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.

Critical evaluation of molecular tumour board outcomes following 2 years of clinical practice in a Comprehensive Cancer Centre.

BACKGROUND: Recently, molecular tumour boards (MTBs) have been integrated into the clinical routine. Since their benefit remains debated, we assessed MTB outcomes in the Comprehensive Cancer Center Ostbayern (CCCO) from 2019 to 2021. METHODS AND RESULTS: In total, 251 patients were included. Targeted sequencing was performed with PCR MSI-evaluation and immunohistochemistry for PD-L1, Her2, and mismatch repair enzymes. 125 treatment recommendations were given (49.8%). High-recommendation rates were achieved for intrahepatic cholangiocarcinoma (20/30, 66.7%) and gastric adenocarcinoma (10/16, 62.5%) as opposed to colorectal cancer (9/36, 25.0%) and pancreatic cancer (3/18, 16.7%). MTB therapies were administered in 47 (18.7%) patients, while 53 (21.1%) received alternative treatment regimens. Thus 37.6% of recommended MTB therapies were implemented (47/125 recommendations). The clinical benefit rate (complete + partial + mixed response + stable disease) was 50.0% for MTB and 63.8% for alternative treatments. PFS2/1 ratios were 34.6% and 16.1%, respectively. Significantly improved PFS could be achieved for m1A-tier-evidence-based MTB therapies (median 6.30 months) compared to alternative treatments (median 2.83 months; P = 0.0278). CONCLUSION: The CCCO MTB yielded a considerable recommendation rate, particularly in cholangiocarcinoma patients. The discrepancy between the low-recommendation rates in colorectal and pancreatic cancer suggests the necessity of a weighted prioritisation of entities. High-tier recommendations should be implemented predominantly.

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.

Efficacy of Vinflunine for Patients with Metastatic Urothelial Cancer after Immune Checkpoint Inhibitor Pretreatment-A Retrospective Multicenter Analysis.

BACKGROUND: Immune checkpoint inhibitors (ICI) are standard of care in patients with metastatic urothelial carcinoma (mUC) ineligible for cisplatin, and as second-line therapy after platinum-based chemotherapy. To date, few data exist about the efficacy of the former second-line chemotherapeutic agent vinflunine after the failure of sequential platinum-based chemotherapy and ICI treatment. The aim of this analysis was to examine the efficacy of vinflunine in a post-ICI third- or later-line setting. METHODS: In this retrospective German multicenter study, data of mUC patients treated with vinflunine were reviewed in six centers between February 2010 and December 2021. All of the 105 included patients had radiologic progression after first-line platinum-based chemotherapy. The objective was to describe the efficacy of vinflunine in terms of overall response rate (ORR), clinical benefit rate (CBR), overall survival (OS), and progression-free survival (PFS) for post-ICI and ICI-naïve patients, respectively. RESULTS: In our cohort, 61 patients (58.1%) had preceding immunotherapy before vinflunine administration, and 44 patients (41.9%) were ICI-naïve. Patients with ICI pretreatment showed an ORR of 22.4% compared to 15.6% within ICI-naïve patients (p = 0.451), and CBR was 51.0% vs. 25.0% (p = 0.020), respectively. Post-ICI patients showed longer OS (8.78 vs. 5.72 months; p = 0.467) and longer PFS (3.09 vs. 2.14 months; p = 0.105). CONCLUSION: This analysis supports the sequential use of vinflunine in post-ICI patients since the vinca-alkaloid retains a measurable clinical activity in these heavily pretreated patients. The therapeutic benefit may be higher than demonstrated in previous studies.

Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial.

PROOF 302 is an ongoing randomized, double-blind, placebo-controlled, adjuvant phase III trial (NCT04197986) in approximately 218 patients from 120 centers worldwide. Eligibility criteria include post-surgical high-risk muscle-invasive upper tract urothelial cancer (85% of patients) or urothelial bladder cancer (15%), susceptible FGFR3 alterations (activating mutations, gene fusions or rearrangements), ≤120 days following radical surgery and ineligible for/or refusing cisplatin-based (neo)adjuvant chemotherapy. Patients receive either oral infigratinib 125 mg or placebo daily on days 1-21 of a 28-day cycle for up to 52 weeks or until recurrence, unacceptable toxicity or death. Primary end point: centrally determined disease-free survival (DFS); secondary end points: investigator-assessed DFS, metastasis-free survival, overall survival and safety/tolerability; exploratory end points: correlative biomarker analysis, quality-of-life and infigratinib pharmacokinetics.

