Royal Marsden NHS Foundation Trust, Sutton, UK; The Institute of Cancer Research, Sutton, UK.
Department of Urology, The Christie and Salford Royal Hospitals, Manchester, UK; The University of Manchester, Manchester, UK.
Eur Urol. 2024 Nov;86(5):422-430. doi: 10.1016/j.eururo.2024.07.026. Epub 2024 Aug 31.
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.
术后放疗（RT）联合雄激素剥夺治疗（ADT）的使用和持续时间尚不明确。RADICALS-HD 研究比较了无（“None”）、6 个月（“Short”）和 24 个月（“Long”）ADT 对长期疗效的影响。
前列腺癌患者术后行 RT 并同意在所有时间点进行随机分组。ADT 时间分别为 0、6 或 24 个月。主要结局指标（OM）为无转移生存（MFS）。次要 OM 包括无远处转移、总生存和开始非方案 ADT。样本量由双向比较确定。分析遵循标准的时间事件方法和意向治疗原则。
2007 年至 2015 年，492 名患者被随机分为三组之一：166 名“None”、164 名“Short”和 162 名“Long”。中位随机分组年龄为 66 岁；手术时的 Gleason 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，MFS 事件报道 89 例（32 例“None”、31 例“Short”和 26 例“Long”），总体 MFS 无差异（对数秩检验 p=0.98），与“None”相比，“Long”的风险比为 0.948（95%置信区间 0.54-1.68）。10 年后，80%的“None”、77%的“Short”和 81%的“Long”患者无转移疾病生存。三次随机分组不能达到常规水平进行评估，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较好。对于接受术后 RT 且适合无、短期或长期 ADT 的患者，添加 ADT 并未改善预后。未来的研究应集中在那些转移风险较高、需要更迫切改善的患者身上。
