[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.

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.

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.

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.

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 (

3D Reconstruction and physical renal model to improve percutaneous punture during PNL

ABSTRACT Introduction and Objectives: We aim to present the use of 3D digital and physical renal model (1-5) to guide the percutaneous access during percutaneous nephrolithotripsy (PNL). Materials and Methods: We present the clinical case of a 30 years old man with left renal stone (25x15 mm). A virtual 3D reconstruction of the anatomical model including the stone, the renal parenchyma, the urinary collecting system (UCS) and the skeletal landmarks (lumbar spine and ribs) was elaborated. Finally, a physical 3D model was created with a 3D printer including the renal parenchyma, UCS and the stone. The surgeon evaluated the 3D virtual reconstruction and manipulated the printed model before surgery to improve the anatomical knowledge and to facilitate the percutaneous access. In prone position, combining ultrasound and fluoroscopy implemented by the preoperative anatomical planning based on the 3D virtual and printed model, an easy and safe access of the inferior calyx was achieved. Then, the patient underwent PNL using a 30 Fr Amplatz sheet with semi-rigid nephroscope and ultrasound energy to achieve a complete lithotripsy of the pelvic stone. Results: The procedure was safely completed with 1 single percutaneous puncture (time of puncture 2 minutes). Overall surgical time was 90 min. No intra and postoperative complications were reported. The CT scan performed before discharge confirmed a complete stone free state. Conclusion: The 3D-guided approach to PNL facilitates the preoperative planning of the puncture with better knowledge of the renal anatomy and may be helpful to reduce operative time and improve the learning curve.

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.

Preoperative Staging With 11C-Choline PET/CT Is Adequately Accurate in Patients With Very High-Risk Prostate Cancer.

PURPOSE: To evaluate the accuracy of 11C-choline positron emission tomography (PET)/computed tomography (CT) for nodal staging of prostate cancer (PCa) in different populations of high-risk patients. PATIENTS AND METHODS: We evaluated 262 individuals with intermediate- or high-risk PCa submitted to radical prostatectomy and extended pelvic lymph node dissection. Within men with high-risk disease, we identified a subgroup of individuals harboring very high-risk (VHR, n = 28) disease: clinical stage ≥ T2c and more than 5 cores with Gleason score 8-10; primary biopsy Gleason score of 5; 3 high-risk features; or prostate-specific antigen ≥ 30 ng/mL. The diagnostic accuracy of PET/CT and contrast-enhanced CT (CECT) was assessed after stratifying patients according to risk group classification on a patient- and anatomic region-based analysis. RESULTS: On patient-based analysis, considering high-risk patients (n = 155), 11C-choline PET/CT versus CECT had sensitivity and specificity of 50% and 76% versus 21% and 92%, respectively. Considering VHR men as separate subgroups (n = 28), 11C-choline PET/CT versus CECT had sensitivity and specificity of 71% and 93% versus 25% and 79%, respectively. Accordingly, in the VHR category, the area under the curve of 11C-choline PET/CT versus CECT was 0.86 (95% confidence interval, 0.71-1.0) versus 0.69 (95% confidence interval, 0.52-0.86), respectively. On anatomic region-based analysis, considering the VHR group, 11C-choline PET/CT versus CECT had sensitivity and specificity of 70.6% and 95.5% versus 35.3% and 98.5%, respectively. CONCLUSION: Patients with VHR characteristics could represent the ideal candidate to undergo disease staging with PET/CT before surgery with the highest cost efficacy.

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.

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.

MRI Displays the Prostatic Cancer Anatomy and Improves the Bundles Management Before Robot-Assisted Radical Prostatectomy.