Cancers of the bladder and other parts in the urinary system, especially those that are invasive and grow into the muscle layer, may need extra treatment after surgical removal of the tumor, particularly if there is a high risk of the cancer coming back. Chemotherapy regimens that include cisplatin are often used postoperatively, although some patients are unable to tolerate this treatment or refuse it. FGFR3, a protein that is encoded by the FGFR3 gene, is often changed in these cancers. This helps the tumor grow. Infigratinib is an investigational drug that targets FGFR3 and inhibits the abnormal growth of the tumor. In the PROOF 302 study, patients are randomly assigned to treatment with infigratinib or a placebo pill for 1 year after surgery to see if the drug is effective. The aim is to see if patients who take infigratinib have a longer time free from the disease than those who receive a placebo. The study will also look at how long patients remain free from cancer spread and how long they live overall. The study will also investigate how safe the treatment is and how easy it is to live with it. PROOF 302 is an important study as it will define the role of infigratinib in patients with cancers of the bladder and urinary system who also have FGFR3 changes, for whom more treatment choices are needed. Clinical Trial Registration: NCT04197986 (ClinicalTrials.gov).

Impact of Male Patient Information on Quality of Urine Examination (PIQUE Study).

BACKGROUND: Urine examination has relevance for treatment, and reliability of positive urine culture (UC) is of importance. The technique of urine sampling (US), storage, and transportation is important. The objective of this study was to investigate if detailed patient information for the technique of US and hygiene reduces rates of contaminated UC in screened male patients, as this group was not investigated yet. METHODS: All patients independently of complaints were enrolled prospectively and consecutively in an outpatient setting in 2 groups - the first group did not receive detailed information and the second group did. We examined 372 consecutive patients in 2017, 190 not receiving (median age 69 years) and 182 receiving information (median age 70 years), with comparable numbers of patients and age. The result of UC and age was imposed. RESULTS: In all,74.2% of preclarification UC showed a contamination (n = 95) and 75.5% after clarification (n = 83), without significant differences (p = 0.827). This study is limited by the fact that adherence could not be checked. CONCLUSIONS: Similar to studies with females, no difference occurred in rates of contaminated UC, so detailed information regarding the US technique does not decrease rates of contaminated UC and vice versa does not increase the quality of midstream-sampled UC in male patients.

Impact of COVID-19 crisis on medical care of patients with metastasized uro-oncologic disease under systemic cancer therapy: a multicenter study in German university hospitals.

PURPOSE: To date, over 4.2 million Germans and over 235 million people worldwide have been infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Uro-oncology (UO) patients are particularly vulnerable but in urgent need of life-saving systemic treatments. Our multicentric study examined the impact of the COVID-19 crisis on the medical care of UO patients in German university hospitals receiving ongoing systemic anti-cancer treatment and to detect the delay of medical care, defined as deferred medical treatment or deviation of the pre-defined follow-up assessment. METHODS: Data of 162 UO patients with metastatic disease undergoing systemic cancer treatment at five university hospitals in Germany were included in our analyses. The focus of interest was any delay or change in treatment between February 2020 and May 2020 (first wave of the COVID-19 crisis in Germany). Statistical analysis of contingency tables were performed using Pearson's chi-squared and Fisher's exact tests, respectively. Effect size was determined using Cramér's V (V). RESULTS: Twenty-four of the 162 patients (14.8%) experienced a delay in systemic treatment of more than 2 weeks. Most of these received immuno-oncologic (IO) treatments (13/24, 54.2%, p = 0.746). Blood tests were delayed or canceled significantly more often in IO patients but with a small effect size (21.1%, p = 0.042, V = 0.230). Treatment of patients with renal cell carcinoma (12/73, 16.4%) and urothelial carcinoma (7/32, 21.9%) was affected the most. CONCLUSIONS: Our data show that the COVID-19 pandemic impacted the medical care of UO patients, but deferment remained modest. There was a tendency towards delays in IO and ADT treatments in particular.

Introduction of a New Score to Assess Surgical Efficiency in Holmium Laser Enucleation of the Prostate.

