直肠间隔器已被证明可以减少接受前列腺放疗的患者的直肠副作用。然而，对于精确和可重复的凝胶注射仍然存在担忧。我们评估了一种新型直肠前列腺间隔球囊的有效性和安全性，该球囊具有可控、适应性强的部署潜力。本研究测试了共同主要假设：1) 球囊间隔器将导致 > 75% 的受试者直肠 V70 降低 ≥ 25%，以及 2) 6 个月内（​​持续时间 ≥ 2）与植入手术相关的直肠 ≥ 1 级不良事件天，CTCAE 4.0) 与对照受试者相比，球囊受试者并不逊色。16 个中心招募了 222 名受试者。所有患者均患有 T1-T3 前列腺癌，无后前列腺外侵犯的 MRI 证据。随机化为 2:1（气球：对照）且受试者盲法。患者接受经会阴 TRUS 引导的基准放置球囊，然后进行 IMRT（1.8 Gy 剂量中的 81 Gy 或生物学等效的大分割剂量）。为了进行疗效比较，中心核心实验室针对植入前和植入后 CT 扫描制定了计划。达到了主要疗效终点，97.9% 的球囊受试者 (139/142) 直肠 V70 降低 >25%（p< 0.001）。植入前平均 V70 为 7.0%，植入后平均 V70 为 1.1%。主要安全终点是球囊受试者经历较少的 ≥ 1 级事件，分别为 18% 和 23%（对于非劣效性，p < 0.001）。在≥ 2 级事件的预定义次要终点中，气球受试者的发生率呈较低趋势（4.3% vs 6.5%，p=0.527）。平均直肠周围间距为 19 ±3.7 毫米，并通过放射治疗维持 (18 ±3.9 毫米)。 98.5% (133/135) 的受试者在 6 个月 CT 中观察到球囊吸收。 EPIC QOL 仪器在整个研究过程中进行收集，并且研究组之间没有统计学差异。可生物降解的直肠间隔球囊可有效显着减少直肠剂量，并与减少累积直肠和植入相关的不良事件相关。 6 个月内始终观察到球囊吸收。版权所有 © 2024。由 Elsevier Inc. 出版。

Rectal spacers have been shown to reduce rectal side effects in patients receiving prostate radiation. However, concerns remain regarding precise and reproducible gel injection. We evaluated efficacy and safety of a novel rectoprostatic spacer balloon which allows potential for controlled, adaptable deployment. This study tested co-primary hypotheses: 1) Balloon spacer would result in ≥ 25% reduction of rectal V70 in > 75% of subjects, and 2) Implantation procedure-related and rectal ≥ Grade 1 adverse events within 6 months (duration ≥ 2 days, CTCAE 4.0) would be non-inferior in balloon vs control subjects.222 subjects were enrolled at 16 centers. All patients had T1-T3 prostate cancer without MRI evidence of posterior extraprostatic invasion. Randomization was 2:1 (balloon: control) and subject-blinded. Patients underwent transperineal TRUS-guided fiducial placement +/- balloon, followed by IMRT (81 Gy in 1.8 Gy fractions or biologically equivalent hypofractionated dose). For efficacy comparisons, plans were generated by a central core lab on pre- and post-implant CT scans.The primary efficacy endpoint was met, with 97.9% of balloon subjects (139/142) having rectal V70 reduction >25% (p<0.001). Mean V70 was 7.0 % pre- vs 1.1% post- implant. The primary safety endpoint was met with balloon subjects experiencing fewer ≥ Grade 1 events, 18% vs 23% (p < 0.001 for non-inferiority). On pre-defined secondary endpoint of ≥ Grade 2 events, rates trended lower in balloon subjects (4.3% vs 6.5%, p=0.527). Mean perirectal spacing was 19 ±3.7mm and maintained through radiation treatment (18 ±3.9mm). Balloon resorption was observed on 6-month CT in 98.5% (133/135) of subjects. The EPIC QOL instrument was collected throughout study, and did not differ statistically between the study arms.Biodegradable rectal spacer balloon was effective in significantly reducing dose to rectum, and associated with decreased cumulative rectal plus implantation-related adverse events. Balloon resorption was consistently observed by 6 months.Copyright © 2024. Published by Elsevier Inc.