Patient Benefits of Radical Prostatectomy in Certified Prostate Cancer Centers: Comparative Results from the Multicenter IMPROVE Study.

INTRODUCTION: We investigated differences in treatment outcomes following radical prostatectomy (RP) between certified centers (CCs) and noncertified centers (nCCs) within the IMPROVE study group. METHODS: A validated survey assessing various factors, including stress urinary incontinence (SUI) and decision regret (DR), was administered to 950 patients who underwent RP across 19 hospitals (12 CCs and 7 nCCs) at a median follow-up of 15 months after RP (interquartile range: 11-20). The response rate was 74%, with 703 patients participating, including 480 (68%) from CCs. Multivariate binary regression models were used to analyze differences between CCs and nCCs regarding the following binary endpoints: nerve-sparing (NS), positive surgical margins (PSM), SUI (defined as >1 safety pad), complications based on the Clavien-Dindo classification (grade ≥1, grade ≥3) and DR (>15 points indicating critical DR). RESULTS: Considering the multivariate analysis, the rate of NS surgery was lower in CCs than in nCCs (OR = 0.52; p = 0.004). No significant differences were observed in the PSM rate (OR = 1.67; p = 0.051), SUI (OR = 1.03; p = 0.919), and DR (OR = 1.00; p = 0.990). SUI (OR 0.39; p < 0.001) and DR (OR 0.62; p = 0.026) were reported significantly less frequently by patients treated with robotic-assisted RP, which was significantly more often performed in CCs than in nCCs (68.3% vs. 18%; p < 0.001). The total complication rate was 45% lower in CCs (OR = 0.55; p = 0.004), although the number of complications requiring intervention (Clavien-Dindo classification ≥3) did not differ significantly between CCs and nCCs (OR = 2.52; p = 0.051). CONCLUSION: Within the IMPROVE study group, similarly favorable outcomes after RP were found in both CCs and nCCs, which, however, cannot be transferred to the general treatment landscape of PCA in Germany. Of note, robotic-assisted RP was more often performed in CCs and associated with less SUI and DR, while open prostatectomy was the treatment of choice in low-volume nCCs. Future prospective and region wide studies should also investigate the surgeon caseload and experience as well as a spillover effect of the certification process on nCCs.

Risk Factors for Ureteral Damage in Ureteroscopic stone Treatment: Results of the German Prospective Multicentre Benchmarks of Ureterorenoscopic Stone Treatment-Results in Terms of Complications, Quality of Life, and Stone-Free Rates Project.

BACKGROUND: The Post-Ureteroscopic Lesion Scale (PULS) is a validated, standardised scale that classifies iatrogenic ureteral lesions during ureteroscopy (URS). OBJECTIVE: To determine risk factors for the various PULS-grades caused by URS. METHOD: We prospectively investigated the independent influence of various risk factors in correlation with PULS-Grade 1+ and 2+ on 307 patients with ureterorenoscopic stone treatment from 14 German urologic departments. RESULTS: The following are the outcomes of the study: 117 (38.4%) and 188 (61.6%) of the calculi (median stone size 6 mm) were found in the kidney or ureter; 70% and 82.4% underwent preoperative or postoperative ureteral stenting; 44.3 and 7.2% received laser or ballistic lithotripsy; 60% of the patients presented with PULS grade 1+ and 8% with PULS grade of 2+. Only intracorporal lithotripsy revealed a significant independent risk factor for PULS grade 1+ or 2+. Both laser and ballistic therapies raised the probability of PULS grade 1+ by the factors 3.6 (p < 0.001) and 3.9 (p = 0.021), respectively. The ORs in conjunction with PULS grade 2+ were 3.1 (p = 0.038) and 5.8 (p = 0.014) respectively. Neither endpoint exhibited a significant difference regarding the lithotripsic procedure (laser vs. ballistic). CONCLUSION: Intracorporal lithotripsy is associated with a significant increase in damage to the ureter; further research is needed to determine its long-term effects.

Ki-67, mini-chromosome maintenance 2 protein (MCM2) and geminin have no independent prognostic relevance for cancer-specific survival in surgically treated squamous cell carcinoma of the penis.

