Cheng Ke, Wang Yuqing, Chen Ye, Zhu Jingjie, Qi Xiaohui, Wang Yachen, Zou Yanqiu, Lu Qiuhan, Li Zhiping
Department of Abdominal Oncology, West China Hospital, Sichuan University, Chengdu, China.
State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, China.
Front Oncol. 2022 Jul 7;12:888707. doi: 10.3389/fonc.2022.888707. eCollection 2022.
Tislelizumab combined with radiotherapy as a salvage treatment for patients with end-stage metastatic castration-resistant prostate cancer (mCRPC) is not reported. This study aimed to describe a protocol to evaluate the safety and efficacy of multisite radiotherapy combined with tislelizumab as a salvage therapy for mCRPC in patients who had at least one second-line treatment failure.
The study included patients with mCRPC who had at least one lesion suitable for radiotherapy and failed androgen deprivation therapy (ADT), followed by at least one novel second-line endocrine therapy. All patients received tislelizumab monotherapy induction therapy for two cycles, then combined with multisite radiotherapy for one cycle, followed by tislelizumab maintenance therapy, until either disease progressed or the patient developed unacceptable toxicity. Radiation methods and lesions were individually selected according to the specified protocol. Primary endpoints included safety and objective response rate. Secondary endpoints included prostate-specific antigen (PSA) response rate, disease control rate, overall survival, radiographic progression-free survival (rPFS), and biochemical progression-free survival (bPFS). Furthermore, the exploratory endpoints included the identification of the predictive biomarkers and exploration of the correlation between biomarkers and the tumor response to the combined regimen.
This study included three treatment stages to evaluate the efficacy of immunotherapy and the combination of immunotherapy and radiotherapy for patients with mCRPC who have had at least second-line treatment failure. Additionally, radiation-related and immune-related early and late toxicities were determined, respectively. Furthermore, the study also aimed to identify the predictive biomarkers associated with immunotherapy for treating mCRPC.
https://www.chictr.org.cn/showproj.aspx?proj=126359, identifier ChiCTR2100046212.
尚无关于替雷利珠单抗联合放疗作为晚期转移性去势抵抗性前列腺癌（mCRPC）患者挽救治疗的报道。本研究旨在描述一项评估多部位放疗联合替雷利珠单抗作为挽救疗法治疗至少经历过一线二线治疗失败的mCRPC患者的安全性和疗效的方案。
本研究纳入了mCRPC患者，这些患者至少有一个适合放疗的病灶，且雄激素剥夺治疗（ADT）失败，随后至少接受过一种新型二线内分泌治疗。所有患者接受替雷利珠单抗单药诱导治疗两个周期，然后联合多部位放疗一个周期，之后接受替雷利珠单抗维持治疗，直至疾病进展或患者出现不可接受的毒性。根据指定方案分别选择放疗方法和病灶。主要终点包括安全性和客观缓解率。次要终点包括前列腺特异性抗原（PSA）缓解率、疾病控制率、总生存期、影像学无进展生存期（rPFS）和生化无进展生存期（bPFS）。此外，探索性终点包括预测生物标志物的鉴定以及生物标志物与联合治疗方案的肿瘤反应之间的相关性探索。
本研究包括三个治疗阶段，以评估免疫治疗以及免疫治疗与放疗联合治疗至少经历过二线治疗失败的mCRPC患者的疗效。此外，分别确定了放疗相关和免疫相关的早期和晚期毒性。此外，该研究还旨在确定与治疗mCRPC的免疫治疗相关的预测生物标志物。
https://www.chictr.org.cn/showproj.aspx?proj=126359，标识符ChiCTR2100046212。