OBJECTIVES: To evaluate the impact of multiparametric magnetic0 resonance imaging (mpMRI) to guide the nerve-sparing (NS) surgical plan in prostate cancer (PCa) patients referred to robot-assisted radical prostatectomy (RARP). METHODS: One hundred thirty-seven consecutive PCa patients were submitted to RARP between September 2016 and February 2017 at two high-volume European centers. Before RARP, each patient was referred to 1.5T or 3T mpMRI. NS was recorded as Grade 1, Grade 2, Grade 3, and Grade 4 according to Tewari and colleagues classification. A preliminary surgical plan to determinate the extent of NS approach was recorded based on clinical data. The final surgical plan was reassessed after mpMRI revision. The appropriateness of surgical plan change was considered based on the presence of extracapsular extension or positive surgical margins (PSMs) at level of neurovascular bundles area at final pathology. Furthermore, we analyzed a control group during the same period of 166 PCa patients referred to RARP in both institutions without preoperative mpMRI to assess the impact of the use of mpMRI on the surgical margins. RESULTS: Considering 137 patients with preoperative mpMRI, the mpMRI revision induced the main surgeon to change the NS surgical plan in 46.7% of cases on patient-based and 56.2% on side-based analysis. The surgical plan change results equally assigned between the direction of more radical and less radical approach both on patient-based (54.7% vs 54.3%) and on side-based levels (50% vs 50%), resulting an overall appropriateness of 75%. Moreover, patients staged with mpMRI revealed significant lower overall PSMs compared with control group with no mpMRI (12.4% vs 24.1%; p ≤ 0.01). CONCLUSIONS: mpMRI induces robotic surgeons to change the surgical plan in almost half of individuals, thus tailoring the NS approach, without compromising the oncologic outcomes. Compared to patients treated without mpMRI, the use of preoperative mpMRI can significantly reduce the overall PSMs.

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

INTRODUCTION: We investigated the diagnostic performance of in-bore endorectal magnetic resonance imaging-guided biopsy (MRI-GB) with a 1.5-T MRI scanner using a 32-channel coil in patients with suspected prostate cancer (PCa). PATIENTS AND METHODS: Seventy patients with ≥ 1 suspicious area found on the preliminary multiparametric MRI scan were enrolled. The index lesion was defined as the lesion with the greatest Prostate Imaging Reporting and Data System, version 2 (PIRADS-v2), score. MRI-GBs were performed with a nonmagnetic biopsy device, needle guide, and titanium double-shoot biopsy gun with dedicated software for needle tracking. Clinically significant PCa was defined as the presence of Gleason score ≥ 7 in the biopsy specimen. RESULTS: Seventy index lesions were scheduled for MRI-GB. The median PIRADS-v2 score and the median number of cores per patient was 4 of 5 (interquartile range, 3-5) and 2 (interquartile range, 1-3), respectively. The PCa detection rate was 45.7%. Of the 70 patients, 24 (75%) had clinically significant PCa, with a significant correlation between the PIRADS-v2 score and the Gleason score in the MRI-GB cores (r = 0.839; 95% confidence interval, 0.535-0.951; P = .003). According to the PIRADs-v2 scheme, the proportion of PCa in the central and anterior regions of the gland was greater in the entire population and in the subgroup of patients with a history of negative transrectal ultrasound-guided biopsy findings (P ≤ .01 for all). On multivariate analysis, a PIRADS-v2 score of 5 of 5 correlated significantly with the likelihood of PCa at biopsy (hazard ratio, 4.69; 95% confidence interval, 0.92-23.74; P = .04). No major complications were recorded. CONCLUSION: MRI-GB has a high detection rate for PCa, especially for lesions located in the central and anterior regions of the prostate.

Adverse Features and Competing Risk Mortality in Patients With High-Risk Prostate Cancer.

PURPOSE: To assess survival and competing causes of mortality in prostate cancer (PCa) patients referred to radical prostatectomy through a combination of unfavorable characteristics. PATIENTS AND METHODS: We evaluated 615 PCa patients referred to radical prostatectomy and pelvic lymph node dissection at single tertiary-care center with at least one adverse feature (AF): preoperative prostate-specific antigen ≥ 20 ng/mL, pathologic Gleason score 8 to 10, and no organ-confined disease at final pathology (seminal vesicle involvement, positive surgical margins, and/or lymph node invasion). Kaplan-Meier analyses were used to assess cancer-specific mortality (CSM)-free survival rates by stratifying patients into 3 risk categories according to the number of AFs (namely, 1, 2, and 3 AFs). Multivariable competing risk Cox regression analyses were used to assess CSM and other cause of mortality. RESULTS: Significant differences were found in terms of preoperative and pathologic tumor characteristics, adjuvant therapies, and biochemical recurrence (BCR). Men with 1 AF had higher CSM-free survival estimates compared to those with 2 and 3 AFs (92.8% vs. 84.2% vs. 27.7% at 10 years' follow-up, P < .001). Moreover, the presence of 3 AFs (hazard ratio [HR], 2.96), postoperative adjuvant treatment status (HR, 2.44), and time to BCR (HR, 0.96) were all independent predictors of CSM (P ≤ .04). Age at surgery and time to BCR were the only independent predictors of other causes of mortality (P ≤ .0009). CONCLUSION: The risk group stratification according to the number of AFs could help physicians to accurately predict oncologic outcomes and to select PCa patients for the most appropriate postoperative strategies.

