The Influence of Endogenous Testosterone Density on Unfavorable Disease and Tumor Load at Final Pathology in Intermediate-Risk Prostate Cancer: Results in 338 Patients Treated with Radical Prostatectomy and Extended Pelvic Lymph Node Dissection.

OBJECTIVE: The aim of this study is to evaluate the influence of endogenous testosterone density (ETD) on features of aggressive prostate cancer (PCa) in intermediate-risk disease treated with radical prostatectomy and extended pelvic lymph node dissection. MATERIALS AND METHODS: Density measurements included the ratio of endogenous testosterone (ET), prostate-specific antigen (PSA), and percentage of biopsy positive cores (BPC) on prostate volume (ETD, PSAD, and BPCD, respectively). The ratio of percentage of cancer invading the gland (tumor load, TL) on prostate weight (TLD) was also calculated. Unfavorable disease (UD) was defined as tumor upgrading (ISUP >3) and/or upstaging (pT >2) and/or lymph node invasion (LNI). Associations of ETD with features of aggressive PCa, including UD and TLD, were evaluated by logistic and linear regression models. RESULTS: Evaluated cases were 338. Subjects with upgrading, upstaging, and LNI were 61/338 (18%), 73/338 (21%), and 25/338 (7.4%), respectively. TLD correlated with UD (Pearson's correlation coefficient, r = 0.204; p < 0.0001), PSAD (r = 0.342; p < 0.0001), BPCD (r = 0.364; p < 0.0001), and ETD (r = 0.214; p < 0.0001), which also correlated with BMI (r = -0.223; p < 0.0001), PSAD (r = 0.391; p < 0.0001), and BPCD (r = 0.407; p < 0.0001). TLD was the strongest independent predictor of UD (OR = 2.244; 95% CI = 1.146-4.395; p = 0.018). In the multivariate linear regression model predicting BPCD, ETD was an independent predictor (linear regression coefficient, b = 0.026; 95% CI: 0.016-0.036; p < 0.0001) together with PSAD (b = 1.599; 95% CI: 0.863-2.334; p < 0.0001) and TLD (b = 0.489; 95% CI: 0.274-0.706; p < 0.0001). According to models, TLD increased as ETD increased accordingly, but mean ET levels were significantly lower for patients with UD. CONCLUSIONS: As ETD measurements incremented, the risk of large tumors extending beyond the prostate increased accordingly, and patients with lower ET levels were more likely to occult UD. The influence of ETD on PCa biology should be addressed by prospective studies.

Prostate volume index and prostatic chronic inflammation predicted low tumor load in 945 patients at baseline prostate biopsy.

PURPOSE: To assess associations of prostate volume index (PVI), defined as the ratio of the volume of the central transition zone to the volume of the peripheral zone of the prostate and prostatic chronic inflammation (PCI) as predictors of tumor load by number of positive cores (PC) in patients undergoing baseline random biopsies. METHODS: Parameters evaluated included age, PSA, total prostate volume, PSA density, digital rectal exam, PVI, and PCI. All patients underwent standard transperineal random biopsies. Tumor load was evaluated as absent (no PC), limited (1-3 PC), and extensive (more than 3 PC). The association of factors with the risk of tumor load was evaluated by the multinomial logistic regression model. RESULTS: The study evaluated 945 patients. Cancer PC were detected in 477 (507%) cases of whom 207 (43.4%) had limited tumor load and 270 (56.6%) had extensive tumor load. Among other factors, comparing patients with limited tumor load with negative cases, PVI [odds ratio, OR = 0.521, 95% confidence interval (CI) 0.330-0.824; p < 0.005] and PCI (OR = 0.289, 95% CI 0.180-0.466; p < 0.0001) were inversely associated with the PCA risk. Comparing patients with extensive tumor load with negative patients, PVI (OR = 0.579, 95% CI 0.356-0.944; p = 0.028), and PCI (OR = 0.150, 95% CI 0.085-0.265; p < 0.0001), predicted PCA risk. Comparing extensive tumor load with limited tumor load patients, PVI and PCI did not show any association with the tumor load. CONCLUSIONS: Increased PVI and the presence of PCI decreased the risk of increased tumor load and associated with less aggressive prostate cancer biology in patients at baseline random biopsies.

