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Abstract：
We report results of the first German prospective multicenter single-arm phase II trial (ARO 2013-06; NCT02635256) of hypofractionated robotic stereotactic body radiotherapy (SBRT) for patients with localized prostate cancer (HYPOSTAT).
Patients eligible for the HYPOSTAT study had localized prostate cancer (cT1‑3 cN0 cM0), Gleason score ≤ 7, prostate-specific antigen (PSA) ≤ 15 ng/ml, prostate volume ≤ 80 cm3, and an International Prostate Symptom Score (IPSS) ≤ 12. Initially, inclusion was limited to patients ≥ 75 years or patients 70-74 years with additional risk factors. The trial protocol was later amended to allow for enrolment of patients aged ≥ 60 years. The treatment consisted of 35 Gy delivered in 5 fractions to the prostate and for intermediate- or high-risk patients, also to the proximal seminal vesicles using the CyberKnife system (Accuray Inc., Sunnyvale, CA, USA). Primary endpoint was the rate of treatment-related gastrointestinal or genitourinary grade ≥ 2 toxicity based on the RTOG scale 12-15 months after treatment. Secondary endpoints were acute toxicity, late toxicity, urinary function, quality of life, and PSA response.
From July 2016 through December 2018, 85 eligible patients were enrolled and received treatment, of whom 83 could be evaluated regarding the primary endpoint. Patients mostly had intermediate-risk disease with a median PSA value of 7.97 ng/ml and Gleason score of 7a and 7b in 43.5% and 25.9% of patients, respectively. At the final follow-up 12-15 months after treatment, no patient suffered from treatment-related gastrointestinal or genitourinary grade ≥ 2 toxicity. Acute toxicity was mostly mild, with three grade 3 events, and the cumulative rate of grade ≥ 2 genitourinary toxicity was 8.4% (95% CI 4.1-16.4%). There were no major changes in urinary function or quality of life. The median PSA value dropped to 1.18 ng/ml 12-15 months after treatment. There was one patient who developed distant metastases.
Robotic SBRT with 35 Gy in 5 fractions was associated with a favorable short-term toxicity profile. Recruitment for the HYPOSTAT‑2 trial (ARO-2018‑4; NCT03795337), which further analyses the late toxicity of this regimen with a planned sample size of 500 patients, is ongoing.
Patients eligible for the HYPOSTAT study had localized prostate cancer (cT1‑3 cN0 cM0), Gleason score ≤ 7, prostate-specific antigen (PSA) ≤ 15 ng/ml, prostate volume ≤ 80 cm3, and an International Prostate Symptom Score (IPSS) ≤ 12. Initially, inclusion was limited to patients ≥ 75 years or patients 70-74 years with additional risk factors. The trial protocol was later amended to allow for enrolment of patients aged ≥ 60 years. The treatment consisted of 35 Gy delivered in 5 fractions to the prostate and for intermediate- or high-risk patients, also to the proximal seminal vesicles using the CyberKnife system (Accuray Inc., Sunnyvale, CA, USA). Primary endpoint was the rate of treatment-related gastrointestinal or genitourinary grade ≥ 2 toxicity based on the RTOG scale 12-15 months after treatment. Secondary endpoints were acute toxicity, late toxicity, urinary function, quality of life, and PSA response.
From July 2016 through December 2018, 85 eligible patients were enrolled and received treatment, of whom 83 could be evaluated regarding the primary endpoint. Patients mostly had intermediate-risk disease with a median PSA value of 7.97 ng/ml and Gleason score of 7a and 7b in 43.5% and 25.9% of patients, respectively. At the final follow-up 12-15 months after treatment, no patient suffered from treatment-related gastrointestinal or genitourinary grade ≥ 2 toxicity. Acute toxicity was mostly mild, with three grade 3 events, and the cumulative rate of grade ≥ 2 genitourinary toxicity was 8.4% (95% CI 4.1-16.4%). There were no major changes in urinary function or quality of life. The median PSA value dropped to 1.18 ng/ml 12-15 months after treatment. There was one patient who developed distant metastases.
