中度低分割前列腺切除术后放疗（MYSTERY）与传统分割前列腺切除术后放疗（COPORT）治疗局限性前列腺癌患者的前瞻性随机试验方案
Moderate Hypofractionated Post-Prostatectomy Radiotherapy (MYSTERY) Versus Conventionally Fractionated Post-Prostatectomy Radiotherapy (COPORT) for the Patients With Localized Prostate Cancer: The Protocol of a Prospective, Randomized Trial.
作者信息
Liang Yiyin, Zhang Weiwei, Zhao Xianzhi, Zhang Huojun
机构信息
Department of Radiation Oncology, Shanghai Changhai Hospital, Naval Medical University, Shanghai, China.
Department of Radiotherapy and Oncology, The Second Affiliated Hospital of Soochow University, Suzhou, China.
出版信息
Cancer Control. 2025 Jan-Dec;32:10732748251317682. doi: 10.1177/10732748251317682.
INTRODUCTION
A few studies have examined whether the safety and efficacy of moderate hypofractionated post-prostatectomy radiotherapy (moderate HYPORT, also called MYSTERY) are equal to those of conventionally fractionated post-prostatectomy radiotherapy (COPORT) in patients with localized prostate cancer. Therefore, this study aims to compare the safety and efficacy of MYSTERY and COPORT in patients with postoperative prostate cancer.
METHODS AND ANALYSIS
This study is a prospective, single-center, open-label, randomized controlled clinical trial. Patients with localized prostate cancer will be randomly allocated to receive COPORT (66-74 Gy at 2 Gy per fraction) or MYSTERY (57.5-65 Gy at 2.5 Gy per fraction). The primary outcomes are radiotherapy-related gastrointestinal and genitourinary adverse events. Secondary outcomes include progression-free survival, quality of life, medical expenses, and overall survival.
引言
一些研究探讨了在局限性前列腺癌患者中，中度低分割前列腺切除术后放疗（中度HYPORT，也称为MYSTERY）的安全性和有效性是否等同于传统分割前列腺切除术后放疗（COPORT）。因此，本研究旨在比较MYSTERY和COPORT在前列腺癌术后患者中的安全性和有效性。
方法与分析
本研究是一项前瞻性、单中心、开放标签、随机对照临床试验。局限性前列腺癌患者将被随机分配接受COPORT（每次分割2 Gy，总剂量66 - 74 Gy）或MYSTERY（每次分割2.5 Gy，总剂量57.5 - 65 Gy）。主要结局是放疗相关的胃肠道和泌尿生殖系统不良事件。次要结局包括无进展生存期、生活质量、医疗费用和总生存期。
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