the Beijing Randomized Study Of Prostate Cancer Screening

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: systemic biopsies; Diagnostic Test: Target biopsies

• Registration Number: NCT05961514
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-17
• Study First Posted: 2023-07-27
• Study Start: 2023-10-31
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional	systemic biopsies	The traditional/control arm consists of systematic biopsies of the prostate if PSA\>4ng/ml.
Experimental	Target biopsies	The experimental arm consists of MRI tests and targeted biopsies if PI-RADS scores ≥3 or systematic biopsies if PSA\>10ng/ml.

Primary Outcome Measures

Name	Time	Method
detection of clinically significant prostate cancer （Gleason Score ≥7）	At 2 months after the last included biopsy procedure	Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm

Secondary Outcome Measures

Name	Time	Method
detection of clinically insignificant prostate cancer （Gleason Score 3+3）	At 2 months after the last included biopsy procedure	Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm

Trial Locations

Locations (1)

Peking University Cancer Hospital &institute; 🇨🇳 Beijing, Beijing, China