Prostate CancerNCT07319923
Establishment and Promotion of an AI-Based Early Warning System for Prostate and Bladder Cancer Screening in the Male Community Population of Beijing
An observational study of Prostate Cancer and Community-based Screening, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Community-based Screening
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Urology, Peking University First Hospital, Beijing, 100034
Beijing
Zheng Zhang, doczhz@aliyun.com
About this study
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
- Being tested
- No intervention
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum PSA level
Measured: from 2025 to 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Jan 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319923
- Sponsor's protocol ID
- BJCP-AI-UroScreen-2025-001
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Promotion of an AI-Based Early Warning System for Prostate and Bladder Cancer Screening in the Male Community Population of Beijing
- ClinicalTrials.gov ID
- NCT07319923
- Acronym / sponsor ID
- BJCP-AI-UroScreen-2025-001
- Conditions
- Prostate Cancer, Community-based Screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Serum PSA level
Time frame: from 2025 to 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Community-based Screening, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zejin Ou (17310018392, 1522065106@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum PSA level (time frame: from 2025 to 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.