Renal Function Preservation in Purely Off-Clamp Sutureless Robotic Partial Nephrectomy: Initial Experience and Technique.

The aim of our study is to evaluate the effectiveness and safety of a sutureless off-clamp robot-assisted partial nephrectomy (sl-oc RAPN), particularly its impact on renal function. A multicenter study was conducted from April 2021 to June 2022. Patients diagnosed with a renal mass of >2 cm and a PADUA score of ≤6 consecutively underwent an sl-oc RAPN procedure. Tumor features, patients characteristics, and intraoperative outcomes were assessed. An evaluation of renal function was performed preoperatively, and again at 1 and 3 months after surgery by measuring the creatinine and blood urea nitrogen levels. The renal function of the two separate kidneys was assessed by a sequential renal scintigraphy performed before and at least 30 days after surgery. A total of 21 patients underwent an sl-oc RAPN. The median age was 64 years (IQR 52/70), the median tumor diameter was 40 mm (IQR 29/45), and the median PADUA score was 4 (3.5/5). The intraoperative outcomes included operative time (OT), 90 (IQR 74/100) min; estimated blood loss (EBL), 150 (IQR 50/300) mL; and perioperative complications, CD > 3 1(5%); only two patients presented positive surgical margins in their final histology (2/21, 10%). Compared to the preoperative value, a decrease in renal function was highlighted with a statistically significant median decrease of 10 mL/min (p < 0.01). The renal scintigraphy showed an overall decrease in renal function compared to the preoperative value, with a range in the operated kidney that varied from 0 to 15 mL/s and from 0% to 40%, with a median value of 4 mL/s and 12%. sl-oc RAPN is a safe procedure, with a minimal impact on kidney function alteration. This technique has proven effective in preserving renal function and maintaining optimal oncological outcomes with limited complications.

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.

Purely Off-Clamp Sutureless Robotic Partial Nephrectomy for Novice Robotic Surgeons: A Multi-Institutional Propensity Score-Matched Analysis.

Objectives: To compare perioperative outcomes of patients treated with sutureless off-clamp robotic partial nephrectomy (sl-oc RAPN) by either a novice or an expert robotic surgeon at two different institutions. Methods: Data concerning two continuous series of patients with cT1-2N0M0 renal tumors treated with sl-oc RAPN either by a novice or an expert surgeon were extracted from prospectively populated institutional databases over the last 4 years. Perioperative outcomes as well as the baseline characteristics of patients and tumors were compared by using χ2 and Mann-Whitney tests for categorical and continuous variables, respectively. A 1:1 propensity match score analysis (PMSa) generated two homogeneous cohorts. Logistic regression analysis was performed to assess predictors of trifecta outcomes, defined as negative surgical margins, no Clavien-Dindo ≧ 3 grade complications, and no ≧ 30% postoperative eGFR reduction. Results: Overall, 328 patients were treated by an expert surgeon, while 40 were treated by a novice surgeon. After PMSa analysis, two cohorts of 23 patients each were generated, homogeneous for all baseline variables (p ≥ 0.07). Hospital stay was the only significantly different outcome observed between the two groups (5 days vs. 2 days; p < 0.001). No statistically significant differences were recorded when comparing trifecta outcomes (expert: 100% vs. novice: 87%; p = 0.07). In the logistic regression analysis, no statistically significant predictors of trifecta outcomes were recorded. Conclusions: sl-oc RAPN is a feasible and safe nephron sparing technique, even when performed by a novice robotic surgeon.

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.

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.

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.

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.

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.

Statins may increase the risk of being diagnosed with prostate cancer.

BACKGROUND: Although statins are known to protect against cardiovascular accidents, their anti-inflammatory features could play a role in preventing tumorigenesis. We investigated the association between statin intake and prostate cancer (PCa) diagnosis and aggressiveness. METHODS: A retrospective analysis was performed. Our dataset on patients undergone systematic prostate biopsy from December 2008 to December 2022 was searched for histopathologic and clinical data. Prognostic Grade Group ≥3 tumors were defined as high-grade (HG). The association between Metabolic Syndrome (MetS), statin use and PCa diagnosis and HG disease was assessed using logistic regression analyses. RESULTS: Data on 1685 patients were collected; MetS affected 344 (20.4%) men and 138 (36.5%) were taking statins at least for 6 months at the time of biopsy. Among the 671 (39.8%) men diagnosed with PCa, 327 (48.7%) presented with a HG disease. Tumor incidence was higher among men taking statins, compared to controls (46.8% vs. 37.8%; P=0.002); also, high grade diseases were more common in the former group, but the difference did not reach statistical significance (49.1% vs. 48.6%; P=0.89). Statin intake (OR 1.44; 95% CI [1.05-1.98]; P=0.02) independently predicted PCa diagnosis but not high-grade disease (P=0.8). CONCLUSIONS: Statin use may be associated with an increased risk of PCa diagnosis.

