[18F]-Fluciclovine PET/CT for preoperative nodal staging in high-risk primary prostate cancer: final results of a prospective trial.

PURPOSE: The conventional imaging flowchart for prostate cancer (PCa) staging may fail in correctly detecting lymph node metastases (LNM). Pelvic lymph node dissection (PLND) represents the only reliable method, although invasive. A new amino acid PET compound, [18F]-fluciclovine, was recently authorized in suspected PCa recurrence but not yet included in the standard staging work-up of primary PCa. A prospective monocentric study was designed to evaluate [18F]-fluciclovine PET/CT diagnostic performance for preoperative LN staging in primary high-risk PCa. METHODS: Consecutive patients (pts) with biopsy-proven PCa, standard staging (including [11C]choline PET/CT), eligible for PLND, were enrolled to undergo an investigational [18F]-fluciclovine PET/CT. Nodal uptake higher than surrounding background was reported by at least two readers (blinded to [11C]choline) using a visual 5-point scale (1-2 probably negative; 4-5 probably positive; 3 equivocal); SUVmax, target-to-background (aorta-A; bone marrow-BM) ratios (TBRs), were also calculated. PET results were validated with PLND. [18F]-fluciclovine PET/CT performance using visual score and semi-quantitative indexes was analyzed both per patient and per LN anatomical region, compared to conventional [11C]choline and clinical predictive factors (to note that diagnostic performance of [18F]-fluciclovine was explored for LNM but not examined for intrapelvic or extrapelvic M1 lesions). RESULTS: Overall, 94 pts underwent [18F]-fluciclovine PET/CT; 72/94 (77%) high-risk pts were included in the final analyses (22 pts excluded: 8 limited PLND; 3 intermediate-risk; 2 treated with radiotherapy; 4 found to be M1; 5 neoadjuvant hormonal therapy). Median LNM risk by Briganti nomogram was 19%. LNM confirmed on histology was 25% (18/72 pts). Overall, 1671 LN were retrieved; 45/1671 (3%) LNM detected. Per pt, median no. of removed LN was 22 (mean 23 ± 10; range 8-51), of LNM was 2 (mean 3 ± 2; range 1-10). Median LNM size was 5 mm (mean 5 ± 2.5; range 2-10). On patient-based analyses (n = 72), diagnostic performance for LNM resulted significant with [18F]-fluciclovine (AUC 0.66, p 0.04; 50% sensitivity, 81% specificity, 47% PPV, 83% NPV, 74% accuracy), but not with [11C]choline (AUC 0.60, p 0.2; 50%, 70%, 36%, 81%, and 65% respectively). Briganti nomogram (OR = 1.03, p = 0.04) and [18F]-fluciclovine visual score (≥ 4) (OR = 4.27, p = 0.02) resulted independent predictors of LNM at multivariable analyses. On region-based semi-quantitative analyses (n = 576), PET/CT performed better using TBR parameters (TBR-A similar to TBR-BM; TBR-A fluciclovine AUC 0.61, p 0.35, vs choline AUC 0.57 p 0.54; TBR-BM fluciclovine AUC 0.61, p 0.36, vs choline AUC 0.58, p 0.52) rather than using absolute LN SUVmax (fluciclovine AUC 0.51, p 0.91, vs choline AUC 0.51, p 0.94). However, in all cases, diagnostic performance was not statistically significant for LNM detection, although slightly in favor of the experimental tracer [18F]-fluciclovine for each parameter. On the contrary, visual interpretation significantly outperformed PET semi-quantitative parameters (choline and fluciclovine: AUC 0.65 and 0.64 respectively; p 0.03) and represents an independent predictive factor of LNM with both tracers, in particular [18F]-fluciclovine (OR = 8.70, p 0.002, vs OR = 3.98, p = 0.03). CONCLUSION: In high-risk primary PCa, [18F]-fluciclovine demonstrates some advantages compared with [11C]choline but sensitivity for metastatic LN detection is still inadequate compared to PLND. Visual (combined morphological and functional), compared to semi-quantitative assessment, is promising but relies mainly on readers' experience rather than on unquestionable LN avidity. TRIAL REGISTRATION: EudraCT number: 2014-003,165-15.

