Evaluation of Peri-Operative Outcomes after Prostatic Urethral Lift with Emphasis on Urodynamic Changes, Symptom Improvement and Sexual Function.

Background and Aims: The aim of our study is to evaluate the possible urodynamic effect of prostatic urethral lift (PUL) in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. Methods: A consecutive series of patients undergoing PUL placement were consecutively enrolled in two centers. Inclusion criteria: ≥50 years of age, benign prostatic obstruction (BPO), international prostate symptom score (IPSS) ≥ 13, prostate volume ≤ 60 mL, and no middle prostate lobe. All patients were evaluated using a detailed clinical history, a validated questionnaire, flexible cystoscopy, and pressure flow studies (PFS) at baseline. PFS were performed at 6 months to evaluate the urodynamic effect of PUL. Results: Overall, 20 patients with a median age of 63 were enrolled. At six months, statistically significant improvements in terms of median Qmax (11.5 vs. 8.5; p < 0.05) and median IPSS (16 vs. 10.5; p < 0.05) were recorded, and sexual function was maintained. All urodynamic parameters improved at 6 months, and significance was reached for all values except for PdetQmax. Finally, Schäfer's class improved from a median of III to a median of II. More specifically, 16/20 presented an improvement in the Schäfer class, and 12/20 patients presented a BOOI < 20 at 6 months. Conclusions: PUL represents an effective treatment in patients with LUTS due to BPH and improves bladder outlet obstruction without any effect on sexual function.

Urinary Leakage after Robot-Assisted Radical Prostatectomy: Is Always Predictive of Functional Results?

INTRODUCTION: The aim of the study was to evaluate if and when the presence of radiological urinary leakages of vesico-urethral anastomosis, after robotic radical prostatectomy, could provoke urethral strictures or affect continence recovery. METHODS: We enrolled 216 patients, undergoing robot-assisted radical prostatectomy between January 2020 and December 2022 in three high-volume referenced centres for robotic surgery. Before removal of the bladder catheter, all patients underwent a cystourethrography in which the presence/absence of leakage was assessed at level of vesico-urethral anastomosis. Based on degree of severity of urinary leakage on cystourethrography, patients were classified as no leakage or grade 0, grade 1 with transversal diameter ≤1 cm, and grade 2 with transversal diameter ≥1 cm. At follow-up, urethral stenosis formation and urinary continence recovery were assessed; furthermore, post-operative 12-month functional outcome was determined using EORTC-QLQ-PR25 questionnaire. RESULTS: Radiological urinary leakage was found in 30 patients with grade 1 and 33 patients with grade 2, for a total of 63 patients. Only 1 patient (1.5%), grade 2 urinary leakage, developed significant urethral stricture and required endoscopic urethrotomy after 6 months. Analysing the differences in those who removed the bladder catheter after 7-9 days and those who kept it longer, we found no statistically significant differences regarding recovery of continence (p = 0.23) or about urinary symptoms (p = 0.94). CONCLUSIONS: RARP remains gold-standard approach for treatment of localized prostate cancer and the superiority of this technique is safe in preventing urethral strictures and continence recovery, even in presence of significant anastomotic urinary leakage.

Impact of diabetes mellitus on oncologic outcomes in patients receiving robot-assisted radical cystectomy for bladder cancer.

