Publications by authors named "Lorenzo Bianchi"

70 Publications

The Role of [F]Fluciclovine PET/CT in the Characterization of High-Risk Primary Prostate Cancer: Comparison with [C]Choline PET/CT and Histopathological Analysis.

Cancers (Basel) 2021 Mar 29;13(7). Epub 2021 Mar 29.

Nuclear Medicine Unit, Istituto di Ricovero e Cure a Carattere Scientifico (IRCCS), Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.

The primary aim of the study was to evaluate the role of [F]Fluciclovine PET/CT in the characterization of intra-prostatic lesions in high-risk primary PCa patients eligible for radical prostatectomy, in comparison with conventional [C]Choline PET/CT and validated by prostatectomy pathologic examination. Secondary aims were to determine the performance of PET semi-quantitative parameters (SUVmax; target-to-background ratios [TBRs], using abdominal aorta, bone marrow and liver as backgrounds) for malignant lesion detection (and best cut-off values) and to search predictive factors of malignancy. A six sextants prostate template was created and used by PET readers and pathologists for data comparison and validation. PET visual and semi-quantitative analyses were performed: for instance, patient-based, blinded to histopathology; subsequently lesion-based, un-blinded, according to the pathology reference template. Among 19 patients included (mean age 63 years, 89% high and 11% very-high-risk, mean PSA 9.15 ng/mL), 45 malignant and 31 benign lesions were found and 19 healthy areas were selected ( 95). For both tracers, the location of the "blinded" prostate SUVmax matched with the lobe of the lesion with the highest pGS in 17/19 cases (89%). There was direct correlation between [F]Fluciclovine uptake values and pISUP. Overall, lesion-based ( 95), the performance of PET semiquantitative parameters, with either [F]Fluciclovine or [C]Choline, in detecting either malignant/ISUP2-5/ISUP4-5 PCa lesions, was moderate and similar (AUCs ≥ 0.70) but still inadequate (AUCs ≤ 0.81) as a standalone staging procedure. A [F]Fluciclovine TBR-L3 ≥ 1.5 would depict a clinical significant lesion with a sensitivity and specificity of 85% and 68% respectively; whereas a SUVmax cut-off value of 4 would be able to identify a ISUP 4-5 lesion in all cases (sensitivity 100%), although with low specificity (52%). TBRs (especially with threshold significantly higher than aorta and slightly higher than bone marrow), may be complementary to implement malignancy targeting.
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http://dx.doi.org/10.3390/cancers13071575DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8037300PMC
March 2021

Diagnostic performance of MRI/TRUS fusion-guided biopsies vs. systematic prostate biopsies in biopsy-naïve, previous negative biopsy patients and men undergoing active surveillance.

Minerva Urol Nephrol 2021 Mar 26. Epub 2021 Mar 26.

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

Background: We aimed to assess the detection rate of overall PCa and csPCa, and the clinical impact of MRI/TRUS fusion targeted biopsy (FUSION-TB) compared to TRUS guided systematic biopsy (SB) in patients with different biopsy settings.

Methods: 305 patients were submitted to FUSION-TB, divided into three groups: biopsy naïve patients, previous negative biopsies and patients under active surveillance (AS). All patients had a single suspicious index lesion at mpMRI. Within these groups, we enrolled men underwent both to FUSION-TB and SB in the same session. Overall detection rate of PCa and csPCa for the two biopsy methods were compared separately between the three groups of patients.

Results: No differences were observed between the three groups concerning clinical and radiological characteristics. We found no differences in terms of overall PCa detection (66 % vs. 63,8 %, p=0,617) and csPCa detection (56,4 % vs. 51,1 %; p=0,225) concerning biopsy naïve patients. In patients previously submitted to a negative biopsy, FUSION-TB showed higher detection rate of csPCa compared to SB alone (41,3 % vs 27 % respectively, p=0.038). In patients under AS, no differences were observed between FUSION-TB and SB in terms of overall PCa (50 % vs. 73,1 %) and csPCa (30,8 % vs. 26,9 %, respectively; p=0,705) detection.

Conclusions: Our results suggest that in men with previously negative biopsy, FUSION-TB showed significantly higher diagnostic performance for clinically significant PCa as compared to SB. Combination of FUSION-TB and SB should be recommended in AS population to offer higher chance of csPCa diagnosis.
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http://dx.doi.org/10.23736/S2724-6051.20.03758-3DOI Listing
March 2021

PSMA PET/CT to stage high-risk prostate cancer: is already the time to replace conventional imaging?

