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

NCT07319923 | Recruiting

• 1 other identifier: BJCP-AI-UroScreen-2025-001
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Community-based Screening

Outcome Measures

Primary Outcomes (1)

• Serum PSA level

  from 2025 to 2027

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• ）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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Department of Urology, Peking University First Hospital, Beijing, 100034

Beijing, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Zejin Ou

CONTACT

17310018392; 1522065106@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)