the Beijing Randomized Study Of Prostate Cancer Screening (BROPCS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: systemic biopsies; Diagnostic test: Target biopsies

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 Type: Interventional
• Enrollment (Estimated): 30000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yudong Cao, Dr.; Phone Number: +8615110101301; Email: ydcao@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100036
      • Recruiting
      • Peking University Cancer Hospital &institute
      • Contact: Yudong Cao, Dr.; Phone Number: +8615110101301; Email: ydcao@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Traditional; The traditional/control arm consists of systematic biopsies of the prostate if PSA>4ng/ml.	Diagnostic test: systemic biopsies; transrectal ultrasound (TRUS) guided prostate systemic biopsies
Experimental: Experimental; The experimental arm consists of MRI tests and targeted biopsies if PI-RADS scores ≥3 or systematic biopsies if PSA>10ng/ml.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Prostate Cancer; Biopsy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2022-1G-1021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No