.

Minerva Urol Nefrol 2020 May 26. Epub 2020 May 26.

Department of Robotic Urological Surgery, Abano Terme Hospital, Abano Terme, Padua, Italy.

Background: The aim of the present study is to evaluate the difference in terms of feasibility and detection rate of two magnetic resonance imaging (MRI) guided biopsy approaches (MRI fusion versus "in-bore" MRI) in a single tertiary centre.

Methods: We retrospectively identified 297 patients with suspected prostate cancer who underwent MRI based target prostate biopsy (FUSION or "in-bore" approaches) between January 2016 and January 2018 in a single tertiary centre.

Results: Lesion site (peripheral vs central) and localization (anterior vs posterior) were equally comparable among two groups, but maximum diameter of multiparametric-MRI index lesion was slightly superior in the in-bore MRI-GB group (14 vs 12 mm, p=0.002). Mean random biopsy cores taken were 11.2±2.1, with 1.3±2 positive cores in FUSION-GB group. Mean number of targeted biopsy cores taken was significantly superior in the FUSION-GB group as compared to the in-bore MRI-GB group(2.6±0.7 vs 1.7±1, p<0.001), whereas mean number of positive targeted biopsy cores was comparable between two groups (1±1.3 vs 1±0.9, p=0.1). 70 (45.5%) and 75 (52.8%) patients had positive targeted bioptic cores at pathologic examination among FUSION-GB and in-bore MRI-GB groups, respectively (p=0.2). Bioptical ISUP grade was also comparable among two groups (p=0.2) in multivariate analysis PI-RADS score (OR=3.04 and OR=8.32 for PI-RADS 4 and 5, respectively) and PSA density (OR=2.69) were identified as independent predictors of positive targeted cores at histological examination (p<0.001 and p=0.01, respectively).

Conclusions: In-bore MRI-GB approaches represent a promising technique that may offer some advantages compared to standard systematic FUSION-GB despite higher costs of in bore-procedure. Our experience, although not showing a clear advantage between the FUSION technique and the "in- bore" technique, resulted safe and feasible and represents a viable procedure for the diagnosis and characterization of prostate especially in a subgroup of patient with clinically significant disease. Further investigations are needed in order to identify the best approach for MRI-GB.
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http://dx.doi.org/10.23736/S0393-2249.20.03550-XDOI Listing
May 2020

"In-Bore" MRI-Guided Prostate Biopsy for Prostate Cancer Diagnosis: Results from 140 Consecutive Patients.

Curr Urol 2020 Mar 20;14(1):22-31. Epub 2020 Mar 20.

Department of Robotic Urological Surgery, Abano Terme Hospital, Abano Terme.

Objectives: Transrectal ultrasound-guided biopsy (TRUS-GB) is the current reference standard procedure for diagnosis of prostate cancer (PCa) but this procedure has limitations related to the low detection rate (DR) described in the literature. The aim of the study was to evaluate the DR efficiency, and complication rate in a pure "in-bore" magnetic resonance imaging-guided biopsy (MRI-GB) series according to the Prostate Imaging Reporting and Data System, version 2 (PI-RADS v2).

Materials And Methods: From July 2015 to April 2018, a series of 142 consecutive patients undergoing MRI-GB were prospectively enrolled. According to the European Society of Urogenital Radiology guidelines, the presence of clinically significant PCa (csPCa) on multiparametric magnetic resonance imaging was defined as equivocal, likely, or highly likely according to a PI-RADS v2, score of 3, 4, or 5, respectively.

Results: Of 142 patients, 76 (53.5%) were biopsy naive and 66 (46.5%) had ≤ 1 previous negative set of random TRUS-GB findings. The MRI-GB findings were positive in 75 of 142 patients with a DR of 52.8%. Of the 76 patients with ≤ 1 previous set of TRUS-GB, 43 had PCa found by MRI-GB, with a DR of 57.3%. The DR in the 66 biopsy-naive patients was 48% (32/66). Of the 75 patients with positive biopsy findings, 54 (80.5%) were found to have csPCa on histological examination. Of these 54 patients, 28 had an International Society of Urological Pathology grade 2; 5 had grade 3, 19 had grade 4, and 2 had grade 5. Considering the anatomic distribution of the index lesions using the PI-RADS v2 scheme, the probability of PCa was greater for lesions located in the peripheral zone (55 of 75, 73.3%) than for those in the central zone (20 of 75, 26.7%).

Conclusions: Our study conducted on 142 patients confirmed the greater DR of csPCa by MRI-GB, with a very low number of cores needed and a negligible incidence of complications, especially in patients with a previous negative biopsy. MRI-GB is optimal for the diagnosis of anterior and central lesions.
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http://dx.doi.org/10.1159/000499264DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7206582PMC
March 2020

Not fatal venous air embolism after holmium laser enucleation of the prostate: Case report and review of literature.

Arch Ital Urol Androl 2020 Apr 7;92(1):55-57. Epub 2020 Apr 7.

Robotic Urology and Mini Invasive Urologic Surgery Unit, Abano Terme Hospital, Abano Terme (PD).

Objective: Holmium laser has demonstrated high efficacy in urethral disobstruction. Venous air embolism (VAE) is a rare complication of prostate surgery. Only two cases of venous air embolism (VAE) in patients submitted to HoLEP, have been described. In this paper we show a third case of not fatal VAE after HoLEP.

