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 volunteersQualifiers
(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
Cohort
Other
Treatments tested in this trial
Multi-omics profiling
Diagnostic testHE/WSI pathological image analysis Xenium spatial transcriptomics PhenoCycler-Fusion spatial proteomics Whole-exome sequencing (WES) Single-cell transcriptome sequencing
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: