The impact of prostate volume estimation on the risk-adapted biopsy decision based on prostate-specific antigen density and magnetic resonance imaging score.

PURPOSE: Utility of prostate-specific antigen density (PSAd) for risk-stratification to avoid unnecessary biopsy remains unclear due to the lack of standardization of prostate volume estimation. We evaluated the impact of ellipsoidal formula using multiparametric magnetic resonance (MRI) and semi-automated segmentation using tridimensional ultrasound (3D-US) on prostate volume and PSAd estimations as well as the distribution of patients in a risk-adapted table of clinically significant prostate cancer (csPCa). METHODS: In a prospectively maintained database of 4841 patients who underwent MRI-targeted and systematic biopsies, 971 met inclusions criteria. Correlation of volume estimation was assessed by Kendall's correlation coefficient and graphically represented by scatter and Bland-Altman plots. Distribution of csPCa was presented using the Schoots risk-adapted table based on PSAd and PI-RADS score. The model was evaluated using discrimination, calibration plots and decision curve analysis (DCA). RESULTS: Median prostate volume estimation using 3D-US was higher compared to MRI (49cc[IQR 37-68] vs 47cc[IQR 35-66], p < 0.001). Significant correlation between imaging modalities was observed (τ = 0.73[CI 0.7-0.75], p < 0.001). Bland-Altman plot emphasizes the differences in prostate volume estimation. Using the Schoots risk-adapted table, a high risk of csPCa was observed in PI-RADS 2 combined with high PSAd, and in all PI-RADS 4-5. The risk of csPCa was proportional to the PSAd for PI-RADS 3 patients. Good accuracy (AUC of 0.69 and 0.68 using 3D-US and MRI, respectively), adequate calibration and a higher net benefit when using 3D-US for probability thresholds above 25% on DCA. CONCLUSIONS: Prostate volume estimation with semi-automated segmentation using 3D-US should be preferred to the ellipsoidal formula (MRI) when evaluating PSAd and the risk of csPCa.

Disposable grasper-integrated flexible cystoscope for ureteral stent removal in transplanted patients; focus on feasibility, safety, and patient experience. Results and micro-cost analysis from a tertiary referral center.

INTRODUCTION & OBJECTIVES: To evaluate ureteral stent removal (SR) using a grasper-integrated disposable flexible cystoscope (giFC-Isiris ®, Coloplast ®) after kidney transplantation (KT), with a focus on feasibility, safety, patient experience, and costs. MATERIAL AND METHODS: All consecutive KT undergoing SR through giFC were prospectively enrolled from January 2020 to June 2023. Patient characteristics, KT and SR details, urine culture results, antimicrobial prescriptions, and the incidence of urinary tract infections (UTI) within 1 month were recorded. A micro-cost analysis was conducted, making a comparison with the costs of SR with a reusable FC and grasper. RESULTS: A total of 136 KT patients were enrolled, including both single and double KT, with 148 stents removed in total. The median indwelling time was 34 days [26, 47]. SR was successfully performed in all cases. The median preparation and procedure times were 4 min [3,5]. and 45 s[30, 60], respectively. The median Visual Analog Scale (VAS) score was 3 [1, 5], and 98.2% of patients expressed willingness to undergo the procedure again. Only one episode of UTI involving the graft (0.7%) was recorded. Overall, the estimated cost per SR procedure with Isiris ® and the reusable FC was 289.2€ and 151,4€, respectively. CONCLUSIONS: This prospective series evaluated the use of Isiris ® for SR in a cohort of KT patients, demonstrating feasibility and high tolerance. The UTI incidence was 0.7% within 1 month. Based on the micro-cost analysis, estimated cost per procedure favored the reusable FC.

Inguinal Lymphadenectomy for Penile Cancer: An Interim Report from a Trial Comparing Open Versus Videoendoscopic Surgery Using a Within-patient Design.

