143 Background: In ARASENS, darolutamide (DARO) + ADT + docetaxel (DOC) significantly reduced the risk of death by 32.5% (HR 0.68; 95% CI 0.57–0.80; P <0.0001) vs placebo (PBO) + ADT + DOC with similar incidence of treatment-emergent adverse events (TEAEs) between groups in patients (pts) with mHSPC. DARO + ADT + DOC has become one of the standards of care in mHSPC. We report post-hoc efficacy and safety in pts by age subgroups (<75 y, ≥75 y) in ARASENS. Methods: Pts were randomized to receive DARO 600 mg orally twice daily or PBO, with ADT + DOC. Age subgroups were analyzed for baseline characteristics including ongoing comorbidities, treatment duration, completion of DOC therapy, use of first subsequent therapy, key efficacy outcomes, and safety. Results: Of 1305 pts analyzed in ARASENS, ages ranged from 41–89 y, with 1086 pts <75 y (83%; DARO n=546; PBO, n=540) and 219 pts ≥75 y (17%; DARO n=105; PBO n=114). Baseline characteristics were generally similar in the DARO and PBO groups by age subgroup. The most common comorbidities by system organ class in pts <75 y and ≥75 y were vascular (55%, 67%), musculoskeletal/connective tissue (42%, 42%), and metabolism/nutrition (35%, 43%) disorders. Treatment duration was consistently longer with DARO vs PBO (<75 y: 41.2 vs 16.8 mo; ≥75 y: 38.5 vs 15.0 mo). Most patients completed 6 cycles of DOC (<75 y: 89%, 88%; ≥75 y: 80%, 76%). Among pts who entered follow-up, fewer DARO vs PBO pts initiated subsequent therapy independent of age (<75 y: 57% vs 76%; ≥75 y: 54% vs 73%). The overall survival (OS) benefit of DARO vs PBO was consistent across age subgroups (<75 y: HR 0.70, 95% CI 0.58–0.84; ≥75 y: HR 0.61, 95% CI 0.41–0.91). Time to metastatic castration-resistant prostate cancer (mCRPC) was longer with DARO vs PBO across age subgroups (<75 y: HR 0.35, 95% CI 0.30–0.43; ≥75 y: HR 0.42, 95% CI 0.28–0.64) as was time to initiation of subsequent therapy (<75 y: HR 0.40, 95% CI 0.34–0.48; ≥75 y: HR 0.35, 95% CI 0.22–0.54). TEAEs were generally similar between DARO and PBO, with slightly higher incidence rates in older pts. Few patients discontinued DARO or PBO due to TEAEs in both age subgroups (<75 y: 13.2%, 9.1%; ≥75 y: 15.1%, 17.7%). The most common grade 3/4 TEAEs were generally similar between DARO and PBO across age subgroups and occurred most frequently during overlapping DOC treatment. TEAEs commonly associated with androgen receptor pathway inhibitors occurred at similar incidences between treatment groups in both age subgroups. Conclusions: Pts with mHSPC benefited from DARO + ADT + DOC irrespective of age (<75 y and ≥75 y), with consistent improvements in OS, time to mCRPC, and time to initiation of subsequent therapy. DARO was well tolerated in both age subgroups, with similar incidences of TEAEs vs PBO. Clinical trial information: NCT02799602 .

Pembrolizumab has shown manageable safety and modest antitumor activity when used as a single agent in participants with metastatic castration-resistant prostate cancer (mCRPC). Preclinical evidence suggests that lenvatinib, a vascular endothelial growth factor-targeted agent, inhibits angiogenesis and cell migration in prostate cancer. Safety and efficacy of pembrolizumab plus lenvatinib in participants with docetaxel-pretreated mCRPC were evaluated in cohort E of the phase 1b/2 KEYNOTE-365 study. Eligible adults with confirmed mCRPC, Eastern Cooperative Oncology Group performance status (ECOG PS) scores of 0 or 1, and prior docetaxel treatment for mCRPC received pembrolizumab 200 mg intravenously every 3 wk, for ≤35 cycles, plus oral lenvatinib 20 mg daily, continuously from day 1 of cycle 1, unless specific discontinuation criteria were met. Primary endpoints were prostate-specific antigen (PSA) response rate; objective response rate (ORR), per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST) v1.1, by blinded independent central review; and safety. A total of 39 participants received treatment, with a median follow-up of 9.7 mo (interquartile range, 8.5-11.3). Confirmed PSA response rate was 34% (95% confidence interval [CI], 20-51). ORR for participants with RECIST-measurable disease was 36% (95% CI, 18-57). Treatment-related adverse events (AEs) of any grade occurred in 92% of participants and grade 3-5 treatment-related AEs occurred in 62% of participants. Two participants died of non-treatment-related AEs (acute kidney injury and unspecified death). Clinical trial registry: NCT02861573.