The impact of extended pelvic lymph node dissection on the risk of hospital readmission within 180 days after robot assisted radical prostatectomy.

OBJECTIVE: To evaluate the factors associated with the risk of hospital readmission after robot assisted radical prostatectomy (RARP) with or without extended pelvic lymph node dissection (ePLND) for prostate cancer (PCA) over a long term. MATERIALS AND METHODS: The risk of readmission was evaluated by clinical, pathological, and perioperative factors. Skilled and experienced surgeons performed the procedures. Patients were followed for complications and hospital readmission for a period of six months. The logistic regression model and Cox's proportional hazards assessed the association of factors with the risk of readmission. RESULTS: From January 2013 to December 2018, 890 patients underwent RARP; ePLND was performed in 495 of these patients. Hospital readmission was detected in 25 cases (2.8%); moreover, it was more frequent when RARP was performed with ePLND (4.4% of cases) than without (0.8% of patients). On the final multivariate model, ePLND was the only independent factor that was positively associated with the risk of hospital readmission (hazard ratio, HR = 5935; 95%CI 1777-19,831; p = 0.004). CONCLUSIONS: Over the long term after RARP for PCA, the risk of hospital readmission is associated with ePLND. In patients who underwent RARP and ePLND, 4.4% of them had a readmission, compared to RARP alone, in which only 0.8% of cases had a readmission. When ePLND is planned for staging pelvic lymph nodes, patients should be informed of the increased risk of hospital readmission.

External validation of Cormio nomogram for predicting all prostate cancers and clinically significant prostate cancers.

PURPOSE: Recently, the Cormio et al. nomogram has been developed to predict prostate cancer (PCa) and clinically significant PCa using benign prostatic obstruction parameters. The aim of the present study was to externally validate the nomogram in a multicentric cohort. METHODS: Between 2013 and 2019, patients scheduled for ultrasound-guided prostate biopsy were prospectively enrolled at 11 Italian institutions. Demographic, clinical and histological data were collected and analysed. Discrimination and calibration of Cormio nomogram were assessed with the receiver operator characteristics (ROC) curve and calibration plots. The clinical net benefit of the nomogram was assessed with decision curve analysis. Clinically significant PCa was defined as ISUP grade group > 1. RESULTS: After accounting for inclusion criteria, 1377 patients were analysed. 816/1377 (59%) had cancer at final pathology (574/816, 70%, clinically significant PCa). Multivariable analysis showed age, prostate volume, DRE and post-voided residual volume as independent predictors of any PCa. Discrimination of the nomogram for cancer was 0.70 on ROC analysis. Calibration of the nomogram was excellent (p = 0.94) and the nomogram presented a net benefit in the 40-80% range of probabilities. Multivariable analysis for predictors of clinically significant PCa found age, PSA, prostate volume and DRE as independent variables. Discrimination of the nomogram was 0.73. Calibration was poor (p = 0.001) and the nomogram presented a net benefit in the 25-75% range of probabilities. CONCLUSION: We confirmed that the Cormio nomogram can be used to predict the risk of PCa in patients at increased risk. Implementation of the nomogram in clinical practice will better define its role in the patient's counselling before prostate biopsy.

Predictive Factors of the Risk of Long-Term Hospital Readmission after Primary Prostate Surgery at a Single Tertiary Referral Center: Preliminary Report.

OBJECTIVE: To evaluate the predictors of the risk of long-term hospital readmission after radical prostatectomy (RP) in a single tertiary referral center where both open RP (ORP) and robot assisted RP (RARP) are performed. MATERIALS AND METHODS: The risk of readmission was evaluated by clinical, pathological, and perioperative factors. Skilled and experienced surgeons performed the 2 surgical approaches. Patients were followed for complications and hospital readmission for a period of 6 months. The association of factors with the risk of readmission was assessed by Cox's multivariate proportional hazards. RESULTS: From December 2013 to 2017, 885 patients underwent RP. RARP was performed in 733 cases and ORP in 152 subjects. Extended pelvic lymph node dissection (ePLND) was performed in 479 patients. Hospital readmission was detected in 46 cases (5.2%). Using a multivariate model, independent factors associated with the risk of hospital readmission were seminal vesicle invasion (hazard ratio [HR] 2.065; 95% CI 1.116-3.283; p = 0.021), ORP (HR 3.506; 95% CI 1.919-6.405; p < 0.0001), and ePLND (HR 5.172; 95% CI 1.778-15.053; p < 0.0001). CONCLUSIONS: In a large single tertiary referral center, independent predictors of the risk of long-term hospital readmission after RP included ORP, ePLND, and seminal vesicle invasion. When surgery is chosen as a primary treatment of PCA, patients should be informed of the risk of long-term hospital readmission and its related risk factors.

