An observational study in Prostate Cancer Adenocarcinoma, sponsored by Anhui Medical University. Not yet recruiting at 1 site in China. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Anhui Medical University · Observational
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 120 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Anhui Medical University is the lead sponsor of 104 studies on the registry; 50 are open to participants now.
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Histopathologically confirmed prostate cancer, including prostatic acinar adenocarcinoma, ductal adenocarcinoma, intraductal carcinoma, or other pathological types deemed suitable for inclusion by the investigator.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
（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 , 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 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Multi-omics profiling
HE/WSI pathological image analysis Xenium spatial transcriptomics PhenoCycler-Fusion spatial proteomics Whole-exome sequencing (WES) Single-cell transcriptome sequencing
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
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.
Plan to share: Undecided — Genetic information from patients will be analyzed.The research involves genetic/genomic profiling of patient samples.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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