Materials And Methods: A case of VAE occurred in holmium laser enucleation (HoLEP) due to obstructive lower urinary tract symptoms (LUTS) in a 70 years old patient. After the procedure, patient's end tidal carbon dioxide (ETCO2) levels dramatically decreased at 17 mmHg, with pressure airway (PAW)16 mmHg; oxygen saturation level was at 75%, without any loss in the ventilation circuit and with arterial blood pressure of 94/54 mmHg. Due to the negativity for other suspicions, the suspect of VAE was postulated.

Result: The immediate switching from laryngeal mask to Oro Tracheal Intubation increased the oxygen level. A cardiac transthoracic ultrasound was negative for air bubbles inside cardiac cavities, without any alteration in the cardiac kinetics. Arterial blood sample turned negative for any alteration compatible with VAE and catheter continuous vesical irrigation was started to obtain clear washing fluid without blood cloths. The extubated patient showed no neurological defects.

Conclusions: An invasive monitoring system is the key to rapidly and correctly identify any embolic episode during this kind of surgery.
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http://dx.doi.org/10.4081/aiua.2020.1.55DOI Listing
April 2020

Surgical blood loss during holmium laser enucleation of the prostate (HoLEP) is not affected by short-term pretreatment with dutasteride: a double-blind placebo-controlled trial on prostate vascularity.

Aging (Albany NY) 2020 03 11;12(5):4337-4347. Epub 2020 Mar 11.

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

Five α-reductase inhibitors (5ARIs) are able to reduce prostate volume and are a useful treatment for reducing perioperative bleeding during prostate surgery. Holmium laser enucleation of the prostate (HoLEP) is an effective surgical technique for the definitive cure of benign prostate enlargement.We investigated whether pretreatment with dutasteride before HoLEP could reduce intraoperative bleeding. A total of 402 patients were included in this double-blind placebo-controlled trial to receive daily 0.5 mg of dutasteride or placebo over 8 weeks before HoLEP. Vascular endothelial growth factor (VEGF) and microvascular density (MVD) were evaluated. Analysis was also stratified according to prostate volume (<70 mL vs ≥70 mL).Hemoglobin and hematocrit values before and after surgery were not statistically different between the two groups. MVD and VEGF index in smaller prostates were 23.35±1.96 and 4.06±0.76 in the treatment group and 19.04±0.96 and 2.55±0.55 in placebo (p<0.05); in patients with larger prostates MVD and VEGF were 26.83±2.812 and 8.54±1.18 in the treatment group and 20.76±0.79 and 3.21±0.54 in placebo (p<0.05).Vascularization of the prostate was affected by 5ARIs therapy. HoLEP is less burdened in perioperative bleeding and for this reason we did not find any difference in hemoglobin/hematocrit values pre- and post- surgery.
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http://dx.doi.org/10.18632/aging.102883DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7093193PMC
March 2020

Is Fast Track protocol a safe tool to reduce hospitalization time after radical cystectomy with ileal urinary diversion? Initial results from a single high-volume centre.

Arch Ital Urol Androl 2020 Jan 14;91(4):230-236. Epub 2020 Jan 14.

Abano Terme Hospital, Abano Terme (PD).

Introduction And Aim: Radical Cystectomy (RC) with ileal urinary diversion is one of the most complex urological surgical procedure, and many Fast Track (FT) protocols have been described to reduce hospitalization, without increasing postoperatory complications. We present the one-year results of a dedicated protocol developed at a high volume centre.

Materials And Methods: The FT protocol was designed after a review of the literature and a multidisciplinary collegiate discussion, and it was applied to patients scheduled to open RC with intestinal urinary diversion. To validate its feasibility, we compared its results with data collected from a 1:1 matched population of patients who had undergone the same surgical procedure, without the implementation of the FT protocol.

Results: We enrolled in the FT group 11 (55%) patients scheduled to RC with ileal conduit diversion, and 9 patients (45%) scheduled to orthotopic neobladder (Studer) substitution, while a numerically equivalent population was enrolled in the control group, matched according to age at surgery, BMI, gender, ASA score, CCI, preoperative stage and type of urinary diversion. No statistically significant difference was found in terms of pre-operatory and intra-operatory domains. Median overall age was 71 years (Inter Quartile Range - IQR: 63-76) and mean operatory time was 276 ± 57 minutes. Hospitalization time was significantly reduced in the FT group, considering oralization and canalization items we found a significant advantage in the FT group. No statistically significant difference was found in the control of the post-operatory pain. We found no difference, in terms of both early and late complications ratio, among the two populations. Complications graded Clavien ≥ 3 were found in 4 patients of the control group (20%), while in only one patient (5%) in the Fast Track group, though this difference was not statistically significant.

Conclusions: The Fast Track protocol developed in this study has proven to be effective in significantly reducing hospitalization time in patients submitted to RC with intestinal urinary diversion, without increasing post-operatory complications ratio.
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http://dx.doi.org/10.4081/aiua.2019.4.230DOI Listing
January 2020

"In-bore" MRI prostate biopsy is a safe preoperative clinical tool to exclude significant prostate cancer in symptomatic patients with benign prostatic obstruction before transurethral laser enucleation.

Arch Ital Urol Androl 2020 Jan 14;91(4):224-229. Epub 2020 Jan 14.

Department of Urology, Abano Terme Hospital, Padua.

Introduction: Purpose of our study was to investigate the role of a negative in-bore MRI-guided biopsy (MRI-GB) in comparison to a negative multiparametric prostate MRI (mpMRI) and a contextual negative transrectal ultrasound guided biopsy of the prostate with regard to incidental prostate cancer findings in the surgical specimen of men who underwent to Holmium Laser enucleation of prostate (HoLEP) with a preoperative suspicion of prostate cancer.

