低分割放疗治疗局限性前列腺癌:一项前瞻性临床试验方案。

IF 3 4区 医学 Q2 ONCOLOGY
Future oncology Pub Date : 2025-05-01 Epub Date: 2025-04-21 DOI:10.1080/14796694.2025.2489340
Yiyin Liang, Weiwei Zhang, Xianzhi Zhao, Huojun Zhang
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引用次数: 0

摘要

目的:与在较长时间内提供较低剂量的传统分割放疗(CFRT)相比,中度低分割放疗(HFRT)在较短时间内提供较高剂量。越来越多的证据表明,中度HFRT治疗局部PCa的安全性和有效性与CFRT相同。然而,对于局部PCa,中度HFRT的最佳和最低分数需要探索。因此,本试验旨在研究HFRT在15个部位治疗局限性PCa患者的安全性结果。方法与分析:这是一项单中心、单组、开放标签的临床试验。局限性PCa患者将接受HFRT治疗(54 Gy,每日15次,每次3.6 Gy)。主要结局指标是放疗相关胃肠道(GI)和泌尿生殖系统(GU)症状和勃起功能障碍的发生率。次要结局指标包括生化无进展生存期(bPFS)、局部无进展生存期(LPFS)、远端无转移生存期(DMFS)、总生存期(OS)和生活质量(QoL)。临床试验注册:NCT06325774 (Clinicaltrials.gov)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Hypofractionated radiotherapy for localized prostate cancer: the protocol for a prospective clinical trial.

Purpose: Compared to conventional fractionated radiotherapy (CFRT), which delivers lower doses over a longer period, moderate hypofractionated radiotherapy (HFRT) administers higher doses in a shorter period. Increasing evidence has demonstrated that the safety and efficacy of moderate HFRT in 20-28 fractions for localized PCa are equal to those of CFRT. However, the optimal and lowest fractions of moderate HFRT need to be explored for localized PCa. Therefore, this trial aims to investigate the safety outcomes of HFRT in 15 fractions for treating patients with localized PCa.

Methods and analysis: This is a single-center, single-arm, open-label clinical trial. Patients with localized PCa will be enrolled to receive HFRT (54 Gy delivered in 15 daily fractions of 3.6 Gy). The primary outcome measures are the incidence of radiotherapy-related gastrointestinal (GI) and genitourinary (GU) symptoms and erectile dysfunction. Secondary outcome measures include biochemical progression-free survival (bPFS), local progression-free survival (LPFS), distant metastasis-free survival (DMFS), overall survival (OS), and quality of life (QoL).

Clinical trial registration: NCT06325774 (Clinicaltrials.gov).

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来源期刊
Future oncology
Future oncology ONCOLOGY-
CiteScore
5.40
自引率
3.00%
发文量
335
审稿时长
4-8 weeks
期刊介绍: Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.
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