PURPOSE: Aim of this study is to investigate the association between DM and oncological outcomes among patients with muscle-invasive (MI) or high-risk non-muscle invasive (NMI) bladder cancer (BC) who underwent robot-assisted radical cystectomy with intracorporeal urinary diversion (RARC). METHODS: An IRB approved multi-institutional BC database was queried, including patients underwent RARC between January 2013 and June 2023. Patients were divided into two groups according to DM status. Baseline, clinical, perioperative, pathologic data were compared. Chi-square and Student t tests were performed to compare categorical and continuous variables, respectively. Kaplan-Meier method and Cox regression analyses were performed to assess the association between DM and oncologic outcomes. RESULTS: Out of 547 consecutive patients, 97 (17.7%) had DM. The two cohorts showed similar preoperative features, except for ASA score (p = 0.01) and Hypertension rates (p < 0.001). No differences were detected for perioperative complications, pT stage, pN stages and surgical margins status (all p > 0.12). DM patients displayed significantly lower 5-yr disease-free survival (DFS) (44.6% vs. 63.3%, p = 0.007), 5-yr cancer-specific survival (CSS) (45.1% vs. 70.1%, p = 0.001) and 5-yr Overall survival (OS) (39.9% vs. 63.8%, p = 0.001). At Multivariable Cox-regression analyses DM status was identified as independent predictor of worse cancer-specific survival (CSS) (HR 2.1; p = 0.001) and overall survival (OS) (HR 2.05; p < 0.001). CONCLUSION: Among BC patients who underwent RARC, DM patients showed worse oncologic outcomes than the non-DM patients, with DM status playing an independent negative predicting role in CSS and OS. Future prospective studies are awaited, stimulating basic and translational research to identify possible mechanisms of interaction between DM and BC.

Multiparametric Prostate MRI Accuracy of Prostate Imaging Reporting and Data System (v2.1) Scores 4 and 5: The Influence of Image Quality According to the Prostate Imaging Quality Score.

Purpose: The accuracy of multiparametric magnetic resonance imaging (mpMRI) heavily relies on image quality, as evidenced by the evolution of the prostate imaging quality (PI-QUAL) scoring system for the evaluation of clinically significant prostate cancer (csPC). This study aims to evaluate the impact of PI-QUAL scores in detecting csPC within PI-RADS 4 and 5 lesions. Methods: We retrospectively selected from our database all mpMRI performed from January 2019 to March 2022. Inclusion criteria were as follows: (1) mpMRI acquired in our institution according to the technical requirements from the PI-RADS (v2.1) guidelines; (2) single lesion scored as PI-RADS (v2.1) 4 or 5; (3) MRI-TBx performed in our institution; (4) complete histology report; and (5) complete clinical record. Results: A total of 257 male patients, mean age 70.42 ± 7.6 years, with a single PI-RADS 4 or 5 lesion undergoing MRI-targeted biopsy, were retrospectively studied. Of these, 61.5% were PI-RADS 4, and 38.5% were PI-RADS 5, with 84% confirming neoplastic cells. In high-quality image lesions (PI-QUAL ≥ 4), all PI-RADS 5 lesions were accurately identified as positive at the final histological examination (100% of CDR). For PI-RADS 4 lesions, 37 (23%) were negative, resulting in a cancer detection rate of 77% (95% CI: 67.51-84.83). Conclusions: The accuracy of mpMRI, independently of the PI-RADS score, progressively decreased according to the decreasing PI-QUAL score. These findings emphasize the crucial role of the PI-QUAL scoring system in evaluating PI-RADS 4 and 5 lesions, influencing mpMRI accuracy.

MRI-Targeted Prostate Fusion Biopsy: What Are We Missing outside the Target? Implications for Treatment Planning.

Introduction: This study aimed to evaluate the added diagnostic value of systematic biopsies (SBx) after magnetic resonance imaging (MRI)-targeted biopsies (TBx) and the presence of prostate cancer (PCa) outside MRI targets, in a prospective, contemporary, multicentric series of fusion biopsy patients. Methods: We collected data on 962 consecutive patients who underwent fusion biopsy between 2022 and 2024. Prostate cancer was considered clinically significant (csPCa) in the case of grade ≥ 2. Median test and Fisher exact chi-square tests were used. To identify predictors of out-field positivity, univariate and multivariable logistic regression analyses were performed. Results: Prostate cancer and csPCa were detected by TBx only in 56% and 50%, respectively, and by SBx only in 55% and 45%, respectively (p < 0.001). Prostate cancer and csPCa were diagnosed by TBx in 100 (10%) and 82 (8%) SBx-negative cases and by SBx in 86 (9%) and 54 (6%) TBx-negative cases (p < 0.001). Tumors outside MRI targets were found in 213 (33%) cases in the same lobe and 208 (32%) in the contralateral lobe, most of them being csPCa. Predictors of out-field contralateral PCa were positive DRE (HR 1.50, p 0.03), PSA density ≥ 0.15 (HR 2.20, p < 0.001), and PI-RADS score 5 (HR 2.04, p 0.01). Conclusions: Both TBx and SBx identify a non-negligible proportion of csPCa when the other modality is negative. SBx after TBx should always be considered given the risk of missing other csPCa foci within the prostate, especially in patients with positive DRE, PSA density ≥ 0.15, and PIRADS 5 lesions.