Minerva Urol Nephrol 2021 Feb;73(1):135-136

Division of Urology, Sant'Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.

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http://dx.doi.org/10.23736/S2724-6051.21.04343-5DOI Listing
February 2021

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

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

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

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

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

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

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

Percutaneous tumor ablation versus partial nephrectomy for small renal mass: the impact of histologic variant and tumor size.

Minerva Urol Nefrol 2020 Dec 1. Epub 2020 Dec 1.

Department of Urology, Sant' Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.

Background: To investigate recurrence rates in patients with T1 renal cell carcinoma (RCC) undergone partial nephrectomy (PN), radiofrequency ablation (RFA) or cryoablation (Cryo).

Methods: We retrospectively evaluated data from 665 (81.4%), 68 (8.3%) and 83 (10.3%) patients who underwent PN, RFA and Cryo, respectively. Kaplan-Meier curves depict recurrence-free survival (RFS) rates in the overall population and after stratifying according to tumor's histology (namely, clear cell RCC and non-clear RCC) and size (namely < 2 cm and 2-4 cm). Multivariable Cox regression model was used to identify predictors of recurrence. Cumulative-incidence plots evaluated disease recurrence and other causes of mortality (OCM).

Results: Patients referred to PN experienced higher RFS rate compared to those treated with RFA and Cryo at 60-month in the overall population (96.4% vs. 79.4 % vs. 87.8%), in patients with clear cell RCC (93.3% vs 75% vs. 80.4%) and in those with tumor of 2-4 cm (97.3% vs 78% and 84.4%; all p≤0.01). In patients with non-clear cell RCC and with tumor <2cm, PN showed higher RFS rate at 60-month as compared to RFA (97.9% vs 84.4% and 95.1% vs 78.1%, respectively; all p≤0.02). At multi-variate analysis, ablative techniques (RFA [HR=4.03] and Cryo [HR=3.86]) were independent predictors of recurrence (all p<0.03). At competing risks analysis, recurrence rate and OCM were 7.3% and 1.3% vs 25% and 7.2% vs 19.9% and 19.9% for PN, RFA and Cryo, respectively.

Conclusions: PN and Cryo showed similar RFS rates in patients with non-clear cell RCC and with renal mass < 2cm.
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http://dx.doi.org/10.23736/S0393-2249.20.03983-1DOI Listing
December 2020

Postoperative outcomes of Fast Track enhanced recovery protocol in open radical cystectomy: comparison with standard management in a high-volume center and Trifecta proposal.

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

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

Background: We aimed at comparing perioperative outcomes in patients submitted to radical cystectomy followed by Fast Track (FT) protocol or standard management, and propose a definition of Trifecta, to improve standardized quality assessment for RC.

Methods: We considered 191 patients submitted to RC between January 2017 and January 2019. Patients followed FT or standard management according to surgeon's preference. Preoperative and intraoperative characteristics, alongside with postoperative outcomes were compared between the two groups. Trifecta was defined as follows: inhospital stay (HS) ≤ 10 days, time to defecation (TtD) below the overall mean and no major (≥ Clavien-Dindo grade III) complications. Finally, Trifecta achievement rates were assessed in both groups.

Results: 75 patients (39%) followed the FT protocol and 116 (61%) standard management. The two groups were homogeneous for preoperative, intraoperative and pathological characteristics. Patients in the FT group had shorter TtD (5 vs. 6 days p=0.006), HS (12 vs. 14 days p=0.008) and lower readmission rate (8% vs. 19% p=0.04). Early complication rates and grades were similar, while less late complications were found in FT group (6.7% vs. 21.6% p=0,006). Trifecta achievement rate was higher for FT group (31% vs. 8% p<0.001). Single-item failure percentages for HS, TtD and major grade complications were respectively 90%, 60% and 19%, with no difference between the two groups.

Conclusions: FT protocol can safely consent faster bowel recovery and earlier discharge after RC, plus reducing readmission rates. Using a Trifecta incorporating essential perioperative outcomes, could improve standardized quality assessment for RC.
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http://dx.doi.org/10.23736/S0393-2249.20.03843-6DOI Listing
November 2020

The role of multiparametric MRI in active surveillance for low-risk prostate cancer: The ROMAS randomized controlled trial.

Urol Oncol 2020 Nov 13. Epub 2020 Nov 13.

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

Background: We aim to evaluate the impact of multiparametric magnetic resonance imaging and fusion-target biopsy for early reclassification of patients with low-risk Prostate Cancer in a randomized trial.