UNLABELLED: What's known on the subject? and what does the study add?: Only little and partly contradictory data are currently published about the prognostic role of immunohistochemically detectable proliferation-associated biomarkers in surgically treated squamous cell carcinoma of the penis (SCCP), and no data are available at present about their usefulness for refining the delineation between different Broders' grading categories (e.g. still G2 or just G3 SCCP?). Moreover, the accuracy of various conventional histopathological parameters for predicting cancer-specific survival (CSS) in surgically treated SCCP has not been systematically evaluated yet. Based on the so far largest study cohort encompassing 158 consecutive patients with surgically treated PSCCs characterised by means of a central histopathological review, our data add the following to the currently available literature: (i) Ki-67, mini-chromosome maintenance 2 protein (MCM2), and geminin indicate a more aggressive behaviour in SCPP but do not represent independent prognostic parameters in the multivariable analysis in terms of CSS, (ii) these three biomarkers are not helpful for refining the delineation between different Broders' grading categories at the immunohistochemical level, and (iii) the conventional histopathological parameters staging, grading, nodal involvement, and lymphovascular invasion are independent prognostic parameters that together achieve a predictive accuracy of 82% for CSS. OBJECTIVE: To assess the role of cell proliferation-associated biomarkers to predict cancer-specific survival (CSS) in patients with surgically treated squamous cell carcinoma of the penis (SCCP). PATIENTS AND METHODS: A multicentre study enrolling 158 consecutive patients with surgically treated SCCP was performed. After conducting a central histopathological review, the staining profiles of Ki-67, mini-chromosome maintenance 2 protein (MCM2) and geminin were evaluated for their correlation with conventional histopathological criteria and their prognostic relevance for predicting CSS in a multivariable Cox proportional hazards regression model (median [interquartile range] follow-up 33 [6-63] months). RESULTS: Staining evaluation showed high interobserver agreement (92-96%). Ki-67 and MCM2 displayed a significant positive correlation with histological tumour grade, lymphovascular invasion (LVI) and nodal status, whereas geminin expression only correlated with tumour grade. The 5-year CSS for the entire study cohort was 62%. Univariable analysis showed a significant prognostic impact of Ki-67 (P = 0.026), MCM2 (P = 0.007), and geminin (P = 0.036). In multivariable analysis, only pT (hazard ratio [HR] 1.67; P = 0.003) and pN stage (HR 2.62; P = 0.015) as well as tumour grade (HR 1.89; P = 0.036) and LVI (HR 2.66; P = 0.028) were identified as independent prognostic parameters for CSS. The accuracy of the Cox model for CSS prediction was 0.820 (95% confidence interval 0.741-0.898). CONCLUSIONS: At present, conventional histopathological criteria remain the most powerful predictors of CSS in surgically treated SCCP. Due to overlapping staining profiles, Ki-67, MCM2 and geminin, either singly or in various combinations, failed to immunohistochemically refine the boundaries between Broders' grading categories. Ki-67, MCM2 and geminin do not represent independent prognostic parameters but reflect a more aggressive behaviour in surgically treated SCCP. Further studies are needed to clarify the currently contradictory predictive role of proliferation-associated biomarkers in terms of predicting nodal involvement in SCCPs.

Patient's Desire and Real Availability Concerning Supportive Measures Accompanying Radical Prostatectomy: Differences between Certified Prostate Cancer Centers and Non-Certified Centers Based on Patient-Reported Outcomes within the Cross-Sectional Study Improve.

Certification as a prostate cancer center requires the offer of several supportive measures to patients undergoing radical prostatectomy (RP). However, it remains unclear how patients estimate the relevance of these measures and whether the availability of these measures differs between certified prostate cancer centers (CERTs) and non-certified centers (NCERTs). In 20 German urologic centers, a survey comprising questions on the relevance of 15 supportive measures was sent to 1000 patients at a median of 15 months after RP. Additionally, patients were asked to rate the availability of these measures using a four-item Likert scale. The aim of this study was to compare these ratings between CERTs and NCERTs. The response rate was 75.0%. In total, 480 patients underwent surgery in CERTs, and 270 in NCERTs. Patients rated 6/15 supportive measures as very relevant: preoperative medical counselling concerning treatment options, a preoperative briefing answering last questions, preoperative pelvic floor exercises (PFEs), postoperative PFEs, postoperative social support, and postoperative rehabilitation addressing physical fitness recovery. These ratings showed no significant difference between CERTs and NCERTs (p = 0.133-0.676). In addition, 4/9 of the remaining criteria were rated as more detailed by patients in CERTs. IMPROVE represents the first study worldwide to evaluate a patient-reported assessment of the supportive measures accompanying RP. Pertinent offers vary marginally between CERTs and NCERTs.

Prospective evaluation of interobserver variability of the hydronephrosis index and the renal resistive index as sonographic examination methods for the evaluation of acute hydronephrosis.