Background and objective: Nodal metastasis is a major survival and prognostic factor in penile cancer (PeCa). Thus, accurate staging, prognosis, and treatment selection require adequate inguinal lymphadenectomy (ILND). ILND surgery should balance oncologic rigor with morbidity and postoperative complications. Our aim was to compare the feasibility and safety of open ILND (OILND) and videoendoscopic ILND (VEILND) in patients with PeCa. Methods: We conducted a single-center randomized trial with a within-patient design between October 2019 and April 2023. Patients who were undergoing either staging or radical ILND for PeCa were included and randomized to receive either OILND or VEILND on one side, with the other technique then used on the contralateral side. The trial was approved by the local ethics committee and was registered on ClinicalTrials.gov (NCT05887921). The primary outcome was the safety of VEILND. Secondary outcomes included intraoperative and postoperative morbidity rates and surgical outcomes for the two procedures, as well as oncological outcomes according to survival estimates. Key findings and limitations: We included 14 patients in the study. Median follow-up was 12 mo (interquartile range [IQR] 12-17). There were no significant differences in operative time and the number of lymph nodes removed between OILND and VEILND. However, the median time to drain removal was significantly shorter in the VEILND group (15 d, IQR 13-17, 95% confidence interval [CI] 12-17) than in the OILND group (27 d, IQR 20-41, 95% CI 24-31; p = 0.025). No intraoperative complications were observed, but postoperative complications occurred in three cases (21.4%, 95% CI 8.4-37.8%) in the VEILND group and eight (57.1%, 95% CI 18.6-54.3%) in the OILND group (p = 0.032). Conclusions and clinical implications: VEILND represents a safe technique to consider for either staging or curative intent in PeCa and seems to have an advantage over OILND in terms of morbidity. Further high-powered studies are warranted to confirm these preliminary results. Patient summary: We compared the outcomes of two different surgical techniques to remove lymph nodes in patients with penile cancer. We found that a video-assisted keyhole surgery approach seems to result in a lower rate of complications than after open surgery.

Transperineal or Transrectal Magnetic Resonance Imaging-targeted Biopsy for Prostate Cancer Detection.

BACKGROUND AND OBJECTIVE: A notable paradigm shift has emerged in the choice of prostate biopsy approach, with a transition from transrectal biopsy (TRBx) to transperineal biopsy (TPBx) driven by the lower risk of severe urinary tract infections. The impact of this change on detection of clinically significant prostate cancer (csPCa) remains a subject of debate. Our aim was to compare the csPCa detection rate of TRBx and TPBx. METHODS: Patients who underwent magnetic resonance imaging (MRI)-targeted and systematic biopsies for clinically localized PCa at 15 European referral centers from 2016 to 2023 were included. A propensity score matching (PSM) analysis was performed to minimize selection biases. Logistic regression models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). KEY FINDINGS AND LIMITATIONS: Of 3949 patients who met the study criteria, 2187 underwent TRBx and 1762 underwent TPBx. PSM resulted in 1301 matched pairs for analysis. Patient demographics and tumor characteristics were comparable in the matched cohorts. TPBx versus TRBx was associated with greater detection of csPCa, whether defined as International Society of Urological Pathology grade group ≥2 (51% vs 45%; OR 1.37, 95% CI 1.15-1.63; p = 0.001) or grade group ≥3 (29% vs 23%; OR 1.38, 95% CI 1.13-1.67; p = 0.001). Similar results were found when considering MRI-targeted biopsy alone and after stratifying patients according to tumor location, Prostate Imaging-Reporting and Data System score, and clinical features. Limitations include the retrospective nature of the study and the absence of centralized MRI review. CONCLUSIONS: Our findings bolster existing understanding of the additional advantages offered by TPBx. Further randomized trials to fully validate these findings are awaited. PATIENT SUMMARY: We compared the rate of detection of clinically significant prostate cancer with magnetic resonance imaging (MRI)-guided biopsies in which the sample needle is passed through the perineum or the rectum. Our results suggest that the perineal approach is associated with better detection of aggressive prostate cancer.

Radical Prostatectomy for Nonmetastatic Prostate Cancer in Renal Transplant Recipients: Outcomes for a Large Contemporary Cohort and a Matched Comparison to Patients Without a Transplant.