Alkaline phosphatase (ALP) declines and pain responses can occur during radium-223 (223Ra) treatment, but their association with treatment outcomes is unclear. For patients with metastatic castration-resistant prostate cancer treated with 223Ra in the REASSURE study, we investigated whether ALP decline (Week 12) and/or pain response (during treatment) are associated with improved overall survival (OS). The Brief Pain Inventory-Short Form (BPI-SF) was used to assess pain at baseline and pain response (in patients with baseline BPI-SF score ≥2). Of 785 patients with baseline and Week 12 ALP measurements, 779 were eligible for the OS analyses. Overall, 80

148 Background: In ARASENS (NCT02799602), DARO in combination with ADT and DOC significantly reduced the risk of death by 32.5% (HR 0.68; 95% CI 0.57–0.80; P<0.001) vs placebo (PBO) + ADT + DOC in patients with mHSPC. Incidences of treatment-emergent adverse events (TEAEs) were similar between treatment groups. We report dosing, safety, and PK of coadministration of DARO and DOC with ADT. Methods: Patients with mHSPC were randomized 1:1 to DARO 600 mg twice daily or PBO, plus ADT and DOC (75 mg/m2 q21d for 6 cycles). The effect of DARO on DOC PK was assessed by noncompartmental analysis from the first 25 patients with dense PK data and by population PK (PopPK) for all patients. DARO PK from ARASENS were compared with PK data from ARAMIS (NCT02200614; without DOC) to evaluate the impact of DOC on DARO PK. Results: Of 1306 randomized patients, 1305 were included in the full analysis set (DARO, n=651; PBO, n=654). The median treatment duration was longer with DARO vs PBO (41.0 vs 16.7 months) and more DARO-treated patients (45.9% vs 19.1%) were still receiving treatment at primary analysis cutoff (Oct 25, 2021). Almost all patients completed 6 cycles of DOC in both groups (DARO, 87.6%; PBO, 85.5%). The proportion of patients requiring DOC dose modification (interrupted/delayed or reduced) was similar between groups (DARO, 60.0%; PBO, 62.9%). TEAEs led to discontinuation/reduction of DOC in 8.0%/19.9% of DARO patients and 10.3%/19.5% of PBO patients. PopPK analysis indicated that DOC PK in ARASENS was generally consistent with that in the literature. A slight numeric increase in DOC exposure was observed in the DARO + DOC + ADT arm, with 15% higher maximum plasma concentration (geometric mean, 1.93 vs 1.68 µg/mL) and 6% higher area under the concentration-time curve (AUC0-tlast within an 8-hour sampling interval, 2.10 vs 1.99 µg·h/mL) vs PBO + DOC + ADT. This small numeric increase is likely not clinically relevant given the variability in DOC exposure (coefficient of variation, 23%–54%). PK meta-analysis of ARASENS and, which considered patients’ intrinsic characteristics as covariates (eg, age, body weight, region), indicated a 10% lower AUC0-12ss of DARO in patients receiving DOC vs those not receiving DOC, which is not considered clinically relevant. Conclusions: The combination of DARO + DOC + ADT increases overall survival with similar overall incidence of TEAEs and no observed drug-drug interactions between DARO and DOC. DARO can be effectively and safely administered with DOC in patients with mHSPC without clinically relevant changes in PK of DARO or DOC. Clinical trial information: NCT02799602 .

