Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial
Abstract Background 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 therap...
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2025-03-01
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| Online Access: | https://doi.org/10.1186/s12885-025-13826-5 |
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| author | Haichao Huang Tao Wang Wei Li Zhun Wu Xuegang Wang Jinchun Xing Bin Chen Kaiyan Zhang |
| author_facet | Haichao Huang Tao Wang Wei Li Zhun Wu Xuegang Wang Jinchun Xing Bin Chen Kaiyan Zhang |
| author_sort | Haichao Huang |
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| description | Abstract Background 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. Methods 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. Discussion 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. Trial registration Clinicaltrial.gov, NCT06387056. |
| format | Article |
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| issn | 1471-2407 |
| language | English |
| publishDate | 2025-03-01 |
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| spelling | doaj-art-44feb5197fcf446abf06cd75fd4be96c2025-08-20T03:01:37ZengBMCBMC Cancer1471-24072025-03-012511610.1186/s12885-025-13826-5Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trialHaichao Huang0Tao Wang1Wei Li2Zhun Wu3Xuegang Wang4Jinchun Xing5Bin Chen6Kaiyan Zhang7Department of Urology, School of Medicine, The First Affiliated Hospital of Xiamen University, Xiamen UniversityDepartment of Urology, School of Medicine, The First Affiliated Hospital of Xiamen University, Xiamen UniversityDepartment of Urology, School of Medicine, The First Affiliated Hospital of Xiamen University, Xiamen UniversityDepartment of Urology, School of Medicine, The First Affiliated Hospital of Xiamen University, Xiamen UniversityDepartment of Urology, School of Medicine, The First Affiliated Hospital of Xiamen University, Xiamen UniversityDepartment of Urology, School of Medicine, The First Affiliated Hospital of Xiamen University, Xiamen UniversityDepartment of Urology, School of Medicine, The First Affiliated Hospital of Xiamen University, Xiamen UniversityDepartment of Urology, School of Medicine, The First Affiliated Hospital of Xiamen University, Xiamen UniversityAbstract Background 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. Methods 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. Discussion 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. Trial registration Clinicaltrial.gov, NCT06387056.https://doi.org/10.1186/s12885-025-13826-5Genomic biomarker-guidedNeoadjuvant therapyLocally advancedOligometastaticProstate cancer |
| spellingShingle | Haichao Huang Tao Wang Wei Li Zhun Wu Xuegang Wang Jinchun Xing Bin Chen Kaiyan Zhang Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial BMC Cancer Genomic biomarker-guided Neoadjuvant therapy Locally advanced Oligometastatic Prostate cancer |
| title | Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial |
| title_full | Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial |
| title_fullStr | Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial |
| title_full_unstemmed | Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial |
| title_short | Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial |
| title_sort | safety and efficacy of genomic biomarker guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer segno study protocol for an open label prospective phase ii umbrella clinical trial |
| topic | Genomic biomarker-guided Neoadjuvant therapy Locally advanced Oligometastatic Prostate cancer |
| url | https://doi.org/10.1186/s12885-025-13826-5 |
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