前列腺癌研究 5 (PCS5) 对高危前列腺癌 (PCa) 患者进行了传统分割放疗 (CFRT) 与大分割放疗 (HFRT) 的比较，假设毒性和生存结果相似。本报告介绍了疗效分析。PCS5 是一项加拿大多中心、开放标签、3 期随机对照试验。经组织学证实、临床局限性前列腺癌且具有一种或多种高危特征（T3/T4、格里森评分≥8、前列腺特异性抗原>20）的男性符合资格。患者按 1:1 的比例随机接受 CFRT（前列腺 76 Gy/38 分次 [Fx]，盆腔淋巴结 [PLN] 46 Gy/23 Fx）或 HFRT（前列腺 68 Gy/25 Fx，前列腺 45 Gy/23 Fx）。 25 Fx 至 PLN）和 28 个月的雄激素抑制。主要终点是毒性；次要终点包括生存结果。在 329 名患者中，164 名患者被随机分配至 HFRT，165 名患者被随机分配至 CFRT，其中 159 名患者在 HFRT 组，160 名患者在 CFRT 组进行生存分析。在 5 年中位随访中，总生存率（OS；90.3% vs 89.7%；风险比 [RR]：1.01；95% 置信区间 [CI]：0.93-1.09）、PCa- 没有显着差异。特异性生存率（PCSS；97.4% vs 97.5%；RR：1.00；95% CI：0.93-1.07），生化无复发生存率（BCRFS；85.2% vs 85.2%；RR：1.00；95% CI：0.91-1.10） ，或无远处转移生存率（DMFS；87.1% vs 87.1%；RR：1.00；95% CI：0.92-1.09）。 OS 的风险比为 0.92（95% CI：0.56-1.53​​），PCSS 为 1.31（95% CI：0.46-3.78），BCRFS 为 0.85（95% CI：0.56-1.30），BCRFS 为 0.90（95% CI：0.56） -1.43) 对于 DMFS。样本量是一个限制因素。HFRT (68 Gy/25 Fx) 和 CFRT (76 Gy/38 Fx) 之间的生存结果没有差异。 HFRT，包括 PLN 放疗和长期雄激素剥夺治疗，应被视为接受外照射放疗的高危 PCa 患者的新护理标准。版权所有 © 2024。由 Elsevier B.V. 出版。

Prostate Cancer Study 5 (PCS5) compared conventional fractionated radiotherapy (CFRT) with hypofractionated radiotherapy (HFRT) in high-risk prostate cancer (PCa) patients, hypothesizing similar toxicity and survival outcomes. This report presents the efficacy analysis.PCS5 is a Canadian multicenter, open-label, phase 3 randomized control trial. Men with histologically proven, clinically localized PCa with one or more high-risk features (T3/T4, Gleason score ≥8, and prostate-specific antigen >20) were eligible. Patients were randomized 1:1 to CFRT (76 Gy/38 fractions [Fx] to the prostate and 46 Gy/23 Fx to the pelvic lymph nodes [PLNs]) or HFRT (68 Gy/25 Fx to the prostate and 45 Gy/25 Fx to the PLNs) and 28 mo of androgen suppression. The primary endpoint was toxicity; secondary endpoints included survival outcomes.Of 329 patients, 164 were randomized to HFRT and 165 to CFRT, with 159 in the HFRT arm and 160 in the CFRT arm included in survival analyses. At the 5-yr median follow-up, there were no significant differences in overall survival (OS; 90.3% vs 89.7%; risk ratio [RR]: 1.01; 95% confidence interval [CI]: 0.93-1.09), PCa-specific survival (PCSS; 97.4% vs 97.5%; RR: 1.00; 95% CI: 0.93-1.07), biochemical recurrence-free survival (BCRFS; 85.2% vs 85.2%; RR: 1.00; 95% CI: 0.91-1.10), or distant metastasis-free survival (DMFS; 87.1% vs 87.1%; RR: 1.00; 95% CI: 0.92-1.09). Hazard ratios were 0.92 (95% CI: 0.56-1.53) for OS, 1.31 (95% CI: 0.46-3.78) for PCSS, 0.85 (95% CI: 0.56-1.30) for BCRFS, and 0.90 (95% CI: 0.56-1.43) for DMFS. Sample size was a limiting factor.There were no differences in survival outcomes between HFRT (68 Gy/25 Fx) and CFRT (76 Gy/38 Fx). HFRT, including PLN radiotherapy and long-term androgen deprivation therapy, should be considered a new standard of care for high-risk PCa patients undergoing external beam radiotherapy.Copyright © 2024. Published by Elsevier B.V.