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局部晚期前列腺癌中前列腺增强放疗联合立体定向体部放疗(SBRT)或常规分割外照射放疗(EBRT)的随机 II 期临床试验:PBS 试验(NCT03380806)。

A Randomized Phase II Trial of Prostate Boost Irradiation With Stereotactic Body Radiotherapy (SBRT) or Conventional Fractionation (CF) External Beam Radiotherapy (EBRT) in Locally Advanced Prostate Cancer: The PBS Trial (NCT03380806).

机构信息

Radiation Oncology, Department of Oncology, Juravinski Cancer Center, McMaster University, Hamilton, ON, Canada; Department of Oncology, McMaster University, Hamilton, ON, Canada.

Department of Oncology, McMaster University, Hamilton, ON, Canada.

出版信息

Clin Genitourin Cancer. 2020 Aug;18(4):e410-e415. doi: 10.1016/j.clgc.2019.12.020. Epub 2020 Jan 8.

DOI:10.1016/j.clgc.2019.12.020
PMID:32265129
Abstract

Standard therapy for high-risk (HR) prostate cancer (PrCa) involves androgen deprivation therapy (ADT) and pelvic conventional fractionation (CF) external beam radiotherapy (EBRT) followed by boost CF-EBRT treatment to prostate for a total of 78 to 80 Gy in 39 to 40 fractions. This is a long and inconvenient treatment for patients. Brachytherapy boost treatment studies indicate that escalation of biological dose of radiotherapy (RT) can improve outcomes in HR-PrCa. However, brachytherapy is an invasive treatment associated with increased toxicity and requires specialized resources. Stereotactic body radiotherapy (SBRT) is a promising, non-invasive alternative to brachytherapy. However, its impact on patient quality of life (QoL) and RT-associated toxicity has not been investigated in a randomized setting. In this study, we investigate SBRT as a boost treatment, following pelvic CF-EBRT, in patients with HR-PrCa treated with ADT. One hundred patients with locally advanced PrCa will be randomized to receive daily CF-EBRT of 45 to 46 Gy in 23 to 25 fractions followed by either daily CF-EBRT of 32 to 33 Gy in 15 to 16 fractions (control arm) or SBRT boost treatment of 19.5 to 21 Gy in 3 fractions (1 fraction per week) (experimental arm). The primary objective of the PBS trial is early bowel and urinary QoL (expanded prostate index composite [EPIC], up to 6 months after RT). This phase II randomized study (PBS) provides an appropriate setting to investigate effectively the impact of SBRT boost on QoL and toxicity in patients with HR-PrCa, before this modality can be compared against the current standard of care in larger phase III protocols.

摘要

高危(HR)前列腺癌(PrCa)的标准治疗包括雄激素剥夺疗法(ADT)和盆腔常规分割(CF)外束放射治疗(EBRT),然后对前列腺进行 CF-EBRT 推量治疗,总剂量为 78 至 80Gy,共 39 至 40 个分次。这对患者来说是一个漫长而不便的治疗过程。近距离治疗推量治疗研究表明,放射治疗(RT)的生物学剂量升级可以改善 HR-PrCa 的治疗结果。然而,近距离治疗是一种有创性治疗,与毒性增加有关,并且需要专门的资源。立体定向体部放射治疗(SBRT)是一种有前途的非侵入性替代近距离治疗的方法。然而,它对患者生活质量(QoL)和与 RT 相关的毒性的影响尚未在随机环境中进行研究。在这项研究中,我们研究了 SBRT 作为一种在接受 ADT 治疗的 HR-PrCa 患者接受盆腔 CF-EBRT 后的推量治疗。100 例局部晚期 PrCa 患者将被随机分为两组:一组接受每日 CF-EBRT 45 至 46Gy,共 23 至 25 个分次,随后接受每日 CF-EBRT 32 至 33Gy,共 15 至 16 个分次(对照组);另一组接受 SBRT 推量治疗,剂量为 19.5 至 21Gy,共 3 个分次(每周 1 次)(实验组)。PBS 试验的主要目的是早期肠道和泌尿 QoL(扩展前列腺指数综合评分[EPIC],在 RT 后 6 个月内)。这项 II 期随机研究(PBS)为研究 SBRT 推量治疗对 HR-PrCa 患者 QoL 和毒性的影响提供了一个合适的环境,在此之前,这种方法可以在更大的 III 期方案中与当前的标准治疗进行比较。

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引用本文的文献

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