148 Background: More efficacious treatment options are needed to extend survival and disease control for pts with mCRPC whose disease progressed after treatment with docetaxel. The PD-1 inhibitor pembro has shown manageable safety and limited antitumor activity in pts with mCRPC. Preclinical evidence suggests the VEGF/TKI inhibitor lenva inhibits angiogenesis and cell proliferation in prostate cancer. In cohort E of the phase 1b/2 KEYNOTE-365 study (NCT02861573), the safety and efficacy of pembro + lenva was evaluated in pts with docetaxel-pretreated mCRPC. Methods: Eligible pts were aged ≥18 years with confirmed mCRPC, an ECOG PS of 0 or 1, and prior treatment with docetaxel for mCRPC. Prior treatment with 1 other chemotherapy for mCRPC and ≤2 next-generation hormonal manipulations were allowed. Pts received pembro 200 mg IV Q3W for up to 35 cycles plus lenva 20 mg PO QD continuously from day 1 of cycle 1, unless specific withdrawal or discontinuation criteria were met. Primary end points were prostate-specific antigen (PSA) response rate, objective response rate (ORR) per RECIST v1.1 by blinded independent central review (BICR), and safety. Secondary end points included duration of response (DOR) and disease control rate (DCR: CR and PR of any duration and SD or non-CR/non-PD of ≥6 months) per RECIST v1.1 by BICR, radiographic progression-free survival (rPFS) per PCWG3-modified RECIST v1.1 by BICR, and overall survival (OS). Results: Of 39 treated pts, median age was 67 years (range, 55-84), 64% had RECIST v1.1–measurable disease per BICR, and 59% had an ECOG PS of 1. At data cutoff (January 25, 2023), 64% pts had discontinued study treatment, 31% due to PD; 36% pts had ongoing treatment. Median time from first dose to data cut-off was 9.7 months (range, 7.4-15.2). Confirmed PSA response was 34% (95% CI, 20-51 [13/38 pts]) for pts with a baseline PSA measurement. ORR for pts with RECIST v1.1–measurable disease was 36% (95% CI, 18-58 [9 PR]). Median DOR was not reached (NR; range, 2.1+ to 6.9+ months); 3 pts had a response duration of ≥6 months. DCR for all pts was 51%. Median rPFS was 7.9 months (95% CI, 4.1-NR); estimated 12-month rPFS rate was 35%. Median OS was 9.4 months (95% CI, 8.4-NR); estimated 12-month OS rate was 37%. Treatment-related AEs (TRAEs) occurred in 92% of pts; most common (≥30%) were hypertension (51%), hypothyroidism (44%), fatigue (38%), diarrhea (36%), dysphonia (31%), and weight decreased (31%). Grade 3-5 TRAEs occurred in 62% of pts and most common (≥20%) were hypertension (36%) and fatigue (21%). Two pts died of AEs (acute kidney failure and death), but neither were treatment related. Conclusions: Pembro + lenva demonstrated promising and durable antitumor activity in selected pts with docetaxel-pretreated mCRPC. Safety was generally consistent with the individual profiles and for the combination of these agents. Clinical trial information: NCT02861573 .

Background: In addition to erectile dysfunction, urinary incontinence is the most common functional limitation after radical prostatectomy (RPE) for prostate cancer (PCa). The German S3 guideline recommends informing patients about possible effects of the therapy options, including incontinence. However, only little data on continence fromroutine care in German-speaking countries after RPE are currently available, which makes it difficult to inform patients. Objective: The aim of this work is to present data on the frequency and severity of urinary incontinence after RPE from routine care. Materials and methods: Information from the PCO (Prostate Cancer Outcomes) study is used, which was collected between 2016 and 2022 in 125 German Cancer Society (DKG)-certified prostate cancer centers in 17,149 patients using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). Changes in the "incontinence" score before (T0) and 12 months after RPE (T1) and the proportion of patients who used pads, stratified by age and risk group, are reported. Results: The average score for urinary incontinence (value range: 0-worst possible to 100-best possible) was 93 points at T0 and 73 points 12 months later. At T0, 97% of the patients did not use a pad, compared to 56% at T1. 43% of the patients who did not use a pad before surgery used at least one pad a day 12 months later, while 13% use two ormore. The proportion of patients using pads differs by age and risk classification. Conclusion: The results provide a comprehensive insight into functional outcome 12 months after RPE and can be taken into account when informing patients.