INTRODUCTION: While holmium laser enucleation of the prostate (HoLEP) is accepted as safe and efficient, a long learning curve is considered the main reason for its slow adoption in clinical practice. So far, no standardized and easy-to-use parameter has been implemented to measure surgical experience or efficiency which could be useful for training and quality control purposes. The aim of the present study was to evaluate the learning curves of 2 HoLEP beginners and to identify applicable efficiency outcome measures as well as potentially complicating factors in performing HoLEP. PATIENTS AND METHODS: A total of 594 patients treated by HoLEP between September 2016 and May 2019 were enrolled. The procedures were initially performed by 1 HoLEP expert (reference surgeon); over time, 2 further surgeons were trained. Baseline characteristics, enucleation weight, morcellation and enucleation time, laser energy usage, and postoperative results were recorded prospectively. The learning curves of the 2 novices were analyzed and compared to the reference surgeon. Logistic regression analyses were performed to identify predictors for postoperative grade ≥2 complications. RESULTS: Median enucleation ratio and complication rates did not significantly alter along the learning curves. Median enucleation speed and laser energy application of the 2 novices significantly improved with growing experience. Combining these variables, we introduced the "HoLEP efficiency score" (HES) which demonstrated the most appropriate value to reflect the surgical experience and efficiency. The median HES for the reference surgeon was 82.8 min kJ/g. For the 2 novices, a drop from 130 and 124.4 min kJ/g by -57 and -30%, respectively, was observed. Among several tested clinical parameters, the presence of prostate cancer (p = 0.047) and the surgical caseload (p < 0.001) influenced the HES. On multivariable logistic regression, American Society of Anesthesiologists score and prostate cancer were independent predictors for grade ≥2 complications (p = 0.002, odds ratio [OR] 2.042 and p = 0.038, OR 1.940). CONCLUSION: We introduce the HES as an objective and measurable tool to quantify surgical efficiency. In clinical practice, the HES may find application in training and quality control purposes as well as in comparing surgical modifications and hardware. Patients with prostate cancer seem to be more challenging cases and have a higher risk for complications, and may preferably be treated by experienced surgeons.

Ureteroureterostomy in patients with duplex malformations: does a large diameter of the donor ureter affect the outcome?

INTRODUCTION: Ureteroureterostomy is a commonly adopted, minimally invasive approach in the management of duplex anomalies requiring diversion, e.g., ectopic upper pole ureters. OBJECTIVE: The authors hypothesized that a large diameter of the donor ureter could affect the outcome of this procedure. STUDY DESIGN: Forty-two patients from two centers were retrospectively reviewed. To compare patients with small (group 1) vs large donor ureters (group 2), they were split at the median of the sonographically measured diameter at the level of the future anastomosis (n = 20 < 1.2 cm, mean 0.71 cm vs n = 22 ≥ 1.2 cm, mean 1.75 cm; P < 0.001) Figure. Ureteroureterostomy was performed in an end-to-side fashion with the donor ureter being tapered if required. RESULTS: There was no significant difference in operation time (127 vs 121 min; P = 0.59) or duration of hospital stay (4.15 vs 4.09 days; P = 0.89) or number of postoperative complications (3 febrile urinary tract infections [fUTIs] in group 1 and one fUTI in group 2, P = 0.33). Reoperations during follow-up (1 stump resection and 2 endoscopic vesicoureteral reflux procedures) occurred exclusively in group 1 (P = 0.22). The mean pre-operative hydronephrosis grade of the affected moiety was higher in group 2 compared with group 1 (mean 2.73 Society for Fetal Urology classification [SFU] vs 1.65, P < 0.001). During follow-up, the mean hydronephrosis grade in group 2 improved from 2.73 to 1.36 SFU (P = 0.0011). In patients from group 1, the mean hydronephrosis grade remained relatively unchanged, from 1.65 to 1.35 SFU (P = 0.4). DISCUSSION: After its first description in 1928, it took almost 40 years for ipsilateral ureteroureterostomy to become a widely adopted technique in the management of duplex malformations, especially for obstructive or ectopic upper pole moieties. Whereas it has been recently shown that the upper pole function does not seem to matter, there are still only narrative reports about the influence of the donor ureter diameter contributing to potential complications such as a de novo hydronephrosis of the receiving ureter with potential damage of the healthy moiety or the persistence of a pre-operatively marked hydronephrosis. While the study data are retrospective, the authors could demonstrate that a ureteral diameter of ≥1.2 cm is not factoring adversely into the occurrence of postoperative complications. CONCLUSION: A donor ureter diameter ≥1.2 cm in ureteroureterostomy was not associated with a higher complication rate or worse outcome considering further fUTIs or reoperations. The postoperative reduction in hydronephrosis grade was more pronounced in patients with large donor ureters with disappearance of the pre-operative significant difference between the two groups.

