雄激素剥夺疗法（ADT）联合挽救性放射疗法（RT）可改善前列腺癌（PC）根治性前列腺切除术（RP）后前列腺特异性抗原（PSA）复发的患者的生存率，但许多患者会进一步复发。本研究旨在确定 ADT、阿帕他胺、挽救性 RT 和多西他赛联合治疗高危 PSA 复发性 PC 的益处。STARTAR 是一项由研究者发起的多中心 2 期试验，对象为 RP 后 PSA 复发性 PC 男性。主要入选标准包括计算机断层扫描/骨扫描 M0、T3/阳性切缘/N1 疾病的 Gleason 7 或 Gleason 8-10 前列腺腺癌、RP 后 4 年以内 PSA 复发 (0.2-4 ng/ml) 以及更少超过四个阳性切除淋巴结。患者接受阿帕鲁胺 ADT 治疗 9 个月，从第 8 周开始进行 RT，然后接受 6 个周期的多西紫杉醇治疗。主要终点是睾酮恢复后的 36 个月无进展生存期 (PFS)，并与之前的 STREAM 试验进行比较。我们招募了 39 名男性，其中包括 Gleason 8-10 (46%)、pN1 (23%) 的男性； PSA 中位数为 0.58 ng/ml。中位随访时间为 37 个月。所有患者的 PSA 均达到不可检测的最低值。 24 个月和 36 个月时，PFS 率分别为 84% 和 71%，与 3 年 47% 历史 PFS 和 54% 恩杂鲁胺/ADT/RT (STREAM) PFS 率相比显着改善（p = 0.004 和 p = 0.039，分别）。常见的任何级别的不良事件包括 98% 的热潮红、88% 的疲劳、77% 的脱发、53% 的皮疹（10% G3）和 5% 的发热性中性粒细胞减少症。 在这项 ADT、阿帕鲁胺、挽救 RT 和六种药物的 2 期试验中多西紫杉醇治疗高危 PSA 复发的周期，3 年 PFS 率提高至 71%，表明强化治疗可行且有效，且持久缓解超出历史数据。前列腺癌手术切除肿瘤后复发经常发生，目前的治疗限制手术后复发的选择仅部分有效。在这项研究中，我们发现，在标准术后放射治疗和雄激素剥夺治疗中添加雄激素受体抑制剂和多西紫杉醇化疗可显着改善治疗后 3 年的无进展生存期。这些结果表明，手术后强化治疗可以为一部分高危前列腺癌患者提供长期益处。版权所有 © 2024 欧洲泌尿外科协会。由 Elsevier B.V. 出版。保留所有权利。

Androgen deprivation therapy (ADT) with salvage radiation therapy (RT) improves survival for patients with prostate-specific antigen (PSA) recurrence after radical prostatectomy (RP) for prostate cancer (PC), but many patients suffer further relapse. This study aims to determine the benefit of the combination of ADT, apalutamide, salvage RT, and docetaxel for high-risk PSA recurrent PC.STARTAR is a multicenter, investigator-initiated phase 2 trial of men with PSA recurrent PC after RP. The key inclusion criteria included M0 by computed tomography/bone scan, Gleason 7 with either T3/positive margin/N1 disease or Gleason 8-10 prostate adenocarcinoma, PSA relapse (0.2-4 ng/ml) <4 yr after RP, and fewer than four positive resected lymph nodes. Patients received ADT with apalutamide for 9 mo, RT starting week 8, and then six cycles of docetaxel. The primary endpoint was 36-mo progression-free survival (PFS) with testosterone recovery and compared against the prior STREAM trial.We enrolled 39 men, including those with Gleason 8-10 (46%), pN1 (23%); the median PSA was 0.58 ng/ml. The median follow-up was 37 mo. All patients achieved undetectable PSA nadir. At 24 and 36 mo, PFS rates were 84% and 71%, respectively, which improved significantly over 3-yr 47% historic PFS and 54% enzalutamide/ADT/RT (STREAM) PFS rates (p = 0.004 and p = 0.039, respectively). Common any-grade adverse events included 98% hot flashes, 88% fatigue, 77% alopecia, 53% rash (10% G3), and 5% febrile neutropenia.In this phase 2 trial of ADT, apalutamide, salvage RT, and six cycles of docetaxel for high-risk PSA recurrence, the 3-yr PFS rate improved to 71%, indicating feasible and efficacious treatment intensification, with durable remissions beyond historic data.Prostate cancer recurrence after surgical removal of the tumor occurs often, and current treatment options to limit recurrence after surgery are only partially effective. In this study, we found that the addition of an androgen receptor inhibitor and docetaxel chemotherapy to standard postsurgery radiation therapy and androgen deprivation therapy significantly improved progression-free survival at 3 yr after treatment. These results suggest that intensification of treatment after surgery can provide long-term benefit to a subset of patients with high-risk prostate cancer.Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.