Oncological Outcomes of Patients with High-Volume mCRPC: Results from a Longitudinal Real-Life Multicenter Cohort.

Registrative trials recommended the use of upfront chemotherapy in high-volume metastatic prostate cancer. We reported survival outcomes of patients with high-volume mCRPC treated with ARTA in a chemo-naïve setting compared to patients treated with chemotherapy as first-line from a longitudinal real-life multicenter series. We retrospectively collected data on mCRPC patients treated at six centers. The dataset was queried for high-volume disease (defined as more than 6 bone lesions or bulky nodes ≥ 5 cm). We compared the main clinical features of chemo-naïve versus chemo-treated patients. The Mann-Whitney U test and Chi-squared test were used to compare continuous and categorial variables, respectively. The Kaplan-Meier method was used to compare differences in terms of progression-free survival (PFS), cancer specific survival (CSS) and overall survival (OS) in an upfront ARTA or chemo-treated setting. Survival probabilities were computed at 12, 24, 48, and 60 months. Out of 216 patients, 88 cases with high-volume disease were selected. Sixty-nine patients (78.4%) received upfront ARTA, while 19 patients received chemotherapy as the first-line treatment option. Forty-eight patients received Abiraterone (AA), 21 patients received Enzalutamide (EZ) as the first-line treatment. The ARTA population was older (p = 0.007) and less likely to receive further lines of treatment (p = 0.001) than the chemo-treated cohort. The five-year PFS, CSS and OS were 60%, 73.3%, and 72.9%, respectively. Overall, 28 patients (31.8%) shifted after their first-line therapy to a second-line therapy: EZ was prescribed in 17 cases, AA in seven cases and radiometabolic therapy in four patients. Sixteen cases (18.2%) developed significant progression and were treated with chemotherapy. At Kaplan-Meyer analysis PFS, CSS and OS were comparable for upfront ARTA vs chemo-treated patients (log rank p = 0.10, p = 0.64 and p = 0.36, respectively). We reported comparable survival probabilities in a real-life series of high-volume mCRPC patients who either received upfront ARTA or chemotherapy. Patients primarily treated with chemotherapy were younger and more likely to receive further treatment lines than the upfront ARTA cohort. Our data support the use of novel antiandrogens as first line treatment regardless tumor burden, delaying the beginning of a more toxic chemotherapy in case of significant disease progression.

Role of Perilesional Sampling of Patients Undergoing Fusion Prostate Biopsies.

Recently, researchers have proposed perilesional sampling during prostate biopsies to avoid systematic biopsies of patients at risk of prostate cancer. The aim of our study is to evaluate the role of perilesional sampling to avoid systematic biopsies of patients undergoing fusion biopsies. A prospective cohort of patients undergoing transrectal MRI transrectal fusion biopsies were consecutively enrolled. All the patients underwent systematic biopsies (SB), targeted biopsies (TB) and perilesional biopsies within 10 mm from the lesion (PB). The detection rates of different strategies were determined. A total of 262 patients were enrolled. The median age of those enrolled was 70 years. The mean BMI was 27 kg/m2, and the mean and prostate volume was 52 mL. A PIRADS score ≥ 4 was recorded in 163/262 (40%) patients. Overall, the detection rates of cancer were 43.5% (114/262) and 35% (92/262) for csPCa. The use of the target + peri-target strategy resulted in a detection of 32.8% (86/262) of cancer cases and of 29% (76/262) of csPCa cases (Grade Group > 2). Using the target plus peri-target approach resulted in us missing 18/262 (7%) of the csPCa cases, avoiding the diagnosis of 8/262 (3%) of nsPCa cases. A biopsy strategy including lesional and perilesional sampling could avoid unnecessary prostate biopsies. However, the risk of missing significant cancers is present. Future studies should assess the cost-benefit relationship of different strategies.