Materials And Methods: Between 2015 and 2018, patients diagnosed with Prostate Cancer after random biopsy fulfilling PRIAS criteria were enrolled and centrally randomized (1:1 ratio) to study group or control group. Patients randomized to study group underwent multiparametric magnetic resonance imaging at 3 months from enrollment: patients with positive findings (PIRADS-v2>2) underwent fusion-target biopsy; patients with negative multiparametric magnetic resonance imaging or confirmed ISUP - Grade Group 1 at fusion-target biopsy were managed according to PRIAS schedule and 12-core random biopsy was performed at 12 months. Patients in control group underwent PRIAS protocol, including a confirmatory 12-core random biopsy at 12 months. Primary endpoint was a reduction of reclassification rate at 12-month random biopsy in study group at least 20% less than controls. Reclassification was defined as biopsy ISUP Grade Group 1 in >2 biopsy cores or disease upgrading.

Results: A total of 124 patients were randomized to study group (n = 62) or control group (n = 62). Around 21 of 62 patients (34%) in study group had a positive multiparametric magnetic resonance imaging, and underwent fusion-target biopsy, with 11 (17.7%) reclassifications. Considering the intention-to-treat population, reclassification rate at 12-month random biopsy was 6.5% for study group and 29% for control group, respectively (P < 0.001).

Conclusions: The early employment of multiparametric magnetic resonance imaging for active surveillance patients enrolled after random biopsy consents to significantly reduce reclassifications at 12-month random biopsy.
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http://dx.doi.org/10.1016/j.urolonc.2020.10.018DOI Listing
November 2020

Augmented Reality to Guide Selective Clamping and Tumor Dissection During Robot-assisted Partial Nephrectomy: A Preliminary Experience.

Clin Genitourin Cancer 2020 Sep 18. Epub 2020 Sep 18.

Department of Urology, University of Bologna, Azienda Ospedaliero, Universitaria di Bologna, Bologna, Italia; Department of Experimental, Diagnostic, and Specialty Medicine (DIMES), Cardio-Nephro-Thoracic Sciences Doctorate, University of Bologna, Bologna, Italy.

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http://dx.doi.org/10.1016/j.clgc.2020.09.005DOI Listing
September 2020

Long-term outcomes after plaque incision and grafting for Peyronie's disease: comparison of porcine dermal and bovine pericardium grafts.

Andrology 2021 01 11;9(1):269-276. Epub 2020 Oct 11.

Department of Andrology, S.Orsola University Hospital, Bologna, Italy.

Background: Plaque incision and grafting (PEG) is one of the mainstays in surgical therapy for severe penile curvature in Peyronie's disease (PD). Different kinds of grafts are available for covering albugineal defects during PEG, both allografts and xenografts. However, to date, none of these proved superior to others.

Objectives: To compare two different types of xenograft, porcine dermal matrix and bovine pericardium matrix in PEG for PD.

Materials And Methods: From 2010 to 2019, 63 patients with PD underwent PEG, using porcine dermal (n = 25; Group 1) and bovine pericardium (n = 38; Group 2) grafts. Long-term outcomes were evaluated through multi-disciplinary questionnaires administration by phone interview. The following items were considered: correction of penile bending, quality of erection, intercourse ability, penile shortening, and sensitiveness. Overall satisfaction and impact of surgery on sexual activity and quality of life were also investigated.

Results: Plaque median (IQR) size was 29 (22-33) mm and was smaller in Group 1 (27.5 vs. 31 mm; P = .03). Complete follow-up data were available for 53 patients (84%). Considering post-operative outcomes, no differences were found when considering ED rates, penile shortening, sensitiveness, complications, and penile straightening (all P > .1). Patients in Group 2 were more likely to have palpable penile nodules at follow-up (20.6 vs. 0%; P = .03). However, patient's post-operative sexual life satisfaction was consistent between the two groups, with just 1 (5.3) and 8 (23.5) patients in Group 1 and 2 respectively referring a worsening in sexual life satisfaction (P = 0.2). At follow-up, 84.9% of patients that would still undergo surgery for PD, with no statistical difference between the two groups (P = .4).

Conclusions: Corporoplasty with PEG is an effective treatment for men with PD. Porcine dermal and bovine pericardium xenografts seem to have similar long-term outcomes.
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http://dx.doi.org/10.1111/andr.12912DOI Listing
January 2021

Real-time Augmented Reality Three-dimensional Guided Robotic Radical Prostatectomy: Preliminary Experience and Evaluation of the Impact on Surgical Planning.

Eur Urol Focus 2020 Aug 31. Epub 2020 Aug 31.