No clinical benefit from sequential combination of mitomycin C plus bacillus Calmette-Guérin (BCG) than BCG alone in the adjuvant treatment of high risk non muscle invasive bladder cancer: result of a planned interim analysis of a prospective randomized trial.

BACKGROUND: The aim of this study was to evaluate whether the sequential use of Mitomycin C (MMC) and Bacillus Calmette-Guérin (BCG) is superior to BCG alone in reducing the risk of disease recurrence in patients with non-muscle invasive bladder cancer (NMIBC) with high risk of progression. METHODS: Prospective randomized trial was conducted from March 2021 to March 2023 and included 72 patients with high risk NMIBC. Trial registration number: NCT03790384; EUDRACT Number: 2017-004540-37. Thirty-one patients underwent to BCG alone and forty-one to MMC plus BCG during the induction course. The BCG schedule comprised six weekly instillation of 81 mg Connaught strain BCG as the induction course, followed by a further three-monthly instillation at three, six and twelve months, as the maintenance course. Forty mg of MMC were administered the day prior to each weekly BCG instillation in BCG plus MMC arm. A planned interim analysis was carried out in June 2023, at the end of the 12mo follow-up period. RESULTS: Six out of thirteen 6/31(19.3%) and 10/41 (24.4%) patients experienced recurrence in BCG and BCG plus MMC group (P=0.611), respectively. BCG plus MMC did not improve Disease Free Interval (HR: 1.23 95% CI:0.46-3.50; P=0.640). Patients receiving sequential treatment experienced similar AEs (P>0.05) and more urinary symptoms (P<0.05). CONCLUSIONS: This interim pre-planned analysis suggested absence of clinical advantages in terms of disease recurrence rate when MMC is administered one day prior to BCG during induction course.

Post-Voided Residual Ratio Does Not Predict Trifecta Outcome after Transurethral Resection of Prostate.

The purpose of this study was to assess the importance of the post-void residual (PVR) ratio (PVR ratio) in achieving a favorable trifecta outcome for patients suffering from lower urinary tract symptoms and benign prostatic enlargement (LUTS-BPE) who undergo transurethral resection of the prostate (TURP). Starting from 2015, a series of patients with LUTS-BPE who underwent TURP were included in a forward-looking study. These patients were assessed using the international prostate symptom score (IPSS) screening tool, uroflowmetry, and a transrectal ultrasound to measure prostate volume (TRUS). Both the PVR urine volume and the PVR ratio (PVR-R), which is the PVR as a percentage of total bladder volume (voided volume + PVR), were measured. The assessment of outcomes was based on the trifecta favorable outcome, defined as meeting all of the following criteria: (1) absence of perioperative complications, (2) a postoperative IPSS of less than eight, and (3) a postoperative maximum urinary flow rate (Qmax) greater than 15 mL/s. A total of 143 patients were included, with a median age of 70 years (interquartile range 65-73). Of these, 58% (83/143) achieved a positive trifecta outcome. Upon conducting a multivariate analysis, both IPSS and Qmax were identified as predictors of a positive trifecta outcome, whereas the PVR-R did not prove to be an independent predictor. In summary, it was found that preoperative IPSS and Qmax are indicative of a trifecta outcome following TURP, whereas PVR-R is not.

Open versus Robot-Assisted Radical Cystectomy for the Treatment of pT4a Bladder Cancer: Comparison of Perioperative Outcomes.

