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Purpose A multi-centre, longitudinal study was conducted to assess the prevalence of fatigue amongst men with localized prostate cancer, to describe several dimensions of fatigue and to explore the predictability of fatigue by psychological distress and physical function. Methods The prevalence of fatigue was evaluated using the Multidimensional Fatigue Inventory in 329 prostate cancer patients before, 3, 6 and 12 months after surgery. Psychological distress was assessed using the Hospital Anxiety and Depression Scale. Physical function was measured using the EORTC QLQ-C30. Results After surgery, about 14 % of the patients were screened with chronic fatigue. For all dimensions of fatigue, only small longitudinal changes could be observed. Psychological distress could be identified as a good predictor of fatigue after but not before surgery. Conclusions Radical prostatectomy has no or little impact on the prevalence of fatigue. However, about 14 % of patients with chronic fatigue could possibly benefit from psychosomatic interventions. Interventions should consider the simultaneous appearance of fatigue and psychological distress and a reduced physical function.

Organ-confined renal-cell carcinoma is associated with tumour progression in up to 50% of patients after radical nephrectomy. At present, no effective adjuvant treatment is established. We aimed to investigate the effect of an autologous renal tumour cell vaccine on risk of tumour progression in patients with stage pT2–3b pN0–3 M0 renal-cell carcinoma. Between January, 1997, and September, 1998, 558 patients with a renal tumour scheduled for radical nephrectomy were enrolled at 55 institutions in Germany. Before surgery, all patients were centrally randomised to receive autologous renal tumour cell vaccine (six intradermal applications at 4-week intervals postoperatively; vaccine group) or no adjuvant treatment (control group). The primary endpoint of the trial was to reduce the risk of tumour progression, defined as progression or death. All patients were assessed after standardised diagnostic investigations at 6-month intervals for a minimum of 4·5 years. By preoperative and postoperative inclusion criteria, 379 patients were assessable for the intention-to-treat analysis. At 5-year and 70-month follow-up, the hazard ratios for tumour progression were 1·58 (95% CI 1·05–2·37) and 1·59 (1·07–2·36), respectively, in favour of the vaccine group (p=0·0204, log-rank test). 5-year and 70-month progression-free survival rates were 77·4% and 72%, respectively, in the vaccine group and 67·8% and 59·3%, respectively, in the control group. The vaccine was well tolerated, with only 12 adverse events associated with the treatment. Adjuvant treatment with autologous renal tumour cell vaccine in patients with renal-cell carcinoma after radical nephrectomy seems to be beneficial and can be considered in patients undergoing radical nephrectomy due to organ-confined renal-cell carcinoma of more than 2·5 cm in diameter.

An autologous tumor vaccine already used successfully in the immune therapy of renal cell carcinoma was investigated in detail. The evaluation of potential tumor markers should allow for the assessment of potency according to pharmaceutical regulations. A panel of 36 tumor-associated antigens and cellular marker proteins was characterized in a total of 133 tumor cell lysates by methods such as ELISA, Western blots, and topological proteomics. The induction of tumor-associated antigen-specific antibodies was demonstrated by immunization in mice. Tumor heterogeneity was demonstrated: none of the tumor-associated antigens investigated were detectable in each tumor lysate. In parallel, the coincidental presence of potential danger signals was shown for HSP-60 and HSP-70. The presence of both antigen and danger signal allowed a successful induction of an immune response in a murine model. The verified tumor heterogeneity indicates the need for a multi-epitope approach for the successful immunotherapy in renal cell carcinoma.