Materials And Methods: Data of 117 of symptomatic patients for bladder outflow obstruction who subsequently underwent to HoLEP was retrospectively analyzed form a multicentric database. All patients had a raised serum PSA and/or an abnormal digital rectal examination (DRE) with a pre-interventional mpMRI. Prostate cancer was excluded either with an en-bore MRI-GB (group "IN-BORE MRI-GB" n = 57) in case of a suspect area at the mpMRI or with a standard biopsy (group "mpMRI + TRUS-GB" n = 60) in case of a negative mpMRI. Preoperative characteristic surgical and histological outcomes were analyzed. Univariate and multivariate logistic regression model was performed to investigate independent predictors of incidental Prostate Cancer (iPCa).

Results: Both groups presented moderate to severe lower tract urinary symptoms: median IPSS was 19 (IQR: 17.0-22.0) in the IN-BORE MRI-GB group and 20 (IQR: 17.5-22.0) in the mpMRI + TRUS-GB (p = 0.71). No statistically significant difference was found between the two groups besides total prostate volume with 68 cc (IQR: 58.0-97.0) in the IN-BORE MRI-GB group and 84 cc (IQR: 70.0-115.0) in the mpMRI + TRU-GB group (p = 0.01) No differences were registered in surgical time, removed tissue, catheterization time, hospital stay and complications rate. No different rates (p = 0.50) of iPCa were found in the IN-BORE MRI-GB group (14%) in comparison with mpMRI + TRUS-GB group (10 %); pT stage and ISUP Grade Group in iPCa stratification were comparable between the two groups. In multivariate analysis a statistically significant correlation with age as an independent predictive factor of iPCa was found (OR 1.14; 95% CI: 1.02-1.27; p = 0.02) while no correlations were revealed with PSA (OR 1.12; 95% CI: 0.99-1.28; p = 0.08) and a negative in-bore MRI-GB (OR 1.72; 95% CI: 0.51-5.77; p = 0.37).

Conclusions: Including a mpMRI and an eventual in-bore MRIGB represents a novel clinical approach before surgery in patients with symptomatic obstruction with a concomitant suspicion of PCa, leading to low rate of iPCa and avoiding unnecessary standard TRUS-GB biopsies.
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http://dx.doi.org/10.4081/aiua.2019.4.224DOI Listing
January 2020

MRI/TRUS FUSION guided biopsy as first approach in ambulatory setting: Feasibility and performance of a new fusion device.

Arch Ital Urol Androl 2020 Jan 13;91(4):211-217. Epub 2020 Jan 13.

Department of Robotic Urological Surgery, Abano Terme Hospital, Abano Terme.

Purpose: To evaluate the detection rate of Magnetic Resonance Imaging/Transrectal Ultrasound (MRI/TRUS) Fusion Biopsy performed in a series of patients with suspicious prostate cancer in an ambulatory setting.

Materials And Methods: Between March 2018 and January 2019 a series of 155 patients undergoing MRI/TRUS fusionguided biopsy were prospectively enrolled. All patients presented a suspected diagnosis for prostate cancer because of raised Prostate Specific Antigen (PSA) serum level and/or abnormal physical examination (digital rectal examination), and showed at least one suspicious area at the multiparametric Magnetic Resonance Imaging (mpMRI).

Results: Of 155 patients, 58 (37.4%) were biopsy-naïve, 97 (62.6%) had at least 1 previous negative TRUS-guided biopsy. The median age of the patient cohort was 66 years (IQR, 61- 69); the median prebiopsy PSA value was 7.1 ng/ml (IQR, 5- 8.9). Overall, the Fusion-TB findings were positive in 94 of 155 patients with a detection rate (DR) of 60%; a significantly high DR was obtained in terms of clinically significant prostate cancer (csPCa) by Fusion-TB (61 pts; 41.9%). The overall DR in the 121 biopsy-naive patients was 60.6%. In the subgroup of the 34 patients with at least 1 previous set of TRUS-GB, overall DR was 39.3% (35/50).

Conclusions: The targeted MRI/TRUS fusion-guided biopsy represents a safe and accurate approach for diagnosis of csPCa, especially in patient with previous TRUS guided biopsy negative and suspicious prostate cancer.
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http://dx.doi.org/10.4081/aiua.2019.4.211DOI 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

Is robotic approach useful to palliate advanced bladder cancer? A monocentric single surgeon experience.

Cent European J Urol 2019 24;72(2):113-120. Epub 2019 Apr 24.

Abano Terme Hospital, Department of Urology, Abano Terme, Italy.

Introduction: The aim of this study was to assess surgical and functional outcomes of 17 consecutive patients undergoing robot- assisted radical cystectomy (RARC) with palliative intent in a monocentric single surgeon series.

Material And Methods: We collected data from 17 consecutive patients who underwent RARC with palliative intent performed by a single surgeon at our institution. Patients undergoing palliative RARC were those with advanced bladder cancer (BC) or advanced comorbidities. Clinical, surgical and functional outcomes were prospectively collected. Patients completed a specific questionnaire (Functional Assessment of Cancer Therapy-Bladder Cancer, FACT-BL) before and after surgery to assess the role of palliative RARC in terms of quality of life improvement.

