To compare the effectiveness and safety of gonadotropin-releasing hormone (GnRH) antagonist monotherapy to combined androgen blockade (CAB) with a GnRH agonist and bicalutamide in patients with advanced hormone-sensitive prostate cancer (HSPC).
The study was conducted as KYUCOG-1401 trial (UMIN000014243) and enrolled 200 patients who were randomly assigned to either group A (GnRH antagonist monotherapy followed by the addition of bicalutamide) or group B (CAB by a GnRH agonist and bicalutamide). The primary endpoint was PSA progression-free survival. The secondary endpoints were the time to CAB treatment failure, radiographic progression-free survival, overall survival, changes in serum parameters, including PSA, hormones, and bone and lipid metabolic markers, and adverse events.
PSA progression-free survival was significantly longer in group B (hazard ratio [HR], 95% confidence interval [CI]; 1.40, 1.01-1.95, p = 0.041). The time to CAB treatment failure was slightly longer in group A (HR, 95% CI; 0.80, 0.59-1.08, p = 0.146). No significant differences were observed in radiographic progression-free survival or overall survival. The percentage of patients with serum testosterone that did not reach the castration level was higher at 60 weeks (p = 0.046) in group A. No significant differences were noted in the serum levels of bone metabolic or lipid markers between the two groups. An injection site reaction was more frequent in group A.
The present results support the potential of CAB using a GnRH agonist and bicalutamide as a more effective treatment for advanced HSPC than GnRH antagonist monotherapy.
International journal of urology : official journal of the Japanese Urological Association. 2023 Dec 26 [Epub ahead of print]
Akira Yokomizo, Masaki Shiota, Futoshi Morokuma, Masatoshi Eto, Hideyasu Matsuyama, Hiroaki Matsumoto, Toshiyuki Kamoto, Naoki Terada, Kazuya Kawahara, Hideki Enokida, Shuichi Tatarano, Naohiro Fujimoto, Katsuyoshi Higasijima, Hideki Sakai, Tomoaki Hakariya, Tsukasa Igawa, Shigetaka Suekane, Tomomi Kamba, Yutaka Sugiyama, Junji Kishimoto, Seiji Naito
Department of Urology, Harasanshin Hospital, Fukuoka, Japan., Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan., Urology Department, Saga-Ken Medical Centre Koseikan, Saga, Japan., Department of Urology, Graduate School of Medicine, Yamaguchi University, Ube, Yamaguchi, Japan., Department of Urology, University of Miyazaki, Miyazaki, Japan., Department of Urology, University of Fukui, Fukui, Japan., Kawahara Nephro Urology Clinic, Aira, Japan., Department of Urology, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan., Department of Urology, University of Occupational and Environmental Health, Kitakyushu, Japan., Department of Urology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan., Department of Urology, Kurume University School of Medicine, Kurume, Japan., Department of Urology, Kumamoto University, Kumamoto, Japan., Center for Clinical and Translational Research, Kyushu University, Fukuoka, Japan.