旨在评估接受单剂量消融放疗 (SDRT) 治疗的器官局限性不利前列腺癌 (PCa) 患者的晚期胃肠道 (GI) 和泌尿生殖 (GU) 副作用。参加单臂前瞻性试验的 30 名患者接受了 24 Gy SDRT在具有 10MV FFF 单部分弧的直线加速器平台上提供对整个前列腺的尿道保留和器官运动控制。 ADT 是按照护理标准规定的。在不同时间点评估治疗相关的急性和晚期 GU 和 GI 毒性（CTCAE_v5 量表）和 QoL 结局（EORTC QLQ-PR25/C30，IPSS）。最小重要差异 (MID) 被确定为与基线相比 >0.5 合并 SD 的变化。统计分析包括方差分析和逻辑回归。中位随访时间为 18 个月（范围 6-31），未观察到 ≥G3 晚期副作用。 G2 晚期 GI 和 G2 晚期 GU 毒性分别发生在 1 名和 2 名患者中。任何级别的胃肠道毒性均与最大直肠剂量相关（P=0.021）。较低的基线 QoL 评分 (P=0.025)、较高的基线 IPSS 评分 (P=0.049)、急性 GU 毒性 (P=0.029) 和急性泌尿领域 MID (P=0.045) 可预测任何级别的 GU 毒性。在 MVA 中，只有基线 QoL 评分（OR，0.95，P=0.031）和急性 GU 毒性（OR，8.4，P=0.041）仍然显着。仅在泌尿领域观察到显着的 QoL 变化 (P=0.005)，中位数从 8 增加到 17。晚期尿 MID 与急性尿 MID (P=0.003)、急性 QoL MID (P=0.029)、急性 GU 相关毒性（P=0.030）和较低的基线泌尿评分（P=0.033）。在 MVA 中，只有急性尿 MID 可以预测晚期尿 MID（OR，9.7，P=0.035）。我们的研究结果为 24 Gy 全腺 SDRT 的可行性和安全性提供了有希望的数据，保留尿道和器官运动控制，并与 ADT 和对于器官受限的不利 PCa，给予足够的预防性药物治疗。需要长期随访来确认这些结果。版权所有 © 2024。由 Elsevier Inc. 出版。

To assess late gastrointestinal (GI) and genitourinary (GU) side effects in patients with organ-confined unfavorable prostate cancer (PCa) treated with single dose ablative radiotherapy (SDRT).Thirty patients enrolled in a single-arm prospective trial received 24 Gy SDRT to the whole prostate with urethra sparing and organ motion control delivered on a Linac platform with a 10MV FFF single partial arc. ADT was prescribed as per standard of care. Treatment-related acute and late GU and GI toxicities (CTCAE_v5 scale) and QoL outcomes (EORTC QLQ-PR25/C30, IPSS) were assessed at different time points. Minimal Important Difference (MID) was established as a change of >0.5 pooled SD from baseline. Statistical analysis included ANOVA test and logistic regression.Median follow-up was 18 months (range, 6-31), with no ≥G3 late side effects observed. G2 late GI and G2 late GU toxicities occurred in 1 and 2 patients, respectively. GI toxicity of any grade correlated with maximum rectal dose (P=0.021). Lower baseline QoL score (P=0.025), higher baseline IPSS score (P=0.049), acute GU toxicity (P=0.029), and acute urinary domain MID (P=0.045) predicted GU toxicity of any grade. In MVA, only baseline QoL score (OR, 0.95, P=0.031) and acute GU toxicity (OR, 8.4, P=0.041) remained significant. Significant QoL change was observed only in the urinary domain (P=0.005), with a median increase from 8 to 17. Late urinary MID correlated with acute urinary MID (P=0.003), acute QoL MID (P=0.029), acute GU toxicity (P=0.030), and lower baseline urinary score (P=0.033). In MVA, only acute urinary MID predicted late urinary MID (OR, 9.7, P=0.035).Our findings provide promising data on the feasibility and safety of 24 Gy whole gland SDRT with urethra sparing and organ motion control, in association with ADT and an adequate prophylactic medication, in organ confined unfavorable PCa. Long-term follow-up is needed to confirm these results.Copyright © 2024. Published by Elsevier Inc.