the Beijing Randomized Study Of Prostate Cancer Screening

Prostate Cancer Clinical Trial

— BROPCS  

Official title:

The Randomized Controlled Trial of Prostate Cancer Screening in Beijing, China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961514
• Other study ID #: 2022-1G-1021
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: Yudong Cao, Dr.
• Phone: +8615110101301
• Email: ydcao[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BROPCS is a randomized trial study comparing the effectiveness of traditional systematic biopsies and bpMRI followed targeted biopsies with PSA > 4ng/ml in initial screening.

Description:

The aim of BROPCS study is to explore a suitable prostate cancer screening model for Chinese population, which can increase the specificity in early detection of prostate cancer without decreasing the sensitivity of clinically significant prostate cancers, and can reduce prostate cancer-specific mortality.This study will use a cluster randomized controlled trial method with a total of approximately 30,000 participants. The subjects will be randomly assigned to a control group (about 20,000 people) and a screening group (about 10,000 people), and some basic information will be obtained through a questionnaire survey. The screening group will undergo initial prostate-specific antigen (PSA) screening, and high-risk subjects (PSA > 4ng/ml) will be randomly assigned to two groups. The standard biopsy group will undergo traditional systematic biopsy, while the precision screening group will undergo further MRI examination and targeted fusion biopsy for those with positive MRI results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Healthy men aged 60-75 with a life expectancy of more than 10 years;

2. Residing continuously in the community for more than 3 years and not previously diagnosed with prostate cancer;

3. Willing to participate in this project.

Exclusion Criteria:

1. Previously diagnosed with prostate cancer;

2. Previously diagnosed with any malignant tumor within the past 5 years;

3. Used medication within the past 3 months that can affect PSA values, mainly finasteride, dutasteride, and ketoconazole;

4. Recently had acute prostatitis, acute urinary retention, or underwent transurethral procedures (such as urethral dilation, urinary catheterization, cystoscopy, etc.) within the past week;

5. Have other serious illnesses or cannot perform activities of daily living independently.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Target biopsies
MRI/Fusion target biopsies combine magnetic resonance imaging (MRI) with ultrasound-guided biopsy techniques to obtain tissue samples from areas of the prostate gland that appear abnormal on MRI.
• systemic biopsies
transrectal ultrasound (TRUS) guided prostate systemic biopsies

Locations

Country	Name	City	State
China	Peking University Cancer Hospital &institute	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of clinically significant prostate cancer (Gleason Score =7)	Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm	At 2 months after the last included biopsy procedure
Secondary	detection of clinically insignificant prostate cancer (Gleason Score 3+3)	Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm	At 2 months after the last included biopsy procedure