Aturo

ZusammenfassungIm Rahmen der Phase III-Studie ERA-223 wurde bei Patienten mit einem metastasierten kastrationsresistenten Prostatakarzinoms (mCRPC) unter einer Kombinationstherapie mit Radium-223 und Abirateron ein erhöhtes Fraktur- und möglicherweise auch ein erhöhtes Sterberisiko festgestellt. Dies hat im Jahr 2018 zu einer Änderung des Zulassungstextes geführt. Radium-223 darf in Deutschland erst in der 3. Therapielinie als Monotherapie neben der Androgendeprivations-Therapie (ADT) beim mCRPC mit symptomatischen Knochenmetastasen ohne bekannte viszerale Metastasen oder bei Patienten mit mCRPC, für die keine andere verfügbare systemische Therapie geeignet ist, eingesetzt werden. Da zur Versorgungrealität in Deutschland kaum Daten existieren, wurden in der vorliegenden Studie die Mitglieder von d-uo (Deutsche Uro-Onkologen) bezüglich ihres Therapieverhaltens befragt. Es konnten Daten von 123 Patienten analysiert werden, welche zwischen 2014 und 2019 eine Behandlung mit Radium-223 erhielten. Es zeigte sich, dass knapp 50% der mCRPC-Patienten bereits vor der Label-Änderung Radium-223 erst nach 2 Vortherapien erhalten haben. Etwa die Hälfte der Patienten erhielt parallel eine der neuen Androgenrezeptor- gerichteten Therapien (Androgen Receptor Targeting Agents, ARTA). Das führte jedoch im Gegensatz zur ERA-223 nicht zu einer erhöhten Frakturrate. Allerdings erhielten ein Großteil der Patienten zeitgleich eine Osteoprotektion. Trotz des späten Einsatzes von Radium-223 zeigten noch knapp die Hälfte der Patienten ein Ansprechen auf die Therapie.

At the beginning of 2017, the German Society of Uro-Oncologists (d-uo) had the idea of designing a documentation platform that would enable d-uo members to report cancer cases to the cancer registry and transfer data to d-uo's own database - without a double effort. The cancer registry reimburses the first notification of a tumour with €18. As the only provider, d-uo reimburses its members for the documentation effort associated with the additional notification to d-uo with a further €18. In addition to the basic oncological data set, further parameters were defined by d-uo. This data is collected, evaluated and interpreted as part of the VERSUS study. At the end of 2022, 14,834 patients with a newly diagnosed urological tumour were included in the VERSUS study. Almost two thirds of all patients had prostate cancer. About half of all patients with prostate cancer were diagnosed as part of an early detection measure. These patients then also had more favourable tumour stages. Overall, almost every eighth patient already had metastases at the time of initial diagnosis. Data from the VERSUS study are available for 2,167 operations on prostate cancer with tumour category T2 or T3. There were 1,360 operations in patients with a T2 tumour (62.8%) and 807 operations in patients with T3 tumours (37.2%). A positive margin was present in 25.5% of all operated-on patients. In relation to tumour categories T2 and T3, the proportion of a positive resection margin was 14.3% and 44.2%, respectively. The VERSUS study will continue to provide answers to many questions from the uro-oncological field with reference to the "real world" situation in Germany.

Objective Micro-ultrasound is an imaging modality used to visualize and target prostate cancer during transrectal or transperineal biopsy. We evaluated the effectiveness of a micro-ultrasound training program and estimated the learning curve for prostate biopsy. Methods A training program registry was assessed for the rate of clinically significant prostate cancer (csPCa, grade group ≥ 2), negative predictive value, and specificity at each stage of the program. Nine metrics of biopsy quality were evaluated in 4 stages for each practitioner. Non-linear fitting and logistic regression models were used to evaluate the time-course of these metrics over training. Results Thirteen practitioners from 8 institutions completed stages 1 to 3 of the program, and 9 completed all 4 stages. Over 1190 micro-ultrasound biopsy procedures were performed. Detection of csPCa increased from 40% to 57% from stage 1 to stage 4 (P < 0.01). Stage 4 “expert” level was independently associated with higher detection of csPCa when correcting for overall risk factors (OR 1.95; P = 0.03). Limitations include the retrospective analysis and variation in biopsy protocols. Conclusion The micro-ultrasound training program was effective in improving biopsy quality and rate of csPCa detection. The presented learning curve provides an initial guide for acquiring expertise with real-time micro ultrasound image-guided biopsy.