BACKGROUND AND OBJECTIVE: It is unknown whether renal transplant receipt (RTR) status can affect perioperative and oncological outcomes of radical prostatectomy (RP). Our aim was to evaluate oncological and functional outcomes of RTR patients treated with RP for cN0M0 prostate cancer (PCa) via comparison with a no-RTR cohort. METHODS: RTR patients who had undergone RP at seven European institutions during 2001-2022 were identified. A multi-institutional cohort of no-RTR patients treated with RP during 2004-2022 served as the comparator group. Propensity score matching (PSM) at a ratio of 1:4 was used to match no-RTR patients to the RTR cohort according to age, prostate-specific antigen, and final pathology features. We used Kaplan-Meier plots and multivariable Cox, logistic, and Poisson log-linear regression models to test the outcomes of interest. KEY FINDINGS AND LIMITATIONS: After PSM, we analyzed data for 102 RTR and 408 no-RTR patients. RTR patients experienced higher estimated blood loss (EBL), longer length of hospital stay (LOS) and time to catheter removal, higher postoperative complication rates, and a lower continence recovery rate (all p < 0.001). On multivariable analyses, RTR independently predicted unfavorable operative time (odds ratio [OR] 1.22, 95% confidence interval [CI] 1.18-1.25), LOS (OR 1.57, 95% CI 1.32-1.86), EBL (OR 2.24, 95% CI 2.18-2.30), and time to catheter removal (OR 1.93, 95% CI 1.68-2.21), but not complications or continence recovery. There were no significant differences for any oncological outcomes (biochemical recurrence, local or systemic progression) between the RTR and no-RTR groups. While no PCa deaths were recorded, the overall mortality rate was significantly higher in the RTR group (17% vs 0.5%, p < 0.001). CONCLUSIONS AND CLINICAL IMPLICATIONS: Although RP is feasible for RTR patients, the procedure poses non-negligible surgical challenges, with longer operative time and LOS and higher EBL, but no major differences in terms of complications and continence recovery. The RTR group had similar oncological outcomes to the no-RTR group but significantly higher overall mortality related to causes other than PCa. Therefore, careful selection for RP is required among candidates with previous RTR. PATIENT SUMMARY: Removal of the prostate for prostate cancer is possible in patients who have had a kidney transplant, and cancer control outcomes are comparable to those for the general population. However, transplant patients have a higher risk of death from causes other than prostate cancer and the prostate surgery is likely to be more challenging.

The Added Value of Side-specific Systematic Biopsy in Patients Diagnosed by Magnetic Resonance Imaging-targeted Prostate Biopsy.

BACKGROUND: Systematic biopsy (SB) combined with magnetic resonance imaging (MRI)-targeted biopsy is still recommended considering the risk of missing clinically significant prostate cancer (csPCa). OBJECTIVE: To evaluate the added value in csPCa detection on side-specific SB relative to MRI lesion and to externally validate the Noujeim risk stratification model that predicts the risk of csPCa on distant SB cores relative to the index MRI lesion. DESIGN, SETTING, AND PARTICIPANTS: Overall, 4841 consecutive patients diagnosed by MRI-targeted biopsy and SB for Prostate Imaging Reporting and Data System score ≥3 lesions were identified from a prospectively maintained database between January 2016 and April 2023 at 15 European referral centers. A total of 2387 patients met the inclusion criteria and were included in the analysis. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: McNemar's test was used to compare the csPCa detection rate between several biopsy strategies including MRI-targeted biopsy, side-specific SB, and a combination of both. Model performance was evaluated in terms of discrimination using area under the receiver operation characteristic curve (AUC), calibration plots, and decision curve analysis. Clinically significant prostate cancer was defined as International Society of Urological Pathology grade group ≥2. RESULTS AND LIMITATIONS: Overall, the csPCa detection rate was 49%. Considering MRI-targeted biopsy as reference, the added values in terms of csPCa detection were 5.8% (relative increase of 13%), 4.2% (relative increase of 9.8%), and 2.8% (relative increase of 6.1%) for SB, ipsilateral SB, and contralateral SB, respectively. Only 35 patients (1.5%) exclusively had csPCa on contralateral SB (p < 0.001). Considering patients with csPCa on MRI-targeted biopsy and ipsilateral SB, the upgrading rate was 2% (20/961) using contralateral SB (p < 0.001). The Noujeim model exhibited modest performance (AUC of 0.63) when tested using our validation set. CONCLUSIONS: The added value of contralateral SB was negligible in terms of cancer detection and upgrading rates. The Noujeim model could be included in the decision-making process regarding the appropriate prostate biopsy strategy. PATIENT SUMMARY: In the present study, we collected a set of patients who underwent magnetic resonance imaging (MRI)-targeted and systematic biopsies for the detection of prostate cancer. We found that biopsies taken at the opposite side of the MRI suspicious lesion have a negligible impact on cancer detection. We also validate a risk stratification model that predicts the risk of cancer on biopsies beyond 10 mm from the initial lesion, which could be used in daily practice to improve the personalization of the prostate biopsy.

Patient and Context Factors in the Adoption of Active Surveillance for Low-Risk Prostate Cancer.

