Establishment and Promotion of an AI-Based Early Warning System for Prostate and Bladder Cancer Screening in the Male Community Population of Beijing

December 20, 2025 updated by: Peking University First Hospital
Prostate cancer is one of the most common malignancies in the male genitourinary system, and it is also the cancer with the fastest-growing incidence and mortality rates among men in China. Although prostate cancer screening can significantly reduce mortality, China has not yet established a well-developed screening system, which is one of the reasons why its mortality rate remains notably higher than that of Western countries. The primary objective of this project is to establish an efficient screening-diagnosis-treatment pathway, beginning with screening in community hospitals, followed by definitive diagnosis in secondary hospitals, and finally treatment in tertiary hospitals. Additionally, the project aims to achieve multi-institutional and multi-terminal sharing of disease information as well as dynamic monitoring and follow-up. The feasibility and effectiveness of this model will be validated through statistical analysis of the data.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

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

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Department of Urology, Peking University First Hospital, Beijing, 100034
        • Contact:

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

Yes

Sampling Method

Non-Probability Sample

Study Population

This study targets male community residents aged 50 years or above who can actively cooperate with researchers in the screening process by completing relevant procedures such as urine and blood sample collection.

Description

Inclusion Criteria:

  • Male community residents aged 50 years or older;

Life expectancy > 10 years and ECOG performance status of 0-2;

Permanent residents of Beijing who are willing to cooperate with researchers in the screening process, complete required tests and questionnaires, and participate in subsequent follow-up;

Support for the research project and provision of signed informed consent.

Exclusion Criteria:

  • 1）Presence of any other malignant tumor or pre-existing prostate malignancy; 2）Presence of prostatitis or active infection in other parts of the urinary system; 3）Inability to cooperate with the study procedures or other factors deemed unsuitable for participation in this study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum PSA level
Time Frame: from 2025 to 2027
from 2025 to 2027

Collaborators and Investigators

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

Sponsor

Peking University First Hospital

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 (Actual)

January 1, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

December 20, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BJCP-AI-UroScreen-2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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