Elevated prostate volume index and prostatic chronic inflammation reduce the number of positive cores at first prostate biopsy set: results in 945 consecutive patients.

OBJECTIVE: To assess the association between prostate volume index (PVI), and prostatic chronic inflammation (PCI) as predictors of prostate cancer (PCA). PVI is the ratio between the central transition zone volume (CTZV) and the peripheral zone volume (PZV). MATERIALS AND METHODS: Parameters evaluated included age, prostate specific antigen (PSA), total prostate volume (TPV), PSA density (PSAD), digital rectal exam (DRE), PVI, PCI and number of positive cores (NPC). All patients underwent baseline 14-core, trans-perineal random biopsies. Associations of parameters with the NPC were investigated by univariate and multivariate linear regression analysis. RESULTS: Between September 2010 to September 2017, 945 patients were evaluated. PCA was detected in 477 cases (50.7%), PCI in 205 cases (21.7%). PCA patients, compared to negative cases, were older (68.3 vs. 64.4 years) with smaller TPV (36 vs. 48.3mL) and CTZV (19.2 vs. 25.4), higher PSAD (0.24 vs. 0.15ng/mL/mL), further PVI values were lower (0.9 vs. 1.18) and biopsy cores less frequently involved by PCI (9.4% vs. 34.2%). High PVI and the presence of PCI were independent negative predictors of NPC in model I considering PSA and TVP (PVI, regression coefficient, RC -0,6; p=0.002) and PCI (RC -1,4; p<0.0001); and in model II considering PSAD (PVI:RC -0,7; p<0,0001; and PCI: RC -1,5; p<0.0001). CONCLUSIONS: High PVI and the presence of PCI lowered the mean rate of NPC and is associated with less aggressive tumor biology expressed by low tumor burden. PVI can give prognostic information before planning baseline random biopsies. Confirmatory studies are required.

Prostate Volume Index Is Able to Differentiate between Prostatic Chronic Inflammation and Prostate Cancer in Patients with Normal Digital Rectal Examination and Prostate-Specific Antigen Values <10 ng/mL: Results of 564 Biopsy Naïve Cases.

INTRODUCTION: To assess the association of prostate volume index (PVI), defined as the ratio of the central transition zone volume to the peripheral zone volume, and prostatic chronic inflammation (PCI) as predictors of prostate cancer (PCA) risk in patients presenting with normal digital rectal exam and prostate-specific antigen (PSA) ≤10 ng/mL at baseline random biopsies. METHODS: We evaluated patients with a negative digital rectal examination (DRE) and a PSA ≤10 ng/mL who underwent initial baseline prostate biopsy from 2010 to 2017. Parameters evaluated included age, PSA, total prostate volume (TPV), PSA density (PSAD), PVI and PCI. All patients underwent 14 core trans-perineal standard biopsies. The association of factors with the risk of PCA was evaluated by logistic regression analysis, utilizing 2 multivariate models: model I included age, TPV, PVI and PCI; model II included age, PSAD, PVI and PC. RESULTS: Overall, 564 Caucasian patients were included. PCA and PCI were detected in 242 (42.9%) and 129 (22.9%) cases respectively. In patients with PCA, the median PVI was 0.83 (interquartile range [IQR] 0.62-1.04). In patients with PCI, the median PVI was 1.12 (IQR 0.81-1.47). In model I, age (OR 1.080) TPV (OR 0.961), PVI (OR 0.517) and PCI (OR 0.249) were associated with PCA risk. In model II, the age (OR 1.074), PSAD (OR 3.080), PVI (OR 0.361) and PCI (OR 0.221) were associated with PCA risk. CONCLUSIONS: Higher PVI and PCI predicted decreased PCA risk in patients presenting with normal DRE, and a PSA ≤10ng/mL at baseline random biopsy. In this subset of patients, PVI is able to differentiate patients with PCI or PCA.