Oncological Outcome and Value of Postoperative Magnetic Resonance Imaging after Focal High-Intensity Focused Ultrasound Therapy for Prostate Cancer.

INTRODUCTION: Focal therapy (FT) by high-intensity focused ultrasound (HIFU) is an emerging option for localized prostate cancer (PC). Due to the lack of long-term data, a close monitoring after FT is essential, but there are still uncertainties about the optimal follow-up regimen. Here we report on a series of FT-HIFU patients with the focus on oncological short-term outcome and the value of postoperative magnetic resonance imaging (MRI). METHODS: We included 21 patients treated by FT-HIFU using the Focal One® device (EDAP TMS, France) between November 2015 and May 2018. PC localization was assessed by preoperative multiparametric MRI (mpMRI) and transrectal ultrasound-guided targeted and systematic biopsy. Oncological follow-up included prostate-specific antigen (PSA) development, mpMRI, control biopsies (targeted and systematic) of the treated and untreated areas and salvage treatment rate. Control mpMRI and control biopsy were performed after 6-12 months. RESULTS: 15 patients (71.4%) were managed by focal ablation of a solitary lesion, while 6 patients (28.6%) underwent zonal tumor ablation. All patients underwent control mpMRI and biopsy. After a mean follow-up period of 11.7 months, cancer relapse was detected in 8 patients (38.1%), with 4 patients (19%) having infield recurrence. Postoperative mpMRI revealed 3 out of 4 infield PC relapses but missed 5 out of 7 outfield relapses. Clinically significant cancer recurrence was present in 1 patient (4.8%), which was missed by mpMRI. Posttreatment mpMRI had a sensitivity, specificity, positive and negative predictive value of 62.5, 92.3, 83.3 and 80.0%, respectively, for overall relapse detection based on patient level. Only 1 of the 8 recurrences was suspected based on PSA progression. 4 of the 8 patients with PC relapse (19%) underwent salvage therapy (2 patients by radical prostatectomy, 2 patients by salvage FT-HIFU). CONCLUSION: Postoperative mpMRI might play a valuable role during follow-up after focal HIFU therapy, particularly in terms of infield relapse detection. Irrespective of mpMRI results, the repeat biopsy regimen should incorporate systematic biopsy including cores of the treated and untreated prostate areas.

Perioperative antibiotic prophylaxis for stone therapy.

PURPOSE OF REVIEW: To give an overview about state-of-the-art antibiotic prophylaxis in urolithasis therapy and focus on recent publications in this field. RECENT FINDINGS: The number of high-quality publications within the recent time is limited. Preoperative inflammatory blood parameters like C-reactive protein and erythrocyte-sedimentation rate might help in prediction of postoperative systemic inflammatory response syndrome (SIRS) after percutaneous nephrolithotomy (PCNL). White blood cell count is nonpredictive for urinary tract infection (UTI) in patients with acute renal colic. In patients with low risk for infectious complications, antibiotic prophylaxis during shock-wave lithotripsy (SWL) is unnecessary and single-dose antibiotics are comparably effective as prolonged antibiotic usage during PCNL and ureterorenoscopy (URS). SUMMARY: Current findings support the American Urological Association (AUA) and European Association of Urology (EAU) guideline recommendations for a risk-adapted minimal antibiotic usage. Single-dose antibiotic prophylaxis is sufficient for low-risk PCNL and URS. For SWL no antibiotic prophylaxis is needed.

Prospective Evaluation of Predictive Parameters for Urinary Tract Infection in Patients with Acute Renal Colic.