OBJECTIVE: To confirm the reliability of assessements of the renal resistive index (RRI) and the hydronephrosis index (HI) comprising two sonographic techniques providing additional information in patients with acute renal colic. PATIENTS AND METHODS: Sonographic measurement of hydronephrosis and assessment of common clinical criteria was performed in 22 consecutive patients presenting with unilateral stone-related renal colic. RRI and HI were separately recorded by two investigators within a prospective study. Interobserver agreement and comparison of sonographic with computed tomography (CT) findings were assessed with the Cohen's kappa statistic (κ) for attributive ordinal characteristics and Spearman's rank correlation/rho (ρ) for attributive metric characteristics. RESULTS: There was a significant correlation between HI and the sonographically-evaluated grade of hydronephrosis, although not between RRI and the grade of hydronephrosis. For all procedures (RRI, HI, sonography and CT), significant differences between the symptomatic and the asymptomatic kidney were assessed. Interobserver agreement was excellent for the grade assessment of hydronephrosis by conventional sonography (κ = 0.82; P < 0.001), good to very good for HI (ρ = 0.60; P = 0.003) and acceptable to good for RRI (ρ = 0.49; P = 0.021). CONCLUSIONS: The RRI and HI methods are both easily practicable as stageless examination methods in patients presenting with stone-related renal colic, and both also reliably distinguish between obstruction and non-obstruction. Exact thresholds for both methods must still be defined based on further successive studies. Additionally, changes of values under medical expulsive therapy and correlation with the functional status of the obstructed kidney remain to be examined.

Patients Regret Their Choice of Therapy Significantly Less Frequently after Robot-Assisted Radical Prostatectomy as Opposed to Open Radical Prostatectomy: Patient-Reported Results of the Multicenter Cross-Sectional IMPROVE Study.

Patient's regret (PatR) concerning the choice of therapy represents a crucial endpoint for treatment evaluation after radical prostatectomy (RP) for prostate cancer (PCA). This study aims to compare PatR following robot-assisted (RARP) and open surgical approach (ORP). A survey comprising perioperative-functional criteria was sent to 1000 patients in 20 German centers at a median of 15 months after RP. Surgery-related items were collected from participating centers. To calculate PatR differences between approaches, a multivariate regressive base model (MVBM) was established incorporating surgical approach and demographic, center-specific, and tumor-specific criteria not primarily affected by surgical approach. An extended model (MVEM) was further adjusted by variables potentially affected by surgical approach. PatR was based on five validated questions ranging 0−100 (cutoff >15 defined as critical PatR). The response rate was 75.0%. After exclusion of patients with laparoscopic RP or stage M1b/c, the study cohort comprised 277/365 ORP/RARP patients. ORP/RARP patients had a median PatR of 15/10 (p < 0.001) and 46.2%/28.1% had a PatR >15, respectively (p < 0.001). Based on the MVBM, RARP patients showed PatR >15 relative 46.8% less frequently (p < 0.001). Consensual decision making regarding surgical approach independently reduced PatR. With the MVEM, the independent impact of both surgical approach and of consensual decision making was confirmed. This study involving centers of different care levels showed significantly lower PatR following RARP.

[Differences between the inpatient complication rate after ureterorenoscopy and the 30-day outcome reported by the patient - results of the German prospective BUSTER study]. / Unterschiede zwischen der stationären Komplikationsdichte nach einer Ureterorenoskopie und dem durch Patienten berichteten 30 Tages-Outcome ­ Ergebnisse der deutschen prospektiven BUSTER-Studie.

