Intratumoral Microbiota and Immune Microenvironment in Prostate Cancer

September 8, 2026 updated by: Sheng Tai, Anhui Medical University

Study on the Characteristics of Intratumoral Microbiota in Prostate Cancer and Their Relationship With the Tumor Immune Microenvironment

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sheng Tai, M.D.
  • Phone Number: 0551-62922234 86-18355159268
  • Email: Taishengwk@163.com

Study Contact Backup

  • Name: Bowen Li, M.D.
  • Phone Number: 0551-62922234 86-18356721482
  • Email: 2534582952@qq.com

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • Universitythe First Affiliatedhospital of Anhuimedical
        • Contact:
        • Contact:
          • Bowen H Li, M.D.
          • Phone Number: 0551-62922234 86-18356721482
          • Email: 2534582952@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a pathological confirmation of prostate cancer, or patients who receive care for benign prostatic conditions and can be used as control subjects.

Description

Inclusion Criteria:

（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 biopsy, 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 informed consent form.

-

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with a pathological diagnosis of prostate cancer, or patients with benign prostatic disease
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Progression-Free Survival (bPFS)
Time Frame: From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (+1 month) for up to 24 months.
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.
From treatment initiation until biochemical progression or last follow-up, assessed every 3 months (+1 month) for up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2026-09-84

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Genetic information from patients will be analyzed.The research involves genetic/genomic profiling of patient samples.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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