展示一个前瞻性多中心II期随机试验的5年结果，比较每隔一天进行尿道保存立体定向体放射治疗（SBRT）和每周一次的治疗模式，用于治疗局限性前列腺癌。2012年至2015年，来自欧洲9个机构的170名患者，患有cT1c-3aN0M0前列腺癌，被分配接受36.25 Gy在5次分次（尿道每次6.5 Gy）的治疗，分为每隔一天治疗组（A组，n=84）和每周一次治疗组（B组，n=86）。随访中位数为A组78个月（四分位距，IQR 23个月），B组77个月（IQR 16个月）。在165名接受治疗并进行最终分析的患者中（A组n=82；B组n=83），急性毒性（CTCAE v4.03判定标准）轻微或不存在，两组之间没有差异。五年≥2级泌尿生殖（GU）毒性无进展生存率分别为A组75.9％和B组76.1％（p=0.945），而五年≥2级胃肠道（GI）毒性无进展生存率分别为A组89％和B组92％（p=0.596）。在5年随访期间，与基线相比，两组在GU、GI和性领域的EORTC QLQ-PR25评分未观察到变化。在最后一次随访中，EOD组的14名患者和QW组的7名患者出现生化失败，A组和B组的五年生化无复发生存率分别为92.2％和93％（p=0.13）。与EOD或QW分次方案无关，前列腺癌SBRT伴随着对尿道的10％剂量减少，对尿路功能和生活质量的影响非常小。生化控制目前在两个研究组中看起来很鼓舞人心，虽然更长时间的随访可能需要评估整体治疗时间对疾病结果的真正价值。版权所有©2023年，由Elsevier Inc.出版。

To present the 5-year results from a prospective multicenter phase II randomized trial of every-other-day (EOD) vs. once-a-week (QW) urethra-sparing stereotactic body radiotherapy (SBRT) for localized prostate cancer.Between 2012 and 2015, 170 patients from nine European institutions with cT1c-3aN0M0 prostate cancer were randomized to 36.25 Gy in 5 fractions (6.5 Gy/fraction to the urethra) delivered either EOD (arm A, n=84), or QW (arm B, n=86). The median follow-up was 78 months (interquartile range, IQR 23 months) and 77 months (IQR 16 months) for arms A and B, respectively.Among the 165 patients treated and retained for the final analysis (arm A, n=82; arm B= 83), acute toxicity (CTCAE v4.03 scale) was mild or absent with no differences between arms. The 5-year ≥ grade-2 genitourinary (GU) toxicity-free survival was 75.9% and 76.1% for arms A and B, respectively (p=0.945), while the 5-year ≥ grade-2 gastrointestinal (GI) toxicity-free survival was 89% and 92% for arms A and B, respectively (p=0.596). No changes in EORTC QLQ-PR25 scores were observed in both arms for GU, GI, and sexual domains at 5-year follow-up compared to baseline. At the last follow-up, biochemical failure was observed in 14 patients in the EOD arm and in 7 patients in the QW arm with a 5-year biochemical relapse-free survival rate of 92.2% and 93% for arms A and B, respectively (p=0.13).Prostate cancer SBRT with a 10% dose reduction to urethra was associated with a minimal impact on urinary function and quality of life regardless of a EOD or QW fractionation schedule. Biochemical control so far, has been encouraging and much alike in both study arms, though longer follow-up is probably needed to assess the true value of overall treatment time on disease outcome.Copyright © 2023. Published by Elsevier Inc.