Importance: Although active surveillance for patients with low-risk prostate cancer (LRPC) has been recommended for years, its adoption at the population level is often limited. Objective: To make active surveillance available for patients with LRPC using a research framework and to compare patient characteristics and clinical outcomes between those who receive active surveillance vs radical treatments at diagnosis. Design, Setting, and Participants: This population-based, prospective cohort study was designed by a large multidisciplinary group of specialists and patients' representatives. The study was conducted within all 18 urology centers and 7 radiation oncology centers in the Piemonte and Valle d'Aosta Regional Oncology Network in Northwest Italy (approximate population, 4.5 million). Participants included patients with a new diagnosis of LRPC from June 2015 to December 2021. Data were analyzed from January to May 2023. Exposure: At diagnosis, all patients were informed of the available treatment options by the urologist and received an information leaflet describing the benefits and risks of active surveillance compared with active treatments, either radical prostatectomy (RP) or radiation treatment (RT). Patients choosing active surveillance were actively monitored with regular prostate-specific antigen testing, clinical examinations, and a rebiopsy at 12 months. Main Outcomes and Measures: Outcomes of interest were proportion of patients choosing active surveillance or radical treatments, overall survival, and, for patients in active surveillance, treatment-free survival. Comparisons were analyzed with multivariable logistic or Cox models, considering centers as clusters. Results: A total of 852 male patients (median [IQR] age, 70 [64-74] years) were included, and 706 patients (82.9%) chose active surveillance, with an increasing trend over time; 109 patients (12.8%) chose RP, and 37 patients (4.3%) chose RT. Median (IQR) follow-up was 57 (41-76) months. Worse prostate cancer prognostic factors were negatively associated with choosing active surveillance (eg, stage T2a vs T1c: odds ratio [OR], 0.51; 95% CI, 0.28-0.93), while patients who were older (eg, age ≥75 vs <65 years: OR, 4.27; 95% CI, 1.98-9.22), had higher comorbidity (Charlson Comorbidity Index ≥2 vs 0: OR, 1.98; 95% CI, 1.02-3.85), underwent an independent revision of the first prostate biopsy (OR, 2.35; 95% CI, 1.26-4.38) or underwent a multidisciplinary assessment (OR, 2.65; 95% CI, 1.38-5.11) were more likely to choose active surveillance vs active treatment. After adjustment, center at which a patient was treated continued to be an important factor in the choice of treatment (intraclass correlation coefficient, 18.6%). No differences were detected in overall survival between active treatment and active surveillance. Treatment-free survival in the active surveillance cohort was 59.0% (95% CI, 54.8%-62.9%) at 24 months, 54.5% (95% CI, 50.2%-58.6%) at 36 months, and 47.0% (95% CI, 42.2%-51.7%) at 48 months. Conclusions and Relevance: In this population-based cohort study of patients with LRPC, a research framework at system level as well as favorable prognostic factors, a multidisciplinary approach, and an independent review of the first prostate biopsy at patient-level were positively associated with high uptake of active surveillance, a practice largely underused before this study.

Single-use digital flexible cystoscope for double J removal versus reusable instruments: a prospective, comparative study of functionality, risk of infection, and costs.

BACKGROUND: The removal of ureteral stent can be performed with disposable or reusable flexible cystoscopes, but limited comparative data are available on functionality, risk of infections, and costs. METHODS: We performed a multicentric, prospective, observational study on patients undergoing in-office ureteral stent removal with Isiris-α® or a reusable Storz™ flexible cystoscope. Study endpoints were the functionality and effectiveness of the devices, the rate of postoperative bacteriuria and UTIs, and the costs of the procedure. RESULTS: A total of 135 patients were included, 80 (59.2%) treated with reusable cystoscopes and 55 (40.8%) with Isiris-α®. No significant baseline differences between groups were detected. Isiris-α® outperformed the reusable device in terms of quality of vision (p 0.001), manoeuvrability (p 0.001), grasper functionality (p < 0.001), and quality of the procedure (p 0.01). Mean procedure time was shorter with Isiris-α® (p < 0.001) due to a shorter instrument preparation time (p < 0.001). No differences were found in terms of perceived patient pain (p 0.34), nor postoperative bacteriuria or symptomatic UTIs. According to our cost analysis, the in-office procedure performed with Isiris-α® was more expensive (+ 137.8€) but was independent from instrument turnover or disinfection. Among limitations of study we acknowledge the lack of randomization, the use of antibiotic prophylaxis in several patients, and the high rate of missing preoperative urine cultures. CONCLUSIONS: Isiris-α® outperforms reusable cystoscopes for in-office ureteral stent removal in terms of total operative time and quality of the procedure, at the cost of being more expensive. No significant differences in postoperative bacteriuria or symptomatic UTIs were found.

Diagnosis of prostate cancer with magnetic resonance imaging in men treated with 5-alpha-reductase inhibitors.