Results: Median age at surgery was 78 years, with median Charlson Comorbidity Index (CCI) and age-adjusted CCI of 3 and 7, respectively. Clinical stage was T2, T3 or T4 in 7, 8 and 2 patients respectively, with 52.9% and 29.4% with cN+ and cM+ disease. Median estimated blood loss was 200 ml, with 1 patient requiring intra-operative blood transfusion. Median hospital stay was 7 days. A total of 3 and 2 patients were re-hospitalized during the first 30 and 30-90 post-operative days, respectively. One major Clavien grade complication was recorded.At median follow-up of 8 months, 9 and 2 patients succumbed due to tumor progression and other causes. Pre-operative and post-operative FACT-BL scores improved significantly in each domain.

Conclusions: A RARC is a safe and feasible technique which could be offered as part of palliative care in patients with advanced BC or comorbidities. Precise guidelines for palliating BC patients should be better.
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http://dx.doi.org/10.5173/ceju.2019.1902DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6715081PMC
April 2019

Preoperative multiparametric prostate magnetic resonance imaging: a safe clinical practice to reduce incidental prostate cancer in Holmium laser enucleation of the prostate.

Cent European J Urol 2019 24;72(2):106-112. Epub 2019 Apr 24.

University of Bologna, Department of Urology, Bologna, Italy.

Introduction: Purpose of the study was to investigate the correlation of a preoperative multiparametric magnetic resonance imaging of the prostate (mpMRI) in patients with a suspicion of prostate cancer and eligible for Holmium Laser Enucleation of the Prostate (HoLEP).

Material And Methods: Data of 228 patients who had undergone HoLEP was selected and retrospectively analyzed from a multicentric database. All patients presented with a raised serum PSA and/or an abnormal digital rectal examination (DRE). Prostate cancer (PCa) was excluded either with a negative mpMRI (group 'NEGATIVE MRI' n = 113) or a standard biopsy (group 'NO MRI' n = 115). Preoperative characteristic surgical and histological outcomes were confronted. A univariate and multivariate logistic regression model was performed to investigate independent predictors of incidental Prostate Cancer (iPCa).

Results: Both groups presented with no statistical differences in preoperative characteristics besides previous acute urinary retention rates and post-voided residual volume, found to be higher (27.8% vs. 14.2% and median 120cc vs. 80cc) in NO MRI and NEGATIVE MRI respectively.No differences were registered in surgical time, removed tissue, catheterization time, hospital stay and complications rate.Statistically lower rate of iPCa (p = 0.03) was detected in the NEGATIVE MRI group (6.2%) in comparison with NO MRI group (14.8%). In multivariate logistic regression only presence of a preoperative negative mpMRI correlated (p = 0.04) as an independent predictive factor (OR 2.63; 95% CI: 1.02-6.75).

Conclusions: A negative mpMRI might be a useful tool to be included in a novel preoperative assessment to patients eligible for HoLEP with a suspicion of PCa in order to avoid an incidental PCa.
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http://dx.doi.org/10.5173/ceju.2019.1943DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6715077PMC
April 2019

Mini-invasive robotic assisted pyelolithotomy: Comparison between the transperitoneal and retroperitoneal approach.

Arch Ital Urol Androl 2019 Jul 2;91(2). Epub 2019 Jul 2.

Department of Robotic Urological Surgery, Abano Terme Hospital, Abano Terme.

Objective: To compare the retroperitoneal with the transperitoneal approach in a series of patients underwent to robotic-assisted pyelolithotomy (RP).

Materials And Methods: From January 2015 to December 2018 we evaluated 20 patients subjected to robotic pyelolithotomy; 11 patients were treated with retroperitoneal approach (RRP) and 9 with transperitoneal approach (TRP). For each patient intra and perioperative data were recorded: operative time (OT), blood loss (BL), length of hospital stay (LOS), stone clearance, post-operative complications and time to remove the drain. The presence of stone fragments < 4 mm was considered as stone free rate.

Results: The principal stone burden was greater in the TRP group than in the RRP group (48 ± 10 mm vs 32 ± 14 mm, p = 0.12). Preoperative hydronephrosis was present in 7 (64%) patients in RRP group and a mild hydronephrosis in 3 of TRP group (p = 0.04). The average operative time was higher in the RRP group than in the TRP group (203 ± 45 min vs 137 ± 31 min, p = 0.002). The average blood loss was 305 ± 175 ml in the RRP group versus 94 ± 104 ml in the TRP group (p = 0.005). The stone free rate was similar between the two groups, 36% (4 patients) in the RRP group and 44% (4 patients) in the TRP (p = 0.966).

Conclusions: RP appears to be a safe and effective minimally invasive treatment for some patients with renal staghorn calculi or urinary tract malformations. The TRP may give lower operative time and better results in terms of blood loss and length of hospital stay.
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http://dx.doi.org/10.4081/aiua.2019.2.107DOI Listing
July 2019

Comparison between "In-bore" MRI guided prostate biopsy and standard ultrasound guided biopsy in the patient with suspicious prostate cancer: Preliminary results.

Arch Ital Urol Androl 2019 Jul 2;91(2). Epub 2019 Jul 2.

Department of Robotic Urological Surgery, Abano Terme Hospital, Abano Terme.

Objectives: To evaluate the detection rate of prostate cancer (PCa) in patients who underwent to "in bore" Magnetic Resonance Imaging -guided prostate (MRI-GB) biopsy compared to the standard transrectal ultrasound guided prostate biopsy (TRUS-GB).

Materials And Methods: Between January 2017 and March 2015 a cohort of 39 consecutive patients was prospectively enrolled. All the patients underwent an "in-bore" guided MRI prostatic biopsy and subsequently ultrasound-guided standard prostate biopsy.

