Nicht erst seit der gesetzlichen Verpflichtung zur Meldung von Tumorpatienten an die Krebsregister ist eine flächendeckende Erhebung onkologischer Daten in Deutschland überfällig. Die Versorgungsforschung führt allerdings derzeit im Vergleich zu prospektiv randomisierten Phase I-III-Studien immer noch ein Schattendasein. Letztere sind sicherlich unabdingbar für die Entwicklung und Zulassung neuer Medikamente. Auch die Untersuchung von deren Wirksamkeit im Vergleich zum aktuellen Standard unter kontrollierten Studienbedingungen ist zur Einordnung in den Therapiealgorithmus essentiell. Nach der Zulassung besteht jedoch ein dringender Bedarf an sog. „real life“-Daten. Nur ein breites Monitoring des Einsatzes neuer Onkologika kann die Wirksamkeit unter Alltagsbedingungen sowie seltene Nebenwirkungen und Wechselwirkungen mit anderen Pharmaka offenlegen.

Therapies currently available in Germany for metastatic castration-resistant prostate cancer (mCRPC) include docetaxel, cabazitaxel, abiraterone acetate, enzalutamide and radium-223, all of which offer a potential survival benefit that adds up in their sequential application to a significant overall survival benefit. However, the optimal sequencing of these agents is still unclear. In the absence of evidence, treatment selection is based on the particular situation and on comorbid conditions of each individual patient. Furthermore, predictive markers to facilitate the selection of patients for a specific therapy or sequence of therapies remain an unmet need. However, with the recently discovered androgen receptor splice variant V7, which mediates (cross)resistance to or between abiraterone and enzalutamide, the first such marker has been identified. It is critical to monitor the response to treatments at prespecified intervals in order to optimize treatment sequencing so that the patient does not miss a valuable therapeutic window to receive alternative treatment that may prolong his life along with good symptom control and preservation of quality of life.

Background. 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.Objectives. 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.Results. Molecular markers are an important aid for future patient selection and individualized therapy for optimal use of the available forms of therapy.

Für die Therapie des metastasierten Prostatakarzinoms (mPC) stehen sowohl antihormonelle als auch zytotoxische Therapieoptionen zur Verfügung. Da v. a. beim metastasierten kastrationsresistenten Prostatakarzinom (mCRPC) bisher keine vergleichenden Studien zur Verfügung stehen bleibt unklar, welcher Patient von welcher Therapie am besten profitiert.

This position paper is intended to help to structure and to standardize therapy monitoring in patients with metastatic castration-resistant prostate cancer (mCRPC). With the treatment options available today, patients with metastatic disease can often maintain good quality of life and stable disease for several years. It is crucial that once a therapy becomes insufficiently effective that it be replaced in a timely manner by a new treatment option. From a prognostic point of view, it is important that patients receive as many as possible and in the ideal case all currently available treatment options.

Androgen deprivation therapy is an integral part of the treatment of advanced and progressive prostate cancer. Various prospective randomised trials have investigated whether or not temporary suspension of androgen deprivation might delay the emergence of castration resistant prostate cancer and concomitantly improve quality of life. Until now, no phase III trial has been able to prove that intermittent androgen deprivation might delay the development of castration resistant tumours. Data from previous trials, except for one study, did at least not show adverse effects on survival. Data on quality of life are inconsistent, showing a trend towards improved quality of life with IAD. German as well as European guidelines reflect IAD as an established constituent of day-to-day medical practice. This review is intended to provide a code of practice for an individualised treatment as based on recently published studies.

Die Androgendeprivation ist ein wesentlicher Bestandteil der Behandlung fortgeschrittener Prostatakarzinome. In zahlreichen prospektiv randomisierten Studien wurde der Frage nachgegangen, ob zeitweise Unterbrechungen des Androgenentzugs die Entwicklung einer Kas­trationsresistenz hinauszögern und gleichzeitig die Lebensqualität der Patienten verbessern kann. Ein Herauszögern der Kastrationsresistenz durch intermittierende Androgendeprivation (IAD) wurde in keiner Phase-III-Studie belegt. Die Überlebensdaten der bisherigen Phase-III-Studien zeigten mit Ausnahme einer Untersuchung zumindestens keinen Überlebensnachteil. Die Daten zur Lebensqualität sind uneinheitlich mit einem Trend zur Verbesserung unter IAD. Dass die IAD fester Bestandteil der Behandlungspraxis ist, spiegelt sich sowohl in der deutschen als auch in der europäischen Leitlinie wider. In dieser Übersichtsarbeit soll ein Leitfaden für eine individualisierte Behandlung auf der Basis der aktuell publizierten Studien vorgestellt werden.

The partial androgen deficiency in aging male (PADAM) has been of great interest to investigators and the public in the last few years. For males, androgens are said to be essential for the maintenance of quality of life (QoL) but there are no data available with respect to QoL and PADAM yet. In order to evaluate changes of individual well-being of males older than 50 years and with subnormal levels of free testosterone (FT) (< 200 pmol l(-1)), these men were asked to fill in a questionnaire regarding QoL. The objective of this study was to compare age-matched males with androgen deficiency (group 1; n = 24) and normoandrogenic elderly men (group 2; n = 24) with respect to QoL and somatic indicators of the endocrine status. Participants suffered from benign prostatic hyperplasia (BPH) and were hospitalized for prostate surgery. Health-related QoL was assessed by the SF-12 Health Survey, including the physical health index and the mental health index. The SF-12 was enlarged by the scales 'vitality' and 'psychological well-being' of the SF-36. Additionally, patients were asked about social and clinical items. There were no statistically significant differences between the two groups regarding social and clinical parameters. The physical health index was reduced in group 1 (P < 0.05; effect size was medium (d = 0.57)) whereas the mental health index was similar in both groups. The correlation between the two health indices was very low and not statistically significant (r = 0.05, P = 0.72). Patients of group 1 described a lower vitality compared to group 2 (P < 0.05), but no differences could be observed regarding psychological well-being. Therefore, androgen-deficient patients seem to have the impression of a reduced physical ability. Our data emphasize that the subjective description of health-related aspects of QoL is a very sensitive methodological approach to discover psychological differences between patients. For the differentiation between androgen-deficient patients and those with normal testosterone levels the physical health index seems to be more sensitive than the mental health index. A question of interest is whether this difference remains detectable if testosterone is supplemented to androgen-deficient men. Whether testosterone supplementation is beneficial to these patients has to be carefully considered.