e17102 Background: Besides erectile dysfunction, urinary incontinence is the most common functional impairment after radical prostatectomy (RP) for localized and (locally) advanced prostate cancer (PCa). Clinical guidelines recommend informing patients about incontinence and other functional impairment of the different therapy options. Yet, real-world data on incontinence following RP is sparse in most countries, impeding the information of patients. This work aims to present data on urinary incontinence after RP from routine care in Germany, Switzerland and Austria using the EPIC-26 urinary incontinence score and the single item on pad use. Methods: We analyzed data from the prospective cohort study PCO (Prostate Cancer Outcomes Study), partly funded by the Movember Foundation. The data presented was based on patients treated with RP for localized and (locally) advanced PCa in one of 118 Certified Prostate Cancer Centers between 2016 and 2021. The Berlin Medical Association's ethics board and local ethics boards approved the study. Each patient gave informed written consent. Patients included in the analytic sample had to complete a baseline questionnaire (EPIC-26) before (T0) and a follow-up questionnaire 12 months after RP (T1). Questionnaire data were linked to clinical data and analyzed descriptively: We report changes in the urinary incontinence score between T0 and T1 and the proportion of patients using pads ("pad use") stratified by age and risk group according to the German clinical guideline (based on the d’Amico risk groups). Results: 14,920 patients from 118 centers were included in the analysis. The median age was 66 (interquartile range 61-70). The average urinary incontinence score (value range: 0 - worst possible to 100 - best possible) was 93 points at T0 and 73 points 12 months later. 97% of the patients did not use pads at T0, compared to 57% using at least one pad per day at T1. Among patients who did not use pads at T0, 42% used at least one pad a day 12 months later, and 12% used two or more pads per day. The proportion of patients using pads differs meaningfully according to age and risk group and across centers. Conclusions: The data presented gives insight into real-world functional outcomes after RP. These results may help inform providers and patients when discussing treatment options in an easy-to-understand way. Availability of comparable data from other countries is limited, with Australian registry data suggesting slightly better outcomes at 12 months. Results are limited to Prostate Cancer Centers certified according to the requirements of the German Cancer Society. They are thus a selection of units with at least 50 RPs per year and many other quality standards met.

Harninkontinenz ist neben Störungen der erektilen Funktionsfähigkeit die häufigste Funktionseinschränkung nach radikaler Prostatektomie (RPE) beim Prostatakarzinom (PCa). Die deutsche S3-Leitlinie empfiehlt, Patienten über mögliche Auswirkungen der Therapieoptionen zu informieren (darunter die Inkontinenz). Allerdings liegen bislang nur ungenaue Daten zur Kontinenz aus der Routineversorgung im deutschsprachigen Raum nach RPE vor, was die Information der Patienten erschwert. Ziel dieser Arbeit ist es, Daten zur Häufigkeit und Ausprägung der Harninkontinenz nach RPE aus der Routineversorgung vorzustellen. Genutzt werden Angaben aus der PCO (Prostate Cancer Outcomes)-Studie, die zwischen 2016 und 2022 in 125 von der Deutschen Krebsgesellschaft (DKG) zertifizierten Prostatakrebszentren bei 17.149 Patienten mittels Expanded Prostate Cancer Index Composite Short Form (EPIC-26) erhoben wurden. Berichtet werden Veränderungen im Score „Inkontinenz“ vor (T0) und 12 Monate nach RPE (T1) und die Anteile der Patienten, die Einlagen nutzten („pad use“), stratifiziert nach Alter und Risikogruppe. Der Durchschnitt des Scores Harninkontinenz (Wertebereich: 0 – schlechtestmöglich bis 100 – bestmöglich) betrug zu T0 93, 12 Monate später 73 Punkte. 97

Pathologic examination of prostate biopsies is time consuming due to the large number of slides per case. In this retrospective study, we validate a deep learning-based classifier for prostate cancer (PCA) detection and Gleason grading (AI tool) in biopsy samples. Five external cohorts of patients with multifocal prostate biopsy were analyzed from high-volume pathology institutes. A total of 5922 H&E sections representing 7473 biopsy cores from 423 patient cases (digitized using three scanners) were assessed concerning tumor detection. Two tumor-bearing datasets (core n = 227 and 159) were graded by an international group of pathologists including expert urologic pathologists (n = 11) to validate the Gleason grading classifier. The sensitivity, specificity, and NPV for the detection of tumor-bearing biopsies was in a range of 0.971–1.000, 0.875–0.976, and 0.988–1.000, respectively, across the different test cohorts. In several biopsy slides tumor tissue was correctly detected by the AI tool that was initially missed by pathologists. Most false positive misclassifications represented lesions suspicious for carcinoma or cancer mimickers. The quadratically weighted kappa levels for Gleason grading agreement for single pathologists was 0.62–0.80 (0.77 for AI tool) and 0.64–0.76 (0.72 for AI tool) for the two grading datasets, respectively. In cases where consensus for grading was reached among pathologists, kappa levels for AI tool were 0.903 and 0.855. The PCA detection classifier showed high accuracy for PCA detection in biopsy cases during external validation, independent of the institute and scanner used. High levels of agreement for Gleason grading were indistinguishable between experienced genitourinary pathologists and the AI tool.