A review discussing fluciclovine (18F) PET/CT imaging in the detection of recurrent prostate cancer.

A significant number of patients radically treated for prostate cancer (PCa) will develop prostate-specific antigen recurrence (27-53%). Localizing the anatomical site of relapse is critical, in order to achieve the optimal treatment management. To date the diagnostic accuracy of standard imaging is low. Several desirable features have been identified for the amino-acid-based PET agent, fluciclovine (18F) including: long 18F half-life which allows more practical use in centers without a cyclotron onsite; acting as a substrate for amino acid transporters upregulated in PCa or associated with malignant phenotype; lacking of incorporation into protein; and limited urinary excretion. Fluciclovine (18F) is currently approved both in USA and Europe with specific indication in adult men with suspected recurrent PCa based on elevated prostate-specific antigen following prior treatment.

The impact of a structured intensive modular training in the learning curve of robot assisted radical prostatectomy.

AIM: The success of Robot Assisted Laparoscopic Prostatectomy (RALP) is mainly due to his relatively short learning curve. Twenty cases are needed to reach a "4 hours-proficiency". However, to achieve optimal functional outcomes such as urinary continence and potency recovery may require more experience. We aim to report the perioperative and early functional outcomes of patients undergoing RALP, after a structured modular training program. METHODS: A surgeon with no previous laparoscopic or robotic experience attained a 3 month modular training including: a) e-learning; b) assistance and training to the operating table; c) dry console training; d) step by step in vivo modular training performing 40 surgical steps in increasing difficulty, under the supervision of an experienced mentor. Demographics, intraoperative and postoperative functional outcomes were recorded after his first 120 procedures, considering four groups of 30 cases. RESULTS: All procedures were completed successfully without conversion to open approach. Overall 19 (15%) post operative complications were observed and 84% were graded as minor (Clavien I-II). Overall operative time and console time gradually decreased during the learning curve, with statistical significance in favour of Group 4. The overall continence rate at 1 and 3 months was 74% and 87% respectively with a significant improvement in continence rate throughout the four groups (p = 0.04). Considering those patients submitted to nerve-sparing procedure we found a significant increase in potency recovery over the four groups (p = 0.04) with the higher potency recovery rate up to 80% in the last 30 cases. CONCLUSIONS: Optimal perioperative and functional outcomes have been attained since early phase of the learning curve after an intensive structured modular training and less than 100 consecutive procedures seem needed in order to achieve optimal urinary continence and erectile function recovery.

(18)F-FACBC (anti1-amino-3-(18)F-fluorocyclobutane-1-carboxylic acid) versus (11)C-choline PET/CT in prostate cancer relapse: results of a prospective trial.

