Kim Yeon Joo, Ahn Hanjong, Kim Choung-Soo, Lee Jae-Lyun, Kim Young Seok
Department of Radiation Oncology, Asan Medical Center, University of Ulsan, College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.
Department of Urology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Republic of Korea.
Trials. 2018 Apr 2;19(1):212. doi: 10.1186/s13063-018-2574-y.
Combination therapy using external-beam radiotherapy (EBRT) with a brachytherapy boost has demonstrated superior biochemical control than dose-escalated EBRT alone. Whereas brachytherapy is disadvantageous because it is an invasive procedure, stereotactic body-radiotherapy (SBRT) using CyberKnife could emulate the dose distribution of brachytherapy and is a non-invasive and safe modality to control intra-fractional movement. We therefore adopted SBRT using CyberKnife as a boost therapy after whole-pelvic radiotherapy (WPRT).
METHODS/DESIGN: In this prospective, randomized, single-center, pilot study for intermediate- and high-risk prostate cancer without nodal or distant metastasis, after androgen-deprivation therapy and WPRT, patients will be randomized to one of two SBRT boost regimens, i.e., 18 or 21 Gy administered in three fractions every other day.
The aim of this trial is to evaluate acute toxicities using both physician- and patient-reported outcomes and short-term biochemical control with SBRT boost following WPRT. Additionally, chronic toxicities and long-term biochemical control will be evaluated as secondary endpoints in this trial. Based on the generated results, we will plan the full-scale phase II study for selecting the SBRT boost dose.
ClinicalTrials.gov, ID; NCT03322020 . Retrospectively registered on 26 October 2017.
外照射放疗（EBRT）联合近距离放疗增敏治疗已显示出比单纯剂量递增的EBRT具有更好的生化控制效果。然而，近距离放疗存在劣势，因为它是一种侵入性操作，而使用射波刀的立体定向体部放疗（SBRT）可以模拟近距离放疗的剂量分布，并且是一种控制分次内运动的非侵入性且安全的方式。因此，我们采用射波刀SBRT作为全盆腔放疗（WPRT）后的增敏治疗。
方法/设计：在这项针对无淋巴结或远处转移的中高危前列腺癌的前瞻性、随机、单中心试点研究中，在雄激素剥夺治疗和WPRT后，患者将被随机分为两种SBRT增敏方案之一，即每隔一天分三次给予18或21 Gy。
本试验的目的是使用医生和患者报告的结果评估急性毒性，并评估WPRT后SBRT增敏的短期生化控制情况。此外，慢性毒性和长期生化控制将作为本试验的次要终点进行评估。根据产生的结果，我们将规划全面的II期研究以选择SBRT增敏剂量。
ClinicalTrials.gov，标识符：NCT03322020。于2017年10月26日进行回顾性注册。
