雄激素剥夺疗法（ADT）联合术后放疗（RT）的使用和持续时间尚不确定。 RADICALS-HD 比较了不添加 ADT（“无”）、6 个月（“短”）或 24 个月（“长”）ADT 来研究长期疗效。患有前列腺癌的参与者被指示进行术后 RT 并同意所有持续时间之间的随机化。 ADT 分配为 0、6 或 24 个月。主要结局指标（OM）是无转移生存期（MFS）。次要 OM 包括无远处转移、总体生存率和开始非方案 ADT。样本量通过双向比较确定。分析遵循标准的事件发生时间方法和意向治疗原则。2007 年至 2015 年间，492 名参与者被随机分为三组：166 名无组、164 名短组和 162 名长组。随机分组时的中位年龄为 66 岁；手术时格里森评分如下：<7 = 64 (13%)、3 4 = 229 (47%)、4 3 = 127 (26%) 和 8 = 72 (15%)； T3b 为 112（23%）； T4为5（1%）。中位随访时间为 9.0 年，89 名参与者报告了 MFS 事件（32 名无参与者、31 名短参与者和 26 名长参与者），没有证据表明 MFS 总体存在差异（对数秩 p = 0.98），并且，长参与者与长参与者相比，没有证据表明 MFS 存在差异。无，风险比 = 0.948（95% 置信区间 0.54-1.68）。 10 年后，80% 无转移、77% 短转移和 81% 长转移患者仍存活。三路随机化并未达到常规评估水平，但提供了公平的比较。根治性前列腺切除术后的长期结果通常是有利的。对于那些需要术后放疗并被认为适合不进行短期或长期 ADT 的患者，没有证据表明添加 ADT 可以改善病情。未来的研究应重点关注转移风险较高且亟需改善的患者。版权所有 © 2024。由 Elsevier B.V. 出版。

The use and duration of androgen deprivation therapy (ADT) with postoperative radiotherapy (RT) have been uncertain. RADICALS-HD compared adding no ("None"), 6-months ("Short"), or 24-mo ("Long") ADT to study efficacy in the long term.Participants with prostate cancer were indicated for postoperative RT and agreed randomisation between all durations. ADT was allocated for 0, 6, or 24 mo. The primary outcome measure (OM) was metastasis-free survival (MFS). The secondary OMs included freedom from distant metastasis, overall survival, and initiation of nonprotocol ADT. Sample size was determined by two-way comparisons. Analyses followed standard time-to-event approaches and intention-to-treat principles.Between 2007 and 2015, 492 participants were randomised one of three groups: 166 None, 164 Short, and 162 Long. The median age at randomisation was 66 yr; Gleason scores at surgery were as follows: <7 = 64 (13%), 3+4 = 229 (47%), 4+3 = 127 (26%), and 8+ = 72 (15%); T3b was 112 (23%); and T4 was 5 (1%). The median follow-up was 9.0 yr and, with MFS events reported for 89 participants (32 None, 31 Short, and 26 Long), there was no evidence of difference in MFS overall (logrank p = 0.98), and, for Long versus None, hazard ratio = 0.948 (95% confidence interval 0.54-1.68). After 10 yr, 80% None, 77% Short, and 81% Long patients were alive without metastatic disease. The three-way randomisation was not powered to conventional levels for assessment, yet provides a fair comparison.Long-term outcomes after radical prostatectomy are usually favourable. In those indicated for postoperative RT and considered suitable for no, short-term, or long-term ADT, there was no evidence of improvement with addition of ADT. Future research should focus on patients at a higher risk of metastases in whom improvements are required more urgently.Copyright © 2024. Published by Elsevier B.V.