Inverse Association of Prostatic Chronic Inflammation among Prostate Cancer Tumor Grade Groups: Retrospective Study of 738 Consecutive Cases Elected to a First Random Biopsy Set.

OBJECTIVES: The study aimed to evaluate associations of prostatic chronic inflammation (PCI) with prostate cancer (PCA) grade groups by the International Society of Urological Pathology (ISUP). METHODS: The study evaluated retrospectively 738 cases. The patient population was sampled into 3 groups collecting cases without and with PCA including subjects with lSUP grade group 1 and grade groups 2-5. RESULTS: PCI was assessed in 185 patients (25.1%) and PCA in 361 patients (48.9%) of whom 188 (25.5%) had ISUP grade and 173 (23.4%) had ISUP groups 2-5 tumors. PCI inversely related to ISUP groups (p < 0.0001). In multivariate analysis, the risk of ISUP grade group 1 PCA compared to negative cases associated positively with age (OR 1.042; p = 0.001) but inversely with total prostate volume (TPV; OR 0.965; p < 0.0001) and PCI (OR 0.314; p < 0.0001). Intermediate-high grade tumors associated positively with age (OR 1.065; p < 0.0001), prostate specific antigen (OR 1.167; p < 0.0001), and abnormal digital rectal examination (OR 2.251; p < 0.0001) but inversely with TPV (OR 0.921; p < 0.0001) and PCI (OR 0.106; p < 0.0001). CONCLUSIONS: PCI decreased the risk of PCA among ISUP tumor grade groups.

Clinical Factors Predicting Tumour Upgrading in Patients Under Active Surveillance and Elected to Active Treatment after Disease Reclassification or Progression.

OBJECTIVES: To evaluate clinical factors associated with tumour upgrading (UPG) in low-intermediate risk patients who progressed while under active surveillance (AS) and underwent delayed radical prostatectomy. MATERIAL AND METHODS: The evaluated factors included prostate specific antigen (PSA), prostate volume, PSA density and number of biopsy positive cores (BPC). Multivariate logistic regression by the forward step Wald procedure was used. RESULTS: The study evaluated 24 patients who had UPG in 13 cases (54.2%). Independent factors associated with tumour UPG included PSA (OR 2.1; p = 0.047) and BPC (OR 2; p = 0.042). CONCLUSIONS: Clinical factors associated with UPG were identified in patients who were under AS for with low-intermediate risk disease. Preoperative PSA levels and number of BPC were independent factors associated with UPG in a contemporary cohort of patients who progressed under AS and underwent delayed active treatment.

Prostate Volume Index Associates with a Decreased Risk of Prostate Cancer: Results of a Large Cohort of Patients Elected to a First Biopsy Set.

Background/Aims/Objectives: In patients elected to the first prostate biopsy set, the risk of prostate cancer (PCA) may be predicted by clinical factors. The aim of this study was to investigate on prostate volume index (PVI), defined as the ratio of volume of the transitional zone to the volume of the peripheral zone, and PCA risk. METHODS: The study retrospectively evaluated 1,327 patients and included only the first biopsy set with 14 cores. PCA risk was assessed by using the multivariate logistic regression model. RESULTS: The analysis evaluated 596 patients. The detection rate of PCA was 49%. Age, prostate specific antigen, PVI and digital rectal exam were independent factors of PCA risk, which was decreased by PVI (OR 0.224; 95% CI 0.157-0.380). The goodness of fit statistics assessed model efficacy. CONCLUSIONS: In a large cohort undergoing the first biopsy set, PVI associated with a decreased risk of PCA. Confirmatory studies are required.

Clinical Factors of Disease Reclassification or Progression in a Contemporary Cohort of Prostate Cancer Patients Elected to Active Surveillance.

