the Beijing Randomized Study Of Prostate Cancer Screening (BROPCS)

Peking University Cancer Hospital & Institute

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: systemic biopsies; Diagnostic Test: Target biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT05961514

2022-1G-1021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30,000 estimated patients

Sex: Male

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30,000 participants in 2 patient groups

Traditional

Other group

Description:

The traditional/control arm consists of systematic biopsies of the prostate if PSA\>4ng/ml.

Treatment:

Diagnostic Test: systemic biopsies

Experimental

Experimental group

Description:

The experimental arm consists of MRI tests and targeted biopsies if PI-RADS scores ≥3 or systematic biopsies if PSA\>10ng/ml.

Treatment:

Diagnostic Test: Target biopsies