Results: Median age of patients was 65.5 years (SD ± 6.6), median total PSA serum level was 6.6 ng/ml (SD ± 4.1), median prostate total volume was 51.1 cc (SD ± 26.7). Thirty of 39 (76.9%) were biopsy-naïve patients while 7/39 (17.9%) had at least one previous negative random TRUS-GB; 2/39 (5.1%) patients were already diagnosed as PCa and were on active surveillance. In 18/39 (53.8%) men Pca was diagnosed; as regards the MRI-GB results related to the PI-RADS score, biopsies of PIRADS 3 lesions were positive in 5/18 cases (27.8%), while the number of positive cases of PI-RADS 4 and 5 lesions was 7/11 (63.6%) and 6/10 (60%)respectively. At the histological examination, 4/39 (10.3%) had a PCa ISUP grade group 1, 11/39 (28.2%) had a ISUP 2, 6/39(15.4%) had a ISUP grade group 3 and 2/39 (5.1%) had a ISUP 4-5.

Conclusions: MRI-GB represents a promising technique that may offer some of advantages compared to standard systematic TRUSGB. Our preliminary experience in MRI-GB resulted safe and feasible and represents a viable procedure for the diagnosis and characterization of PCa.
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http://dx.doi.org/10.4081/aiua.2019.2.87DOI Listing
July 2019

Can preoperative multiparametric MRI avoid unnecessary prostate biopsies before holmium laser enucleation of the prostate? Preliminary results of a multicentric cohort of patients.

Minerva Urol Nefrol 2019 Oct 4;71(5):524-530. Epub 2019 Jun 4.

Department of Urology, Abano Terme Hospital, Abano Terme, Padua, Italy.

Background: Holmium laser enucleation of the prostate (HoLEP) is a surgical technique that allows to safely and effectively treat bladder outlet obstruction due to benign prostate enlargement and retrieve an adequate surgical specimen. We investigated the role of multiparametric magnetic resonance imaging of the prostate (mpMRI) as a tool to exclude incidental prostate cancer (iPCa) and to compare mpMRI alone with a contextual transrectal ultrasound guided biopsy (TRUS-GB).

Methods: Retrospective multicentric evaluation of 244 patients underwent to HoLEP with a suspicion of prostate cancer (PCa) due to raised PSA and/or abnormal digital rectal examination (DRE) and a negative mpMRI (PI-RADS score <3), was performed. Of these, 118 patients had only a negative mpMRI (MRI group) while 126 had a negative mpMRI and a contextual preoperative negative TRUS-GB (MRI + TRUS-GB group). Comparison between the two groups, univariate and multivariate analysis were conducted in order to identify any predictive factors of iPCa.

Results: Median age, PSA, prostate volume and PSA density were 64.0 years (IQR: 58.0-69.0), 6.10 ng/mL (IQR: 4.76-9.65), 86.0 cc (IQR: 65.0-115.0), 50.0 cc (IQR: 37.5-80.0) and 0.08 ng/mL/cc (IQR: 0.06-0.10), respectively. In surgical specimen, iPCa was detected in 21 cases (8.8%). No statistically differences between MRI and MRI + TRUS-GB group were found in terms of iPCa (7.6% and 8.5%, respectively), pathological T stage and ISUP Grade Group. A contextual TRUS-GB added to mpMRI did not correlate to iPCa either at uni- and multivariate analysis while a significant correlation of a PSA density >0.15 ng/mL/cc was found only at univariate analysis.

Conclusions: Including a mpMRI in clinical evaluation of patients eligible to HoLEP with a preoperative PCa suspicion leads to low the rates of iPCa and might avoid unnecessary TRUS-GB.
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http://dx.doi.org/10.23736/S0393-2249.19.03463-5DOI Listing
October 2019

Robot-Assisted Radical Cystectomy with Intracorporeal Orthotopic Ileal Neobladder: A Safe Strategy in Elderly Patients? Results of Propensity Score Matching in a Single High-Volume Center.

Surg Technol Int 2019 May;34:302-309

Robotic Urology and Mini Invasive Urologic Surgery Unit, Policlinico Abano TermeAbano Terme Padua (PD), Italy.

Aim: To compare surgical, functional and early survival outcomes for robot-assisted radical cystectomy (RARC) with intracorporeal orthotopic neobladder (ONB) reconstruction in patients age = 75 y to those in patients age < 75 y using Propensity Score Matching.

Methods: We collected data from 15 patients age = 75 y from among 60 consecutive RARC with ONB reconstruction performed at our institution from January 2015 to July 2018. All procedures were performed by a single surgeon after modular training under the supervision of a skilled surgeon. Demographic, surgical, functional and survival data were prospectively collected and compared to the corresponding data from 15 patients from the same series age < 75 y, matched according to the ASA score, body mass index, clinical stage and associated carcinoma in situ using Propensity Score Matching.

Results: There were no significant differences between the two groups with regard to preoperative parameters, such as ASA score, BMI and preoperative stage. The same homogeneity was found for intraoperative parameters, such as operation time, number of nodes retrieved and ONB time. The only statistically significant difference noted was in the percentage of nerve-sparing procedures, which was higher in the younger patient group (p < 0.001). The percentages of early and late postoperative complications were higher in the older patients, but the differences were not statistically significant. Moreover, there were no differences among the two populations in terms of functional outcomes (daytime and nighttime continence, potency), or in either cancer-specific or overall mortality.

Conclusions: RARC with totally intracorporeal ONB diversion can be offered to older patients with an expectation of good surgical, functional and early survival outcomes, although further studies with a larger sample size will be needed to confirm these results.
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May 2019

Minimally Invasive Pyelolithotomy: Comparison of Robot-assisted and Laparoscopic Techniques.