Department of Urology, Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni 15, Bologna- Italia; Department of Experimental, Diagnostic and Specialty Medicine (DIMES), Cardio-Nephro-Thoracic Sciences Doctorate, University of Bologna, Bologna, Italy.

Background: Augmented reality (AR) is a novel technology adopted in prostatic surgery.

Objective: To evaluate the impact of a 3D model with AR (AR-3D model), to guide nerve sparing (NS) during robot-assisted radical prostatectomy (RARP), on surgical planning.

Design, Setting, And Participants: Twenty-six consecutive patients with diagnosis of prostate cancer (PCa) and multiparametric magnetic resonance imaging (mpMRI) results available were scheduled for AR-3D NS RARP.

Intervention: Segmentation of mpMRI and creation of 3D virtual models were achieved. To develop AR guidance, the surgical DaVinci video stream was sent to an AR-dedicated personal computer, and the 3D virtual model was superimposed and manipulated in real time on the robotic console.

Outcome Measurements And Statistical Analysis: The concordance of localisation of the index lesion between the 3D model and the pathological specimen was evaluated using a prostate map of 32 specific areas. A preliminary surgical plan to determinate the extent of the NS approach was recorded based on mpMRI. The final surgical plan was reassessed during surgery by implementation of the AR-3D model guidance.

Results And Limitations: The positive surgical margin (PSM) rate was 15.4% in the overall patient population; three patients (11.5%) had PSMs at the level of the index lesion. AR-3D technology changed the NS surgical plan in 38.5% of men on patient-based and in 34.6% of sides on side-based analysis, resulting in overall appropriateness of 94.4%. The 3D model revealed 70%, 100%, and 92% of sensitivity, specificity, and accuracy, respectively, at the 32-area map analysis.

Conclusions: AR-3D guided surgery is useful for improving the real-time identification of the index lesion and allows changing of the NS approach in approximately one out of three cases, with overall appropriateness of 94.4%.

Patient Summary: Augmented reality three-dimensional guided robot-assisted radical prostatectomy allows identification of the index prostate cancer during surgery, to tailor the surgical dissection to the index lesion and to change the extent of nerve-sparing dissection.
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http://dx.doi.org/10.1016/j.euf.2020.08.004DOI Listing
August 2020

Negative 11C-choline PET/computed tomography imaging in restaging of patients with prostate cancer with serum prostate-specific antigen values >20 ng/mL.

Nucl Med Commun 2020 Nov;41(11):1178-1182

Service of Nuclear Medicine, S. Orsola Hospital, University of Bologna.

Objective: Several studies have reported about the performance of C-choline-PET/computed tomography (CT) (choline) in patients with biochemical recurrent (BCR) prostate cancer, but there is a lack of information regarding negative choline in the same clinical setting. Our aim was to retrospectively analyse negative choline in a cohort of BCR-patients with high prostate-specific antigen (PSA).

Methods And Results: We retrospectively analysed all choline-scans performed at two high-volume imaging centres between 2005 and 2018, selecting those of interest according to the following inclusion criteria: (1) proven prostate cancer treated either with radical prostatectomy or primary external beam radiation therapy (EBRT), (2) BCR after radical prostatectomy or EBRT, (3) PSA serum values >20 ng/mL at the time of scan and (4) scan reported as negative for active disease. Overall, among 5792 scans performed for BCR-prostate cancer, 14 matched the inclusion criteria and were classified as follows: 5/14(36%) inaccurate reports, 3/14(21%) questionable underestimation of positive findings, originally described as unclear, 6/14(43%) negatives. Choline showed a high detection rate in BCR-prostate cancer patients with PSA >20 ng/mL.

Conclusions: Although negative reports can be found in this clinical setting, in our review various disease-relevant findings were identified in more than half of the cases originally reported as negative warranting a double reading in such cases to avoid false-negative reports.
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http://dx.doi.org/10.1097/MNM.0000000000001266DOI Listing
November 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

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

Secondary bladder amyloidosis due to Crohn's disease: a case report and literature review.

CEN Case Rep 2020 11 22;9(4):413-417. Epub 2020 Jun 22.

Department of Urology, S. Orsola-Malpighi University Hospital, Via P. Palagi 9, 40138, Bologna, Italy.

