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Clinical Trials in China / NCT07818395
Starting soon Observational

Spatial Multi-Omics of Perineural Invasion Microenvironment and Prognosis in Prostate Cancer

NCT07818395 · tracked via the Priya Life Science China tracker
Sponsor
Anhui Medical University
Phase
Observational
Started
2026-10-01
Last updated
2026-09-14

Condition(s) studied

Prostate Cancer Adenocarcinoma

Investigational drug(s) / intervention(s)

Multi-omics profiling

Multi-omics profiling: HE/WSI pathological image analysis Xenium spatial transcriptomics PhenoCycler-Fusion spatial proteomics Whole-exome sequencing (WES) Single-cell transcriptome sequencing

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * （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. Exclusion Criteria: * （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.

Primary outcome measure(s)

  • Persistent PSA elevation — 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.

Trial sites (1)

FacilityCityRegionStatus
Universitythe First Affiliatedhospital of Anhuimedical Hefei Anhui

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Other trials for the same condition

Intratumoral Microbiota and Immune Microenvironment in Prostate Cancer Starting soon
Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07818395 on ClinicalTrials.gov ↗ ← All trials in China