Surg Technol Int 2019 May;34:296-301

Department of Robotic Urological Surgery, Abano Terme Hospital, Abano Terme (PD), Italy.

Objectives: To compare the perioperative and short-term outcomes of robotic pyelolithotomy (RP) and laparoscopic pyelolithotomy (LP) for the treatment of renal stones.

Materials And Methods: We retrospectively evaluated 39 patients who underwent robotic or laparoscopic pyelolithotomy from January 2015 to December 2018.

Results: The preoperative characteristics of the two groups were comparable. The mean operative time was 173 ± 51 and 182 ± 62 min in the RP and LP groups, respectively (p=0.6). Blood loss and length of hospital stay with the robotic approach were lower than those with the laparoscopic approach (210 ± 180 ml vs. 639 ± 412 ml, p<0.001, and 3.8 ± 3 days vs. 7.3 ± 2.8 days, p=0.001). A complete stone-free status was achieved in 17 (85%) patients in the RP group and 8 (42%) in the LP group (p=0.01). Post-operative complications with the two approaches were also similar.

Conclusions: In some selected cases, laparoscopic and robotic pyelolithotomy are alternative procedures for large, multiple and complex kidney stones. The robotic approach was associated with less intraoperative blood loss and fewer days of hospitalization compared to the laparoscopic method, and also gives a better stone-free rate.
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May 2019

Ejaculation Sparing Bladder Neck Incision with Holmium Laser in Patients with Urinary Symptoms and Small Prostates: Short-Term Functional Results.

Urol Int 2019 9;103(1):102-107. Epub 2019 Apr 9.

Department of Robotic Urological Surgery, Abano Terme Hospital, Abano Terme, Italy.

Background: The treatment options for male lower urinary tract symptoms (LUTS) widely range from self-monitoring to oral medications to surgical procedures. As far as concerns surgical treatment of obstructive LUTS, transurethral incision of the prostate is considered as the gold standard in patients with mild benign prostatic enlargement.

Objectives: The aim of our study is to describe this novel approach to perform ejaculation sparing Holmium laser bladder neck incision (ES-HoBNI), with particular regard to its effect on ejaculation and LUTS relief.

Methods: We evaluated prospective clinical data from 143 consecutive patients who underwent ES-HoBNI at our institution from January 2012 to February 2018. Procedures were performed with a continuous flow 26 Ch resectoscope and a 550 µm holmium laser end-fire fiber. The stenotic bladder neck was deeply incised at 3 and 9'o clock down to the prostatic capsule in a retrograde direction to either side in front of the veromontanum.

Results: Median Qmax, postvoid residual volume, International Prostate Symptom Score, and quality of life were 9 mL/s (7.4-10.2), 130 mL (100-190), 15 (13-19), and 3 (2-4), respectively. In total, 110 (76.9) reported regular anterograde ejaculation. Median operative time was 20 min (15-26). Median catheterization time and hospital stay were 3 days (3-4) and 22 h (20-24), respectively. Moreover, we have compared the frequency of anterograde ejaculation, which slightly increases after ES-HoBNI (77 vs. 81.2%) when compared to baseline data, despite not reaching statistical significancy.

Conclusions: ES-HoBNI is a safe, reproducible technique to relieve obstructive LUTS in men with small prostates while preserving ejaculation in younger and sexually active individuals.
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http://dx.doi.org/10.1159/000499410DOI Listing
February 2020

Pubis bone osteomyelitys after robotic radical cystectomy with continent intracorporeal urinary diversion: Multidisciplinary approach to a complex situation.

Arch Ital Urol Androl 2019 Mar 29;91(1):63-67. Epub 2019 Mar 29.

Robotic Urology and Mini Invasive Urologic Surgery Unit, Abano Terme Hospital, Abano Terme (PD).

Pubic bone osteomyelitis is a rare infectious condition which is characterized by a complex diagnostic and therapeutic workup, due to its various clinical manifestations. Among the many causes of this condition, urinary fistula is the most common in case of previous urological procedures. In order to solve this complication, it is crucial to treat both the fistula and (moreover) the infectious locus arising from it, because treating the fistula alone does not provide any control on the infectious noxa. We present the first case of pubic bone osteomyelitis arising from a urinary fistula after a robotic radical cystectomy with intra corporeal continent neobladder, which has been successfully treated through a multidisciplinary approach.
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http://dx.doi.org/10.4081/aiua.2019.1.63DOI Listing
March 2019

Posterior muscle-fascial reconstruction and knotless urethro-neo bladder anastomosis during robot-assisted radical cystectomy: Description of the technique and its impact on urinary continence.

Arch Ital Urol Androl 2019 Mar 29;91(1):5-10. Epub 2019 Mar 29.

Department of Urology, Policlinic of Abano Terme (Padova); Department of Urology, S. Orsola-Malpighi Hospital, University of Bologna.

Objective: The aim of our study is to describe the use of posterior muscle-fascial reconstruction during urethro-ileal anastomosis in bladder cancer (BC) patients submitted to robot-assisted radical cystectomy (RC) with orthotopic neobladder (ON) and its role in facilitating day- and night-time continence recovery during a 12-month follow up.

