Department of Urology, Nara Medical University, Kashihara, Japan;
Department of Prostate Brachytherapy, Nara Medical University, Kashihara, Japan.
In Vivo. 2024 Nov-Dec;38(6):3091-3105. doi: 10.21873/invivo.13794.
BACKGROUND/AIM: Radiotherapy is one of the most frequently used options for prostate cancer (PCa). However, adverse effects related to irradiation of surrounding normal organs are significant clinical concerns. Specifically, genitourinary toxicity can dramatically reduce the quality of life. This clinical trial investigated the efficacy of oral 5-aminolevulinic acid phosphate combined with sodium ferrous citrate (ALA-SFC) in patients treated with low-dose-rate brachytherapy (LDR-BT) using an iodine-125 seed source.
The AMBER study was a prospective single-center trial involving patients with localized PCa who underwent LDR-BT without external-beam radiotherapy (jRCTs051190077). Fifty patients were included and instructed to take capsules of ALA-SFC twice a day (200 mg phosphate salt and 229.42 mg per day) for six months from the day of seed implantation (prescribed radiation dose of 160 Gy). Patient data were collected before implantation, during ALA-SFC treatment, and at 1, 3, 6, 9, and 12 months post-LDR-BT. The primary endpoint of this trial was urinary frequency at three months. Other patient-reported outcomes, investigator-reported adverse events, and oncological outcomes were secondary endpoints.
Of 50 enrolled cases (45 in the per-protocol analysis, 49 in the safety analysis), urinary frequency and its increase from baseline did not differ from 141 historical controls at any time point, including at three months post-LDR-BT. Propensity score matched analysis confirmed no time-course differences in frequency, volume, or urinary symptom scores between groups. Biochemical failure-free and metastasis-free survival also remained similar.
Oral supplementation of ALA-SFC to LDR-BT did not alleviate radiation-induced toxicity or improve oncological outcomes.
背景/目的：放射治疗是前列腺癌（PCa）最常用的治疗方法之一。然而，与周围正常器官照射相关的不良反应是一个重大的临床关注点。具体来说，泌尿生殖系统毒性会显著降低生活质量。本临床试验旨在研究口服 5-氨基酮戊酸磷酸酯联合硫酸亚铁钠（ALA-SFC）在接受低剂量率近距离放射治疗（LDR-BT）联合碘-125 种子源治疗的患者中的疗效。
AMBER 研究是一项前瞻性单中心试验，纳入了接受 LDR-BT 治疗而未接受外照射放疗（jRCTs051190077）的局限性 PCa 患者。共纳入 50 例患者，从种子植入日起（规定的放射剂量为 160Gy），每天口服两次 ALA-SFC 胶囊（200mg 磷酸盐盐和 229.42mg），持续 6 个月。在植入前、ALA-SFC 治疗期间以及 LDR-BT 后 1、3、6、9 和 12 个月收集患者数据。该试验的主要终点为 3 个月时的尿频率。其他患者报告结局、研究者报告的不良事件和肿瘤学结局为次要终点。
在 50 例入组患者中（符合方案分析 45 例，安全性分析 49 例），任何时间点的尿频率及其与基线相比的增加均与 141 例历史对照无差异，包括 LDR-BT 后 3 个月。倾向评分匹配分析证实，两组间频率、尿量或尿症状评分无时间差异。生化无失败和无转移生存也相似。
LDR-BT 联合口服 ALA-SFC 不能减轻放射性毒性或改善肿瘤学结局。
