Abstract：
OBJECTIVE: New fractionation schedules with modern tools are a very rapidly developing area in curative radiotherapy (RT) for early prostate cancer (PC). To apply these techniques in everyday clinical practice, we planned this phase II trial with different fractionation schedules and followed up patients using careful health-related quality of life (QoL) questionnaires for three years.
METHODS: Seventy-three PC patients with one or two intermediate PC risk factors according to the National Comprehensive Cancer Network criteria were recruited. Forty-two patients were treated with 78/2 Gy (conventional fractionation, CF) or 60/3 Gy (moderately hypofractionation RT, MHF), and 31 patients were treated with 36.25/7.25 Gy (stereotactic body RT, SBRT). Their PSA levels were measured, and QoL data were assessed for genitourinary (GU), gastrointestinal (GI), and sexual well-being between the baseline and three years after treatment. A Rectafix™ (RF) fixation device was used in 30 patients in the CF/MHF group.
RESULTS: Three years after radiotherapy (RT), there were no differences between the groups regarding GU, GI, sexual well-being, PSA response, or clinical outcomes. On QoL questionnaires, men in the SBRT group were more satisfied with their QoL at the end of RT. Urinary symptoms (p=0.004) and urinary incontinence were more common in the CF/MHF group (p=0.016) three months after RT. The use of RF reduced GI toxicity, especially urgency (p=0.002), at three years after RT.
CONCLUSIONS: Modern, short, five-fraction stereotactic radiotherapy as a local curative treatment for PC is well tolerated and safe. Our novel results showing a decrease in GI toxicity using Rectafix™ fixation should be confirmed in future randomized trials.
METHODS: Seventy-three PC patients with one or two intermediate PC risk factors according to the National Comprehensive Cancer Network criteria were recruited. Forty-two patients were treated with 78/2 Gy (conventional fractionation, CF) or 60/3 Gy (moderately hypofractionation RT, MHF), and 31 patients were treated with 36.25/7.25 Gy (stereotactic body RT, SBRT). Their PSA levels were measured, and QoL data were assessed for genitourinary (GU), gastrointestinal (GI), and sexual well-being between the baseline and three years after treatment. A Rectafix™ (RF) fixation device was used in 30 patients in the CF/MHF group.
RESULTS: Three years after radiotherapy (RT), there were no differences between the groups regarding GU, GI, sexual well-being, PSA response, or clinical outcomes. On QoL questionnaires, men in the SBRT group were more satisfied with their QoL at the end of RT. Urinary symptoms (p=0.004) and urinary incontinence were more common in the CF/MHF group (p=0.016) three months after RT. The use of RF reduced GI toxicity, especially urgency (p=0.002), at three years after RT.
CONCLUSIONS: Modern, short, five-fraction stereotactic radiotherapy as a local curative treatment for PC is well tolerated and safe. Our novel results showing a decrease in GI toxicity using Rectafix™ fixation should be confirmed in future randomized trials.
摘要：
目的：使用现代工具的新分割时间表是早期前列腺癌（PC）的根治性放疗（RT）中发展非常迅速的领域。为了在日常临床实践中应用这些技术，我们采用不同的分级方案计划了这项II期试验,并使用仔细的健康相关生活质量(QoL)问卷对患者进行了为期3年的随访.
方法：根据国家综合癌症网络标准，招募了73名具有一个或两个中间PC危险因素的PC患者。42例患者接受了78/2Gy的治疗（常规分割，CF）或60/3Gy（中度低分馏RT，MHF),31例患者接受36.25/7.25Gy（立体定向体RT，SBRT）。测量了他们的PSA水平,和QoL数据评估泌尿生殖系统（GU），胃肠（GI），基线和治疗后三年之间的性生活。在CF/MHF组的30名患者中使用了Rectafix™（RF）固定装置。
结果：放疗（RT）后三年，两组之间在GU方面没有差异，GI,性福,PSA反应,或临床结果。在QoL问卷上，SBRT组的男性在RT结束时对他们的QoL更满意。在RT后三个月的CF/MHF组（p=0.016）中，排尿症状（p=0.004）和尿失禁更为常见。使用RF降低GI毒性，特别是紧迫性（p=0.002），在RT之后的三年。
结论：现代，短,5次立体定向放疗作为PC的局部治愈性治疗具有良好的耐受性和安全性.我们的新结果显示使用Rectafix™固定的GI毒性降低应在未来的随机试验中得到证实。
方法：根据国家综合癌症网络标准，招募了73名具有一个或两个中间PC危险因素的PC患者。42例患者接受了78/2Gy的治疗（常规分割，CF）或60/3Gy（中度低分馏RT，MHF),31例患者接受36.25/7.25Gy（立体定向体RT，SBRT）。测量了他们的PSA水平,和QoL数据评估泌尿生殖系统（GU），胃肠（GI），基线和治疗后三年之间的性生活。在CF/MHF组的30名患者中使用了Rectafix™（RF）固定装置。
结果：放疗（RT）后三年，两组之间在GU方面没有差异，GI,性福,PSA反应,或临床结果。在QoL问卷上，SBRT组的男性在RT结束时对他们的QoL更满意。在RT后三个月的CF/MHF组（p=0.016）中，排尿症状（p=0.004）和尿失禁更为常见。使用RF降低GI毒性，特别是紧迫性（p=0.002），在RT之后的三年。
结论：现代，短,5次立体定向放疗作为PC的局部治愈性治疗具有良好的耐受性和安全性.我们的新结果显示使用Rectafix™固定的GI毒性降低应在未来的随机试验中得到证实。
