We conducted a retrospective evaluation of the clinical outcomes and prognostic factors in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) treated with first-line androgen receptor signaling inhibitors (ARSI) in real-world clinical practice in Japan. Between 2012 and 2023, a total of 127 consecutive patients with nmCRPC received ARSI treatment. Overall survival (OS), metastatic-free survival (MFS), and prostate-specific antigen–progression-free survival (PSA–PFS) from ARSI initiation were assessed using the Kaplan–Meier methodology. Clinical factors associated with OS in nmCRPC were analyzed using the Cox proportional hazards model. Among the patients, 72, 26, 12, and 17 received enzalutamide (ENZ), abiraterone (ABI), apalutamide (APA), and darolutamide (DARO) as first-line therapy. The median OS and MFS for all patients were 79.0 and 42.0 months, respectively. Median PSA–PFS was 27.0, 20.0, 10.0, and 14.0 months for patients treated with ENZ, ABI, APA, and DARO, respectively (p= 0.33). Multivariate analysis revealed that a baseline PSA level ≥ 3.67 ng/mL at ARSI initiation was significantly associated with poorer OS (p= 0.002). ARSI demonstrated favorable efficacy in nmCRPC patients. There were no significant differences in clinical outcomes among different types of ARSI therapy for nmCRP. Elevated baseline PSA at ARSI initiation was significantly associated with poorer OS.
我们对日本真实世界临床实践中接受一线雄激素受体信号抑制剂(ARSI)治疗的非转移性去势抵抗性前列腺癌(nmCRPC)患者的临床结局及预后因素进行了回顾性评估。2012年至2023年间,共有127例连续入组的nmCRPC患者接受了ARSI治疗。采用Kaplan-Meier法评估了从ARSI治疗开始的总生存期(OS)、无转移生存期(MFS)以及前列腺特异性抗原无进展生存期(PSA-PFS)。使用Cox比例风险模型分析了与nmCRPC患者OS相关的临床因素。患者中分别有72例、26例、12例和17例接受恩扎卢胺(ENZ)、阿比特龙(ABI)、阿帕他胺(APA)和达罗他胺(DARO)作为一线治疗。所有患者的中位OS和中位MFS分别为79.0个月和42.0个月。接受ENZ、ABI、APA和DARO治疗患者的中位PSA-PFS分别为27.0、20.0、10.0和14.0个月(p=0.33)。多变量分析显示,ARSI治疗开始时基线PSA水平≥3.67 ng/mL与较差的OS显著相关(p=0.002)。ARSI在nmCRPC患者中显示出良好的疗效。不同类型的ARSI疗法在nmCRPC的临床结局方面无显著差异。ARSI治疗开始时基线PSA升高与较差的OS显著相关。