We compared the perioperative outcomes of open (ORC) vs. robot-assisted (RARC) radical cystectomy in the treatment of pT4a MIBC. In total, 212 patients underwent ORC (102 patients, Group A) vs. RARC (110 patients, Group B) for pT4a bladder cancer. Patients were prospectively followed and retrospectively reviewed. We assessed operative time, estimated blood loss (EBL), intraoperative and postoperative complications, length of stay, transfusion rate, and oncological outcomes. Preoperative features were comparable. The mean operative time was 232.8 vs. 189.2 min (p = 0.04), and mean EBL was 832.8 vs. 523.7 mL in Group A vs. B (p = 0.04). An intraoperative transfusion was performed in 32 (31.4%) vs. 11 (10.0%) cases during ORC vs. RARC (p = 0.03). The intraoperative complications rate was comparable. The mean length of stay was shorter after RARC (12.6 vs. 7.2 days, p = 0.02). Postoperative transfusions were performed in 36 (35.3%) vs. 13 (11.8%) cases (p = 0.03), and postoperative complications occurred in 37 (36.3%) vs. 29 (26.4%) patients in Groups A vs. B (p = 0.05). The positive surgical margin (PSM) rate was lower after RARC. No differences were recorded according to the oncological outcomes. ORC and RARC are feasible treatments for the management of pT4a bladder tumors. Minimally invasive surgery provides shorter operative time, bleeding, transfusion rate, postoperative complications, length of stay, and PSM rate.

Is early continence recovery related to the length of spared urethra? A prospective multicenter study comparing preoperative MRI and histologic specimen measurements after robotic radical prostatectomy.

BACKGROUND: Urinary incontinence (UI) is a common complication after radical prostatectomy, significantly affecting patients' quality of life. This study aimed to correlate the length of preserved urethra in robotic radical prostatectomy (RALP) patients with short-term urinary continence rates within 90 days post-surgery. METHODS: A prospective multicentric study enrolled 190 prostate adenocarcinoma patients undergoing RALP. Using preoperative magnetic resonance imaging (mpMRI), urethral length was measured from the external urethral sphincter to the bladder neck. After surgery, histological measurements of the removed urethra were compared to the preoperative mpMRI data. Patients were categorized into two groups at the three-month follow-up based on urinary continence assessed through Urodynamic Study (UDS): Group A (94 patients without UI) and Group B (96 patients with UI). RESULTS: Results revealed a significant difference in mean UI recovery time (Group A: 12.35 days, SD: 3.09 vs. Group B: 93.86 days, SD: 34.8, p < 0.0001). A ROC curve identified a 16.5% cut-off value (p < 0.000, sensitivity 87.5%, specificity 91.8%). Both groups showed a significant negative correlation between preserved urethral percentage and UI recovery time (Group A: r -0.655, p < 0.0001; Group B: r -0.340, p: 0.017). Group A had an average of 21.52% preserved urethra, while Group B had 13.86% (p < 0.0001). At one-year follow-up, 93.2% overall patients reported urinary continence without pads. CONCLUSIONS: This study emphasizes the positive correlation between preserved urethra percentage in RALP and early urinary continence recovery, highlighting its surgical significance.

Medications Mostly Associated With Ejaculatory Disorders: Assessment of the Eudra-Vigilance and Food and Drug Administration Pharmacovigilance Databases Entries.

