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

NCT07818395 | Not Yet Recruiting DMC

• 1 other identifier: KY2026-09-80
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer Adenocarcinoma

Keywords

Prostate cancer; Perineural invasion; Spatial multi-omics; Tumor microenvironment; Prognostic risk stratification

Outcome Measures

Primary Outcomes (1)

• Persistent PSA elevation

  Record PSA levels at 6-8 weeks and 3 months post-surgery; predefined thresholds in the study protocol may be used for exploratory analyses.

  post-operative PSA levels at 6-8 weeks and 3 months

Secondary Outcomes (1)

• 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.

Study Arms (1)

Patients who have prostate cancer tissue specimens collected during urological care at the First Aff

Diagnostic Test: Multi-omics profiling

Interventions

Multi-omics profiling DIAGNOSTIC_TEST

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

Patients who have prostate cancer tissue specimens collected during urological care at the First Aff

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Histopathologically confirmed prostate cancer, including prostatic acinar adenocarcinoma, ductal adenocarcinoma, intraductal carcinoma, or other pathological types deemed suitable for inclusion by the investigator.

You may qualify if:

• （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.

You may not qualify if:

• （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.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Universitythe First Affiliatedhospital of Anhuimedical

Hefei, Anhui, 230022, China

Location

Related Publications (17)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Patients who have undergone radical prostatectomy, prostate biopsy, or other clinical diagnostic/therapeutic interventions, and from whom prostate tissue samples are collected and are usable for research purposes

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Sheng Tai, M.D.

  THE FIRST AFFILIATED HOSPITAL OF ANHUI MEDICALUNIVERSITY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Tai, M.D.

CONTACT

86-18355159268; Taishengwk@163.com

Bowen Li, M.D.

CONTACT

86-18356721482; 2534582952@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the chief of the ward

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

CN (1)