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.

Comprehensive analysis of complications after transperineal prostate biopsy without antibiotic prophylaxis: results of a multicenter trial with 30 days' follow-up.

BACKGROUND: To investigate infectious and non-infectious complications after transperineal prostate biopsy (TPB) without antibiotic prophylaxis in a multicenter cohort. Secondly, to identify whether increasing the number of cores was predictive for the occurrence of complications. Thirdly, to examine the relation between TPB and erectile dysfunction. METHODS: We analyzed a retrospective multicenter cohort of 550 patients from three different urological centers undergoing TPB without antibiotic prophylaxis. The median number of cores was 26. Demographic and clinical data were extracted by reviewing patients' electronic medical records and follow-up data such as postoperative complications obtained by structured phone interviews. To investigate the influence of the number of cores taken on the occurrence of complications, we performed univariate and multivariate mixed effects logistic regression models. RESULTS: There was no case of sepsis reported. Overall, 6.0% of patients (33/550) presented with any complication besides mild macrohematuria. In all, 46/47 (98%) complications were ≤Grade 2 according to Clavien-Dindo. In multivariate regression analyses, an increased number of cores was associated with overall complications (odds ratio (OR) 1.08, 95% confidence interval (CI) 1.02-1.14, P = 0.01) and specifically bleeding complications (OR 1.28, 95% CI 1.11-1.50, P = 0.01) but not with infectious complications (OR 1.03, 95% CI 0.97-1.10, P = 0.67). A total of 14.4% of patients referred impairment of erectile function after TPB. Of note, 98% of these men were diagnosed with prostate cancer. CONCLUSIONS: This is the first multicenter trial to investigate complications after TPB without antibiotic prophylaxis. In our study, we found no case of sepsis. This underlines the safety advantage of TPB even without antibiotic prophylaxis and supports the ongoing initiative to abandon TRB of the prostate. A higher number of cores were associated with an increase in overall complications specifically bleeding complications, but not with infectious complications. Post-biopsy erectile dysfunction was mainly present in patients diagnosed with PCa.

99mTc-labelled PSMA ligand for radio-guided surgery in nodal metastatic prostate cancer: proof of principle.

PURPOSE: Intraoperative identification of prostate cancer (PCa) lymph node (LN) metastases (LNM) detected by preoperative PSMA PET/CT may be facilitated by PSMA radio-guided surgery (RGS) with use of a γ-probe. Earlier we demonstrated excellent performance of the 111In-labelled PSMA ligand DKFZ-617 ([111In]In-PSMA-617) in RGS for ex situ distinction of LN vs LNM at lymphadenectomy (LA) at a single LN level. In comparison with indium-111, technetium-99m has better physical properties for γ-probe measurements, better availability and lower radiation exposure for patients and medical personnel. Against this background, we evaluated the uptake of 99mTc-PSMA-I&S ligand at the level of single LN and its power to discriminate between unaffected LN and LNM. METHODS: Six patients with PCa with the suspicion of LNM on preoperative PSMA-PET/CT underwent [99mTc]Tc-PSMA-I&S RGS (4 salvage LA, 2 primary LA) with intravenous injection of [99mTc]Tc-PSMA-I&S 24 h prior to surgery. Resected samples were isolated manually aiming at the level of single LN. Uptake measurements were done ex situ with a high-purity germanium detector. Receiver operating characteristic (ROC) analysis was performed based on [99mTc]Tc-PSMA-I&S uptake expressed as lean body mass standard uptake value (SUL). RESULTS: Separation of the tissue samples from 73 subregions resulted in 498 single samples. After final histopathology 356 LN, 160 LNM und 11 non-nodal PCa samples were identified. Median SUL of tumor-free samples (0.26) and samples with cancer (3.5) was significantly different (p < 0.0001). ROC analysis revealed an area under the curve (AUC) of 0.917 (95% CI 0.89-0.95). Using a SUL cutoff of 1.1, sensitivity, specificity, positive predictive value, and negative predictive values were 76.6%, 94.4%, 89.4% and 86.9%. CONCLUSION: Ex situ analysis of [99mTc]Tc-PSMA-I&S uptake at single LN level showed good diagnostic performance for the ex situ distinction of tumor-bearing vs tumor-free LN during RGS.

