Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany.
Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany.
Brachytherapy. 2022 Jul-Aug;21(4):415-423. doi: 10.1016/j.brachy.2022.02.003. Epub 2022 Apr 6.
This prospective trial investigates side effects and efficacy of focal dose escalation with brachytherapy for patients with prostate cancer.
In the Phase II, monocentric prospective trial 101 patients with low-/intermediate- and high-risk prostate cancer were enrolled between 2011 and 2013. Patients received either PDR-/HDR-brachytherapy alone with 86-90 Gy (EQD2, α/β = 3 Gy) or PDR-/HDR-brachytherapy as boost after external beam radiation therapy up to a total dose of 91-96 Gy (EQD2, α/β = 3 Gy). Taking place brachytherapy all patients received the simultaneous integrated focal boost to the intra-prostatic tumor lesions visible in computer-aided ultrasonography (HistoScanning™) - up to a total dose of 108-119 Gy (EQD2, α/β = 3 Gy). The primary endpoint was toxicity. Secondary endpoints were cumulative freedom from local recurrence, PSA-free survival, distant metastases-free survival, and overall survival. This trial is registered with ClinicalTrials.gov, number NCT01409876.
Median follow-up was 65 months. Late toxicity was generally low with only four patients scoring urinary grade 3 toxicity (4/101, 4%). Occurrence of any grade of late rectal toxicities was very low. We did not register any grade ≥2 of late rectal toxicities. The cumulative 5 years local recurrence rate (LRR) for all patients was 1%. Five years- biochemical disease-free survival estimates according Kaplan-Meier were 98,1% and 81,3% for low-/intermediate-risk and high-risk patients, respectively. Five years metastases-free survival estimates according Kaplan-Meier were 98,0% and 83,3% for all patients, low-/intermediate-risk and high-risk patients, respectively.
The 5 years-results from this Phase II Trial show that focal dose escalation with computer-aided ultrasonography and brachytherapy for patients with non-metastatic prostate cancer is safe and effective.
本前瞻性试验旨在研究前列腺癌患者局部剂量递增的副作用和疗效，采用近距离放射治疗。
在 2011 年至 2013 年间，进行了这项 II 期、单中心前瞻性试验，共纳入 101 例低/中危和高危前列腺癌患者。患者接受单纯 PDR-/HDR-近距离放射治疗，剂量为 86-90Gy（EQD2，α/β=3Gy），或 PDR-/HDR-近距离放射治疗作为外照射放疗的补充，总剂量为 91-96Gy（EQD2，α/β=3Gy）。所有接受近距离放射治疗的患者均接受计算机辅助超声（HistoScanning™）可见的前列腺内肿瘤病变的同期综合局部加量，总剂量为 108-119Gy（EQD2，α/β=3Gy）。主要终点是毒性。次要终点是局部无复发生存率、PSA 无复发生存率、远处转移无复发生存率和总生存率。该试验在 ClinicalTrials.gov 注册，编号为 NCT01409876。
中位随访时间为 65 个月。晚期毒性一般较低，仅有 4 例患者出现尿毒性 3 级（4/101，4%）。任何级别的晚期直肠毒性均非常低。我们没有登记任何≥2 级的晚期直肠毒性。所有患者的 5 年局部复发率（LRR）为 1%。根据 Kaplan-Meier 估计，5 年生化无病生存率分别为低/中危患者 98.1%和高危患者 81.3%。5 年无转移生存率分别为所有患者 98.0%、低/中危患者 83.3%和高危患者 83.3%。
这项 II 期试验的 5 年结果表明，对于非转移性前列腺癌患者，采用计算机辅助超声和近距离放射治疗进行局部剂量递增是安全有效的。