PURPOSE: The primary aim of this study was to evaluate if exposure to 5-alpha-reductase inhibitors (5-ARIs) modifies the effect of MRI for the diagnosis of clinically significant Prostate Cancer (csPCa) (ISUP Gleason grade ≥ 2). METHODS: This study is a multicenter cohort study including patients undergoing prostate biopsy and MRI at 24 institutions between 2013 and 2022. Multivariable analysis predicting csPCa with an interaction term between 5-ARIs and PIRADS score was performed. Sensitivity, specificity, and negative (NPV) and positive (PPV) predictive values of MRI were compared in treated and untreated patients. RESULTS: 705 patients (9%) were treated with 5-ARIs [median age 69 years, Interquartile range (IQR): 65, 73; median PSA 6.3 ng/ml, IQR 4.0, 9.0; median prostate volume 53 ml, IQR 40, 72] and 6913 were 5-ARIs naïve (age 66 years, IQR 60, 71; PSA 6.5 ng/ml, IQR 4.8, 9.0; prostate volume 50 ml, IQR 37, 65). MRI showed PIRADS 1-2, 3, 4, and 5 lesions in 141 (20%), 158 (22%), 258 (37%), and 148 (21%) patients treated with 5-ARIs, and 878 (13%), 1764 (25%), 2948 (43%), and 1323 (19%) of untreated patients (p < 0.0001). No difference was found in csPCa detection rates, but diagnosis of high-grade PCa (ISUP GG ≥ 3) was higher in treated patients (23% vs 19%, p = 0.013). We did not find any evidence of interaction between PIRADS score and 5-ARIs exposure in predicting csPCa. Sensitivity, specificity, PPV, and NPV of PIRADS ≥ 3 were 94%, 29%, 46%, and 88% in treated patients and 96%, 18%, 43%, and 88% in untreated patients, respectively. CONCLUSIONS: Exposure to 5-ARIs does not affect the association of PIRADS score with csPCa. Higher rates of high-grade PCa were detected in treated patients, but most were clearly visible on MRI as PIRADS 4 and 5 lesions. TRIAL REGISTRATION: The present study was registered at ClinicalTrials.gov number: NCT05078359.

Cohort profile: the Turin prostate cancer prognostication (TPCP) cohort.

Introduction: Prostate cancer (PCa) is the most frequent tumor among men in Europe and has both indolent and aggressive forms. There are several treatment options, the choice of which depends on multiple factors. To further improve current prognostication models, we established the Turin Prostate Cancer Prognostication (TPCP) cohort, an Italian retrospective biopsy cohort of patients with PCa and long-term follow-up. This work presents this new cohort with its main characteristics and the distributions of some of its core variables, along with its potential contributions to PCa research. Methods: The TPCP cohort includes consecutive non-metastatic patients with first positive biopsy for PCa performed between 2008 and 2013 at the main hospital in Turin, Italy. The follow-up ended on December 31st 2021. The primary outcome is the occurrence of metastasis; death from PCa and overall mortality are the secondary outcomes. In addition to numerous clinical variables, the study's prognostic variables include histopathologic information assigned by a centralized uropathology review using a digital pathology software system specialized for the study of PCa, tumor DNA methylation in candidate genes, and features extracted from digitized slide images via Deep Neural Networks. Results: The cohort includes 891 patients followed-up for a median time of 10 years. During this period, 97 patients had progression to metastatic disease and 301 died; of these, 56 died from PCa. In total, 65.3% of the cohort has a Gleason score less than or equal to 3 + 4, and 44.5% has a clinical stage cT1. Consistent with previous studies, age and clinical stage at diagnosis are important prognostic factors: the crude cumulative incidence of metastatic disease during the 14-years of follow-up increases from 9.1% among patients younger than 64 to 16.2% for patients in the age group of 75-84, and from 6.1% for cT1 stage to 27.9% in cT3 stage. Discussion: This study stands to be an important resource for updating existing prognostic models for PCa on an Italian cohort. In addition, the integrated collection of multi-modal data will allow development and/or validation of new models including new histopathological, digital, and molecular markers, with the goal of better directing clinical decisions to manage patients with PCa.

Impact of operator expertise on transperineal free-hand mpMRI-fusion-targeted biopsies under local anaesthesia for prostate cancer diagnosis: a multicenter prospective learning curve.

PURPOSE: Transperineal mpMRI-targeted fusion prostate biopsies (TPFBx) are recommended for prostate cancer diagnosis, but little is known about their learning curve (LC), especially when performed under local anaesthesia (LA). We investigated how operators' and institutions' experience might affect biopsy results. METHODS: Baseline, procedure and pathology data of consecutive TPFBx under LA were prospectively collected at two academic Institutions, from Sep 2016 to May 2019. Main inclusion criterion was a positive MRI. Endpoints were biopsy duration, clinically significant prostate cancer detection rate on targeted cores (csCDR-T), complications, pain and urinary function. Data were analysed per-centre and per-operator (with ≥ 50 procedures), comparing groups of consecutive patient, and subsequently through regression and CUSUM analyses. Learning curves were plotted using an adjusted lowess smoothing function. RESULTS: We included 1014 patients, with 27.3% csCDR-T and a median duration was 15 min (IQR 12-18). A LC for biopsy duration was detected, with the steeper phase ending after around 50 procedures, in most operators. No reproducible evidence in favour of an impact of experience on csPCa detection was found at operator's level, whilst a possible gentle LC of limited clinical relevance emerged at Institutional level; complications, pain and IPSS variations were not related to operator experience. CONCLUSION: The implementation of TPFBx under LA was feasible, safe and efficient since early phases with a relatively short learning curve for procedure time.

