对激素难治性前列腺癌（PRADO）患者有症状的优势病灶进行姑息性放疗。
Palliative radiotherapy to dominant symptomatic lesion in patients with hormone refractory prostate cancer (PRADO).
机构信息
Department of Oncology and Palliative Units, Zealand University Hospital, Naestved, Denmark.
Department of Radiation Oncology, University of Lübeck, Lübeck, Germany.
出版信息
Radiat Oncol. 2019 Jan 10;14(1):3. doi: 10.1186/s13014-019-1209-0.
BACKGROUND
This study was conducted to investigate a new short-course radiotherapy regimen for patients with metastatic hormone refractory prostate cancer (HRPC) presenting with a dominant debilitating symptom.
METHODS / DESIGN: This is an international, multi-center single arm prospective feasibility study that aims to include 34 patients with HRPC and a dominant debilitating symptom. The dominant symptomatic lesion will receive 4 × 5 Gy of high-precision radiotherapy, and the most aggressive part of the lesion 4 × 7 Gy using a simultaneous integrated boost technique. Based on advanced magnetic resonance imaging (MRI), an apparent diffusion coefficient (ADC) map will be calculated for the lesion using diffusion weighted imaging sequences. The dominant symptomatic lesion (GTV1) is drawn manually using the information from T2w-MRI and computed tomography scans. The most aggressive part of the dominant lesion (GTV2) is defined by using the ADC map. An auxiliary volume is created including only voxels in the GTV1 that presents with ADC values below 1200 × 10 mm/s. The most aggressive part is defined as voxels with an ADC value below the median ADC value. Primary endpoint is feasibility, i.e. proportion of patients who complete radiotherapy with ≥90% of the prescribed dose. Secondary endpoints include dominant symptom score, progression-free survival (freedom from symptoms), overall survival, acute toxicity, quality of life, change in ADC from baseline to end of treatment and 6 months following treatment.
DISCUSSION
If this new radiotherapy regimen proves to be feasible, a prospective randomized phase II/III dose escalation study will be designed in order to improve the outcomes of palliative radiotherapy of symptomatic metastatic HRPC.
STUDY STATUS
The study is ongoing and will be recruiting patients soon.
TRIAL REGISTRATION
clinicaltrials.gov NCT03658434 . Initially registered on 30th of July, 2018.
背景
本研究旨在探讨一种新的短程放疗方案，用于治疗转移性去势抵抗性前列腺癌（HRPC）伴主要进行性衰弱症状的患者。
方法/设计：这是一项国际多中心单臂前瞻性可行性研究，旨在纳入 34 例 HRPC 伴主要进行性衰弱症状的患者。主要症状性病变接受 4×5Gy 的高精度放疗，病变最具侵袭性部分采用同步整合升压技术给予 4×7Gy 放疗。基于高级磁共振成像（MRI），使用扩散加权成像序列计算病变的表观扩散系数（ADC）图。使用 T2w-MRI 和计算机断层扫描信息手动绘制主要症状性病变（GTV1）。通过 ADC 图定义主要病变的最具侵袭性部分（GTV2）。创建一个辅助容积，仅包含 ADC 值低于 1200×10mm/s 的 GTV1 中的体素。最具侵袭性的部分定义为 ADC 值低于中位数 ADC 值的体素。主要终点是可行性，即完成≥90%规定剂量放疗的患者比例。次要终点包括主要症状评分、无进展生存期（免于症状）、总生存期、急性毒性、生活质量、治疗结束时与基线相比 ADC 值的变化以及治疗后 6 个月。
讨论
如果这种新的放疗方案被证明是可行的，将设计一项前瞻性随机 II/III 期剂量递增研究，以改善姑息性转移性 HRPC 症状放疗的结果。
研究状态
该研究正在进行中，即将招募患者。
试验注册
clinicaltrials.gov NCT03658434. 最初于 2018 年 7 月 30 日注册。
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