Radiation Oncology, Geneva University Hospital, CH-1211, 14, Geneva, Switzerland.
Faculty of Medicine, Geneva University, Geneva, Switzerland.
Radiat Oncol. 2018 Sep 4;13(1):166. doi: 10.1186/s13014-018-1112-0.
Stereotactic body radiotherapy (SBRT) is an emerging treatment alternative for patients with localized prostate cancer. Promising results in terms of disease control and toxicity have been reported with 4 to 5 SBRT fractions. However, question of how far can the number of fractions with SBRT be reduced is a challenging research matter. As already explored by some authors in the context of brachytherapy, monotherapy appears to be feasible with an acceptable toxicity profile and a promising outcome. The aim of this multicenter phase I/II prospective trialis to demonstrate early evidence of safety and efficacy of a single-fraction SBRT approach for the treatment of localized disease.
Patients with low- and intermediate-risk localized prostate cancer without significant tumor in the transitional zone will be treated with a single SBRT fraction of 19 Gy to the whole prostate gland with urethra-sparing (17 Gy). Intrafractional motion will be monitored with intraprostatic electromagnetic transponders. The primary endpoint of the phase I part of the study will be safety as assessed by CTCAE 4.03 grading scale, while biochemical relapse-free survival will be the endpoint for the phase II. The secondary endpoints include acute and late toxicity, quality of life, progression-free survival, and prostate-cancer specific survival.
This is the first multicenter phase I/II trial assessing the efficacy and safety of a single-dose SBRT treatment for patients with localized prostate cancer. If positive, results of ONE SHOT may help to design subsequent phase III trials exploring the role of SBRT monotherapy in the exclusive radiotherapy treatment of localized disease.
Clinicaltrials.gov identifier: NCT03294889 ; Registered 27 September 2017.
立体定向体部放射治疗（SBRT）是一种治疗局限性前列腺癌的新兴替代方法。已经有报道称，4-5 次 SBRT 分割治疗在疾病控制和毒性方面有较好的效果。然而，SBRT 分割次数可以减少到多少的问题仍然是一个具有挑战性的研究课题。正如一些作者在近距离放射治疗的背景下所探索的那样，单纯治疗似乎是可行的，具有可接受的毒性特征和有前途的结果。这项多中心 I/II 期前瞻性试验的目的是证明单次 SBRT 治疗局限性疾病的安全性和有效性的早期证据。
患有低危和中危局限性前列腺癌且移行区无明显肿瘤的患者将接受单次 SBRT 治疗，前列腺全腺 19Gy 分割，同时保留尿道（17Gy）。采用前列腺内电磁传感器监测分次内运动。研究 I 期部分的主要终点为采用 CTCAE 4.03 分级量表评估的安全性，而 II 期的主要终点为生化无复发生存率。次要终点包括急性和晚期毒性、生活质量、无进展生存率和前列腺癌特异性生存率。
这是第一项评估单次剂量 SBRT 治疗局限性前列腺癌的疗效和安全性的多中心 I/II 期试验。如果结果为阳性，ONE SHOT 的结果可能有助于设计后续的 III 期试验，以探讨 SBRT 单纯治疗在局限性疾病的单纯放疗治疗中的作用。
Clinicaltrials.gov 标识符：NCT03294889；注册日期：2017 年 9 月 27 日。