Machine Learning CT-Based Automatic Nodal Segmentation and PET Semi-Quantification of Intraoperative 68Ga-PSMA-11 PET/CT Images in High-Risk Prostate Cancer: A Pilot Study.

High-resolution intraoperative PET/CT specimen imaging, coupled with prostate-specific membrane antigen (PSMA) molecular targeting, holds great potential for the rapid ex vivo identification of disease localizations in high-risk prostate cancer patients undergoing surgery. However, the accurate analysis of radiotracer uptake would require time-consuming manual volumetric segmentation of 3D images. The aim of this study was to test the feasibility of using machine learning to perform automatic nodal segmentation of intraoperative 68Ga-PSMA-11 PET/CT specimen images. Six (n = 6) lymph-nodal specimens were imaged in the operating room after an e.v. injection of 2.1 MBq/kg of 68Ga-PSMA-11. A machine learning-based approach for automatic lymph-nodal segmentation was developed using only open-source Python libraries (Scikit-learn, SciPy, Scikit-image). The implementation of a k-means clustering algorithm (n = 3 clusters) allowed to identify lymph-nodal structures by leveraging differences in tissue density. Refinement of the segmentation masks was performed using morphological operations and 2D/3D-features filtering. Compared to manual segmentation (ITK-SNAP v4.0.1), the automatic segmentation model showed promising results in terms of weighted average precision (97-99%), recall (68-81%), Dice coefficient (80-88%) and Jaccard index (67-79%). Finally, the ML-based segmentation masks allowed to automatically compute semi-quantitative PET metrics (i.e., SUVmax), thus holding promise for facilitating the semi-quantitative analysis of PET/CT images in the operating room.

Prechemotherapy Transperitoneal Robotic-Assisted Partial Nephrectomy (RAPN) for a Wilms Tumor: Surgical and Oncological Outcomes in a Four-Year-Old Patient.

BACKGROUND: Wilms tumor (WT) is the most frequent renal tumor in children. The SIOP-UMBRELLA Guidelines allow for nephron-sparing surgery (NSS) in syndromic patients, as well as in cases of small (<300 mL) non-syndromic unilateral WTs, without lymph node involvement, and with a substantial expected remnant renal function, following neoadjuvant chemotherapy. We present a case of prechemotherapy transperitoneal robot-assisted partial nephrectomy (RAPN) for a unilateral, non-syndromic Wilms tumor. METHODS: A four-year-old child presented with a solid mass measuring 3.6 cm in diameter involving the upper right renal pole, incidentally detected during an abdominal echotomography. CT scan and abdominal MRI revealed no local infiltration or lymph node involvement, suggesting that the exophytic mass could be easily resected via an NSS robotic approach. Preoperative imaging did not strongly suggest WT. A virtual 3D reconstruction of the tumor was performed. RESULTS: After the oncologic board approval, a robot-assisted partial nephrectomy with an intraperitoneal approach was performed. Histopathological analysis confirmed the diagnosis of WT. The patient subsequently received 10 doses of vincristine as adjuvant chemotherapy. A 28-month follow-up showed no tumor recurrence. CONCLUSIONS: Intraperitoneal RAPN may be an option for selected WT and warrants consideration as a challenging but advantageous approach.

Robot-assisted PSMA-radioguided Surgery to Assess Surgical Margins and Nodal Metastases in Prostate Cancer Patients: Report on Three Cases Using an Intraoperative PET-CT Specimen Imager.

INTRODUCTION: The aim of this feasibility study was to test the intraoperative use of this brand-new specimen PET/CT to guide robot-assisted radical prostatectomy and pelvic lymph node dissection. MATERIALS AND METHODS: Three cases of robot-assisted radical prostatectomy and pelvic lymph node dissection were performed with intraoperative use of the specimen imager. Surgeries were performed with Da Vinci Xi robot. An intravenous injection of 68Ga-PSMA-11 was performed in the OR and after complete excision, the specimens were analyzed with the imager. RESULTS: The average nodal yield was 17.3 (5.8 SD) nodes per patient. Specimen PET/CT images showed a focal uptake in a metastatic node (TBR 13.6), and no uptake or diffuse, faint uptake in negative nodes (TBR range: 1-5.3). The specimen imager provided intraoperative PET/CT images that clearly showed negative surgical margins in two patients, whereas the results were uncertain in a locally advanced case. CONCLUSION: The intraoperative use of the specimen PET/CT imager is safe and feasible and could improve the evaluation of prostate surgical margins and lymph node status.