BACKGROUND: Following ureterorenoscopic stone removal (URS), patients are generally discharged after a short hospital stay, so that the estimation of complication rates is based on a narrow timeframe. Data derived from the so-called BUSTER-project (Evaluation of ureterorenoscopic stone management - results in terms of complications, quality of life and stone-free rates) were therefore analysed with respect to complication rates during hospital stay and patient-reported 30-day-complication rates and then correlated with quality of life (QoL) data. METHODS: Data of 307 patients undergoing URS were recorded in 14 German centres 01/2015 - 04/2015. Complications (classified according to the Clavien-Dindo classification, CDG) and data on QoL were additionally assessed 30 days after surgery, using questionnaires which were completed by 169/307 patients. The subgroups were analysed: no increase in CDG 30 days after surgery (n = 128), increase in CDG without any additional intervention (n = 39), and increase in CDG with an additional intervention (n = 2). The correlation between this categorisation and data on QoL were analysed by bivariate correlations according to Spearman's rank correlation coefficient (ρ). The impact of different clinic parameters on the endpoint "increase in CDG 30 days after surgery" was evaluated by a multivariate logistic regression model. RESULTS: During hospital stay, complications occurred in 13 patients (7.7 %, mostly CDG1). 30 days after surgery, 43 patients (25.4 %) reported complications (16 CDG2 and 2 CDG3). A statistically significant correlation was shown between an increase in CDG and all aspects of QoL, with the strongest correlation concerning pain (ρ = 0.425; p < 0.001). Stone size was the only factor associated with an independent impact on the endpoint "increase in CDG 30 days after surgery" (OR: 1.09; 95 % confidence interval [CI] 1.01 - 1.17; p = 0.040). Postoperative ureteral stenting had no significant impact on this endpoint, despite a remarkable odds ratio (OR: 4.19; 95 % CI 0.64 - 27.32; p = 0.134). This might be explained by a significantly imbalanced distribution of this covariate (86.4 % postoperative stenting). CONCLUSIONS: Assessment of complications should exceed the timeframe of hospital stay, as complications increased within 30 days of surgery and were associated with impairment of QoL. Further studies have to evaluate if lower complication rates and better QoL might be achieved by abstaining from postoperative ureteral stenting.

Postoperative Leukocytosis After Robotic-Assisted Radical Prostatectomy Is Not Associated with Perioperative Outcome and Histopathological Findings.

INTRODUCTION: Recently a retrospective study has been published describing a significant correlation of immediate postoperative leukocytosis (IPLC) and a favorable pathological Gleason score (pGS) in patients undergoing robotic-assisted radical prostatectomy (RARP). The aim of the present study was to prospectively validate these results on an external dataset. MATERIALS AND METHODS: In total, 346 patients undergoing RARP as first-line therapy for localized prostate cancer were included. Clinical and histopathological parameters, criteria of IPLC, and pGS were recorded prospectively. Potential association between IPLC and pGS was evaluated by univariate and multivariate analyses. RESULTS: IPLC was found in 77.2% (n = 267) of all patients with a median leukocyte blood count (LBC) of 12.5 × 10(9)/L (interquartile range, 10.2-15 × 10(9)/L). Of these, in 255 patients IPLC was found within the range of 10-20 × 10(9)/L, whereas an IPLC of >20 × 10(9)/L was found in only 12 patients. Of the patients, 49.1%, 40.5%, and 10.4% presented with a pGS6, pGS7, and pGS8-10 tumor, respectively. There was neither a univariate nor a multivariate correlation between IPLC and pGS. Furthermore, no significant correlation could be detected between IPLC and other clinical, intraoperative, or histopathological criteria. In 175 (66%) patients with IPLC normal LBC levels were measured on postoperative Day 4. CONCLUSIONS: IPLC was not associated with more favorable tumor biology (lower pGS, better tumor stage) and not influenced by patient conditions (age, body mass index, American Society of Anesthesiologists score, smoking) or intraoperative parameters (blood loss, operating time, surgeon). In addition, there was no significant correlation with serious complications (Clavien-Dindo Grade 3a/b) within a period of 90 days.

Subcapsular orchiectomy in the primary therapy of patients with bone metastasis in advanced prostate cancer: an anachronistic intervention?

Background. The therapeutic impact of palliative androgen deprivation in metastatic prostate cancer is indisputable. Bilateral orchiectomy represents the traditional method of AD but was reduced during the last years in favor for treatment with LHRH analogues. Due to limited economic resources of the health care system, the economically priced definite surgical castration might experience a renaissance. Methods. In this single-center retrospective study, 83 consecutive patients with osseous metastasized prostate cancer were evaluated, who had primarily been treated by subcapsular bilateral orchiectomy. Response to therapy, time until therapy failure, overall survival time, psychological disorders due to loss of organ, and disease-associated and postoperative surgical complications were recorded. The median followup was 35 months (IQR: 26-46). Results. Patients' mean age at surgery was 72.1 (54-91) years. Six patients (7.2%) displayed immediate tumor progression after orchiectomy. Median time of tumor remission and overall survival time were 29 and 36 months, respectively. 14% of the study group showed minor postoperative complications. No psychological problems occurred following bilateral orchiectomy. Conclusion. Due to an effective and persistent oncological effectiveness, less morbidity, and absence of psychological implications, bilateral subcapsular orchiectomy seems to be a practicable and advisable alternative in the first-line therapy of metastasized PCa.