Greenlight photo-selective vaporization of the prostate (GL-PVP) has gained international acceptance as a safe and effective alternative procedure for the treatment of benign prostatic hyperplasia (BPH), especially in anticoagulated men. This descriptive analysis aims to characterize the current state of GL-PVP, pooling data from international centers. Data from 3627 patients who underwent GL-PVP with the XPS-180W system in seven international centers performed by eight expert surgeons between 2011 and 2019 were retrospectively analyzed. Demographic, perioperative, and postoperative data were collected, including IPSS, QoL, Qmax, PVR, and PSA, and complications. At baseline, median age, prostate volume, PSA, and IPSS were 70years (interquartile range 64-77), 64 (47-90), 3.1ng/mL (1.8-6), and 22 (19-27), respectively. Median lasing and operative time were 34 (23-48) and 62min (46-85), respectively. Median energy use was 250.0kJ (168.4-367.9), with 92.6% of procedures being completed with one laser fiber. In 60.1% of cases, catheter was removed on postoperative day 1 with median length of 2days. All-cause mortality within 30days was 0.3%. Median PSA reduction at 3months and 60months compared to baseline was 43.9 and 46.4%, respectively (p < 0.001). All functional outcomes (IPSS, QoL, Qmax, and PVR) were significantly improved across study period when compared to baseline (p < 0.001). For those men with longer follow-up available, the observed surgical BPH retreatment rate was 1.5% CONCLUSION: Using the largest multi-user, international database of GL-PVP, Greenlight XPS laser treatment in experienced hands is a safe, effective, and durable BPH treatment option.

Objectives: We investigated the diagnostic efficacy of the prostate health index (PHI) and PHI density (PHID) to avoid unnecessary prostate biopsies in 3 urological practices. Methods: In 122 patients, total prostate-specific antigen (PSA), free PSA (f-PSA), the quotient from total PSA and f-PSA (f-PSA%), and [–2]pro-PSA were measured in the serum; PHI, PHID, and PSA density (PSAD) were calculated prior to prostate biopsy. Tissue sampling via transrectal biopsy was indicated in case of suspicious PSA (progression and/or elevation of PSA) and/or suspicious digital rectal examination. PSAD, PHI, and PHID were not used for biopsy indication. The diagnostic efficacy was determined with receiver-operating characteristic (ROC)and decision curve analyses. Results: Based on prostate biopsies, 38% (n = 46) of the cases had no prostate carcinoma (PCa), 21% (n = 26) no clinically significant (insignificant) PCa, and 41% (n = 50) had clinically significant PCa. ROC analyses of the PSA parameters showed higher diagnostic efficacy for PHI and PHID (AUC 0.722 and 0.739) than for f-PSA%, PSA, and PSAD (AUC 0.612, 0.595, and 0.698, respectively) regarding carcinoma diagnosis. With a combined use of PHI and PHID (cutoff >40 and >0.9, respectively), only 1 clinically significant PCa would have been missed (sensitivity 98%); in 24 (20%) patients, biopsy could have been avoided. Conclusion:The integration of PHI and PHID could improve the diagnostic efficacy of risk calculators to avoid unnecessary prostate biopsies. However, as a prerequisite, validation of cutoff values in prospective studies is urgently required.

In March 2015, the first Advanced Prostate Cancer Consensus Conference (APCC) took place in St. Gallen. 41experts from 17countries reviewed important areas of controversy in advanced hormone-naive and castration-resistant prostate cancer and gave therapy recommendations. These results have been recently published in "Annals of Oncology". While most of the recommendations from St. Gallen are comprehensible, some of them need to be further discussed. Therefore, we as aGerman expert panel will critically debate the St. Gallen recommendations. For metastatic hormone-naive prostate cancer, continuous androgen deprivation remains the standard. There is no evidence for superiority of primary maximal androgen deprivation. Patients suitable for chemotherapy, especially in the presence of high tumour burden, should receive androgen deprivation plus taxanes upfront. In metastatic castration resistant prostate cancer, novel hormonal agents like abiraterone or enzalutamid should be the treatment of choice in the majority of patients. Taxanes should be used first-line in patients with unfavourable prognostic markers. Radium-223 is an option in symptomatic patients with bone metastases. There is first evidence that second-line hormonal treatment after first-line failure of anovel endocrine agent has ahigh failure rate. Cabazitaxel should be part of the treatment sequence in patients with a good performance status. Baseline staging for castration-resistant prostate cancer should include CT-abdomen/-chest and bone scan. Radiographic monitoring should be performed 2 to 3 times ayear. Determination of PSA and ALP is to take place every 2 to 4months.

Antihormonal and cytotoxic therapy options are available for the therapy of metastasized prostate cancer (mPC). Because no comparative studies are available, especially for castration-resistant prostate cancer (mCRCP), it remains unclear which patients will profit best from which therapy. Previous data on the sequence of the various therapy options show that correct selection of the first line therapy for mCRPC can have an influence on the prognosis of the patient. In this position paper the various therapy options are critically illustrated and the clinical and pathohistological criteria for selection of the first line therapy of mCRPC are discussed. Molecular markers are an important aid for future patient selection and individualized therapy for optimal use of the available forms of therapy.

Radium-223 dichloride (Ra-223) is an alpha emitter with low toxicity for the treatment of patients with castrations-resistant prostate cancer (CRPC) and symptomatic bone metastases showing a 30% reduction in the risk of death, as compared to placebo. Because of the favorable physical and chemical characteristics, Ra-223 can be handled easily in daily practice based on interdisciplinary co-operation between urology and nuclear medicine. Ra-223 has been approved under the product name Xofigo® by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).