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.

Adverse events related to alpha-blockers: analysis of real-life data from Eudra-Vigilance.

BACKGROUND: Patients on alpha-blockers (ABs) treatment may have an increased risk of adverse events (AEs). Aim of our study was to compare real-life data on neuro-vascular and sexual AEs associated with ABs based on Eudra-Vigilance reported AEs. METHODS: Eudra-Vigilance (EV) database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We recorded the number of sexual and neuro-vascular AEs for tamsulosin, alfuzosin, silodosin, prazosin and doxazosin per category and severity until July 30th, 2022. Pooled Relative Risk (PRR) was used to compare data between drugs. RESULTS: Overall the number of AEs were 2842 for Alfuzosin, 11,086 for tamsulosin, 792 for terazosin, 572 for prazosin and 4641 for doxazosin. Different percentages of AEs were obtained for each drug and in different age groups according to EV sub-groups (≤65, 65-85, ≥85). On PRR analysis, the risk of ejaculatory disorders for Silodosin (11%) is 18.5 times higher (PRR 18.5 95%CI; 10.7-31.8; P<0.05) when compared to alfuzosin and the risk of orthostatic hypotension is 2 times lower (PRR=1,84 95%CI 1.32-2.57; P<0.05). CONCLUSIONS: Real life data is consistent with registry studies regarding side effects related to alpha-blockers. Alfuzosin is safer in terms of ejaculatory disorders while silodosin and tamsulosin in terms of orthostatic hypotension. Clinicians should consider these data when prescribing ABs especially in younger and older patients.

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.

Patients' Preferences and Expectations in Overactive Bladder: A Systematic Review.

The aim of our study is to review the current available knowledge regarding preferences and expectations of patients with overactive bladder (OAB). The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement guidelines were followed for this manuscript's preparation. Three online databases were searched: PubMed/Medline, Embase, and Scopus, while a combination of the following keywords was used: detrusor overactivity, overactive bladder, urinary incontinence, perspectives, expectations, and preferences. Overall, 1349 studies were retrieved and screened while only 10 studies appeared to be relevant for the scope of this review. Most of the studies were related to preferences about OAB medications (i.e., antimuscarinics); four of them reported patients' inclinations to alternative treatments in the case of medication therapy failure (i.e., neuromodulation, Botox). No data were found about diagnosis or other aspects of disease management (i.e., surgery, follow-up). Based on these findings, from the patient's point of view, the ideal medication should be cheap, without risk of cognitive function impairment, and able to reduce daytime urinary frequency and incontinence episodes.

Physical Inactivity, Metabolic Syndrome and Prostate Cancer Diagnosis: Development of a Predicting Nomogram.

Insufficient physical activity (PA) may be a shared risk factor for the development of both metabolic syndrome (MetS) and prostate cancer (PCa). To investigate this correlation and to develop a nomogram able to predict tumor diagnosis. Between 2016 and 2018, a consecutive series of men who underwent prostate biopsy at three institutions were prospectively enrolled. PA was self-assessed by patients through the Physical Activity Scale for the Elderly (PASE) questionnaire; MetS was assessed according to Adult Treatment Panel III criteria. A logistic regression analyses was used to identify predictors of PCa diagnosis and high-grade disease (defined as International Society of Uro-Pathology grade >2 tumors). A nomogram was then computed to estimate the risk of tumor diagnosis. A total of 291 patients were enrolled; 17.5% of them (n = 51) presented with MetS. PCa was diagnosed in 110 (38%) patients overall while 51 presented high-grade disease. At multivariable analysis, age (OR 1.04; 95%CI: 1.00−1.08; p = 0.048), prostate volume (PV) (OR 0.98; 95%CI: 0.79−0.99; p = 0.004), suspicious digital rectal examination (OR 2.35; 95%CI: 1.11−4.98; p = 0.02), total PSA value (OR 1.12; 95%CI: 1.05−1.2; p < 0.001), and PASE score (OR 0.99; 95%CI: 0.98−0.99; p = 0.01) were independent predictors of tumor diagnosis. The latter two also predicted high-grade PCa. MetS was not associated with PCa diagnosis and aggressiveness. The novel nomogram displayed fair discrimination for PCa diagnosis (AUC = 0.76), adequate calibration (p > 0.05) and provided a net benefit in the range of probabilities between 20% and 90%. reduced PA was associated with an increased risk of PCa diagnosis and high-grade disease. Our nomogram could improve the selection of patients scheduled for prostate biopsy at increased risk of PCa.