Robotic SBRT with 35 Gy in 5 fractions was associated with a favorable short-term toxicity profile. Recruitment for the HYPOSTAT‑2 trial (ARO-2018‑4; NCT03795337), which further analyses the late toxicity of this regimen with a planned sample size of 500 patients, is ongoing.
摘要：
目的：我们报告了德国首个前瞻性多中心单臂II期临床试验（ARO2013-06；NCT02635256）的大分割机器人立体定向身体放疗（SBRT）治疗局限性前列腺癌（HYPOSTAT）的结果。
方法：符合HYPOSTAT研究条件的患者患有局限性前列腺癌（cT1‑3cN0cM0），Gleason评分≤7，前列腺特异性抗原（PSA）≤15ng/ml，前列腺体积≤80cm3，国际前列腺症状评分（IPSS）≤12。最初，纳入仅限于≥75岁的患者或有其他危险因素的70~74岁的患者.后来修改了试验方案，允许年龄≥60岁的患者入组。治疗包括35Gy，分5个部分输送到前列腺和中危或高危患者，还使用Cyberknife系统（AccurayInc.，桑尼维尔,CA,美国）。主要终点是治疗后12-15个月基于RTOG量表的治疗相关胃肠道或泌尿生殖道毒性≥2级的发生率。次要终点是急性毒性，晚期毒性，泌尿功能,生活质量,PSA的反应。
结果：从2016年7月到2018年12月，85名符合条件的患者被纳入并接受治疗，其中83人可以就主要终点进行评估。在43.5%和25.9%的患者中，患者大多患有中危疾病，PSA中位数为7.97ng/ml，Gleason评分为7a和7b。分别。在治疗后12-15个月的最后随访中，没有患者出现与治疗相关的胃肠道或泌尿生殖系统等级≥2的毒性.急性毒性大多轻微，有三个三级活动，≥2级泌尿生殖系统毒性的累积率为8.4%(95%CI4.1-16.4%)。泌尿功能或生活质量没有重大变化。治疗后12-15个月，PSA中位数降至1.18ng/ml。有一名患者发生远处转移。
结论：机器人SBRT在5个部分中具有35Gy与良好的短期毒性有关。HYPOSTAT‑2试验招募（ARO-2018‑4；NCT03795337），它进一步分析了该方案的晚期毒性，计划样本量为500名患者，正在进行中。
方法：符合HYPOSTAT研究条件的患者患有局限性前列腺癌（cT1‑3cN0cM0），Gleason评分≤7，前列腺特异性抗原（PSA）≤15ng/ml，前列腺体积≤80cm3，国际前列腺症状评分（IPSS）≤12。最初，纳入仅限于≥75岁的患者或有其他危险因素的70~74岁的患者.后来修改了试验方案，允许年龄≥60岁的患者入组。治疗包括35Gy，分5个部分输送到前列腺和中危或高危患者，还使用Cyberknife系统（AccurayInc.，桑尼维尔,CA,美国）。主要终点是治疗后12-15个月基于RTOG量表的治疗相关胃肠道或泌尿生殖道毒性≥2级的发生率。次要终点是急性毒性，晚期毒性，泌尿功能,生活质量,PSA的反应。
结果：从2016年7月到2018年12月，85名符合条件的患者被纳入并接受治疗，其中83人可以就主要终点进行评估。在43.5%和25.9%的患者中，患者大多患有中危疾病，PSA中位数为7.97ng/ml，Gleason评分为7a和7b。分别。在治疗后12-15个月的最后随访中，没有患者出现与治疗相关的胃肠道或泌尿生殖系统等级≥2的毒性.急性毒性大多轻微，有三个三级活动，≥2级泌尿生殖系统毒性的累积率为8.4%(95%CI4.1-16.4%)。泌尿功能或生活质量没有重大变化。治疗后12-15个月，PSA中位数降至1.18ng/ml。有一名患者发生远处转移。
结论：机器人SBRT在5个部分中具有35Gy与良好的短期毒性有关。HYPOSTAT‑2试验招募（ARO-2018‑4；NCT03795337），它进一步分析了该方案的晚期毒性，计划样本量为500名患者，正在进行中。