Materials And Methods: We prospectively collected data from 42 consecutive patients who underwent RARC with totally intracorporeal ON and extended pelvic lymph node dissection (PLND) at our Institution from June 2014 to October 2017. Prior to the urethro-neobladder anastomosis we reconstructed the Denonvilliers Fascia (DF) as previously described for radical prostatectomy using a bidirectional barbed suture. Day and night-time recovery rates were reported at 3, 6 and 12 months after surgery, with continent patients being those using either no urinary pads or 1 safety pads.

Results: Median age at surgery was 63 yrs, 41 (97.6%) patients were male. 28 (66.7%) patients presented a clinical T2 disease. Median operative time and median ON reconstruction time were 450 minutes and 180 minutes respectively. 13 (31%) individuals had non-organ confined disease, with 11 (26.2%) patients with positive lymph nodes (median 3 positive lymph nodes) and 2 (4.8%) with non-urothelial cancer at final pathologic examination. Median hospital stay and median catheterization time were 7 (IQR 7-8) and 21 (IQR 19-22). During first 30 post-operative days we recorded 7 (16.7%) low-grade Clavien and 2 (4.8%) IIIa Clavien complications, whereas between 30 and 90 postoperative days we recorded 4 (9.5%) low-grade, 4 (9.5) IIIa and 1 (2.4%) IIIb complications. Day-time and night-time continence rates were 61.9% vs 52.4%, 73.8% vs 64.3% and 90.5% vs 73.8% at three, six and twelve months follow up. Day-time continence was significantly superior in the younger group (97% vs 57%, p 0.01); night-time continence rates were also superior among < 70 yrs patients, despite not reaching statistical significance (77% vs 57%, p 0.3).

Conclusions: Posterior muscle-fascial reconstruction aids continence recovery in BC patients undergoing RARC with ON, with younger and fitter patients most benefitting from ON reconstruction.
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http://dx.doi.org/10.4081/aiua.2019.1.5DOI Listing
March 2019

"In-bore" MRI-guided Prostate Biopsy Using an Endorectal Nonmagnetic Device: A Prospective Study of 70 Consecutive Patients.

Clin Genitourin Cancer 2017 06 1;15(3):417-427. Epub 2017 Feb 1.

Department of Urology, Abano Policlinic Hospital, Padua, Italy.

Introduction: We investigated the diagnostic performance of in-bore endorectal magnetic resonance imaging-guided biopsy (MRI-GB) with a 1.5-T MRI scanner using a 32-channel coil in patients with suspected prostate cancer (PCa).

Patients And Methods: Seventy patients with ≥ 1 suspicious area found on the preliminary multiparametric MRI scan were enrolled. The index lesion was defined as the lesion with the greatest Prostate Imaging Reporting and Data System, version 2 (PIRADS-v2), score. MRI-GBs were performed with a nonmagnetic biopsy device, needle guide, and titanium double-shoot biopsy gun with dedicated software for needle tracking. Clinically significant PCa was defined as the presence of Gleason score ≥ 7 in the biopsy specimen.

Results: Seventy index lesions were scheduled for MRI-GB. The median PIRADS-v2 score and the median number of cores per patient was 4 of 5 (interquartile range, 3-5) and 2 (interquartile range, 1-3), respectively. The PCa detection rate was 45.7%. Of the 70 patients, 24 (75%) had clinically significant PCa, with a significant correlation between the PIRADS-v2 score and the Gleason score in the MRI-GB cores (r = 0.839; 95% confidence interval, 0.535-0.951; P = .003). According to the PIRADs-v2 scheme, the proportion of PCa in the central and anterior regions of the gland was greater in the entire population and in the subgroup of patients with a history of negative transrectal ultrasound-guided biopsy findings (P ≤ .01 for all). On multivariate analysis, a PIRADS-v2 score of 5 of 5 correlated significantly with the likelihood of PCa at biopsy (hazard ratio, 4.69; 95% confidence interval, 0.92-23.74; P = .04). No major complications were recorded.

Conclusion: MRI-GB has a high detection rate for PCa, especially for lesions located in the central and anterior regions of the prostate.
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http://dx.doi.org/10.1016/j.clgc.2017.01.013DOI Listing
June 2017

Italian Prostate Biopsies Group: 2016 Updated Guidelines Insights.

Anticancer Res 2017 02;37(2):413-424

Institute of Urology, S. Orsola - Malpighi Hospital, University of Bologna, Bologna, Italy.

Aim: To present a summary of the updated guidelines of the Italian Prostate Biopsies Group following the best recent evidence of the literature.

Materials And Methods: A systematic review of the new data emerging from 2012-2015 was performed by a panel of 14 selected Italian experts in urology, pathology and radiology. The experts collected articles published in the English-language literature by performing a search using Medline, EMBASE and the Cochrane Library database. The articles were evaluated using a systematic weighting and grading of the level of the evidence according to the Grading of Recommendations Assessment, Development and Evaluation framework system.

Results: An initial prostate biopsy is strongly recommended when i) prostate specific antigen (PSA) >10 ng/ml, ii) digital rectal examination is abnormal, iii) multiparametric magnetic resonance imaging (mpMRI) has a Prostate Imaging Reporting and Data System (PIRADS) ≥4, even if it is not recommended. The use of mpMRI is strongly recommended only in patients with previous negative biopsy. At least 12 cores should be taken in each patient plus targeted (fusion or cognitive) biopsies of suspicious area (at mpMRI or transrectal ultrasound). Saturation biopsies are optional in all settings. The optimal strategy for reducing infection complications is still a controversial topic and the instruments to reduce them are actually weak. The adoption of Gleason grade groups in adjunction to the Gleason score when reporting prostate biopsy results is advisable.

