Draulans Cédric, Joniau Steven, Fonteyne Valérie, Delrue Louke, Decaestecker Karel, Everaerts Wouter, Dirix Piet, Van den Bergh Laura, Crijns Wouter, Vandendriessche Hans, Van Wynsberge Lodewijk, Ost Piet, Lumen Nicolaas, Buelens Pieterjan, Haustermans Karin, Berghen Charlien, De Meerleer Gert
Department of Radiation Oncology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.
Department of Urology, University Hospitals Leuven, University of Leuven, Leuven, Belgium.
JMIR Res Protoc. 2018 Dec 13;7(12):e11256. doi: 10.2196/11256.
In patients with prostate cancer (PCa) with histopathologically proven pelvic lymph node (LN) metastasis (pN1) after extended pelvic lymph node dissection (ePLND), multimodality treatment consisting of treatment of the primary tumor and whole pelvic radiotherapy (WPRT) combined with androgen deprivation therapy (ADT) offers promising results, leading to better cause-specific survival rates compared with ADT alone. However, in case more than one pelvic LN is invaded by the tumor, approximately 40% of the patients relapse biochemically and clinically. Clinical relapse is present in the para-aortic LNs (M1a disease) in up to 77% of the relapsing cases.
We hypothesize that, based on the evidence that positive LNs represent the door to hematogenous dissemination, elective para-aortic irradiation will reduce the development of both retroperitoneal nodal (M1a) and distant metastasis (M1b or M1c disease), postpone the need for palliative ADT, and prolong the time to castration-refractory disease.
To test this hypothesis, we will conduct a prospective, nonrandomized phase II trial to study the efficacy of additional elective para-aortic radiotherapy (PART) in pN1 patients compared with those who were historically treated with adjuvant WPRT alone. We aim to include 137 patients with PCa and presence of pN1 disease after ePLND. With this number of patients, an improvement of 15% in the 5-year clinical relapse-free survival can be detected with a power of 80%.
Recruitment of patients for this trial started in 2017 and will be completed approximately by March 2020.
This is the first phase II trial to investigate the benefits of an elective PART in patients with PCa. The results of this trial will potentially serve as a sound base for a later randomized phase III trial. All participants are given a PART information sheet and required to give written informed consent. Results are expected to be published in a peer-reviewed journal.
ClinicalTrials.gov NCT03079323; https://clinicaltrials.gov/ct2/show/NCT03079323 (Archived by WebCite at http://www.webcitation.org/73ELimv1d).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/11256.
在经组织病理学证实盆腔淋巴结（LN）转移（pN1）的前列腺癌（PCa）患者中，在扩大盆腔淋巴结清扫术（ePLND）后，由原发肿瘤治疗、全盆腔放疗（WPRT）联合雄激素剥夺治疗（ADT）组成的多模式治疗取得了令人鼓舞的结果，与单纯ADT相比，导致更好的病因特异性生存率。然而，如果不止一个盆腔LN被肿瘤侵犯，约40%的患者会出现生化和临床复发。在复发病例中，高达77%的患者腹主动脉旁LN出现临床复发（M1a期疾病）。
我们假设，基于阳性LN是血行播散途径的证据，选择性腹主动脉旁照射将减少腹膜后淋巴结转移（M1a）和远处转移（M1b或M1c期疾病）的发生，推迟姑息性ADT的需求，并延长去势抵抗性疾病的时间。
为验证这一假设，我们将进行一项前瞻性、非随机的II期试验，以研究与历史上仅接受辅助WPRT治疗的患者相比，额外的选择性腹主动脉旁放疗（PART）在pN1患者中的疗效。我们的目标是纳入ePLND后患有PCa且存在pN1疾病的137名患者。有了这个患者数量，在80%的检验效能下，可以检测到5年临床无复发生存率提高15%。
该试验的患者招募于2017年开始，预计大约在2020年3月完成。
这是第一项研究选择性PART对PCa患者益处的II期试验。该试验结果可能为后续的随机III期试验奠定坚实基础。所有参与者都收到了PART信息表，并被要求给予书面知情同意书。预计结果将发表在同行评审期刊上。
ClinicalTrials.gov NCT03079323；https://clinicaltrials.gov/ct2/show/NCT03079323（由WebCite存档于http://www.webcitation.org/73ELimv1d）。
国际注册报告识别码（IRRID）：PRR1-10.2196/11256。