Cardiovascular adverse events-related to GnRH agonists and GnRH antagonists: analysis of real-life data from Eudra-Vigilance and Food and Drug Administration databases entries.

INTRODUCTION AND OBJECTIVES: GnRH agonists and GnRH antagonists are two of the mainstays of hormonal therapy (HT) for prostate cancer (PCa). These drugs are at increased risk of cardiovascular (CV) adverse events (AEs). Aim of our study was to compare real-life data on AEs associated with GnRH agonists and GnRH antagonists based on Eudra-Vigilance (EV) and Food and Drug Administration (FDA) reported AEs. MATERIALS AND METHODS: EV and FDA databases were queried and the number of CV adverse events (AEs) for degarelix, buserelin, goserelin, leuprorelin, triptorelin until September 2021 were recorded. Specific CV AEs were recorded and data were analyzed per age and severity. pooled relative risk (PRR) was used to compare data between drugs. RESULTS: CV events were reported in 315/5128 (6%) for Degarelix, in 55/628 for Buserelin (9%), in 843/12,145 (7%) for Goserelin, in 3395/71,160 (5%) for Leuprorelin and in 214/4969 (5%) for Triptorelin. In terms of specific CV disorders, Degarelix presented lower risk of hypertension (PRR 0.60 (95% CI 0.37-0.98), p = 0.04), of myocardial infarction (PRR 0.05 (95% CI 0.01-0.39), p < 0.01) and thrombosis (PRR 0.14 (0.02-1.07), p = 0.06) when compared to GnRH agonists. Overall, younger patients (<65 years) presented a very low risk of CV AEs. Side effects were classified as serious in 90-96% of the cases. Fatal AEs were 5-20% over the CV AEs and 0.2-1% over the total AEs. CONCLUSIONS: Real-life data are consistent with registry studies regarding side effects related to HT. Real-life data suggest GnRH agonists are associated with higher CV AEs when compared to GnRH antagonists. Clinicians should consider these data when prescribing HT especially in patients with CV comorbidities.

Post-voided residual urine ratio as a predictor of bladder outlet obstruction in men with lower urinary tract symptoms: development of a clinical nomogram.

PURPOSE: To confirm the correlation between post-void residual urine ratio (PVR-R) and BOO diagnosed by pressure-flow studies (PFS) in males with lower urinary tract symptoms (LUTS) and to develop a clinical nomogram. METHODS: A consecutive series of patients aged 45 years or older with non-neurogenic LUTS were prospectively enrolled. Patients underwent standard diagnostic assessment for BOO including International Prostatic Symptoms Score, uroflowmetry, urodynamic studies, suprapubic ultrasound of the prostate, and ultrasound measurements of the bladder wall thickness (BTW). PVR-R was defined as follows: PVR-R = (PVR/total Bladder Volume [BV]) × 100). Logistic regression analysis was used to investigate predictors of pathological bladder emptying (BOO) defined as Schafer > II. A nomogram to predict BOO based on the multivariable logistic regression model was then developed. RESULTS: Overall 335 patients were enrolled. Overall, 131/335 (40%) presented BOO on PFS. In a multivariable logistic age-adjusted regression model BWT (odds ratio [OR]: 2.21 per mm; 95% confidence interval [CI], 1.57-3.09; p = 0.001), PVR-R (OR: 1.02 per %; 95% CI, 1.01-1.03; p = 0.034) and prostate volume (OR: 0.97 per mL; 95% CI, 0.95-0.98; p = 0.001) were significant predictors for BOO. The model presented an accuracy of 0.82 and a clinical net benefit in the range of 10-90%. CONCLUSIONS: The present study confirms the important role of PVR-ratio in the prediction of BOO. For the first time, we present a clinical nomogram including PVR-ratio for the prediction of BOO.