Das konventionelle Röntgen stellte vor einigen Jahren noch ein Basisdiagnoseverfahren in der Urologie dar. Durch die flächendeckende Verfügbarkeit der modernen Schnittbildverfahren hat das konventionelle Röntgen jedoch in der Diagnostik an Bedeutung verloren. Das konventionelle Röntgen, vor allem in der Form der Durchleuchtung, ist und bleibt jedoch ein wichtiges Hilfsmittel für die Durchführung dynamischer Untersuchungen und bildgesteuerter urologischer Eingriffe. Das konventionelle Röntgen und die Durchleuchtung ermöglichen mit Hilfe der Röntgenkontrastmittelgabe die Darstellung der harnableitenden Strukturen und der eventuell vorhandenen Pathologien. Die Strahlenbelastung und die Bildqualität der Röntgenuntersuchung konnten mit der Einführung des digitalen Röntgen deutlich verbessert werden. Dieses Kapitel behandelt die konventionelle Röntgenuntersuchung der urologischen retroperitonealen Organe wie der Niere, des Harnleiters und der Harnblase. Das konventionelle Röntgen stellte vor einigen Jahren noch ein Basisdiagnoseverfahren in der Urologie dar. Durch die flächendeckende Verfügbarkeit der modernen Schnittbildverfahren hat das konventionelle Röntgen jedoch in der Diagnostik an Bedeutung verloren. Das konventionelle Röntgen, vor allem in der Form der Durchleuchtung, ist und bleibt jedoch ein wichtiges Hilfsmittel für die Durchführung dynamischer Untersuchungen und bildgesteuerter urologischer Eingriffe. Das konventionelle Röntgen und die Durchleuchtung ermöglichen mit Hilfe der Röntgenkontrastmittelgabe die Darstellung der harnableitenden Strukturen und der eventuell vorhandenen Pathologien. Die Strahlenbelastung und die Bildqualität der Röntgenuntersuchung konnten mit der Einführung des digitalen Röntgen deutlich verbessert werden. Das folgende Kapitel behandelt die konventionelle Röntgenuntersuchung der urologischen retroperitonealen Organe wie der Niere, des Harnleiters und der Harnblase.

NG2 is expressed by a variety of immature glia in the CNS including oligodendrocyte progenitor cells, paranodal astrocytes and perisynaptic glia. The protein has a large extracellular domain with two LNS/Lam G domains at the N-terminus and a short intracellular tail with a PDZ-recognition domain at the C-terminus. Experiments suggest that the protein plays a role in migration. The PDZ protein GRIP was identified as an intracellular binding partner of NG2 in immature glial cells. A complex is formed between GRIP, NG2 and the AMPA class of glutamate receptors: this may position these glial receptors towards sites of neuronal glutamate release at synapses and during myelination. Identification of neuronal receptors and links to the cytoskeleton of NG2 is of critical importance. Some Mutiple Sclerosis patients have autoantibodies to NG2 in the cerebral spinal fluid: such antibodies could interfere with remyelination by lysing oligodendrocyte progenitor cells or blocking their migration but may also cause pathology by disrupting glial–neuronal signalling at synapses and paranodes.

5041 Background: Ra-223 extends OS in pts with mCRPC. Predictive markers of response to Ra-223 are needed to help select pts who would benefit most from Ra-223 therapy. The ALSYMPCA study suggested a correlation between ALP decline and longer OS. Here, we evaluated whether ALP decline is associated with OS in the global real-world REASSURE study. Methods: Pts treated with Ra-223 were grouped by baseline ALP ≤147 U/L vs >147 U/L and any ALP decline vs no decline at week 12 from the first Ra-223 dose. The 147 U/L cut-off was selected based on the highest upper limit of normal for ALP from literature. Pts with a trend of decreasing ALP at closest value to week 12 between weeks 8 and 16 were included in the any decline group. Association of ALP decline with OS was assessed in the ≤147 U/L and >147 U/L groups separately. Median OS is provided with an unadjusted hazard ratio (HR) (95% confidence interval [CI]). Multivariate Cox models provided adjusted HRs (95% CI) for the association of ALP decline with OS. Some baseline covariates were not included in the models due to missing data. Results: 785 of 1465 pts had baseline ALP measurements, of whom 779 had week 12 ALP measurements: 443 had ≤147 U/L and 336 >147 U/L. In the ≤147 U/L group, median OS was 23.0 months (m) (95% CI 20.9–25.7) in pts with ALP decline (n=329) and 16.4 m (95% CI 14.1–20.4) in pts with no decline (n=114). In the >147 U/L group, median OS was 12.9 m (95% CI 11.7–14.3) in pts with ALP decline (n=295) and 8.1 m (95% CI 5.6–10.3) in pts with no decline (n=41). Comparison of unadjusted and adjusted HRs is shown in the Table. Conclusions: Pts with an ALP decline in first 12 weeks of Ra-223 treatment had longer OS. The effect of other baseline variables, including age, PSA, Hgb and prior treatments, provided adjustment but did not change this outcome. [Table: see text]

