Study on Spatial Multi-Omics Deciphering of the Perineural Invasion Microenvironment and Its Prognostic Value in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Persistent PSA elevation
研究概览
简要总结
Prostate cancer is a common malignancy in men, with substantial prognostic heterogeneity that calls for improved risk stratification at the tissue microenvironment level. Perineural invasion (PNI) is a frequent pathological feature in prostate cancer, associated with local aggressiveness and postoperative recurrence; however, its microenvironmental characteristics and prognostic value remain incompletely characterized. This study plans to enroll approximately 120 prostate cancer patients, collecting tissue specimens and clinicopathological data. We will integrate HE/WSI pathological images, Xenium spatial transcriptomics, PhenoCycler-Fusion spatial proteomics, whole-exome sequencing, and single-cell transcriptomics to systematically compare PNI-positive regions, PNI-negative tumor regions, and adjacent-normal regions in terms of cellular composition, spatial proximity relationships, molecular pathway activities, and genomic alterations. The objectives are to screen candidate molecular markers associated with PNI burden, local invasion, and poor postoperative outcomes, and to explore the establishment of a PNI classification and prognostic risk assessment model based on spatial multi-omics features, thereby providing a foundation for individualized risk stratification and further mechanistic studies in prostate cancer.
详细描述
This study will utilize tissue specimens and clinical follow-up data from prostate cancer patients, integrating HE/WSI pathological images, spatial transcriptomics, spatial proteomics, whole-exome sequencing (WES), and single-cell transcriptomics to systematically characterize the cellular composition, spatial proximity relationships, molecular expression profiles, and genomic alterations within the perineural invasion (PNI) microenvironment of prostate cancer.
Specifically, this study aims to delineate the spatial multi-omics differences among PNI-positive regions, PNI-negative tumor regions, and adjacent-normal regions; to screen for candidate molecular markers associated with PNI burden, local tumor aggressiveness, and poor postoperative outcomes; and to explore the establishment of a PNI classification and prognostic risk assessment model based on spatial multi-omics features, thereby providing a foundation for individualized risk stratification and future mechanistic investigations in prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •（1）Age >18 years and <85 years. （2）Histopathologically confirmed prostate cancer, including prostatic acinar adenocarcinoma, ductal adenocarcinoma, intraductal carcinoma, or other pathological types deemed suitable for inclusion by the investigator.
- •（3）Have undergone radical prostatectomy, prostate biopsy, or other clinical diagnostic or therapeutic procedures, and have prostate tissue specimens obtained and available for research purposes.
- •（4）Tissue specimens meet the basic quality requirements for HE pathological assessment, spatial transcriptomics, spatial proteomics, whole-exome sequencing (WES), or single-cell transcriptome sequencing.
- •（5）Have available basic clinical data, pathological data, treatment information, and follow-up data, including PSA levels, pathological grade, pathological stage, margin status, perineural invasion (PNI) status, and postoperative re-examination information.
- •（6）For prospectively enrolled new patients, written informed consent must be voluntarily signed. For archived leftover specimens and medical records obtained during prior clinical care, a waiver of informed consent or waiver of documentation of informed consent may be applied for, provided that ethical requirements are satisfied.
排除标准
- •（1）Insufficient tissue sample quantity, severe disruption of tissue architecture, excessively low tumor cellularity, or nucleic acid/protein quality that fails to meet the requirements for the intended assays.
- •（2）Severe deficiency in clinicopathological data, precluding the determination of perineural invasion (PNI) status, major pathological parameters, or key follow-up outcomes.
- •（3）Concurrent other malignancies that, in the investigator's judgment, may significantly affect the prognostic assessment of prostate cancer.
- •（4）The patient explicitly refuses to allow their samples or clinical information to be used for scientific research.
- •（5）Other conditions deemed unsuitable for inclusion in this study by the investigator.
研究组 & 干预措施
Patients who have prostate cancer tissue specimens collected during urological care at the First Aff
干预措施: Multi-omics profiling (Diagnostic Test)
结局指标
主要结局
Persistent PSA elevation
时间窗: post-operative PSA levels at 6-8 weeks and 3 months
Record PSA levels at 6-8 weeks and 3 months post-surgery; predefined thresholds in the study protocol may be used for exploratory analyses.
次要结局
- Biochemical Progression-Free Survival (bPFS)(From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (+1 month) for up to 24 months.)
研究者
Sheng Tai
the chief of the ward
Anhui Medical University