OBJECTIVE: To identify which medications are mostly associated with ejaculatory disorders through a disproportionality analysis. METHODS: The Food and Drug Administration Adverse Event Reporting System (FDA-FAERS) and the Eudra-Vigilance (EV) database were queried to identify medications more commonly associated to ejaculatory disorders from September 10, 2012 to June 1, 2023. Proportional Reported Ratios (PRRs) were computed for all the selected drugs. RESULTS: Overall, 7404 reports of ejaculatory disorders reports were identified, and of these, 6854 cases (92.6%) were attributed to ten specific medications. On FDA-FAERS and EV databases, Paroxetine and Tamsulosin were the main responsible of delayed ejaculation (103/448 events, 23.0%) and retrograde ejaculation (366/1033 events, 35.4%), respectively. Finasteride was mostly related to painful ejaculation and ejaculation failure, with 150 events (7.8%) and 735 events (38.4%) respectively. Within the group of high-risk medications, Sildenafil presented higher risk of ejaculatory disorders than Tadalafil (PRR=5.85 (95%CI 5.09-6.78), P < .01). CONCLUSION: Ten drugs were recognized to display significant reporting levels of ejaculatory disorders. Among them, Finasteride and Sildenafil were responsible for the most reports in FDA-FAERS and in EV databases, respectively. Physicians should thoroughly counsel patients treated with these drugs about the risk of ejaculatory disorders. Further integration into clinical trials is needed to enhance the applicability and significance of these results.

Residents and Consultants Have Equal Outcomes When Performing Transrectal Fusion Biopsies: A Randomized Clinical Trial.

The aim of our study was to compare the performance of residents vs. consultants in transrectal fusion prostate biopsies (FUS-PBs), as well as patient-reported comfort. Between January 2021 and October 2022, a consecutive series of patients undergoing FUS-PBs were randomized into two groups: (A) FUS-PBs performed by a consultant; (B) FUS-PBs performed by trained residents (>50 procedures). All patients underwent FUS-PBs with 12 systematic cores and 3/6 target cores. The detection rate and number of positive cores in the target lesion were compared between groups, and the patient's discomfort after the procedure was evaluated using the VAS scale. Overall, 140 patients with a median age of 72 years were enrolled. Overall, 69/140 (49.3%) presented prostate cancer and 53/69 (76.8%) presented a clinically significant cancer (Grade Group ≥ 2). Consultants presented a detection rate of 37/70 (52.9%) and residents a detection rate of 32/70 (45.7%) (p > 0.2); the mean number of positive cores in the index lesion was similar in both groups (1.5 vs. 1.1; p > 0.10). In terms of the patients' experiences, the procedure was well tolerated, with a median VAS score of 2 in both groups, with no statistically significant differences. Residents showed satisfactory outcomes in terms of detection rate, procedural time, and patient comfort when performing prostate biopsies. Residents, after adequate training, can safely perform prostate biopsies.

Quality of information and appropriateness of Open AI outputs for prostate cancer.

Chat-GPT, a natural language processing (NLP) tool created by Open-AI, can potentially be used as a quick source for obtaining information related to prostate cancer. This study aims to analyze the quality and appropriateness of Chat-GPT's responses to inquiries related to prostate cancer compared to those of the European Urology Association's (EAU) 2023 prostate cancer guidelines. Overall, 195 questions were prepared according to the recommendations gathered in the prostate cancer section of the EAU 2023 Guideline. All questions were systematically presented to Chat-GPT's August 3 Version, and two expert urologists independently assessed and assigned scores ranging from 1 to 4 to each response (1: completely correct, 2: correct but inadequate, 3: a mix of correct and misleading information, and 4: completely incorrect). Sub-analysis per chapter and per grade of recommendation were performed. Overall, 195 recommendations were evaluated. Overall, 50/195 (26%) were completely correct, 51/195 (26%) correct but inadequate, 47/195 (24%) a mix of correct and misleading and 47/195 (24%) incorrect. When looking at different chapters Open AI was particularly accurate in answering questions on follow-up and QoL. Worst performance was recorded for the diagnosis and treatment chapters with respectively 19% and 30% of the answers completely incorrect. When looking at the strength of recommendation, no differences in terms of accuracy were recorded when comparing weak and strong recommendations (p > 0,05). Chat-GPT has a poor accuracy when answering questions on the PCa EAU guidelines recommendations. Future studies should assess its performance after adequate training.

Intermittent Versus Continuous Androgen Deprivation Therapy for Biochemical Progression After Primary Therapy in Hormone-Sensitive Nonmetastatic Prostate Cancer: Comparative Analysis in Terms of CRPC-M0 Progression.

