the Beijing Randomized Study Of Prostate Cancer Screening

NCT ID: NCT05961514

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2024-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Traditional

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

Group Type: OTHER

systemic biopsies

Intervention Type: DIAGNOSTIC_TEST

transrectal ultrasound (TRUS) guided prostate systemic biopsies

Experimental

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

Group Type: EXPERIMENTAL

Target biopsies

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

systemic biopsies

transrectal ultrasound (TRUS) guided prostate systemic biopsies

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Cancer Hospital &institute

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yudong Cao, Dr.

Role: CONTACT

ydcao@bjmu.edu.cn

+8615110101301

Facility Contacts

Yudong Cao, Dr.

Role: primary

ydcao@bjmu.edu.cn

+8615110101301

Other Identifiers

2022-1G-1021

Identifier Type: -

Identifier Source: org_study_id