Bertrand F Tombal, Francisco Gomez-Veiga, Alvaro Gomez-Ferrer, Fernando López-Campos, Piet Ost, Thierry Andre Roumeguere, Bernardo Herrera-Imbroda, Lionel A D'Hondt, Magali Quivrin, Paolo Gontero, Salvador Villà, Hussein Khaled, Beatrice Fournier, Jammbe Musoro, Joanna Krzystyniak, Yassin Pretzenbacher, Yohann Loriot
BACKGROUND AND OBJECTIVE: Darolutamide is an androgen receptor inhibitor that increases overall survival in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive and nonmetastatic castration-resistant prostate cancer (PCa). This phase 2 study assessed the efficacy and safety of darolutamide as monotherapy without ADT in patients with eugonadal testosterone levels. METHODS: This was a 24-wk, open-label, randomized study of patients with hormone-sensitive, histologically confirmed PCa requiring gonadotropin-releasing hormone (GnRH); an Eastern Cooperative Oncology Group performance status score of 0/1; and life expectancy >1 yr...
January 24, 2024: European Urology Oncology