INTRODUCTION: To analyze whether the use of an intermittent (IAD) versus continuous (CAD) androgen deprivation therapy for the treatment of biochemical progression after primary treatments in prostate cancer can influence the development of nonmetastatic castration resistant prostate cancer (CRPC-M0). PATIENTS: 170 male patients with an histologically confirmed diagnosis of PC, presenting a biochemical progression after primary treatments (82 after radical prostatectomy and 88 after external radiation therapy), nonmetastatic at imaging were considered for continuous (85 cases) or intermittent (85 cases) administration of androgen deprivation therapy. METHODS: we retrospectively collect all data regarding histological diagnosis, primary treatment, imaging for M0-M1 staging, PSA at progression, time to biochemical progression from primary therapy, ADT used, IAD cycles, so to compare in 2 groups (IAD vs. CAD) time for progression from the beginning of ADT treatment and type of progression in terms of CRPC-M0 versus CRPC-M1 cases. RESULTS: no significant (P= .4955) difference in the whole CRPC progression was found between IAD (25.8%) and CAD (30.5%) treatment at a mean of 32.7 ± 7.02 months and 35.6 ± 13.1 months respectively (P= .0738). Mean PSA at CRPC development was significantly higher in the IAD group (5.16 ± 0.68 ng/mL) than in the CAD group (3.1 ± 0.7 ng/mL) (P < .001). In all cases, imaging to detect M status at CRPC development was PET TC scan. At univariate analysis CAD administration significantly increases the RR for CRPC-M0 progression (RR 3.48; 95%CI 1.66-7.29; P = .01) when compared to the IAD administration, and this effect at multivariate analysis remained significant and independent to the other variables (RR 2.34, 95%CI 1.52-5.33; P = .03). CONCLUSIONS: in our population with biochemical progression after primary treatment for PC, the intermittent administration of ADT significantly reduces the risk to develop CRPC-M0 disease when compared to a continuous administration of ADT, whereas no difference between the 2 strategies in terms of CRPC-M1 progression exists.

Medications mostly associated with hematuria: assessment of the EudraVigilance and Food and Drug Administration pharmacovigilance databases entries.

BACKGROUND: Drugs may have a direct causative role in triggering hematuria. The range of medications which may be responsible for hematuria is wide, but little is known on those which are most frequently involved. The aim of our study was to identify and compare drugs mostly related with hematuria. METHODS: The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database and the EudraVigilance (EV) database were queried to identify the drugs which were associated the most with hematuria individual reports till 30 September 2021. Rivaroxaban, aspirin, warfarin sodium, clopidogrel bisulfate, dabigatran etexilate mesylate, apixaban, warfarin, cyclophosphamide, lansoprazole, enoxaparin sodium, and ibuprofen were analyzed. Analysis per gender, age and severity was performed. Disproportional analysis was performed to compare drugs. RESULTS: Overall, 15,687 reports of hematuria were recorded in the FDA database and 15 007 in the EV database. Rivaroxaban and Warfarin appear to be the most dangerous medications in terms of hematuria when compared to the other medications (PRR>1, P<0.05) while apixaban is the safest one (PRR<1, P<0.05) when compared to the other medications. In terms of severity only 162/15 007 (1.08%) were fatal. Between the drugs analyzed cyclophosphamide 7.2%, enoxaparin (3%) and dabigatran (2.5%) presented a higher number of fatal hematuria episodes when compared to the other drugs (<1%). CONCLUSIONS: Anticoagulants and antiplatelets are more frequently related to hematuria episodes however some differences exist between them. Particularly warfarin and rivaroxaban should be prescribed with caution in patients at increased risk of hematuria. Prescribers should inform those treated with these medications about the risk of hematuria and its sequelae.

Robot-Assisted Sacrocolpopexy versus Trans-Vaginal Multicompartment Prolapse Repair: Impact on Lower Bowel Tract Function.

