■放射治疗是前列腺癌患者最常选择的治疗方案之一。然而,与受照射的周围正常器官有关的不良反应是临床关注的重要问题。具体来说,泌尿生殖系统和胃肠道毒性可导致生活质量大大降低。这项临床试验的目的是确定口服5-氨基乙酰丙酸(ALA)磷酸盐和柠檬酸亚铁钠(SFC)在使用碘125种子源进行低剂量率近距离放射治疗(LDR-BT)治疗的患者中的疗效。
■琥珀研究是一项前瞻性研究,在接受LDR-BT的局限性前列腺癌患者中进行的单中心试验。接受补充束外放疗的患者被排除在外,而那些接受植入前短期(4-6个月)雄激素剥夺治疗以减少前列腺体积和/或改善肿瘤结局的患者也包括在内.经过筛选和登记,患者将被指示从种子植入之日起每天两次服用ALA-SFC胶囊(每天200mg和229.42mg),持续6个月(规定的放射剂量为160Gy).患者数据将在植入前收集;在口服ALA-SFC治疗期间;以及在种子植入后1、3、6、9和12个月收集。该试验的主要终点是种子植入后3个月的尿频。每次访问,24小时尿频,总作废量,记录频率容积图上的平均排尿容积和其他患者报告的结局.审判案件的数据将与历史对照的数据进行比较,在2016年1月至2019年1月期间,连续接受LDR-BT而未进行补充束外放疗的患者。对于审判案件,受试者的数量已设置为50名,对于历史对照案件,受试者的数量设置为150名。比较两组治疗前后临床病理因素。
■本试验的目标是确定ALA-SFC对接受LDR-BT的患者的潜在益处。据我们所知,本研究是第一项调查放疗后口服ALA-SFC潜在临床获益的研究.需要进一步的随机对照试验的更多证据来改变护理标准并导致更好的放疗后管理。
■该临床试验于2019年12月5日在日本临床试验注册中心进行了前瞻性注册。参考号是jRCTs051190077,nara0013(奈良医科大学认证审查委员会)。
UNASSIGNED: Radiotherapy is one of the most frequently selected treatment options for patients with prostate cancer. However, adverse effects related to the irradiated surrounding normal organs are significant clinical concerns. Specifically, genitourinary and gastrointestinal toxicities can lead to a dramatically reduced quality of life. The aim of this clinical trial is to determine the efficacy of oral 5-aminolevulinic acid (ALA) phosphate with sodium ferrous citrate (SFC) in patients treated with low-dose-rate brachytherapy (LDR-BT) using an iodine-125 seed source.
UNASSIGNED: The AMBER study is a prospective, single-center trial in patients with localized prostate cancer undergoing LDR-BT. Patients who undergo supplementary extra-beam radiotherapy are excluded, whereas those who undergo pre-implantation short-term (4-6 months) androgen deprivation therapy to decrease the prostate volume and/or improve oncological outcomes are included. After the screening and registration, the patients will be instructed to take capsules of ALA-SFC twice a day (200 mg and 229.42 mg per day) for 6 months from the day of seed implantation (prescribed radiation dose of 160 Gy). Patient data will be collected before the implantation; during oral ALA-SFC treatment; and 1, 3, 6, 9, and 12 month(s) after seed implantation. The primary endpoint of this trial is the urinary frequency 3 months after seed implantation. At each visit, the 24-h urinary frequency, total voided volume, and mean voided volume on a frequency volume chart and other patient-reported outcomes are recorded. The data of the trial cases will be compared with those of historical controls, who are consecutive patients undergoing LDR-BT without supplementary extra-beam radiotherapy between January 2016 and January 2019. The number of subjects has been set to be 50 for trial cases and 150 for the historical control cases. Pre- and post-treatment clinicopathologic factors are compared between two groups.
UNASSIGNED: The goal of this trial is to determine the potential benefit of ALA-SFC in patients who undergo LDR-BT. To the best of our knowledge, this is the first study investigating the potential clinical benefit of oral ALA-SFC after radiotherapy. More evidence from a further randomized controlled trial is needed to change the standard of care and lead to better post-radiotherapy management.
UNASSIGNED: This clinical trial was prospectively registered with the Japan Registry of Clinical Trials on 5 December 2019. The reference number is jRCTs051190077, nara0013 (Certified Review Board of Nara Medical University).