OBJECTIVES: To evaluate clinical predictors of disease reclassification or progression (DR/P) in prostate cancer patients elected to active surveillance (AS). MATERIAL AND METHODS: Patients were assessed on the basis of DR/P criteria. Predictors of DR/P were evaluated by multivariate logistic regression and Cox proportional hazards. RESULTS: The median DR/P free time was 16.5 months. DR/P was detected in 30 out of 84 cases (35.7%). In DR/P cases, the median prostate volume (PV) was significantly lower (34.7 vs. 42.7 ml) and the percentage of cases with 2 or 3 vs. 1 initial biopsy positive cores (BPC) was significantly higher (36.7 vs. 7.4%). The multivariate logistic regression model showed that PV (OR 0.9; p = 0.021) and initial n >1 BPC (OR 9.8; p = 0.001) were independent predictors of DR/P. By Cox multivariate proportional hazards, only n >1 BPC predicted early DR/P (hazard ratio 3.1; p = 0.003). CONCLUSIONS: In a contemporary cohort of patients elected to AS, independent factors stratifying the risk of DR/P were PV and initial BPC, which also predicted early DR/P. In patients elected to AS, the identification of risk factors of DR/P require early re-biopsy. Confirmatory studies are required.

Patterns of prescription and adherence to European Association of Urology guidelines on androgen deprivation therapy in prostate cancer: an Italian multicentre cross-sectional analysis from the Choosing Treatment for Prostate Cancer (CHOICE) study.

OBJECTIVE: To evaluate both the patterns of prescription of androgen deprivation therapy (ADT) in patients with prostate cancer (PCa) and the adherence to European Association of Urology (EAU) guidelines for ADT prescription. METHODS: The Choosing Treatment for Prostate Cancer (CHOICE) study was an Italian multicentre cross-sectional study conducted between December 2010 and January 2012. A total of 1 386 patients, treated with ADT for PCa (first prescription or renewal of ADT), were selected. With regard to the EAU guidelines on ADT, the cohort was categorized into discordant ADT (Group A) and concordant ADT (Group B). RESULTS: The final cohort included 1 075 patients with a geographical distribution including North Italy (n = 627, 58.3%), Central Italy (n = 233, 21.7%) and South Italy (n = 215, 20.0%). In the category of patients treated with primary ADT, a total of 125 patients (56.3%) were classified as low risk according to D'Amico classification. With regard to the EAU guidelines, 285 (26.51%) and 790 patients (73.49%) were classified as discordant (Group A) and concordant (Group B), respectively. In Group A, patients were more likely to receive primary ADT (57.5%, 164/285 patients) than radical prostatectomy (RP; 30.9%, 88/285 patients), radiation therapy (RT; 6.7%, 19/285 patients) or RP + RT (17.7%, 14/285 patients; P < 0.01). Multivariate logistic regression analysis, adjusted for clinical and pathological variables, showed that patients from Central Italy (odds ratio [OR] 2.86; P < 0.05) and South Italy (OR 2.65; P < 0.05) were more likely to receive discordant ADT. CONCLUSION: EAU guideline adherence for ADT was low in Italy and was influenced by geographic area. Healthcare providers and urologists should consider these results in order to quantify the inadequate use of ADT and to set policy strategies to overcome this risk.

Prostate volume index and chronic inflammation of the prostate type IV with respect to the risk of prostate cancer.

BACKGROUND: Benign prostatic hyperplasia and prostate cancer (PCA) alter the normal growth patterns of zonal anatomy with changes of prostate volume (PV). Chronic inflammatory infiltrates (CII) type IV are the most common non-cancer diagnosis of the prostate after biopsy. OBJECTIVE: To evaluate associations of both PV index (PVI), i.e. the ratio of transitional zone volume (TZV) to peripheral zone volume (PZV), and CII with PCA in patients undergoing biopsy. SUBJECTS AND METHODS: Between January 2007 and December 2008, 268 consecutive patients who underwent prostate biopsy were retrospectively evaluated. PV and TZV were measured by transrectal ultrasound. PZV was computed by subtracting the PV from the TZV. CII were evaluated according to standard criteria. Significant associations of PVI and the presence of CII (CII+) with PCA risk were assessed by statistical methods. RESULTS AND LIMITATIONS: We evaluated 251 patients after excluding cases with painful rectal examinations, prostate-specific antigen (PSA) >20 µg/ml and metastases. The PCA detection rate was 41.1%. PVI was a negative independent predictor of PCA. A PVI ≤1.0 was directly [odds ratio (OR) = 2.36] associated with PCA, which was detected more frequently in patients with a PVI ≤1.0 (29.1%) than in those with a PVI >1.0 (11.9%). CII+ was inversely (OR = 0.57) and independently associated with PCA, which was detected less frequently in cases with CII (9.9%) than in those without CII (21.1%). Potential study limitations might relate to the fact that PV was not measured by prostatectomy specimens and there was PSA confounding for CII and PCA. CONCLUSIONS: Low values of PVI are directly associated with risk of PCA, which was almost 2.5 times higher in patients with a PVI ≤1.0. The PVI might be an effective parameter for clustering patients at risk of PCA. CII+ was inversely associated with risk of PCA and decreased the probability of detecting PCA by 43%. The role of the PVI and CII in PCA carcinogenesis needs further research.