BACKGROUND: This study evaluated the effectiveness, safety, and possible changes in bowel symptoms after multicompartment prolapse surgery by comparing two different surgical approaches, transvaginal mesh surgery with levatorplasty (TVMLP) and robot-assisted sacrocolpopexy (RSC). METHODS: All patients underwent pelvic (POP-Q staging system) and rectal examination to evaluate anal sphincter tone in the lithotomy position with the appropriate Valsalva test. The preoperative evaluation included urodynamics and pelvic magnetic resonance defecography. Patient Global Impression of Improvement (PGI-I) at follow-up measured subjective improvement. All patients completed Agachan-Wexner's questionnaire at 0 and 12 months of follow-up to evaluate bowel symptoms. RESULTS: A total of 73 cases were randomized into the RSC group (36 cases) and TVMLP group (37 cases). After surgery, the main POP-Q stage in both groups was stage I (RCS 80.5% vs. TVMLP 82%). There was a significant difference (p < 0.05) in postoperative anal sphincter tone: 35%. The TVMLP group experienced a hypertonic anal sphincter, while none of the RSC group did. Regarding subjective improvement, the median PGI-I was 1 in both groups. At 12 months of follow-up, both groups exhibited a significant improvement in bowel symptoms. CONCLUSIONS: RSC and TVMLP successfully corrected multicompartment POP. RSC showed a greater improvement in the total Agachan-Wexner score and lower bowel symptoms.

Adverse events related to darolutamide treatment: analysis of "real life" data from EudraVigilance and the Food and Drug Administration database entries.

BACKGROUND: Aim of our study was to analyze adverse events (AEs) associated with darolutamide using real life data from Eudra-Vigilance (EV) and the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) databases. METHODS: EV database in European Economic Area (EEA) and the FDA FAERS database were queried to identify darolutamide AEs occurred from 30th July 2019 to May 2022. AEs were recorded in according to category and severity. Real-life data was compared to Aramis registry study. RESULTS: The total number of AEs including data from both databases was 409 reported by FDA-FAERS and 253 reported by EV databases. On registry study, 794 AEs were reported, with serious AEs occurring in 24.8% of patients in the darolutamide group and with 1 death related to trial regimen. The most frequently reported AEs from both database were general disorders (33% and 26%), investigations (19% and 22%), gastrointestinal (15% and 11%), renal and urinary (9%), gastrointestinal (6%) and musculoskeletal disorder (5%). CONCLUSIONS: According to our results darolutamide is safe in a real-life scenario and the most frequent side effect is fatigue. Although up to now there are few reports in both real-life databases, these data are encouraging for clinicians using darolutamide in every day clinical practice.

Cancer Stem Cells and Prostate Cancer: A Narrative Review.

Cancer stem cells (CSCs) are a small and elusive subpopulation of self-renewing cancer cells with the remarkable ability to initiate, propagate, and spread malignant disease. In the past years, several authors have focused on the possible role of CSCs in PCa development and progression. PCa CSCs typically originate from a luminal prostate cell. Three main pathways are involved in the CSC development, including the Wnt, Sonic Hedgehog, and Notch signaling pathways. Studies have observed an important role for epithelial mesenchymal transition in this process as well as for some specific miRNA. These studies led to the development of studies targeting these specific pathways to improve the management of PCa development and progression. CSCs in prostate cancer represent an actual and promising field of research.

The impact of radical prostatectomy on global climate: a prospective multicentre study comparing laparoscopic versus robotic surgery.

