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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-85
SponsorAnhui Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

(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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Patients who have prostate cancer tissue specimens collected during urological care at the First Aff1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Biochemical Progression-Free Survival (bPFS)

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.

Time frame
From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (+1 month) for up to 24 months.

Other outcomes

Sponsors and contacts

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