Abstract：
OBJECTIVE: To present the outcome and toxicity results of a prospective trial of 21 Gy single fraction high-dose-rate (HDR) brachytherapy for men with low- or intermediate-risk prostate cancer.
METHODS: Patients were treated according to an IRB-approved prospective study of single fraction HDR brachytherapy. Eligible patients had low- or intermediate-risk prostate cancer with tumor stage ≤ T2b, PSA ≤ 15, and Gleason score ≤ 7. Patients underwent trans-rectal ultrasound-guided trans-perineal implant of the prostate followed by single fraction HDR brachytherapy to a dose of 21 Gy. The primary endpoint was grade ≥ 2 urinary/GI toxicity rates.
RESULTS: Twenty-six patients were enrolled with a median follow up of 5.1 years and median age of 64 years. 88.5% of patients had T1 disease, 15.4% had Gleason score 6 (84.6% Gleason 7), and median pre-treatment PSA was 5.0 ng/mL. Acute and chronic grade ≥ 2 urinary toxicity rates were 38.5% and 38.5%, respectively. There were no grade ≥ 2 acute or chronic GI toxicities. Six (23.1%) patients experienced biochemical failure, six (23.1%) patients experienced radiographic local failure, and five (19.2%) patients had biopsy-proven local failure. No patients developed regional lymph node recurrence or distant metastasis. 5-year overall survival and cause-specific survival were 96.2% and 100%, respectively.
CONCLUSIONS: 21 Gy single fraction HDR brachytherapy was associated with modestly higher-than-anticipated chronic urinary toxicity, as well as high biochemical and local failure rates. The results from this prospective pilot study do not support the use of this regimen in standard clinical practice.
METHODS: Patients were treated according to an IRB-approved prospective study of single fraction HDR brachytherapy. Eligible patients had low- or intermediate-risk prostate cancer with tumor stage ≤ T2b, PSA ≤ 15, and Gleason score ≤ 7. Patients underwent trans-rectal ultrasound-guided trans-perineal implant of the prostate followed by single fraction HDR brachytherapy to a dose of 21 Gy. The primary endpoint was grade ≥ 2 urinary/GI toxicity rates.
RESULTS: Twenty-six patients were enrolled with a median follow up of 5.1 years and median age of 64 years. 88.5% of patients had T1 disease, 15.4% had Gleason score 6 (84.6% Gleason 7), and median pre-treatment PSA was 5.0 ng/mL. Acute and chronic grade ≥ 2 urinary toxicity rates were 38.5% and 38.5%, respectively. There were no grade ≥ 2 acute or chronic GI toxicities. Six (23.1%) patients experienced biochemical failure, six (23.1%) patients experienced radiographic local failure, and five (19.2%) patients had biopsy-proven local failure. No patients developed regional lymph node recurrence or distant metastasis. 5-year overall survival and cause-specific survival were 96.2% and 100%, respectively.
CONCLUSIONS: 21 Gy single fraction HDR brachytherapy was associated with modestly higher-than-anticipated chronic urinary toxicity, as well as high biochemical and local failure rates. The results from this prospective pilot study do not support the use of this regimen in standard clinical practice.
摘要：
目的：介绍21Gy单部分高剂量率（HDR）近距离放射治疗男性低或中危前列腺癌的前瞻性试验的结果和毒性结果。
方法：根据IRB批准的单部分HDR近距离放射治疗的前瞻性研究对患者进行治疗。符合条件的患者患有低或中危前列腺癌，肿瘤分期≤T2b，PSA≤15，Gleason评分≤7。患者接受了经直肠超声引导的经会阴前列腺植入，然后进行单次HDR近距离放射治疗，剂量为21Gy。主要终点为≥2级尿/胃肠道毒性率。
结果：26例患者入组，中位随访时间为5.1年，中位年龄为64岁。88.5%的患者有T1疾病,15.4%的格里森评分为6分(84.6%的格里森评分为7分)，治疗前PSA中位数为5.0ng/mL。急、慢性≥2级尿毒性发生率分别为38.5%和38.5%,分别。无≥2级急性或慢性胃肠道毒性。6例（23.1%）患者出现生化衰竭，6名(23.1%)患者出现放射学局部失效,5例(19.2%)患者活检证实局部失败.无局部淋巴结复发或远处转移。5年总生存率和病因特异性生存率分别为96.2%和100%，分别。
结论：21Gy单部分HDR近距离放射治疗与适度高于预期的慢性尿毒性相关，以及高生化和局部故障率。这项前瞻性试点研究的结果不支持在标准临床实践中使用该方案。
方法：根据IRB批准的单部分HDR近距离放射治疗的前瞻性研究对患者进行治疗。符合条件的患者患有低或中危前列腺癌，肿瘤分期≤T2b，PSA≤15，Gleason评分≤7。患者接受了经直肠超声引导的经会阴前列腺植入，然后进行单次HDR近距离放射治疗，剂量为21Gy。主要终点为≥2级尿/胃肠道毒性率。
结果：26例患者入组，中位随访时间为5.1年，中位年龄为64岁。88.5%的患者有T1疾病,15.4%的格里森评分为6分(84.6%的格里森评分为7分)，治疗前PSA中位数为5.0ng/mL。急、慢性≥2级尿毒性发生率分别为38.5%和38.5%,分别。无≥2级急性或慢性胃肠道毒性。6例（23.1%）患者出现生化衰竭，6名(23.1%)患者出现放射学局部失效,5例(19.2%)患者活检证实局部失败.无局部淋巴结复发或远处转移。5年总生存率和病因特异性生存率分别为96.2%和100%，分别。
结论：21Gy单部分HDR近距离放射治疗与适度高于预期的慢性尿毒性相关，以及高生化和局部故障率。这项前瞻性试点研究的结果不支持在标准临床实践中使用该方案。