PURPOSE: To compare the accuracy of (18)F-FACBC and (11)C-choline PET/CT in patients radically treated for prostate cancer presenting with biochemical relapse. METHODS: This prospective study enrolled 100 consecutive patients radically treated for prostate cancer and presenting with rising PSA. Of these 100 patients, 89 were included in the analysis. All had biochemical relapse after radical prostatectomy (at least 3 months previously), had (11)C-choline and (18)F-FACBC PET/CT performed within 1 week and were off hormonal therapy at the time of the scans. The two tracers were compared directly in terms of overall positivity/negativity on both a per-patient basis and a per-site basis. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were calculated for both the tracers; follow-up at 1 year (including correlative imaging, PSA trend and pathology when available) was considered as the standard of reference. RESULTS: In 51 patients the results were negative and in 25 patients positive with both the tracers, in eight patients the results were positive with (18)F-FACBC but negative with (11)C-choline, and in five patients the results were positive with (11)C-choline but negative with (18)F-FACBC. Overall in 49 patients the results were false-negative (FN), in two true-negative, in 24 true-positive (TP) and in none false-positive (FP) with both tracers. In terms of discordances between the tracers: (1) in one patient, the result was FN with (11)C-choline but FP with (18)F-FACBC (lymph node), (2) in seven, FN with (11)C-choline but TP with (18)F-FACBC (lymph node in five, bone in one, local relapse in one), (3) in one, FP with (11)C-choline (lymph node) but TP with (18)F-FACBC (local relapse), (4) in two, FP with (11)C-choline (lymph nodes in one, local relapse in one) but FN with (18)F-FACBC, and (5) in three, TP with (11)C-choline (lymph nodes in two, bone in one) but FN with (18)F-FACBC. With (11)C-choline and (18)F-FACBC, sensitivities were 32 % and 37 %, specificities 40 % and 67 %, accuracies 32 % and 38 %, PPVs 90 % and 97 %, and NPVs 3 % and 4 %, respectively. Categorizing patients by PSA level (<1 ng/ml 28 patients, 1 - <2 ng/ml 28 patients, 2 - <3 ng/ml 11 patients, ≥3 ng/ml 22 patients), the number (percent) of patients with TP findings were generally higher with (18)F-FACBC than with (11)C-choline: six patients (21 %) and four patients (14 %), eight patients (29 %) and eight patients (29 %), five patients (45 %) and four patients (36 %), and 13 patients (59 %) and 11 patients (50 %), respectively. CONCLUSION: (18)F-FACBC can be considered an alternative tracer superior to (11)C-choline in the setting of patients with biochemical relapse after radical prostatectomy.

Three Unusual Cases of Nutcracker Syndrome Caused by Increased Blood Flow within the Left Renal Vein.

Nutcracker syndrome (NCS) refers to the compression of the left renal vein (LRV) between the aorta and the superior mesenteric artery. It can cause both microscopic and gross haematuria, with or without flank pain. The diagnosis is often delayed in a majority of symptomatic patients. On the other hand, the use of CT in routine abdominal explorations has increased the detection of the compression of the LRV in healthy and asymptomatic patients, but its diagnostic value remains uncertain. In this paper, we report 3 cases of the NCS associated with an increased blood flow in the LRV, due to different conditions, which we believe could produce the appearance of clinical symptoms.

Active surveillance for clinically localized renal tumors: An updated review of current indications and clinical outcomes.

The widespread use of abdominal imaging has led to an increasing detection of small renal masses, and approximately 20-30% of those tumors will prove to be benign, with low metastatic potential if not immediately treated. In elderly or comorbid patients diagnosed with small renal masses, competing cause mortality seems to exceed cancer-specific mortality at short- and intermediate-term follow up. In these cases, surgery might represent an overtreatment, and an expectant management, such as active surveillance, might be proposed. According to the current available evidence, active surveillance is a safe and reasonable option for patients with renal tumors ≤4 cm (cT1a) and short life expectancy. A few studies with short-term follow up reported the preliminary results of active surveillance even in cT1b-cT2 tumors, with acceptable risk of disease progression and mortality, even if this approach should be considered in this setting only for highly-selected and well-informed patients. Furthermore, surveillance protocols can be proposed in selected patients with uncomplicated benign tumors, such as angiomyolipomas, in which active surveillance should be considered the initial standard management. At present, reliable clinical predictors of a tumor's growth rate and aggressiveness are not available. Renal tumor biopsy is useful in the clinical work-up of patients who are candidates for active surveillance, in order to improve patient selection based on tumor histological characterization. Despite the proof of safety offered by expectant management for small renal masses in selected patients, further prospective studies with longer follow up are required in order to confirm the indications and long-term oncological outcomes of active surveillance protocols for renal tumors.

Preservation of the smooth muscular internal (vesical) sphincter and of the proximal urethra for the early recovery of urinary continence after retropubic radical prostatectomy: a prospective case-control study.