The presence of amyloid deposits in bladder walls is a rare histological finding. It can be linked to primary (limited to bladder) or secondary (systemic, associated with chronic inflammatory disorders) amyloidosis. Secondary bladder involvement is very uncommon; it usually presents with gross hematuria, which is challenging to manage, due to frail bladder mucosa and/or necrosis. We present a case of 54-year old man with secondary bladder amyloidosis due to Crohn's disease, that caused gross hematuria and severe anemia, which was managed conservatively by endoscopic transurethral resection, diatermocoagulation, clot evacuation and urinary drainage by bilateral percutaneous nephrostomy, with spontaneous resolution. Secondary bladder amyloidosis is a rare condition that presents with severe hematuria, difficult to control with standard management. Owing to chronic nature of the disease, treatment should be aimed to a conservative approach whenever possible. In case of failure, invasive procedures should be considered as salvage therapies.
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http://dx.doi.org/10.1007/s13730-020-00497-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7502084PMC
November 2020

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

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

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

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

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

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

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

The Impact of 3D Digital Reconstruction on the Surgical Planning of Partial Nephrectomy: A Case-control Study. Still Time for a Novel Surgical Trend?

Clin Genitourin Cancer 2020 Dec 8;18(6):e669-e678. Epub 2020 Apr 8.

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

Introduction: The purpose of this study was to evaluate the impact of 3-dimensional (3D) digital reconstructions of renal models on the arterial clamping approach during partial nephrectomy (PN).

Patients And Methods: Fifty-seven patients with T1 renal mass, referred for PN, were prospectively enrolled in 2 groups: Group 1 (n = 32) with revision of both 2-dimensional (2D) computed tomography (CT) imaging and 3D virtual model before surgery; Group 2 (n = 25) with revision of 2D CT imaging. Segmentation of the 3D models from preoperative high-quality CT scan was achieved using D2P software. In a sub-analysis of patients treated with PN with the on-clamp approach (n = 36), the effective intraoperative level of arterial clamping was compared with the preoperative planning.

Results: In the sub-group of patients referred to PN with the on-clamp approach, the intraoperative selective clamping was performed in 12 (57.1%) patients of Group 1 and in 2 (13.3%) cases of Group 2 (P = .01). The intraoperative management of the renal pedicle was done as preoperatively planned in 61.9% of patients in Group 1 and in 86.6% of cases in Group 2 (P = .1).

Conclusion: The 3D-guided plan of PN allows to perform selective clamping in higher proportion of patients compared with the standard 2D-guided approach without increasing intraoperative and postoperative complications.
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http://dx.doi.org/10.1016/j.clgc.2020.03.016DOI Listing
December 2020

Predicting positive surgical margins in partial nephrectomy: A prospective multicentre observational study (the RECORd 2 project).

Eur J Surg Oncol 2020 07 22;46(7):1353-1359. Epub 2020 Jan 22.

Department of Urology, University of Florence, Unit of Oncologic Minimally-Invasive Urology and Andrology, Careggi Hospital, Florence, Italy. Electronic address:

Purpose: to evaluate clinical predictors of positive surgical margins (PSMs) in a large multicenter prospective observational study and to develop a clinic nomogram to predict the likelihood of PSMs after partial nephrectomy (PN).

Materials And Methods: We prospectively evaluated 4308 patients who had surgical treatment for renal tumors between January 2013 and December 2016 at 26 urological Italian Centers (RECORd 2 project). Two multivariable logistic models were evaluated to predict the likelihood of PSMs. Center caseload was dichotomized using a visual assessment adjusted for several predictors of PSMs. A nomogram predicting PSMs was developed.

Results: Overall, 2076 patients treated with PN were evaluated. pT1a, pT1b, pT2 and pT3a were recorded in 68.7%, 22.6%, 2.1% and 6.6% of the patients, respectively. PSMs were recorded in 342 (16.5%) patients. From a null multivariable model against number of PN/year, 60 PN/year were identified as the best cut-off to define a high-volume centre. At multivariable analysis, clinical stage (cT1a vs. cT2 [OR 1.94]; p = 0.03), volume centre (≤60 PN/year) (OR 2.22; p < 0.0001), imperative vs elective indication (OR 2.10; p = 0.04), surgical technique (laparoscopic vs. open [OR 1.62; p = 0.002), lymphovascular invasion (OR 2.27; p = 0.01) and upstaging to pT3a (OR 2.81; p < 0.0001) were independent predictors of PSMs. The final nomogram included age, ASA score, Charlson score, clinical tumor stage, surgical indication, surgical approach, surgical technique, PADUA score, clamp procedure and volume centre.

Conclusions: PSMs after PN were significantly more likely in patients with lower clinical stage, higher PADUA score, in individuals referred to laparoscopic PN and in those treated at lower volume centers. We used these data to develop a nomogram to predict such risk.
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http://dx.doi.org/10.1016/j.ejso.2020.01.022DOI Listing
July 2020

Predictive accuracy and clinical benefit of a nomogram aimed to predict Ga-PSMA PET/CT positivity in patients with prostate cancer recurrence and PSA < 1 ng/ml external validation on a single institution database.

