To evaluate the real-world clinical usage and effectiveness of apalutamide in men with nonmetastatic castration-resistant prostate cancer (nmCRPC).
We retrospectively reviewed the data of 186 men who received apalutamide across 17 institutions. The primary outcomes were the clinical usage of apalutamide for nmCRPC: prior usage of other androgen receptor signaling inhibitors (ARSIs), prior radical treatment, and the distribution of the prostate-specific antigen (PSA) doubling time (PSA-DT) at the initial administration of apalutamide. The secondary outcomes were the efficacy of apalutamide: PSA response (50% or 90% decline), progression-free survival, and skin-adverse events (AEs).
We identified 75 patients with nmCRPC. A total of 31 (41.3%) patients received prior treatment with other ARSIs. A total of 42 men (56%) did not receive any prior radical treatment. The PSA-DT was <3.0, 3.0-5.9, 6.0-10, and > 10 months in 34.7%, 40%, 14.7%, and 10.6% of the patients, respectively. Patients receiving prior treatment with other ARSIs showed a significantly lower PSA response (PSA 50% decline, 88.4% vs. 18.8%; PSA 90% decline, 60.5% vs. 6.2%, P < .001, respectively) and significantly shorter progression-free survival (median: 37 months vs. 4 months; log-rank P < .001) than those without prior ARSI treatment, although cancer status did not differ between the groups. Skin-AEs were observed in 42.7%.
This real-world study revealed that apalutamide was used for the treatment after other ARSIs in >40% of patients with nmCRPC and showed limited efficacy in this context, although the effectiveness of apalutamide without prior other ARSI treatment was comparable with that reported in clinical trial results.
Japanese journal of clinical oncology. 2025 Feb 02 [Epub ahead of print]
Yoichiro Tohi, Keita Kobayashi, Kei Daizumoto, Yohei Sekino, Hideo Fukuhara, Heima Niigawa, Satoshi Katayama, Ryutaro Shimizu, Atsushi Takamoto, Kenichi Nishimura, Taichi Nagami, Yushi Hayashida, Hiromi Hirama, Koji Shiraishi, Ryotaro Tomida, Kohei Kobatake, Keiji Inoue, Yoshiyuki Miyaji, Kensuke Bekku, Shuichi Morizane, Noriyoshi Miura, Koichiro Wada, Mikio Sugimoto, Chu-shikoku Japan Urological Consortium
Department of Urology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan., Department of Urology, Graduate School of Medicine, Yamaguchi University, 1-1-1, Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan., Department of Urology, Tokushima University Graduate School of Biomedical Sciences, 3-18- 15 Kuramoto, Tokushima 770-8503, Japan., Department of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan., Department of Urology, Kochi Medical School, 185-1, Kohasu, Oko, Nankoku, Kochi 783-8505, Japan., Department of Urology, Kawasaki Medical School, 577, Matsushima, Kurashiki, Okayama 701-0192, Japan., Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, 2-5-1 Shikata-Cho, Kita-Ku, Okayama 700-8558, Japan., Division of Urology, Department of Surgery, Faculty of Medicine, Tottori University, 86 Nishi-cho, Yonago, Tottori 683-8503, Japan., Department of Urology, Fukuyama City Hospital, 5-23-1, Zao, Fukuyama, Hiroshima 720-8505, Japan., Department of Urology, Ehime University, 454, Shitsukawa, Toon, Ehime 791-0295, Japan., Department of Urology, Shimane University Faculty of Medicine, Shimane, Japan., Department of Urology, Sakaide City Hospital, 3-2-1, Kotobuki, Sakaide, Kagawa 762-8550, Japan., Department of Urology, KKR Takamatsu Hospital, 4-18, Tenjin, Takamatsu, Kagawa 760-0018, Japan.