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

8. september 2026 oppdatert av: Sheng Tai, Anhui Medical University

Study on Spatial Multi-Omics Deciphering of the Perineural Invasion Microenvironment and Its Prognostic Value in Prostate Cancer

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

120

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Sheng Tai, M.D.
  • Telefonnummer: 0551-62922234 86-18355159268
  • E-post: Taishengwk@163.com

Studer Kontakt Backup

  • Navn: Bowen Li, M.D.
  • Telefonnummer: 0551-62922234 86-18356721482
  • E-post: 2534582952@qq.com

Studiesteder

  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230022
        • Universitythe First Affiliatedhospital of Anhuimedical
        • Ta kontakt med:
        • Ta kontakt med:
          • Bowen Li, M.D.
          • Telefonnummer: 0551-62922234 86-18356721482
          • E-post: 2534582952@qq.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Patients who have prostate cancer tissue specimens collected during urological care at the First Aff
Diagnostisk test: Multi-omics profiling
HE/WSI pathological image analysis Xenium spatial transcriptomics PhenoCycler-Fusion spatial proteomics Whole-exome sequencing (WES) Single-cell transcriptome sequencing

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Persistent PSA elevation
Tidsramme: 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.
post-operative PSA levels at 6-8 weeks and 3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Biochemical Progression-Free Survival (bPFS)
Tidsramme: From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (+1 month) for up to 24 months.
Time from initiation of ADT plus ARPl therapy to biochemical progression or deathfrom any cause, whichever occurs first. Biochemical progression is defined as a PSA rise to a0.2ng/mL after having reached an undetectable level, confirmed by a second measurement at least 2weeks apart. Participants without an event will be censored at the date of last follow-up.
From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (+1 month) for up to 24 months.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Anhui Medical University

Etterforskere

  • Hovedetterforsker: Sheng Tai, M.D., THE FIRST AFFILIATED HOSPITAL OF ANHUI MEDICALUNIVERSITY

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

31. mars 2027

Studiet fullført (Antatt)

31. oktober 2027

Datoer for studieregistrering

Først innsendt

8. september 2026

Først innsendt som oppfylte QC-kriteriene

8. september 2026

Først lagt ut (Faktiske)

14. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KY2026-09-80

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Genetic information from patients will be analyzed.The research involves genetic/genomic profiling of patient samples.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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