Within the BUSTER trial, we analyzed the surgeon’s amount of experience and other parameters associated with URS procedures regarding the stone-free rate, complication rate, and operative time. Patient characteristics and surgical details on 307 URS procedures were prospectively documented according to a standardized study protocol at 14 German centers 01–04/2015. Surgeon’s experience was correlated to clinical characteristics, and its impact on the stone-free rate, complication rate, and operative time subjected to multivariate analysis. 76 (25%), 66 (21%) and 165 (54%) of 307 URS procedures were carried out by residents, young specialists, and experienced specialists (> 5 years after board certification), respectively. Median stone size was 6 mm, median operative time 35 min. A ureteral stent was placed at the end of 82% of procedures. Stone-free rate and stone-free rate including minimal residual stone fragments (adequate for spontaneous clearance) following URS were 69 and 91%, respectively. No complications were documented during the hospital stays of 89% of patients (Clavien–Dindo grade 0). According to multivariate analysis, experienced specialists achieved a 2.2-fold higher stone-free rate compared to residents (p = 0.038), but used post-URS stenting 2.6-fold more frequently (p = 0.023). Surgeon’s experience had no significant impact on the complication rate. We observed no differences in this study’s main endpoints, namely the stone-free and complication rates, between residents and young specialists, but experienced specialists’ stone-free rate was significantly higher. During this cross-sectional study, 75% of URS procedures were performed by specialists. The experienced specialists’ more than two-fold higher stone-free rate compared to residents’ justifies ongoing efforts to establish structured URS training programs.

Purpose White light cystoscopy (WLC) is the standard procedure for visualising non-muscle invasive bladder cancer (NMIBC). However, WLC can fail to detect all cancerous lesions, and outcomes with transurethral resection of the bladder differ between institutions, controlled trials, and possibly between trials and routine application. This noninterventional study assessed the benefit of hexaminolevulinate blue light cystoscopy (HALC; Hexvix ® , Ipsen Pharma GmbH, Germany) plus WLC versus WLC alone in routine use. Methods From May 2013 to April 2014, 403 patients with suspected NMIBC were screened from 30 German centres to perform an unprecedented detailed assessment of the additional detection of cancer lesions with HALC versus WLC alone. Results Among the histological results for 929 biopsy samples, 94.3 % were obtained from suspected cancerous lesions under either WLC or HALC: 59.5 % were carcinoma tissue and 40.5 % were non-cancerous tissue. Of all cancer lesions, 62.2 % were staged as Ta, 20.1 % as T1, 9.3 % as T2, 7.3 % as carcinoma in situ (CIS), and 1.2 % were unknown. Additional cancer lesions (+6.8 %) and CIS lesions (+25 %, p  < 0.0001) were detected by HALC plus WLC versus WLC alone. In 10.0 % of patients, ≥1 additional positive lesion was detected with HALC, and 2.2 % of NMIBC patients would have been missed with WLC alone. No adverse events were observed. Conclusions The results of this study demonstrate that HALC significantly improves the detection of NMIBC versus WLC alone in routine clinical practice in Germany. While this benefit is statistically significant across all types of NMIBC, it seems most relevant in CIS.

SummaryBackgroundDespite the high utilisation of ureterorenoscopy (URS) in interventional stone treatment, there is little evidence of any link between annual hospital volume and outcome.MethodsFrom January to April 2015, data from 307 URS patients were prospectively recorded in the multicentre observational BUSTER-Trial (Benchmarks of ureterorenoscopic stone treatment-results in terms of complications, quality of life, and stone-free rates). The best threshold value for annual hospital volume with an independent effect on the outcome (measured on stone-free and complication rates) of our study group was established with logistic regression.ResultsIn 38.4% of cases of renal and 61.6% of ureteral stones, median stone size was 6 mm with an interquartile range (IQR) of 4–8 mm. The annual URS rate in the 14 participating hospitals ranged from 77 to 333 (median 144; IQR 109–208). The binary endpoint as a combination of completely stone-free or residual fragments small enough to pass spontaneously and a maximum complication severity of Clavien–Dindo grade 1 was attained in 234/252 (92.9%) cases with a hospital volume of ≥ 99 URS compared with 43/55 (78.2%) in < 99 URS (p = 0.002). Adjusted for patient-, stone- and physician-related factors, an annual hospital URS volume of ≥ 99 increases the chance of an optimum outcome (OR = 3.92; 95% CI 1.46–10.51; p = 0.007).ConclusionsAn independent effect of URS hospital volume on outcome quality in the 14 participating hospitals was demonstrated. Threshold values for annual case numbers should be scientifically established irrespective of the considered procedure.