Eur J Nucl Med Mol Imaging 2020 08 31;47(9):2100-2105. Epub 2020 Jan 31.

Department of Specialistic, Diagnostic and Experimental Medicine (DIMES), University of Bologna, Bologna, Italy.

Purpose: To perform an external validation of a recently published nomogram aimed to predict positive Ga-PSMA-11 PET/CT in patients with biochemical recurrence (BCR) after radical prostatectomy (RP) by Rauscher et al. (Eur Urol 73(5):656-661, 2018).

Methods: Overall, 413 PCa patients with BCR after RP (two consecutive PSA ≥ 0.2 ng/ml) and PSA value between 0.2 and 1 ng/ml were included. A multivariable logistic regression model was produced to assess the predictors of positive Ga-PSMA-11 PET/CT results. The performance characteristics of the model were assessed by quantifying the predictive accuracy, according to model calibration. Yuden's index was used to find the best nomogram's cut-off. Finally, decision curve analysis (DCA) was implemented to quantify the nomogram's clinical value.

Results: In the external cohort, the overall detection rate of Ga-PSMA-11 PET/CT was 44% vs. 64.7% in the original population. At multivariate analysis, PSA at Ga-PSMA-11 PET/CT (OR: 7.06, p < 0.001) and ongoing ADT at time of Ga-PSMA-11 PET/CT (OR: 2.07, p = 0.03) were the only independent predictors of PET/CT positivity. The predictive accuracy of nomogram was suboptimal and comparable to that reported in the original model (64% vs. 67%, respectively). The calibration plot indicated suboptimal concordance. The best nomogram's cut-off to predict positive Ga-PSMA-11 PET/CT was 35% (AUC = 0.61). In DCA, the nomogram revealed clinical net benefit when the threshold probabilities of positive Ga-PSMA-11 PET/CT is > 35%.

Conclusion: We assessed similar suboptimal predictive accuracies in the external cohort compared to the original one. PSA and ongoing ADT were confirmed as positive predictors, and the most informative nomogram cut-off resulted 35%.
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http://dx.doi.org/10.1007/s00259-020-04696-zDOI Listing
August 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

Radiomics of peripheral nerves MRI in mild carpal and cubital tunnel syndrome.

Radiol Med 2020 Feb 26;125(2):197-203. Epub 2019 Nov 26.

Department of Health Sciences (DISSAL), University of Genoa, Via Pastore 1, 16132, Genoa, Italy.

Objective: To assess the discriminative power of radiomics of peripheral nerves at 1.5T MRI, using common entrapment neuropathies of the upper limb as a model system of focal nerve injury.

Materials And Methods: Radiomics was retrospectively done on peripheral nerve fascicles on T1-weighted 1.5T MRI of 40 patients with diagnosis of mild carpal (n = 25) and cubital tunnel (n = 15) syndrome and of 200 controls. Z-score normalization and Mann-Whitney U test were used to compare features of normal and pathological peripheral nerves. Receiver operating characteristic analysis was performed.

Results: A total of n = 104 radiomics features were computed for each patient and control. Significant differences between normal and pathological median and ulnar nerves were found in n = 23/104 features (p < 0.001). According to features classification, n = 5/23 features were shape-based, n = 7/23 were first-order features, n = 11/23 features were classified as gray level run length matrix. Nine of the selected features showed an AUC higher that 0.7: minimum AUC of 0.74 (95% CI 0.61-0.89) for sum variance and maximum AUC of 0.90 (95% CI 0.82-0.99) for zone entropy.

Conclusion: Features analysis demonstrated statistically significant differences between normal and pathological nerve. The results suggested that radiomics analysis could assess the median and ulnar nerve inner structure changes due to the loss of the fascicular pattern, intraneural edema, fibrosis or fascicular alterations in mild carpal tunnel and mild cubital tunnel syndromes even when the nerve cross-sectional area does not change.
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http://dx.doi.org/10.1007/s11547-019-01110-zDOI Listing
February 2020

How can mpMRI help surgical planning in high risk prostate cancer?

Prostate Cancer Prostatic Dis 2020 06 25;23(2):364-365. Epub 2019 Nov 25.

Department of Urology, S. Orsola-Malpighi Hospital, University of Bologna, Via Palagi 9, 40138, Bologna, Italy.