OBJECTIVES: To evaluate the influence of preservation of the muscular internal sphincter and proximal urethra on continence recovery after radical prostatectomy. METHODS: This was a prospective single-center, case-control study. A total of 40 consecutive patients with organ-confined prostate cancer were submitted to radical prostatectomy with the preservation of the muscular internal sphincter and the proximal urethra (group 1), and their outcomes were compared with those of 40 patients submitted to a standard procedure (group 2). Continence rates were assessed using a self-administrated questionnaire at 3, 7 and 30 days, and 3 and 12 months after removal of the catheter. RESULTS: Group 1 had a faster recovery of early continence than group 2 at day 3 (45% vs 22%; P = 0.029) and at day 7 (75% vs 50%; P = 0.018). Considering the number of pads, group 1 had a faster recovery of continence at 3, 7 and 30 days, and also had less incidence of severe incontinence. There was no statistically significant difference in terms of continence at 3 and 12 months among the two groups. Multivariate logistic regression analysis showed that surgical technique and young age were significantly associated with earlier time to continence at 3 and 7 days. The two groups had no significant differences in terms of surgical margins. CONCLUSIONS: Our modified technique of radical retropubic prostatectomy with preservation of the smooth muscular internal sphincter, as well as of the proximal urethra during bladder neck dissection, results in a significantly increased urinary continence at 3, 7 and 30 days after catheter removal, with a minor incidence of severe incontinence. The technique is also oncologically safe, and it does not increase the operative duration of the procedure.

Preservation of the smooth muscular internal (vesical) sphincter and of the proximal urethra during retropubic radical prostatectomy: a technical modification to improve the early recovery of continence.

OBJECTIVE: We describe our technique for preservation of the smooth muscular internal (vesical) sphincter and proximal urethra during radical retropubic prostatectomy (RRP) and present our preliminary clinical results. MATERIALS AND METHODS: The first steps of the prostatectomy reflect the standard RRP, while for the final phases the procedure continues in an anterograde manner with incision of the fibers of the detrusor muscle at the insertion of the ventral surface of the base of the prostate. At this level, the inner circular muscle of the bladder neck forms a sphincteric ring of smooth muscle that covers the longitudinally oriented smooth muscle component of the urethral musculature that extends distally to the verumontanum. These two proximal structures represent the internal sphincter that envelopes and locks the proximal urethra. A blunt dissection is continued until the ring shaped vesical sphincter is separated from the prostate and the longitudinally oriented smooth muscle component of the urethral musculature is identified. The base of the prostate is then gently separated from the urethra and from the bladder until the maximal length of the urethral musculature is isolated and preserved. RESULTS: After 30 initial set-up procedures, 40 consecutive patients with organ confined prostate cancer were submitted to radical retropubic prostatectomy with the preservation of muscular internal sphincter and the proximal urethra and compared to 40 patients submitted to standard procedure who served as control group. The group of patients submitted to our technical modification had a faster recovery of early continence than control group at 3 and 7 days. CONCLUSIONS: The described technique is a feasible and safe method for preservation of the internal urethral sphincter and allows improving the early recovery of urinary continence. The technique does not increase the rate of positive margins and the duration of the procedure.

Differing risk of cancer death among patients with lymph node metastasis after radical prostatectomy and pelvic lymph node dissection: identification of risk categories according to number of positive nodes and Gleason score.

