Clinic of Hematology and Oncology, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
Laboratory of Cancer Epidemiology, National Cancer Institute, Vilnius, Lithuania.
BMJ Open. 2023 May 17;13(5):e070020. doi: 10.1136/bmjopen-2022-070020.
Prostate cancer (PCa) is men's second most predominant cancer worldwide. Because the prostate-specific antigen test is used in diagnostics, PCa is more often diagnosed in the early stages, making radical treatment of the disease possible. However, it is estimated that over a million men worldwide suffer from radical treatment-related complications. Thus, focal treatment has been proposed as a solution, which aims to destroy the predominant lesson that determines the progression of the disease. The main objective of our study is to compare the quality of life and efficacy of patients diagnosed with PCa before and after the treatment with focal high-dose-rate brachytherapy and to compare results with focal low-dose-rate brachytherapy and active surveillance.
150 patients diagnosed with low-risk or favourable intermediate-risk PCa who meet the inclusion criteria will be enrolled in the study. Patients are going to be randomly assigned to the study groups: focal high-dose-rate brachytherapy (group 1), focal low-dose-rate brachytherapy (group 2) and active surveillance (group 3). The study's primary outcomes are quality of life after the procedure and time without biochemical disease recurrence. The secondary outcomes are early and late genitourinary and gastrointestinal reactions after the focal high-dose and low-dose-rate brachytherapies and evaluation of the importance and significance of in vivo dosimetry used for high-dose-rate brachytherapy.
Bioethics committee approval was obtained before this study. The trial results will be published in peer-reviewed journals and at conferences.
Vilnius regional bioethics committee; approval ID 2022/6-1438-911.
前列腺癌（PCa）是全世界男性第二大常见癌症。由于前列腺特异性抗原检测用于诊断，PCa 更常被诊断为早期，从而使疾病的根治性治疗成为可能。然而，据估计，全球有超过 100 万男性患有根治性治疗相关并发症。因此，提出了局灶性治疗作为一种解决方案，旨在破坏决定疾病进展的主要病变。我们研究的主要目的是比较诊断为 PCa 的患者在接受局灶性高剂量率近距离放射治疗前后的生活质量和疗效，并将结果与局灶性低剂量率近距离放射治疗和主动监测进行比较。
将纳入研究的 150 名符合纳入标准的低危或中危有利 PCa 患者随机分配到研究组：局灶性高剂量率近距离放射治疗（第 1 组）、局灶性低剂量率近距离放射治疗（第 2 组）和主动监测（第 3 组）。研究的主要结局是治疗后生活质量和生化疾病无复发时间。次要结局是局灶性高剂量和低剂量率近距离放射治疗后早期和晚期泌尿生殖和胃肠道反应，以及评估用于高剂量率近距离放射治疗的体内剂量学的重要性和意义。
本研究获得了维尔纽斯地区生物伦理委员会的批准。试验结果将发表在同行评议的期刊和会议上。
维尔纽斯地区生物伦理委员会；批准号 2022/6-1438-911。