BACKGROUND: Acute renal colic (ARC) is an emergency that can mostly be treated conservatively, but can be life threatening in combination with urinary tract infection (UTI). Assessment for infection includes white blood cell (WBC) count and C-reactive protein (CRP), but these parameters are often unspecifically elevated and might lead to antibiotic over-therapy. In times of increasing antibiotic resistance, however, unnecessary antibiotic therapy should be avoided. OBJECTIVES: The goal of the study was to investigate the prevalence of UTI proven by urine culture (UC) in patients with ARC and to identify predictive factors in the emergency setting. PATIENTS AND METHODS: We prospectively enrolled 200 consecutive patients with ARC and evaluated blood test results, urinalysis, UC, symptoms suspicious for UTI, and time between symptom onset and admission, as well as body temperature. Logistic regression analyses were performed to identify predictive factors. RESULTS: There were 196 patients eligible for statistical analysis. UTI proven by positive UC was detected in 26 patients (13%). On multivariate logistic regression analysis, suspicious urinalysis (positive nitrite or bacteria > 20/high-power field [hpf] or WBC > 20/hpf), patient age ≥ 54 years and CRP ≥ 1.5 mg/dL (fivefold increase) were significant predictors for the presence of UTI. Neither elevated WBC count nor typical UTI symptoms were associated with UTI. CONCLUSIONS: Based on our results, a routine antibiotic prophylaxis in patients with ARC does not seem to be appropriate. Patient age and CRP can help to decide if antibiotic treatment might be indicated, even in case of a not clearly suspicious urinalysis.

Prediction of cancer-specific survival after radical cystectomy in pT4a urothelial carcinoma of the bladder: development of a tool for clinical decision-making.

OBJECTIVE: To externally validate the pT4a-specific risk model for cancer-specific survival (CSS) proposed by May et al. (Urol Oncol 2013; 31: 1141-1147) and to develop a new pT4a-specific nomogram predicting CSS in an international multicentre cohort of patients undergoing radical cystectomy (RC) for urothelial carcinoma of the bladder (UCB) PATIENTS AND METHODS: Data from 856 patients with pT4a UCB treated with RC at 21 centres in Europe and North-America were assessed. The risk model proposed by May et al., which includes female gender, presence of positive lymphovascular invasion (LVI) and lack of adjuvant chemotherapy administration as adverse predictors for CSS, was applied to our cohort. For the purpose of external validation, model discrimination was measured using the receiver-operating characteristic-derived area under the curve. A nomogram for predicting CSS in pT4a UCB after RC was developed after internal validation based on multivariable Cox proportional hazards regression analysis evaluating the impact of clinicopathological variables on CSS. Decision-curve analyses were applied to determine the net benefit derived from the two models. RESULTS: The estimated 5-year-CSS after RC was 34% in our cohort. The risk model devised by May et al. predicted individual 5-year-CSS with an accuracy of 60.1%. In multivariable Cox proportional hazards regression analysis, female gender (hazard ratio [HR] 1.45), LVI (HR 1.37), lymph node metastases (HR 2.54), positive soft tissue surgical margins (HR 1.39), neoadjuvant (HR 2.24) and lack of adjuvant chemotherapy (HR 1.67, all P < 0.05) were independent predictors of an adverse CSS rate and formed the features of our nomogram with a predictive accuracy of 67.1%. Decision-curve analyses showed higher net benefits for the use of the newly developed nomogram in our cohort over all thresholds. CONCLUSIONS: The risk model devised by May et al. was validated with moderate discrimination and was outperformed by our newly developed pT4a-specific nomogram in the present study population. Our nomogram might be particularly suitable for postoperative patient counselling in the heterogeneous cohort of patients with pT4a UCB.

Antiplatelet and anticoagulative medication during shockwave lithotripsy.

BACKGROUND AND PURPOSE: Shockwave lithotripsy (SWL) is the gold standard treatment of patients with most renal and proximal ureteral calculi. Severe bleeding complications in SWL are extremely rare. Uncorrected bleeding diathesis might increase the risk and is considered to be an absolute contraindication for SWL. Perioperative management of anticoagulative and antiplatelet therapy has changed in the recent past. In particular, low-dose acetylsalicylic acid (ASA) is no longer a contraindication for many surgical procedures. METHODS: A systematic Medline/PubMed literature search of peer-reviewed scientific articles in urology and cardiovascular medicine was performed concerning the management of anticoagulative and antiplatelet medication during SWL. RESULTS: The literature on medically acquired and pathological bleeding diathesis and SWL in general is rare, retrospective, nonstandardized, and of low quality. Routine cessation of obligatory indicated anticoagulative or antiplatelet medication implies a significant risk for cardiovascular adverse events (CAE). Ureterorenoscopy is recommended in patients with uncorrected bleeding diathesis, although this is not based on high-level evidence. CONCLUSION: In patients with obligatory intake of anticoagulative or antiplatelet medication, the risk for CAE must be balanced against the SWL-induced bleeding risk. In patients with low-dose ASA-intake, SWL should be considered as an option instead of being disregarded as an absolute contraindication. Prospective randomized trials designed to define the optimal management of anticoagulants and antiplatelets during SWL are warranted.