OBJECTIVES: To evaluate the outcomes in patients with node-positive prostate cancer (PCa) after radical prostatectomy (RP) and pelvic lymph node dissection (PLND) according to the number of positive lymph nodes (LNs). To identify different risk groups among patients with node-positive PCa. PATIENTS AND METHODS: We evaluated 98 consecutive patients with pN1M0 PCa who underwent RP between November 1995 and May 2011. Kaplan-Meier and Cox proportional univariable and multivariable regression models were used to analyse the survival rates. Patients were divided into two groups according to number of positive LNs using the most informative positive LN theshold for predicting survival, then into three different risk groups according to number of positive LNs and pathological Gleason score (GS). RESULTS: Mean (range) follow-up was 68.4 (10-192) months. Patients with 1-3 positive LNs (n = 75; 76.5%) had significantly better cancer-specific survival (CSS) and overall survival (OS) compared with those with >3 positive nodes (n = 23; 23.4%; P < 0.01). Patients with 1-3 positive LNs and pathological GS ≤7 (Group 1) had significantly better CSS than those with >3 positive LNs or GS 8-10 (Group 2 [P = 0.015]). Group 2 patients, moreover, had significantly better CSS (P = 0.019) and OS (P = 0.021) than those with >3 positive LNs and GS 8-10 (Group 3). CONCLUSIONS: Patients with 1-3 positive LNs have higher CSS and OS rates than those with >3 metastatic LNs. Taking into account the pathological GS, as well as the number of positive nodes, three risk group categories with considerable differences in terms of survival can be found. Patients with LN-positive PCa should be stratified into different groups according to these two measures, to obtain a better prediction of oncological outcomes.

Massive hematuria due to ruptured iatrogenic aortic pseudoaneurysm: a case report.

We report an interesting case of massive haematuria secondary to a rupture of a pseudoa- neurysm of the abdominal aorta below the renal vessels. A 65-year-old woman present- ed at our institution with a painful massive haematuria and anaemia. Two months before, she undergone a pelvic surgery complicated by an accidental injury of the right ureter sutured with a end-to-end anastomosis. An abdominal computed tomography (CT) scan with intravenous contrast showed a right-sided hydronephrosis with clots in the lumen of the right pelvis with a massive retroperitoneal hematoma due to a rupture of a iatrogenic pseudoaneurysm of the abdominal aorta below the origin of the renal arteries.

Preservation of the smooth muscular internal (vesical) sphincter and of the proximal urethra during retropubic radical prostatectomy: description of the technique.

We describe our technique for preservation of the smooth muscular internal (vesical) sphincter and proximal urethra during radical retropubic prostatectomy. The first steps of the prostatectomy reflect the standard retropubic prostatectomy; whereas for the final phases, the procedure continues in an anterograde manner with incision of the fibers of the detrusor muscle at the insertion of the ventral surface of the base of the prostate. At this level, the inner circular muscle of the bladder neck forms a sphincteric ring of smooth muscle that covers the longitudinally-oriented smooth muscle component of the urethra that extends distally to the verumontanum; these two proximal structures represent the internal sphincter that envelops and locks the proximal urethra. A blunt dissection is continued until the ring-shaped vesical sphincter is separated from the prostate and the longitudinally-oriented smooth muscle component of the urethral musculature is identified. The base of the prostate is then gently separated from the urethra and from the bladder until the maximal length of the urethral musculature is isolated and preserved. Finally, a urethra-urethral anastomosis is carried out and the ventral stitches are placed through the circular fibres of the bladder neck. In all cases we carry out circumferential biopsies of the proximal urethra and of the base of the prostate. The described technique is a feasible and safe method for preservation of the internal urethral sphincter. Despite the enthusiasm regarding our positive functional results, further studies with larger series are required to confirm these findings.

Diagnostic accuracy of the Novel 29 MHz micro-ultrasound "ExactVuTM" for the detection of clinically significant prostate cancer: A prospective single institutional study. A step forward in the diagnosis of prostate cancer.