Robot-assisted Salvage Lymph Node Dissection for Clinically Recurrent Prostate Cancer.

BACKGROUND: Salvage lymph node dissection has been described as a feasible treatment for the management of prostate cancer patients with nodal recurrence after primary treatment. OBJECTIVE: To report perioperative, pathologic, and oncologic outcomes of robot-assisted salvage nodal dissection (RASND) in patients with nodal recurrence after radical prostatectomy (RP). DESIGN, SETTING, AND PARTICIPANTS: We retrospectively evaluated 16 patients affected by nodal recurrence following RP documented by positive positron emission tomography/computed tomography scan. SURGICAL PROCEDURE: Surgery was performed using DaVinci Si and Xi systems. A pelvic nodal dissection that included lymphatic stations overlying the external, internal, and common iliac vessels, the obturator fossa, and the presacral nodes was performed. In 13 (81.3%) patients a retroperitoneal lymph node dissection that included all nodal tissue located between the aortic bifurcation and the renal vessels was performed. MEASUREMENTS: Perioperative outcomes consisted of operative time, blood loss, length of hospital stay, and complications occurred within 30 d after surgery. Biochemical response (BR) was defined as a prostate-specific antigen level <0.2 ng/ml at 40 d after RASND. RESULTS AND LIMITATIONS: Median operative time, blood loss, and length of hospital stay were 210min, 250ml, and 3.5 d. The median number of nodes removed was 16.5. Positive lymph nodes were detected in 11 (68.8%) patients. Overall, four (25.0%) and five (31.2%) patients experienced intraoperative and postoperative complications, respectively. Overall, one (6.3%) and four (25.0%) patients had Clavien I and II complications within 30 d after RASND, respectively. Overall, five (33.3%) patients experienced BR after surgery. Our study is limited by the small cohort of patients evaluated and by the follow-up duration. CONCLUSIONS: RASND represents a feasible procedure in patients with nodal recurrence after RP and provides acceptable short-term oncologic outcomes, where one out of three patients experience BR immediately after surgery. Long-term data are needed to confirm the effectiveness of this approach. PATIENT SUMMARY: We report our initial experience with robot-assisted salvage nodal dissection for the management of patients with lymph node recurrence after radical prostatectomy. This technique represents a feasible and effective approach, where no high-grade complications were recorded and one out of three patients experienced biochemical response at 40 d after surgery.

Metabolic Imaging in Prostate Cancer: Where We Are.

In recent years, the development of diagnostic methods based on metabolic imaging has been aimed at improving diagnosis of prostate cancer (PCa) and perhaps at improving therapy. Molecular imaging methods can detect specific biological processes that are different when detected within cancer cells relative to those taking place in surrounding normal tissues. Many methods are sensitive to tissue metabolism; among them, positron emission tomography (PET) and magnetic resonance spectroscopic imaging (MRSI) are widely used in clinical practice and clinical research. There is a rich literature that establishes the role of these metabolic imaging techniques as valid tools for the diagnosis, staging, and monitoring of PCa. Until recently, European guidelines for PCa detection still considered both MRSI/MRI and PET/CT to be under evaluation, even though they had demonstrated their value in the staging of high risk PCa, and in the restaging of patients presenting elevated prostatic-specific antigen levels following radical treatment of PCa, respectively. Very recently, advanced methods for metabolic imaging have been proposed in the literature: multiparametric MRI (mpMRI), hyperpolarized MRSI, PET/CT with the use of new tracers and finally PET/MRI. Their detection capabilities are currently under evaluation, as is the feasibility of using such techniques in clinical studies.

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

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