Conclusion: These updated guidelines and recommendations are intended to assist physicians and patients in the decision-making regarding when and how to perform a prostatic biopsy.
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http://dx.doi.org/10.21873/anticanres.11333DOI Listing
February 2017

Empiric antibiotics therapy for mildly elevated prostate specific antigen: Helpful to avoid unnecessary biopsies?

Arch Ital Urol Androl 2014 Sep 30;86(3):202-4. Epub 2014 Sep 30.

Urology, Casa di Cura Giovanni XXIII Monastier, Treviso.

Purpose: The management of mildly elevated (4.0-10.0 ng/ml) prostate specific antigen (PSA) is uncertain. Immediate prostate biopsy, antibiotic treatment, or monitoring PSA level for 1-3 months is still in controversy.

Materials And Methods: We retrospectively analysed the effect of empiric antibiotics on an increased PSA in a mono-institutional study. We analysed the data of 100 patients with a PSA of 4-10 ng/ml and normal digital rectal examination undergoing their first prostate biopsy. Patients were divided in two different cohorts. One cohort was submitted to antibiotic therapy (Levoxacin 500 mg daily for 20 days) and both cohort had a re-dosing of PSA before the prostate biopsy.

Results: Average age of the whole group of patients was 66.48 ± 8.32 years and their average initial PSA level was 6.67 ± 1.57 ng/mL. In the treated group (N = 49) 29 patients had a decreasing PSA value from mean baseline PSA value of 6.6 ± 1.54 ng/ml to the re-dosed mean PSA level of 5.4 ± 1,61 ng/ml (p = 0.7); 20 patients didn't experience a decrease PSA value, with a mean PSA level of 6.9 ± 1.68 ng/ml. In the control group (N = 51), 30 patients had a decrease of PSA level from mean baseline PSA level of 6.5 ± 1,59 ng/ml to a re-dosed PSA level of 5.5 ± 1.57 ng/ml; 21 patients didn't experience a decrease of PSA value, with a mean PSA level of 6.7 ± 1.71 ng/ml. Multivariate analysis of age, PSA changes, antibiotics therapy and biopsy results (presence or absence of cancer) revealed no significant difference between the two cohorts. Sepsis after biopsy occurred in 3 patient in the antibiotics group (6%) and in one of the control group (2%).

Conclusions: The study, even with some limitations, does not seem to show an advantage due to the administration of antibacterial therapy to reduce PSA values before prostate biopsy and subsequently to reduce unnecessary prostate biopsies.
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http://dx.doi.org/10.4081/aiua.2014.3.202DOI Listing
September 2014

Observational database serenoa repens (DOSSER): overview, analysis and results. A multicentric SIUrO (Italian Society of Oncological Urology) project.

Arch Ital Urol Androl 2012 Sep;84(3):117-22

Clinica Urologica, Policlinico Sant'Orsola-Malpighi, Università di Bologna, Italy.

Objective: Men affected with Benign Prostate Hyperplasia (BPH) and Lower Urinary Tract Symptoms (LUTS) are demonstrating to require an increasing amount of attention from Urologists and Primary-care Physicians. Over the years, common urological medications were based on either alpha-blockers and/or 5alpha-reductase inhibitors. During the last decade the phytotherapeutic drugs are gaining a more often central role in the BPH and LUTS managements. In particular, clinical usage of the extract of the dried ripe fruit of serenoa repens with a dosage of 320 mg per day, has shown its clinical efficacy and its superiority. Purpose of this multicentric observational retrospective study was to evaluate all the urological aspects (clinical, biochemical, instrumental and pathological) of patients affected by BPH and LUTS, with a PSA < 10 ng/ml, a previous negative prostatic biopsy and in therapy with a daily dose of 320/640 mg of serenoa repens.

Patients And Methods: The study was conducted in 8 different centers throughout Italy from September 2010 to November 2011. Data and information of 298 men with an average of 63 years (mean PSA of 5.4 ng/ml and mean prostate gland volume of 57 cc), affected by non-acute urinary symptoms caused by BPH, a dosed PSA level inferior to 10 ng/ml, a previous negative prostate biopsy and in therapy with serenoa repens alone or associated to an alpha-blocker, were retrospectively inserted in an extensive on-line SIUrO Database. Comprehensive questionnaires were filled in for each patient at 3 and 6 months of follow-up. Each questionnaire contained various sections, each of them composed by several items: dosed PSA levels, uroflowmetry, International Prostate Symptoms Score (IPSS), International Index of Erectile Function (IIEF-5), trans-rectal ultrasound (TRUS) patterns, digital rectal examinations (DRE) aspects, previous prostate bioptical results (histology) and side effects.

Results: PSA levels weren't subjected to an increase, revealing a stabilizing or downward trend. Percentage of patients with PSA below the level of 4 ng/mL was lower at the end of the study. The overall changes in the uroflowmetry were similar and parallel both in the group with only serenoa repens intake and in the group with serenoa repens plus alpha-blocker. The mean medium flow and the mean maximum flow had a slightly increase along the observation time. There was a substantial decreasing in the amount of patients presenting severe prostatic symptoms. Patients reported through the IIEF-5 score a sexual activity substantially unchanged after 6 months of follow-up. The serenoa repens intake resulted in an improvement of the "inflammatory-like reports", in terms of ultrasound patterns, DRE and bioptical features.

Conclusions: serenoa repens demonstrated its efficacy reducing dysuria with minimal side effects. Further prospective studies might confirm its stabilization or lowering role on PSA levels in this cohort of patients and its possible clinical anti-inflammatory action.
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September 2012