The impact of single-use digital flexible cystoscope for double J removal on hospital costs and work organization: A multicentric evaluation.

BACKGROUND: Isiris-α® is a single-use digital flexible cystoscope with an integrated grasper designed for double J (DJ) stent removal. Aim of this study was to conduct a multicentric evaluation of the costs and criticalities of stent removals performed with Isiris®-α in different hospitals and health systems, as compared to other DJ removal procedures. METHODS: After gathering 10 institutions worldwide with experience on Isiris-α®, we performed an analysis of the reported costs of DJ removal with Isiris-α®, as compared to the traditional reusable equipment used in each institution. The cost evaluation included instrument purchase, Endoscopic Room (EnR)/ Operatory Room (OR) occupancy, medical staff, instrument disposal, maintenance, repairs, decontamination or sterilization of reusable devices. RESULTS: The main factor affecting the costs of the procedure was OR/EnR occupancy. Decontamination and sterilization accounted for a less important part of total costs. Isiris-α® was more profitable in institutions where DJ removal is usually performed in the EnR/OR, allowing to transfer the procedure to outpatient clinic, with a significant cost saving and EnR/OR time saving to be allocated to other activities. In the only institution where DJ removal was already performed in outpatient clinics, there is a slight cost difference in favor of reusable instruments in high-volume institutions, given a sufficient number to guarantee the turnover. CONCLUSION: Isiris-α® leads to significant cost benefit in the institutions where DJ removal is routinely performed in EnR/OR, and brings significant improvement in organization, cost impact and turnover.

Predictors of Prostate Cancer at Fusion Biopsy: The Role of Positive Family History, Hypertension, Diabetes, and Body Mass Index.

BACKGROUND: PSA density and an elevated PI-RADS score are among the strongest predictors of prostate cancer (PCa) in a fusion biopsy. Positive family history, hypertension, diabetes, and obesity have also been associated with the risk of developing PCa. We aim to identify predictors of the prostate cancer detection rate (CDR) in a series of patients undergoing a fusion biopsy. METHODS: We retrospectively evaluated 736 consecutive patients who underwent an elastic fusion biopsy from 2020 to 2022. Targeted biopsies (2-4 cores per MRI target) were followed by systematic mapping (10-12 cores). Clinically significant PCa (csPCa) was defined as ISUP score ≥ 2. Uni- and multi-variable logistic regression analyses were performed to identify predictors of CDR among age, body mass index (BMI), hypertension, diabetes, positive family history, PSA, a positive digital rectal examination (DRE), PSA density ≥ 0.15, previous negative biopsy status, PI-RADS score, and size of MRI lesion. RESULTS: The median patients' age was 71 years, and median PSA was 6.6 ng/mL. A total of 20% of patients had a positive digital rectal examination. Suspicious lesions in mpMRI were scored as 3, 4, and 5 in 14.9%, 55.0%, and 17.5% of cases, respectively. The CDR was 63.2% for all cancers and 58.7% for csPCa. Only age (OR 1.04, p < 0.001), a positive DRE (OR 1.75, p = 0.04), PSA density (OR 2.68, p < 0.001), and elevated PI-RADS score (OR 4.02, p = 0.003) were significant predictors of the CDR in the multivariable analysis for overall PCa. The same associations were found for csPCa. The size of an MRI lesion was associated with the CDR only in uni-variable analysis (OR 1.07, p < 0.001). BMI, hypertension, diabetes, and a positive family history were not predictors of PCa. CONCLUSIONS: In a series of patients selected for a fusion biopsy, positive family history, hypertension, diabetes, or BMI are not predictors of PCa detection. PSA-density and PI-RADS score are confirmed to be strong predictors of the CDR.

Surgical and Functional Outcomes of Penile Amputation and Perineal Urethrostomy Configuration in Invasive Penile Cancer.