Fast track surgery to reduce short-term complications following radical cystectomy and intestinal urinary diversion with Vescica Ileale Padovana neobladder: proposal for a tailored enhanced recovery protocol and preliminary report from a pilot study.

OBJECTIVE: Different fast track programs for patients undergoing radical cystectomy (RC) can be found in the current literature. The aim of this work was to develop a new enhanced recovery protocol (ERP). PATIENTS AND METHODS: The ERP was designed after a structured literature review focusing on reduced bowel preparation, standardized feeding, postoperative nausea, vomiting and pain control. In order to test the ERP, a pilot observational prospective cohort study was planned, enrolling all patients consecutively undergoing RC and Vescica Ileale Padovana (VIP) neobladder. These patients were compared with a matched group of subjects who had undergone RC and VIP neobladder before implementation of the ERP. To achieve good comparability, a propensity score-matching was performed. The primary aim was to assess the ERP's feasibility; the secondary outcome measures were early morbidity and mortality. RESULTS AND LIMITATIONS: After an exhaustive literature search and a multidisciplinary consultation, an ERP was designed. Nine consecutive patients participated in the pilot study and were compared to 13 patients treated before implementation of the ERP. We did not find any statistically significant difference in terms of mortality rate (none died peri- or postoperatively in both groups). The complication rate, according to the modified Clavien classification, was significantly lower in the ERP group (22.22 vs. 84.61%, p < 0.004). The major limitations are the low number of patients enrolled to test the protocol and the lack of randomization for the comparative evaluations. CONCLUSION: The introduction of our ERP was proven to be feasible in the management of patients undergoing RC and intestinal urinary diversion with VIP neobladder. The postoperative course was enhanced by a significant reduction in both nasogastric tube insertion and parenteral nutrition support, with early postoperative feeding. All these findings were associated with no deleterious effect on morbidity or mortality, indeed there was a reduced occurrence of postoperative complication rates.

Portal vein thrombosis with renal cell carcinoma: a case report.

Portal vein thrombosis refers to an obstruction of blood flow in the portal vein; this rare disease can be both local and systemic. Local risk factors, accounting for about 70% of cases, can be abdominal cancers, inflammatory of infective diseases, surgical procedures or cirrhosis. A 62-year-old man, affected by hypertension and taking acetylsalicylic acid after a myocardial infarction in 1994, developed deep venous thrombosis on the right leg. Six months later the patient was admitted to the emergency unit due to abdominal pain. A CT scan revealed the presence of a complete splanchnic vein thrombosis and a primary tumor on the right kidney. The patient was treated with total parenteral nutrition and intravenous solution of heparin sodium first and then, because of occurrence of allergy, fondaparinux, with improvement of the abdominal pain. Subsequently he underwent right radical nephrectomy.

Transrectal versus transperineal 14-core prostate biopsy in detection of prostate cancer: a comparative evaluation at the same institution.