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http://dx.doi.org/10.1038/s41391-019-0192-8DOI Listing
June 2020

Which patients with clinical localized renal mass would achieve the trifecta after partial nephrectomy? The impact of surgical technique.

Minerva Urol Nefrol 2020 Jun 10;72(3):339-349. Epub 2019 Oct 10.

Department of Urology, Sant'Orsola-Malpighi University Hospital, University of Bologna, Bologna, Italy.

Background: To develop a clinical nomogram aimed to predict the achievement of trifecta in patients treated with open, laparoscopic and robotic partial nephrectomy (PN) for localized renal masses (
Methods: We retrospectively evaluated 482 consecutive patients who underwent PN with open (OPN: 243), laparoscopic (LPN: 156) and robotic (RAPN: 83) approach for T1 renal mass at single tertiary center. Trifecta was defined as follows: warm ischemia time (WIT) <20 min and no positive surgical margins (PSM) and no postoperative complications. First, we compared clinical, pathologic and perioperative outcomes within the three surgical approaches. Second, multivariable logistic regression was performed to identify the independent predictors of the trifecta's achievement. Finally, regression-based coefficients were used to develop a nomogram predicting the likelihood to achieve the trifecta and 200 bootstrap resamples were used for internal validation.

Results: The three cohorts were comparable in terms of demographics and clinical characteristics. Trifecta has been achieved in 49%, 50.6% and 69.9% of patients undergoing OPN, LPN and RAPN, respectively (P=0.003). At multivariable analyses, American Anesthesiologists Score (ASA) score 3-4 (Odd Ratio [OR]: 0.63; P=0.02), urinary collecting system (UCS) involvement (OR 0.56; P=0.02) and surgical approach (LPN and OPN vs. RAPN: OR: 0.39 and 0.38, respectively; P=0.001) were independent predictors of trifecta's achievement. A nomogram based on covariates included in the multivariable model demonstrated bootstrap-corrected predictive accuracy of 63%.

Conclusions: ASA Score, UCS involvement and the surgical technique were independent predictors of trifecta outcome. Our nomogram could facilitate the preoperative counselling and to choose the best surgical approach for PN.
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http://dx.doi.org/10.23736/S0393-2249.19.03485-4DOI Listing
June 2020

Testis Sparing Surgery of Small Testicular Masses: Retrospective Analysis of a Multicenter Cohort.

J Urol 2020 04 3;203(4):760-766. Epub 2019 Oct 3.

Sapienza University of Rome, Rome, Italy.

Purpose: We evaluated possible factors predicting testicular cancer in patients undergoing testis sparing surgery.

Materials And Methods: We retrospectively analyzed the records of all patients who underwent testis sparing surgery for a small testicular mass at a total of 5 centers. All patients with 1 solitary lesion 2 cm or less on preoperative ultrasound were enrolled in the study. Testis sparing surgery consisted of tumor enucleation for frozen section examination. Immediate radical orchiectomy was performed in all cases of malignancy at frozen section examination but otherwise the testes were spared. Univariate and multivariate analysis were performed and ROC curves were produced to evaluate preoperative factors predicting testicular cancer.

Results: Overall 147 patients were included in the study. No patient had elevated serum tumor markers. Overall 21 of the 147 men (14%) presented with testicular cancer. On multivariate analysis the preoperative ultrasound diameter of the lesion was a predictor of malignancy (OR 6.62, 95% CI 2.26-19.39, p=0.01). On ROC analysis lesion diameter had an AUC of 0.75 (95% CI 0.63-0.86, p=0.01) to predict testicular cancer. At the best cutoff of 0.85 the diameter of the lesion had 81% sensitivity, 58% specificity, 24% positive predictive value and 95% negative predictive value.

Conclusions: Our study confirms that small testicular masses are often benign and do not always require radical orchiectomy. Preoperative ultrasound can assess lesion size and the smaller the nodule, the less likely that it is malignant. Therefore, we suggest a stepwise approach to small testicular masses, including tumorectomy, frozen section examination and radical orchiectomy or testis sparing surgery according to frozen section examination results.
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http://dx.doi.org/10.1097/JU.0000000000000579DOI Listing
April 2020

Prediction nomogram for Ga-PSMA-11 PET/CT in different clinical settings of PSA failure after radical treatment for prostate cancer.

Eur J Nucl Med Mol Imaging 2020 01 6;47(1):136-146. Epub 2019 Sep 6.

Metropolitan Nuclear Medicine, S.Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.

Objective: The objective of this study was to develop a clinical nomogram to predict gallium-68 prostate-specific membrane antigen positron emission tomography/computed tomography (Ga-PSMA-11-PET/CT) positivity in different clinical settings of PSA failure.

