这是一项 I 期试验，主要目的是确定使用风险容量适应、大分割、术后放疗 (PORT) 治疗生化复发性前列腺癌的最压缩剂量方案 (DS)。次要终点包括生化无进展生存期 (bPFS) 和生活质量 (QOL)。患者接受 3 个等效剂量方案之一（DS1：20 次、DS2：15 次、DS3：10 次）治疗，根据成像剂量递增-确定局部复发（73Gy3 EQD2）并逐步降低前列腺床其余部分的剂量（48Gy3 EQD2）。升级遵循标准 3 3 设计，并按最大耐受大分割剂量方案 (MTHDS) 扩大 6 名患者。剂量限制毒性 (DLT) 定义为 CTCAE v.4.0 3 级毒性，在 PORT 完成后 21 天内持续 > 4 天，或此后出现 4 级胃肠道 (GI) 或泌尿生殖系统 (GU) 毒性。使用 EPIC-26 对 24 个月的生活质量进行纵向评估。在 01/2018 至 12/2023 之间，15 名患者接受了治疗（3 名患者接受 DS1，3 名患者接受 DS2，9 名患者接受 DS3）。中位随访时间为 48 个月。在任何 DS 上均未观察到 DLT，因此在 DS3 上发生了扩展。 24 个月时，G3 GI 和 GU 毒性的累积发生率分别为 7% 和 9%，未观察到 G4 事件。短暂的急性 G2 胃肠道毒性是最常见的。在尿失禁、胃肠道和性子领域的研究随访期间，生活质量短暂恶化，但 24 个月时与基线相似。 24 个月和 60 个月时的 bPFS 均为 91%。大分割、风险容量适应 PORT 的最大耐受大分割剂量方案确定为 DS3（前列腺床 36.4Gy，影像定义复发 47.1Gy）每日 10 次）。没有观察到 >G3 事件。生活质量的短暂下降并没有持续 24 个月。版权所有 © 2024。由 Elsevier Inc. 出版。

This is a phase I trial with the primary objective of identifying the most compressed dose schedule (DS) tolerable using risk-volume-adapted, hypofractionated, post-operative radiotherapy (PORT) for biochemically recurrent prostate cancer. Secondary endpoints included biochemical progression free survival (bPFS) and quality of life (QOL).Patients were treated with one of 3 isoeffective dose schedules (DS1: 20 fractions, DS2: 15 fractions, DS3: 10 fractions) that escalated dose to the imaging-defined local recurrence (73Gy3 EQD2) and de-escalated dose to the remainder of the prostate bed (48Gy3 EQD2). Escalation followed a standard 3+3 design with a 6-patient expansion at the maximally tolerated hypofractionated dose schedule (MTHDS). Dose limiting toxicity (DLT) was defined as CTCAE v.4.0 grade (G) 3 toxicity lasting >4 days within 21 days of PORT completion or grade 4 gastrointestinal (GI) or genitourinary (GU) toxicities thereafter. QOL was assessed longitudinally through 24 months with the EPIC-26.Between 01/2018 and 12/2023, 15 patients were treated (3 with DS1, 3 with DS2, and 9 with DS3). The median follow-up was 48 months. No DLTs were observed on any DS, and, thus, expansion occurred at DS3. The cumulative incidence of G3 GI and GU toxicity was 7% and 9% at 24 months, respectively, with no G4 events observed. Transient, acute G2+ GI toxicity was most common. QOL worsened transiently during study follow-up in urinary incontinence, GI, and sexual subdomains but was similar to baseline by 24 months. The bPFS was 91% at both 24- and 60-months.The maximally tolerated hypofractionated dose schedule for hypofractionated, risk-volume-adapted PORT was determined to be DS3 (36.4Gy to the prostate bed and 47.1Gy to the imaging-defined recurrence in 10 daily fractions). No >G3 events were observed. Transient declines in QOL did not persist through 24 months.Copyright © 2024. Published by Elsevier Inc.