BACKGROUND: The ideal bioptic strategy for CaP detection is still to be completely defined. The aim of our study is to compare transperineal (TP) and transrectal (TR) approaches, in a 14-core initial prostate biopsy for CaP detection. MATERIAL AND METHODS: A prospective controlled study was conducted enrolling 108 consecutive patients with a PSA level greater than 4 ng/mL and/or an abnormal DRE. TR versus TP 14-core initial prostatic biopsies were performed on 54 and 54 patients, respectively, with a randomisation ratio of 1:1. RESULTS: The cancer detection rates were 46.29 (25 out of 54 patients), and 44.44% (24 out of 54 patients), respectively, using the TR or the TP approach (p = 0.846). The overall cancer core rate was significantly higher when the TP approach was used: 21.43% (162 out of 756 cores) and 16.79% (127 out of 756 cores), with the TP and the TR approach, respectively (p = 0.022). The cores were significantly longer performing TP approach: at the site "1" (14.92 versus 12.97 mm, p = 0.02); at "5" (15.53 versus 13.69 mm, p = 0.037); at "7" (15.06 versus 12.86 mm, p = 0.001); at "9" (14.92 versus 13.38 mm, p = 0.038); at "11" (16.32 versus 12.31 mm, p = 0.0001); at "12" (15.14 versus 12.19 mm, p = 0.0001); at "13" (17.49 versus 13.98 mm, p = 0.0001); at "14" (16.77 versus 13.36 mm, p = 0.0001). As to the biopsy related pain, the mean pain level perceived by patients during the TR approach was 1.56 ± 1.73 versus 1.42 ± 1.37 registered during TP approach (p = 0.591). CONCLUSIONS: No significant differences were found in cancer detection rate, cancer core rate between TP and TR approaches for prostatic biopsy. Even in terms of complication rate or pain level, it cannot be concluded that one procedure is superior to the other one. Apparently, strictly following our protocol, TP approach seems to offer a better sampling at the level of the apex and the TZ, however without adding any significant advantage in terms of overall cancer detection rate.

American Society of Anesthesiologists (ASA) physical status system predicts the risk of postoperative Clavien-Dindo complications greater than one at 90 days after robot-assisted radical prostatectomy: final results of a tertiary referral center.

To test the hypothesis of an association between the American Society of Anesthesiologists (ASA) physical status classification system and the risk of 90-days postoperative complications after robot-assisted radical prostatectomy (RARP), graded using the Clavien-Dindo classification system (CDS). In a period ranging from January 2013 to October 2020, 1143 patients were evaluated. ASA classification was computed by trained anesthesiologists. Postoperative complications at 90 days after RARP were grouped as greater than one (CDS between 2 and 4a) versus up to one (CDS between 0 and 1). The risk association was computed using logistic regression models. According to ASA physical status classification system, patients were distributed as follows: 102 (8.9%) ASA 1, 934 (81.7%) ASA 2, and 107 (9.4%) ASA 3. Overall, 90-days postoperative complications occurred in 277 (24.2%) cases, of which 137 (12%) were graded as CDS 1 vs. 105 (9.2%) CDS 2 vs. 17 (1.5%) CDS 3a vs. 15 (1.3%) CDS 3b vs. 3 (0.3%) CDS 4a. ASA 2 and 3 patient categories were more likely to have 90-days postoperative complications CDS > 1 (12.5% and 16.8%, respectively) compared to ASA 1 patients (4.9%). The risk association was stronger for ASA 3 (odds ratio, [OR]: 4.085; 95%CI: 1.457-11.455; p = 0.007) than for ASA 2 (OR: 2.907; 95%CI: 1.106-7.285; p = 0.023) patient categories. After adjustment for clinical, pathological, and perioperative covariates, including pelvic lymph node dissection (performed vs. not performed), either ASA 2 or 3 categories remained independent predictors of 90-days postoperative complications CDS > 1. The risk of 90-days postoperative complications CDS > 1 after RARP increased as the ASA physical status deteriorated independently by performing or not an extended pelvic lymph node dissection. In the ASA 3 patients category, RARP should be performed at tertiary referral centers to safely manage the risk of postoperative complications.

American Society of Anesthesiologists' (ASA) Physical Status System and Risk of Major Clavien-Dindo Complications After Robot-Assisted Radical Prostatectomy at Hospital Discharge: Analysis of 1143 Consecutive Prostate Cancer Patients.

Objective: To test the hypothesis of associations of preoperative physical status system with major postoperative complications at hospital discharge in prostate cancer (PCa) patients treated with robot-assisted radical prostatectomy (RARP). Materials and Methods: In a period ranging from January 2013 to October 2020, 1143 patients were evaluated. The physical status was assessed by the American Society of Anesthesiologists' (ASA) system, which was computed trained anesthesiologists. The Clavien-Dindo system was used to classify postoperative complications, which were coded as major if greater than 1. Results: ASA physical status system included class I in 102 patients (8.9%), class II in 934 subjects (81.7%), and class III in 107 cases (9.4%). Clavien-Dindo complications were distributed as follows: grade 1: 141 cases (12.3%), grade 2: 108 patients (9.4%), grade 3a: 5 subjects (0.4%), grade 3b: 9 patients (0.8%), and grade 4a: 3 cases (0.3%). Overall, major complications were detected in 125 cases (10.9%). On multivariate analysis, major Clavien-Dindo complications were predicted by ASA score grade II (adjusted odds ratio, OR = 2.538; 95%CI 1.007-6.397; p = 0.048) and grade III (adjusted OR 3.468; 95%CI 1.215-9.896; p = 0.020) independently by pelvic lymph node dissection (PLND) and/or blood lost. Conclusion: In RARP surgery, the risk of major postoperative Clavien-Dindo complications increased as the physical status system deteriorated independently by performing or not a PLND and/or large intraoperative blood lost. The ASA score system was an effective predictor of major Clavien-Dindo complications, which delayed LOHS in RARP surgery. Confirmatory studies are required. Supplementary Information: The online version contains supplementary material available at 10.1007/s13193-022-01577-9.

