Huang Haichao, Wang Tao, Li Wei, Wu Zhun, Wang Xuegang, Xing Jinchun, Chen Bin, Zhang Kaiyan
Department of Urology, School of Medicine, The First Affiliated Hospital of Xiamen University, Xiamen University, 55 Zhenhai Road, Siming District, Xiamen, 361003, Fujian, China.
The School of Clinical Medicine, Fujian Medical University, Fuzhou, 350122, Fujian, China.
BMC Cancer. 2025 Mar 10;25(1):432. doi: 10.1186/s12885-025-13826-5.
The management of locally advanced prostate cancer (PCa) and oligometastatic prostate cancer (OMPCa) remains a clinical challenge. The heterogeneous nature of PCa prompts a need for precision treatment. This study aims to verify whether genomic biomarker-guided neoadjuvant therapy for locally advanced PCa and OMPCa can result in an improvement in the pathological responses and survival outcomes in a Chinese population.
In this open-label prospective phase II umbrella clinical trial, 40 patients will be enrolled. Next-generation sequencing data analysis of PCa tissues from the diagnostic needle biopsies will be performed. The genomically evaluable patients will be divided into 4 groups on the basis of genomic testing results, and receive 6 cycles of patient-tailored neoadjuvant systemic therapy targeted to alternative molecular pathways (including parmiparib, cisplatin, tislelizumab or docetaxel, respectively), and both in combination with rezvilutamide and goserelin microspheres. The primary endpoint is the rate of pathologic complete response. Secondary endpoints include rates of clinical complete response and pathological minimal residual disease (defined as residual tumor 5 mm or less), overall survival, progression-free survival and safety outcomes.
SEGNO, to the best of our knowledge, is the first umbrella clinical trial designed to provide high-level evidence to support the implementation of genomic biomarker-guided neoadjuvant therapy for locally advanced PCa and OMPCa.
Clinicaltrial.gov, NCT06387056.
局部晚期前列腺癌（PCa）和寡转移前列腺癌（OMPCa）的管理仍然是一项临床挑战。PCa的异质性促使需要精准治疗。本研究旨在验证基因组生物标志物指导的局部晚期PCa和OMPCa新辅助治疗是否能改善中国人群的病理反应和生存结果。
在这项开放标签的前瞻性II期伞式临床试验中，将招募40名患者。将对诊断性穿刺活检的PCa组织进行二代测序数据分析。根据基因组检测结果，可进行基因组评估的患者将被分为4组，并接受6个周期的针对不同分子途径的个体化新辅助全身治疗（分别包括帕米帕利、顺铂、替雷利珠单抗或多西他赛），且均与瑞维鲁胺和戈舍瑞林微球联合使用。主要终点是病理完全缓解率。次要终点包括临床完全缓解率和病理微小残留病（定义为残留肿瘤5毫米或更小）、总生存期、无进展生存期和安全性结果。
据我们所知，SEGNO是首个旨在提供高级别证据以支持对局部晚期PCa和OMPCa实施基因组生物标志物指导的新辅助治疗的伞式临床试验。
Clinicaltrial.gov，NCT06387056。
