In the randomized phase III, open-label trial PRESTO, the effect of potentiating androgen deprivation therapy (ADT) on improving oncological outcomes in patients with biochemically recurrent prostate cancer (BRPC) was assessed. Patients with BRPC (n = 503) and a short PSA doubling time (≤9 months) were enrolled and randomized 1:1:1 to receive ADT (control arm), ADT + apalutamide, or ADT + apalutamide + abiraterone acetate plus prednisone (AAP). Results from the first planned interim analysis of this study showed increased PSA progression-free survival (PSA-PFS) in both experimental arms compared with the control arm (median: 24.9 months for ADT + apalutamide, 26.0 months for ADT + apalutamide + AAP, and 20.3 months for ADT; P = 0.00047 and P = 0.00008 for the double and triple combination therapy versus ADT, respectively). The time to testosterone recovery was not affected by treatments. These results indicate that intensified ADT can be a potential therapeutic option for patients with BRPC, with improved PSA-PFS and moderate adverse events.

在随机 III 期、开放标签试验 PRESTO 中，评估了增强雄激素剥夺疗法 (ADT) 对改善生化复发性前列腺癌 (BRPC) 患者肿瘤结局的影响。患有 BRPC（n  = 503）且 PSA 倍增时间短（≤9 个月）的患者入组并按 1:1:1 随机分配接受 ADT（对照组）、ADT + 阿帕鲁胺或 ADT + 阿帕鲁胺 + 醋酸阿比特龙加泼尼松（美国联合总会）。本研究的第一次计划中期分析结果显示，与对照组相比，两个实验组的 PSA 无进展生存期 (PSA-PFS) 均有所增加（中位值：ADT + 阿帕鲁胺为 24.9 个月，ADT + 阿帕鲁胺 + AAP 为 26.0 个月， ADT 为 20.3 个月；双联和三联联合疗法与 ADT 相比分别为P  = 0.00047 和P =  0.00008）。睾酮恢复的时间不受治疗的影响。这些结果表明，强化 ADT 可能是 BRPC 患者的潜在治疗选择，具有改善的 PSA-PFS 和中度不良事件。