The core question of the study was whether the nerve-sparing status and surgical approach affected the patients’ sexual life in the first year after surgery. In addition, determinants of erectile function (EF) and the extent of sexual activity were investigated. We conducted a multicentric, longitudinal study in seven German hospitals before, 3, 6 and 12 months after radical prostatectomy (RP). A total of 329 patients were asked to self-assess the symptoms associated with erectile dysfunction (ED). These symptoms were assessed using the International Index of Erectile Function and EORTC QLQ-PR25 questionnaires. A multiple regression model was used to test the influence of clinical, socio-demographic and quality-of-life-associated variables on the patients’ EF 1 year after RP. Before surgery, 39% of patients had a severe ED (complete impotence). At 3, 6 and 12 months after surgery, it was 80, 79 and 71%, respectively. Although the surgical approach had no significant effect on EF, patients who had undergone nerve-sparing surgery had significantly lower ED rates. Nevertheless, 1 year after RP, 66% of these patients had severe ED. Age, nerve-sparing status and the burden of urinary symptoms had the greatest impact on the patients’ EF. Regardless of nerve-sparing status and surgical approach, postsurgical improvement of EF does not mean a full convalescence of presurgical EF. Instead, it may rather reduce the degree of postsurgical ED in time. Consequently, urologists should disclose to the patient that ED is a likely side effect of RP.

Objectives: Patient satisfaction plays an important role in the outcome quality of treatment for localized prostate carcinoma. This paper identifies factors that impact patients' assessment of therapy success one year after surgery. Methods: Patient assessment of therapy success was measured with the Hamburger Fragebogen zum Krankenhausaufenthalt (Lecher et al. 2002). Also, several sociodemographic, clinical and quality-of-life factors were tested for their impact on the patient assessment of therapy success. Results: 25 % of patients gave a negative assessment of therapy success. Factors with the strongest impact were urinary incontinence, sexual impotence, younger age and higher risk of recidive. Conclusions: Especially the prevention of urinary continence and sexual dysfunction may lead to a better assessment of therapy. Moreover, the patients' expectations have a great impact on the assessment of therapy success. Fragestellung: Die Patientenzufriedenheit ist ein wesentlicher Teil der Ergebnisqualität der Therapie des lokal begrenzten Prostatakarzinoms. Diese Arbeit zeigt, welche Faktoren die Einschätzung des Behandlungserfolges ein Jahr nach der Operation beeinflussen. Methode: Der Behandlungserfolg wurde mit einem Item aus dem „Hamburger Fragebogen zum Krankenhausaufenthalt“ gemessen (Lecher et al. 2002). Als Einflussgrößen wurden verschiedene soziodemographische, klinische und lebensqualitätsbezogene Variablen getestet. Ergebnisse: 25 % der Patienten beurteilen den Therapieerfolg negativ. Die stärksten Einflussgrößen waren eine vorliegende Harninkontinenz, sexuelle Impotenz, jüngeres Alter sowie ein erhöhtes Rezidivrisiko. Schlussfolgerung: Vor allem die Verhinderung von Harninkontinenz und sexueller Impotenz lassen eine stärkere Zufriedenheit mit dem Behandlungserfolg erwarten. Auch die Erwartungshaltung der Patienten hat einen großen Einfluss auf die Bewertung des Therapieerfolgs.

The purpose of this study was to evaluate the oncological and functional outcome of retropubic and perineal approaches to radical prostatectomy. Data from 1,304 patients who underwent either radical retropubic (RRP) or radical perineal prostatectomy (RPP) over a 12-year period were compared. Variables included age, prostate-specific antigen (PSA) level preoperative, prostate volume, Gleason score, estimated blood loss (EBL), blood transfusion rate (BTR), operative duration, surgical margin, pathological stage, short and long-term complication rates, impotence, and incontinence rates. RRP had a longer operative duration, higher EBL, higher BTR, and longer hospital stay. The 5-year biochemical-free survival rates were not significantly different between the two techniques. These results indicate there are no significant differences in oncological and functional outcomes between RRP and RPP. However, RPP demonstrates minimal EBL, low BTR, and shorter operative duration.