Is a Drain Needed After Robotic Radical Prostatectomy With or Without Pelvic Lymph Node Dissection? Results of a Single-Center Randomized Clinical Trial.

Objective: To investigate by means of a randomized clinical trial the safety of no drain in the pelvic cavity after robot-assisted radical prostatectomy (RARP) with or without extended pelvic lymph node dissection (ePLND). Materials and Methods: From May to December 2016, 112 consecutive patients who underwent RARP with or without ePLND were prospectively randomized into a control group (CG) and study group (SG). In the CG, a drain was placed in the pelvic cavity at the end of surgery and removed after 24 hours. The trial was designed to assess noninferiority. The primary endpoint was evaluated as complication rates graded by the Clavien-Dindo score (CDS). Secondary endpoints included length of hospital stay (LOHS) and hospital readmission (RAD). Results and Limitations: At final analysis, 56 patients were in the CG and 54 belonged to the SG. The groups were homogenous for all preoperative and perioperative variables and did not show any difference in CDS complication rates (28.9% in the CG and 20.4% in the SG; p = 0.254), LOHS (on average 4 days in each group; p = 0.689), and RAD rates (3.6% in the CG and 3.7% in the SG; p = 0.970). Conclusions: In a modern cohort of patients who underwent RARP with or without ePLND, a single-center randomized controlled trial showed that no-drain policy is equivalent to drain after RARP in terms of CDS complication rate, LOHS, and RAD rate. The option of placing a postoperative drain for the first 24 hours could be considered in cases of difficult urethrovesical anastomosis with uncertain watertightness.

Endogenous testosterone density predicts unfavorable disease at final pathology in intermediate risk prostate cancer.

OBJECTIVE: To test the hypothesis that endogenous testosterone (ET) density could be associated with tumor load (TL) in patients with intermediate risk (IR) prostate cancer (PCa). MATERIALS AND METHODS: Endogenous testosterone density (ETD, ratio between ET and prostate volume [PV]), biopsy positive cores density (BPCD, the ratio between the number of positive cores and PV) and prostate-specific antigen density (PSAD, ratio between total PSA and PV) were retrospectively evaluated on a prospectively collected data on 430 patients with IR PCa submitted to radical prostatectomy (RP). Tumor load (TL) was measured as the percentage of prostatic volume occupied by cancer at final pathology. Unfavorable disease (UD) was defined as tumor upgrading (ISUP grading group 4, 5) and/or upstaging (pT3a or 3b) in prostate specimens. Associations were assessed by the logistic regression and linear regression models. RESULTS: Overall, UD, which was detected in 122 out of 430 IR patients (28.4%), was predicted by BPCD (odd ratio, OR = 1.356; 95% CI 1.048-1.754; p = 0.020) with a sensitivity 98.4% and overall accuracy 71.9%. On multivariate analysis, BPCD was independently predicted by PSAD (regression coefficient, b = 1.549; 95% CI 0.936-2.162; p < 0.0001), ETD (b = 0.032; 95% CI 0.023-0.040; p < 0.0001) and TL (b = 0.009; 95% CI 0.005-0.014; p < 0.0001). As BPCD increased, ETD and ET levels increased accordingly, but patients with BPCD > 1.0%/mL had significantly lower ET levels. CONCLUSIONS: As ETD increased, BPCD and TL increased, accordingly; furthermore, patients with lower ET levels were more likely to have occult UD. The influence of tumor load, and unfavorable disease on ET and ETD needs to be addressed by further studies.