INTRODUCTION AND OBJECTIVE: ExactVuTM is a real-time micro-ultrasound system which provides, according to the Prostate Risk Identification Using Micro-Ultrasound protocol (PRI-MUS), a 300% higher resolution compared to conventional transrectal ultrasound. To evaluate the performance of ExactVuTM in the detection of Clinically significant Prostate Cancer (CsPCa). MATERIALS AND METHODS: Patients with Prostate Cancer diagnosed at fusion biopsy were imaged with ExactVuTM. CsPCa was defined as any Gleason Score ≥ 3+4. ExactVuTM examination was considered as positive when PRI-MUS score was ≥ 3. PRI-MUS scoring system was considered as correct when the fusion biopsy was positive for CsPCa. A transrectal fusion biopsy- proven CsPCa was considered as a gold standard. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and area under the receiver operator characteristic (ROC) curve (AUC) were calculated. RESULTS: 57 patients out of 68 (84%) had a csPCa. PRI-MUS score was correctly assessed in 68% of cases. Regarding the detection of CsPCa, ExactVuTM 's sensitivity, specificity, PPV, and NPV was 68%, 73%, 93%, and 31%, respectively and the AUC was 0.7 (95% CI 0.5-0-8). For detecting CsPCa in the transition/ anterior zone the sensitivity, specificity, PPV, and NPV was 45%, 66%, 83% and 25% respectively ant the AUC was 0.5 (95% CI 0.2-0.9). Accounting only the CsPCa located in the peripheral zone, sensitivity, specificity, PPV, and NPV raised up to 74%, 75%, 94%, 33%, respectively with AUC 0.75 (95% CI 0.5-0-9). CONCLUSIONS: ExactVuTM provides high resolution of the prostatic peripheral zone and could represent a step forward in the detection of CsPCa as a triage tool. Further studies are needed to confirm these promising results.

The Role of [18F]Fluciclovine PET/CT in the Characterization of High-Risk Primary Prostate Cancer: Comparison with [11C]Choline PET/CT and Histopathological Analysis.

The primary aim of the study was to evaluate the role of [18F]Fluciclovine PET/CT in the characterization of intra-prostatic lesions in high-risk primary PCa patients eligible for radical prostatectomy, in comparison with conventional [11C]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 (n = 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 [18F]Fluciclovine uptake values and pISUP. Overall, lesion-based (n = 95), the performance of PET semiquantitative parameters, with either [18F]Fluciclovine or [11C]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 [18F]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.

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

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: in-hospital 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: Seventy-five 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.

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

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.

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

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.

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

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.

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

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 (

Oncologic outcomes in prostate cancer patients treated with robot-assisted radical prostatectomy: results from a single institution series with more than 10 years follow up.

BACKGROUND: Robot-assisted radical prostatectomy (RARP) has gained increasing diffusion as standard of care in the surgical treatment of prostate cancer (PCa) patients, even in the absence of robust long-term oncologic comparative data. This article is a report of oncologic outcomes of RARP at more than 10 years follow-up. METHODS: We retrospectively evaluated 173 consecutive PCa patients underwent RARP between 2002 and 2005 at a single European center with complete clinic and pathologic data and potential follow-up of at least 10 years. Kaplan-Meier analyses assessed biochemical recurrence free survival (BCR-FS), clinical recurrence free survival (CR-FS), cancer specific mortality free survival (CSM-FS), other causes mortality free survival (OCM-FS) in the overall population and CR-FS after stratification according to pathologic stage and Gleason score. Multi-variable Cox regression analyses were performed to assess the predictors of BCR and CR. RESULTS: Median follow-up (Interquatile Range [IQR]) was 133 (123-145) months. The BCR-FS, CR-FS, CSM-FS and OCM-FS rates at median follow-up were 73.4%, 81.1%, 95.7%, and 68.6%, respectively. Patients staged as pT3b-T4 and men with Gleason score 8-10 experienced significantly lower CR-FS rates as compared to those with less aggressive pathologic features (all P≤0.001). At multivariable analysis, pathologic Gleason score 8-10 (Hazard Ratio [HR]: 2.85), pathologic stage pT3b-pT4 (HR: 2.76) and adjuvant therapy (HR: 2.09 for radiotherapy [RT] and HR: 13.66 for androgen deprivation therapy [ADT]) were independent predictors of BCR (all p≤0.02). While, pathologic Gleason score 8-10 (HR: 4.05) and pathologic stage pT3b-pT4 (HR: 6.78) were found to be independently related to higher risk of CR (all P≤0.03). Retrospective data and limited number of patients included could have affected our analyses. CONCLUSIONS: In experienced centers, RARP allows optimal oncologic outcomes at long term follow-up. Adverse pathologic characteristics are independent predictors of BCR and CR.