Department of Medicine, Inova Fairfax Medical Center, Fairfax, VA 22042, USA.
Department of Medicine, Virginia Commonwealth University, Richmond, VA 23219, USA.
Asian J Androl. 2019 Mar-Apr;21(2):107-108. doi: 10.4103/aja.aja_88_18.
PROSPER is an international Phase III trial demonstrating the beneficial role of enzalutamide, an androgen receptor antagonist, in prolonging metastasis-free survival in men with nonmetastatic castration-resistant prostate cancer. The trial showed that the median metastasis-free survival was 21.9 months longer for those treated with enzalutamide (36.6 months) compared to those treated with placebo (14.7 months). Enzalutamide also showed prolonged time to PSA progression, PSA response, and time to initiating additional antineoplastic therapy although overall survival is not yet reached. Enzalutamide is the second antiandrogen (next to apalutamide) that has gained the United States Food and Drug Administration (US FDA) label indication for use in the setting of nonmetastatic castration-resistant prostate cancer.
PROSPER 是一项国际性的 III 期临床试验,证明了雄激素受体拮抗剂恩扎卢胺在延长非转移性去势抵抗性前列腺癌男性无转移生存方面的有益作用。该试验表明,接受恩扎卢胺治疗的患者(36.6 个月)的无转移生存中位数比接受安慰剂治疗的患者(14.7 个月)长 21.9 个月。尽管尚未达到总生存时间,但恩扎卢胺也显示出延长 PSA 进展时间、PSA 反应时间和开始额外抗肿瘤治疗时间。恩扎卢胺是继阿帕鲁胺之后第二种获得美国食品和药物管理局(US FDA)批准用于非转移性去势抵抗性前列腺癌的抗雄激素药物。