Materials And Methods: Seven hundred three (n = 703) prostate cancer (PCa) patients with confirmed PSA failure after radical therapy were enrolled. Patients were stratified according to different clinical settings (first-time biochemical recurrence [BCR]: group 1; BCR after salvage therapy: group 2; biochemical persistence after radical prostatectomy [BCP]: group 3; advanced-stage PCa before second-line systemic therapies: group 4). First, we assessed Ga-PSMA-11-PET/CT positivity rate. Second, multivariable logistic regression analyses were used to determine predictors of positive scan. Third, regression-based coefficients were used to develop a nomogram predicting positive Ga-PSMA-11-PET/CT result and 200 bootstrap resamples were used for internal validation. Fourth, receiver operating characteristic (ROC) analysis was used to identify the most informative nomogram's derived cutoff. Decision curve analysis (DCA) was implemented to quantify nomogram's clinical benefit.

Results: Ga-PSMA-11-PET/CT overall positivity rate was 51.2%, while it was 40.3% in group 1, 54% in group 2, 60.5% in group 3, and 86.9% in group 4 (p < 0.001). At multivariable analyses, ISUP grade, PSA, PSA doubling time, and clinical setting were independent predictors of a positive scan (all p ≤ 0.04). A nomogram based on covariates included in the multivariate model demonstrated a bootstrap-corrected accuracy of 82%. The nomogram-derived best cutoff value was 40%. In DCA, the nomogram revealed clinical net benefit of > 10%.

Conclusions: This novel nomogram proved its good accuracy in predicting a positive scan, with values ≥ 40% providing the most informative cutoff in counselling patients to Ga-PSMA-11-PET/CT. This tool might be important as a guide to clinicians in the best use of PSMA-based PET imaging.
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http://dx.doi.org/10.1007/s00259-019-04505-2DOI Listing
January 2020

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

Three-dimensional digital reconstruction of renal model to guide preoperative planning of robot-assisted partial nephrectomy.

Int J Urol 2019 09 24;26(9):931-932. Epub 2019 Jun 24.

Department of Urology, Sant'Orsola Hospital, University of Bologna, Bologna, Italy.

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http://dx.doi.org/10.1111/iju.14038DOI Listing
September 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

Patterns of positive surgical margins after open radical prostatectomy and their association with clinical recurrence.

Minerva Urol Nefrol 2020 Aug 28;72(4):464-473. Epub 2019 May 28.

Department of Urology, S. Orsola-Malpighi Hospital, Bologna, Italy.

Background: We report long-term oncologic outcomes in patients with positive surgical margins (PSMs) at radical prostatectomy (RP) and the oncologic impact of different scenarios of PSMs presentation.

Methods: We selected 494 men with at least 3 years follow-up after surgery. PSMs patterns were recorded as: burden (focal vs. multifocal), site (apical-anterior vs. posterolateral vs. base-bladder neck vs. multiple) and side (unilateral vs. bilateral). Kaplan-Meier curves depicted the clinical recurrence-free survival (CR-FS) rates at 10-year in the overall population, after biochemical recurrence and according to different PSMs patterns. Multivariate Cox-regression analysis was performed to predict CR.

Results: Overall, PSMs sites were apical-anterior, postero-lateral, base-bladder neck and multiple in 19.8%, 23.7%, 3.4% and 43.8%, respectively. Out of 494 patients, 278 (56.3%) had a focal margin, while 216 (43.7%) had a multifocal margin. In 268 (54.3%) and 87 (17.6%) men, PSMs were unilateral and bilateral, respectively. Median follow-up was 93 months. No significant differences were found in CR-FS rates after stratifying according to burden and site of PSMs. Men with unilateral PSMs experienced significant higher CR-FS rates compared to those with bilateral PSMs (87.1% vs. 71.3% at 10 years, P<0.001). At multivariate Cox regression Gleason score 8-10 (HR: 2.53, Confidence Interval [CI]: 1.01-6.33; P=0.04), pathologic stage pT3b-pT4 (HR 3.02, CI: 1.60-7.85; P=0.02) and adjuvant radiotherapy (HR: 0.30, CI: 0.11-0-86; P=0.02) were independent predictors of CR.

Conclusions: Men with bilateral PSMs had higher risk to experience CR, suggesting that the different patterns of PSMs, should be considered during patients counseling to guide postoperative treatments. Retrospective nature of the study and restricted number of patients included consist of main limitations.
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http://dx.doi.org/10.23736/S0393-2249.19.03269-7DOI Listing
August 2020