Safety and side effects of transperineal prostate biopsy without antibiotic prophylaxis.

STUDY AIMS: To investigate safety and side effects of transperineal prostate biopsy without antibiotic prophylaxis. Secondary aim was to identify whether the number of cores influenced the occurrence of complications. PATIENTS AND METHODS: A cohort of 184 patients undergoing perineal prostate biopsy without antibiotic prophylaxis from 2015 to 2017 was analyzed retrospectively. On average, 41 cores were taken via two perineal skin punctures. Demographic and clinical data were obtained from patients´ electronic medical records. Binary logistic regression was performed to identify predictors for complications with the following covariates: age, prostate specific antigen (PSA), prostate volume, Prostate Imaging Reporting and Data System score, history of prostatitis, therapeutic anticoagulation, risk factors for urinary tract infection, surgery duration, and the number of biopsy cores. Furthermore, we calculated chi-squared tests with post hoc analyses for differences in the occurrence of complications between quartiles of the above-mentioned parameters. RESULTS: The overall complication rate was 10.8% (20/185). Out of 20, 19 (95 %) complications were ≤ grade 2 according to the Clavien-Dindo classification. There were two cases of afebrile urinary tract infection, and no patient developed fever or sepsis. Acute urinary retention was reported in 10 patients (5.4 %). The total number of cores was not associated to infectious complications or acute urinary retention rates. CONCLUSIONS: Transperineal prostate biopsy without antibiotic prophylaxis is a safe procedure. Neither postoperative fever nor sepsis occurred. An increased number of cores through two skin punctures was not associated with more complications.

36-month data for the AdVance XP® male sling: results of a prospective multicentre study.

OBJECTIVES: To evaluate the efficacy and safety of the AdVance XP® sling (Boston Scientific, formerly American Medical Systems) in male stress urinary incontinence (SUI) after radical prostatectomy in a prospective multicentre study, as in recent years several studies have shown the effectiveness and safety of the AdVance sling for treating male SUI and in 2010 the second-generation AdVance XP was introduced with several changes in the sling design and a new needle shape. PATIENTS AND METHODS: In all, 115 patients were included. Patients with nocturnal UI, previous UI surgery, previous radiotherapy and a coaptive zone of <1 cm in the preoperative repositioning test were excluded. Postoperatively, a standardised 24-h pad test, quality-of-life scores [International Quality of Life score (IQOL) and International Consultation on Incontinence Questionnaire short form (ICIQ-UI SF)], visual analogue scale (VAS) for pain, five-item version of the International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS) and Patient Global Impression of Improvement (PGI-I) score, were performed. All patients with a 0-5 g pad test were defined as cured and improved with a reduction of urine loss of >50%. All others were classified as failures. Significance analysis was performed using the Wilcoxon test. RESULTS: The mean (median) preoperative urine loss in the 24-h pad test was 272.0 (272.0) g. After a follow-up of 3 months (114 patients), 64.9% of the patients were cured and 31.6% had an improved continence status. The mean urine loss decreased significantly to 34.9 g (P < 0.001), with a mean VAS score of 0.5, and mean PGI-I of 1.5. After a follow-up of 24 months (80 patients), 68.8% of the patients were cured and 22.5% had improved. The mean urine loss decreased significantly to 19.1 g (P < 0.001), with a mean VAS score of 0.3, and mean PGI-I of 1.5. After a follow-up of 36 months (47 patients), 66.0% of the patients were cured and 23.4% had improved. The mean urine loss decreased significantly to 21.8 g (P < 0.001), with a mean VAS score of 0.0, and mean PGI-I of 1.6. The mean IQOL and ICIQ-UI SF improved significantly (both P < 0.001) after 36 months. There were no significant postoperative changes in IIEF-5 and IPSS. No intraoperative and no long-term complications occurred. No erosion or explanations occurred. CONCLUSION: The AdVance XP shows good and stable effectiveness and low complication rates even at a mid-term follow-up of up to 36 months.