Degarelix/bicalutamide combination versus degarelix alone as initial androgen-deprivation therapy

183 Background: Antiandrogens have been used to prevent symptoms due to testosterone surge in the early phase of treatment with gonadotropin-releasing hormone (GnRH) agonist as well as to add antitumor efficacy. Degarelix, an antagonist of GnRH does not introduce testosterone surge, however, the combination of degarelix and antiandrogen can exert a stronger antitumor effect than degarelix alone. We conducted a phase II study to investigate the early-phase efficacy and safety of combination of degarelix and bicalutamide compared with degarelix alone in patients with prostate cancer (PCa). Methods: Patients with histologically proven adenocarcinoma in the prostate indicated for androgen-deprivation therapy (ADT) were randomly assigned to a treatment group with either combination of degarelix and bicalutamide or degarelix alone. Degarelix was administered subcutaneously with an initial dose of 240 mg followed by 80 mg thereafter every four weeks. Bicalutamide was taken 80 mg every day. The primary endpoint w...