Bei Männern mit nicht-metastasiertem, kastrationsresistenten Prostatakarzinom (nmCRPC) und hohem Metastasierungsrisiko, die mit Darolutamid plus Androgendeprivationstherapie (ADT) behandelt wurden, zeigte sich eine signifikante Verbesserung des Gesamtüberlebens (OS) gegenüber Placebo plus ADT (HR=0,69, 95 % KI 0,53–0,88; p=0,003) / Darolutamid zeigte auch eine signifikante Verbesserung der anderen sekundären Endpunkte wie die Verlängerung der Zeit bis zum Beginn der ersten zytotoxischen Chemotherapie und bis zum ersten symptomatischen Skelettereignis (SSE) / Das Sicherheitsprofil stimmte auch bei längerer Beobachtung mit den Ergebnissen der Interims-Analyse überein – die Rate der unerwünschten Ereignisse (UE) (wie z.B. Auswirkungen auf das zentrale Nervensystem, ZNS) war in beiden Studienarmen ähnlich
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