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 and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Anhui Medical University · Observational
Prostate cancer is a common malignancy in men, with rising incidence worldwide. Current clinical risk assessment tools-including PSA, Gleason score/ISUP grade, pathological stage, margin status, perineural invasion, and postoperative PSA kinetics-cannot fully explain the marked heterogeneity in disease progression, recurrence, and treatment response, highlighting the need for novel microenvironment-based biomarkers. Emerging evidence has identified intratumoral microbiota as a component of the tumor microenvironment in various solid tumors (e.g., breast, lung, ovarian, pancreatic, and melanoma), where microbial signals correlate with immune infiltration, inflammation, drug metabolism, and patient outcomes. However, the composition, spatial distribution, and immune-related roles of intratumoral microbiota in prostate cancer remain poorly characterized. Given that prostatic tissue resides at the urogenital junction and is continuously exposed to urine, prostatic fluid, and local inflammation, it is plausible that microbial components influence local immunity and tumor behavior. Importantly, intratumoral microbiota represent low-biomass samples, highly susceptible to contamination from reagents, environment, and laboratory procedures. Therefore, this study incorporates rigorous quality controls-including negative controls, process blanks, batch records, contaminant identification, spatial localization validation, and cross-platform verification-to ensure data reliability. Using residual tissue specimens, archived pathological slides, and comprehensive clinicopathological data from prostate cancer patients, we will employ 16S rRNA sequencing, metagenomic/metatranscriptomic sequencing, spatial transcriptomics, spatial proteomics, immunofluorescence, immunohistochemistry, and bioinformatic analyses to profile intratumoral microbiota. Our specific objectives are: (1) to compare microbial composition, abundance, and diversity among tumor, adjacent-normal, and benign tissues; (2) to validate spatial localization of candidate microbial signals via in situ hybridization, immunohistochemistry, and spatial omics; (3) to assess differences in immune cell infiltration, macrophage polarization, T-cell exhaustion markers, and inflammatory pathways between microbe-high and microbe-cold regions; (4) to explore associations between microbial features and Gleason score/ISUP grade, stage, perineural invasion, margin status, postoperative PSA changes, biochemical recurrence, and other clinical outcomes; and (5) to establish a standardized workflow for low-biomass intratumoral microbiome research in prostate cancer. This study aims to provide new insights into microenvironmental heterogeneity and to lay a foundation for identifying prognostic biomarkers and potential therapeutic targets.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 100 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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Patients with a pathological confirmation of prostate cancer, or patients who receive care for benign prostatic conditions and can be used as control subjects.
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, male.（2）Patients with a pathological diagnosis of prostate cancer, or patients with benign prostatic diseases who undergo diagnostic workup or treatment and are eligible to serve as control samples.（3）Patients who undergo prostate , transurethral prostate surgery, radical prostatectomy, or other relevant diagnostic or therapeutic procedures at the First Affiliated Hospital of Anhui Medical University.（4）Have available residual tissue samples, formalin-fixed paraffin-embedded (FFPE) tissues, frozen tissues, pathological slides, or existing assay data that can be used for research purposes.（5）Have basic clinicopathological data available; postoperative PSA and follow-up information may be obtained when necessary.（6）For subjects from whom additional residual samples are prospectively collected, or for those who need to be actively contacted for supplementary data, the subject or their legal representative must consent to participate in the study and sign the form.
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Exclusion Criteria:
（1）Insufficient sample quantity or sample quality that fails to meet the requirements for the intended assays.（2）Severe deficiency in clinicopathological data, rendering the primary analyses unfeasible.（3）Definite risk of contamination during sample storage, transportation, sectioning, extraction, or library preparation, which cannot be reliably ruled out or eliminated through quality control procedures.（4）The patient explicitly refuses to allow their samples or clinical data to be used for research.（5）Other conditions deemed unsuitable for inclusion by the investigator or the ethics committee.
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.
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.
Diagnostic Test: Validate spatial localization of candidate microbial signals via 16S rRNA ISH, FISH, immunofluorescence, IHC, and spatial omics.
Compare microbe-high and microbe-cold areas for differences in immune cell infiltration, macrophage phenotype, T-cell exhaustion/suppression markers, inflammatory factors, and tumor-associated pathways.
Biochemical Progression-Free Survival (bPFS)
Time from initiation of ADT plus ARPI therapy to biochemical progression or deathfrom any cause, whichever occurs first. Biochemical progression is defined as a PSA rise to 0.2ng/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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