Background: Prostate-specific antigen (PSA)-based detection of prostate cancer (PCa) often leads to negative biopsy results or detection of clinically insignificant PCa, more frequently in the PSA range of 2-10 ng/ml, in men with increased prostate volume and normal digital rectal examination (DRE). Objective: This study evaluated the accuracy of Proclarix, a novel blood-based diagnostic test, to help in biopsy decision-making in this challenging patient population. Design, setting, and participants: Ten clinical sites prospectively enrolled 457 men presenting for prostate biopsy with PSA between 2 and 10 ng/ml, normal DRE, and prostate volume >= 35 cm(3). Transrectal ultrasound-guided and multiparametric magnetic resonance imaging (mpMRI)-guided biopsy techniques were allowed. Outcome measurements and statistical analysis: Serum samples were tested blindly at the end of the study. Diagnostic performance of Proclarix risk score was established in correlation to systematic biopsy outcome and its performance compared with %free PSA (%fPSA) and the European Randomised Study of Screening for Prostate Cancer (ERSPC) risk calculator (RC) as well as Proclarix density compared with PSA density in men undergoing mpMRI. Results and limitations: The sensitivity of Proclarix risk score for clinically significant PCa (csPCa) defined as grade group (GG) >= 2 was 91% (n = 362), with higher specificity than both %fPSA (22% vs 14%; difference = 8% [95% confidence interval {CI}, 2.6-14%], p = 0.005) and RC (22% vs 15%; difference = 7% [95% CI, 0.7-12%], p = 0.028). In the subset of men undergoing mpMRI-fusion biopsy (n = 121), the specificity of Proclarix risk score was significantly higher than PSA density (26% vs 8%; difference = 18% [95% CI, 7-28%], p < 0.001), and at equal sensitivity of 97%, Proclarix density had an even higher specificity of 33% [95% CI, 23-43%]. Conclusions: In a routine use setting, Proclarix accurately discriminated csPCa from no or insignificant PCa in the most challenging patients. Proclarix represents a valuable rule-out test in the diagnostic algorithm for PCa, alone or in combination with mpMRI. Patient summary: Proclarix is a novel blood-based test with the potential to accurately rule out clinically significant prostate cancer, and therefore to reduce the number of unneeded biopsies. (c) 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Bereits seit Gründung der Arbeitsgemeinschaft Urologische Onkologie (AUO) der Deutschen Krebsgesellschaft e. V. in den 90er Jahren war eine Hauptaufgabe der AUO die Förderung von Studien in der Uro-Onkologie. Hierfür unternimmt die AUO verschiedene Anstrengungen, um die Durchführung von qualitativ hochwertigen Studien im Indikationsgebiet zu fördern und zu beschleunigen. So bietet die AUO schon seit vielen Jahren einen GCP-Kurs für Prüfärzte und Study Nurses an. Außerdem unterzieht die AUO ihr eingereichte Studienprotokolle und –entwürfe einer Kurzbegutachtung. Bei positivem Ergebnis der Kurzbegutachtung wird die Studie durch die AUO aktiv gefördert. Hierzu zählt die Publikation von Studienvorstellungen in einschlägigen Medien genauso wie die Präsentation der Studien im AUO-eigenen Newsletter. Die Studien sind auf der AUO-Homepage hinterlegt und werden in Ihrer aktiven Phase in Bezug auf die Rekrutierung durch die AUO begleitet. Aus den somit gewonnen Zahlen kann die AUO für künftig neu eingereichte Studien gezielte Zentren-Empfehlungen abgeben, so dass es den Sponsoren der Studien leichter fällt, für ihre Studie Studienzentren zu finden. Alle Maßnahmen der AUO hierbei zielen darauf ab, für eine schnelle Rekrutierung in qualitativ hochwertige Studien zu sorgen und somit für eine bessere medizinische Versorgung der Patienten von morgen auf Grundlage von evidenz-basierter Medizin einzutreten. Im Folgenden stellen wir Ihnen die Blasen- bzw. Urothelkarzinom-Studien vor, die derzeit durch die AUO unterstützt werden.