BACKGROUND: More than 4% of the global greenhouse gas emissions are generated by healthcare system. Focusing on the environmental impact of minimally invasive surgery, we assessed and compared the CO2 emissions between Robot-assisted (RALP) and Laparoscopic Radical Prostatectomy (LRP). METHODS: In patients prospectively enrolled, we evaluated the age, surgical and anesthesiologic time, postoperative intensive care unit and hospital stay, blood transfusion, pre- and postoperative hemoglobin and Gleason score, open conversion need, and complications (Clavien-Dindo classification). We assessed the life cycle to estimate the energy consumption for surgical procedures and hospital stays. We reported the materials, CO2 produced, and fluid quantity infused and dispersed. Disposable and reusable materials and instruments were weighed and divided into metal, plastic, and composite fibers. The CO2 consumption for disposal and decontamination was also evaluated. RESULTS: Of the 223 patients investigated, 119 and 104 patients underwent RALP and LRP, respectively. The two groups were comparable as regards age and preoperative Gleason score. The laparoscopic and robotic instruments weighed 1733 g and 1737 g, respectively. The CO2 emissions due to instrumentation were higher in the laparoscopic group, with the majority coming from plastic and composite fiber components. The CO2 emissions for metal components were higher in the robotic group. The robot functioned at 3.5 kW/h, producing 4 kg/h of CO2. The laparoscopic column operated at 600 W/h, emitting ~1 kg/h of CO2. The operating room operated at 3,0 kW/h. The operating time was longer in the laparoscopic group, resulting in higher CO2 emissions. CO2 emissions from hospital room energy consumption were lower in the robot-assisted group. The total CO2 emissions were ~47 kg and ~60 kg per procedure in the robot-assisted and laparoscopic groups, respectively. CONCLUSIONS: RALP generates substantially less CO2 than LRP owing to the use of more reusable surgical supplies, shorter operative time and hospital stay.

Focus on the Use of Resveratrol in Bladder Cancer.

Bladder cancer is the most common tumor of the urinary system, with a high incidence in the male population. Surgery and intravesical instillations can eradicate it, although recurrences are very common, with possible progression. For this reason, adjuvant therapy should be considered in all patients. Resveratrol displays a biphasic dose response both in vitro and in vivo (intravesical application) with an antiproliferative effect at high concentrations and antiangiogenic action in vivo (intraperitoneal application) at a low concentration, suggesting a potential role for it in clinical management as an adjuvant to conventional therapy. In this review, we examine the standard therapeutical approach to bladder cancer and the preclinical studies that have investigated resveratrol in xenotransplantation models of bladder cancer. Molecular signals are also discussed, with a particular focus on the STAT3 pathway and angiogenic growth factor modulation.

Comparison of Four Validated Nomograms (Memorial Sloan Kettering Cancer Center, Briganti 2012, 2017, and 2019) Predicting Lymph Node Invasion in Patients with High-Risk Prostate Cancer Candidates for Radical Prostatectomy and Extended Pelvic Lymph Node Dissection: Clinical Experience and Review of the Literature.

BACKGROUND: The indication for extended pelvic lymph node dissection (ePLND) at the time of radical prostatectomy (RP) is based on nomograms predicting the risk of lymph node invasion (LNI). However, limited data are available on the comparison of these predictive models in high-risk prostate cancer (PC) patients. Therefore, we compared the accuracy of the most used nomograms (MSKCC, Briganti 2012, 2017, and 2019) in the setting of high-risk PC patients submitted to ePLND. METHODS: 150 patients with high-risk PC disease treated from 2019 to 2022 were included. Before RP + ePLND, we assessed the MSKCC, Briganti 2012, 2017, and 2019 nomograms for each patient, and we compared the prediction of LNI with the final histopathological analysis of the ePLND using pathologic results as a reference. RESULTS: LNI was found in 39 patients (26%), and 71.3% were cT2. The percentage of patients with estimated LNI risk above the cut-off was significantly higher in pN+ cases than in pN0 for all Briganti nomograms. The percentage of patients at risk of LNI, according to Briganti Nomogram (2012, 2017, and 2019), was significantly higher in pN+ cases than in pN0 (p < 0.04), while MSKCC prediction didn't vary significantly between pN0 and pN+ groups (p = 0.2). All nomograms showed high sensitivity (Se > 0.90), low specificity (Sp < 0.20), and similar AUC (range: 0.526-0.573) in predicting pN+. Particularly, 74% of cases patients with MSKCC estimated risk > 7% showed pN0 compared to 71% with Briganti 2012 > 5%, 69% with Briganti 2017 > 7%, and 70% with Briganti 2019 > 7%. CONCLUSIONS: Despite the high-risk disease, in our patients treated with ePLND emerges a still high number of pN0 cases and a similar low specificity of nomograms in predicting LNI.