NCT07818395Not yet recruiting
Spatial Multi-Omics of Perineural Invasion Microenvironment and Prognosis in Prostate Cancer
Study on Spatial Multi-Omics Deciphering of the Perineural Invasion Microenvironment and Its Prognostic Value in Prostate Cancer
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 8 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Anhui Medical University
- Diseases
- Prostate cancer
- NCT number
- NCT07818395
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 Oct 2026 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- （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.
Who the study is looking for
- （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.
Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitythe First Affiliatedhospital of Anhuimedical Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.