OBJECTIVE: The treatment of invasive penile cancer is based on partial or total penectomy and perineal urethrostomy configuration.1-3 To report surgical and functional outcomes of penile amputation and perineal urethrostomy configuration in a consecutive series of patients with invasive penile cancer. MATERIALS AND METHODS: A single-center retrospective analysis was conducted from January 2018 to December 2022. Data were extracted from clinical records and operative notes. As primary outcomes, surgical complications were described. Oncological outcomes through cancer-specific survival and overall survival were analyzed. Patient survival was estimated by a Kaplan-Meier analysis. Functional outcomes were assessed through the administration of the International Prostatic Symptoms Score (IPSS) questionnaire at 3 months follow-up. RESULTS: Overall 10 patients were enrolled. The median follow-up was 16 months (Interquartile range (IQR 12-18)). The median age was 71 years (IQR 63-79). Operative time was set at 195 minutes (IQR 155-275). The median hospital stay was 8 days (IQR: 6-10). Postoperative complications occurred in 20% of patients, in 1 case surgical revision was necessary. Positive surgical margins were detected only in 1 patient. The median catheterization time was 15 days (IQR: 15-32). One patient developed local recurrence. At 1 year, the cancer-specific survival was 80% and overall survival was 60%. The median preoperative IPSS was 15 (IQR 12-19). The median postoperative IPSS was 6 (IQR 5-7). CONCLUSION: Penile amputation and perineal urethrostomy configuration was demonstrated to be a safe and effective procedure to address invasive penile cancer.

Expanding inclusion criteria for active surveillance in intermediate-risk prostate cancer: a machine learning approach.

PURPOSE: To develop new selection criteria for active surveillance (AS) in intermediate-risk (IR) prostate cancer (PCa) patients. METHODS: Retrospective study including patients from 14 referral centers who underwent pre-biopsy mpMRI, image-guided biopsies and radical prostatectomy. The cohort included biopsy-naive IR PCa patients who met the following inclusion criteria: Gleason Grade Group (GGG) 1-2, PSA < 20 ng/mL, and cT1-cT2 tumors. We relied on a recursive machine learning partitioning algorithm developed to predict adverse pathological features (i.e., ≥ pT3a and/or pN + and/or GGG ≥ 3). RESULTS: A total of 594 patients with IR PCa were included, of whom 220 (37%) had adverse features. PI-RADS score (weight:0.726), PSA density (weight:0.158), and clinical T stage (weight:0.116) were selected as the most informative risk factors to classify patients according to their risk of adverse features, leading to the creation of five risk clusters. The adverse feature rates for cluster #1 (PI-RADS ≤ 3 and PSA density < 0.15), cluster #2 (PI-RADS 4 and PSA density < 0.15), cluster #3 (PI-RADS 1-4 and PSA density ≥ 0.15), cluster #4 (normal DRE and PI-RADS 5), and cluster #5 (abnormal DRE and PI-RADS 5) were 11.8, 27.9, 37.3, 42.7, and 65.1%, respectively. Compared with the current inclusion criteria, extending the AS criteria to clusters #1 + #2 or #1 + #2 + #3 would increase the number of eligible patients (+ 60 and + 253%, respectively) without increasing the risk of adverse pathological features. CONCLUSIONS: The newly developed model has the potential to expand the number of patients eligible for AS without compromising oncologic outcomes. Prospective validation is warranted.

Direct healthcare costs of non-metastatic castration-resistant prostate cancer in Italy.

OBJECTIVES: The management of non-metastatic castration-resistant prostate cancer (nmCRPC) is rapidly evolving; however, little is known about the direct healthcare costs of nmCRPC. We aimed to estimate the cost-of-illness (COI) of nmCRPC from the Italian National Health Service perspective. METHODS: Structured, individual qualitative interviews were carried out with clinical experts to identify what healthcare resources are consumed in clinical practice. To collect quantitative estimates of healthcare resource consumption, a structured expert elicitation was performed with clinical experts using a modified version of a previously validated interactive Excel-based tool, EXPLICIT (EXPert eLICItation Tool). For each parameter, experts were asked to provide the lowest, highest, and most likely value. Deterministic and probabilistic sensitivity analyses (PSA) were carried out to test the robustness of the results. RESULTS: Ten clinical experts were interviewed, and six of them participated in the expert elicitation exercise. According to the most likely estimate, the yearly cost per nmCRPC patient is €4,710 (range, €2,243 to €8,243). Diagnostic imaging (i.e., number/type of PET scans performed) had the highest impact on cost. The PSA showed a 50 percent chance for the yearly cost per nmCRPC patient to be within €5,048 using a triangular distribution for parameters, and similar results were found using a beta-PERT distribution. CONCLUSIONS: This study estimated the direct healthcare costs of nmCRPC in Italy based on a mixed-methods approach. Delaying metastases may be a reasonable goal also from an economic standpoint. These findings can inform decision-making about treatments at the juncture between non-metastatic and metastatic prostate cancer disease.