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the Beijing Randomized Study Of Prostate Cancer Screening (BROPCS)

Primary Purpose

Prostate Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Target biopsies
systemic biopsies
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring Prostate Cancer, MRI, Biopsy

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy men aged 60-75 with a life expectancy of more than 10 years; Residing continuously in the community for more than 3 years and not previously diagnosed with prostate cancer; Willing to participate in this project. Exclusion Criteria: Previously diagnosed with prostate cancer; Previously diagnosed with any malignant tumor within the past 5 years; Used medication within the past 3 months that can affect PSA values, mainly finasteride, dutasteride, and ketoconazole; Recently had acute prostatitis, acute urinary retention, or underwent transurethral procedures (such as urethral dilation, urinary catheterization, cystoscopy, etc.) within the past week; Have other serious illnesses or cannot perform activities of daily living independently.

Sites / Locations

  • Peking University Cancer Hospital &institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Traditional

Experimental

Arm Description

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

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

Outcomes

Primary Outcome Measures

detection of clinically significant prostate cancer (Gleason Score ≥7)
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm

Secondary Outcome Measures

detection of clinically insignificant prostate cancer (Gleason Score 3+3)
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm

Full Information

First Posted
July 17, 2023
Last Updated
July 17, 2023
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05961514
Brief Title
the Beijing Randomized Study Of Prostate Cancer Screening
Acronym
BROPCS
Official Title
The Randomized Controlled Trial of Prostate Cancer Screening in Beijing, China
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, MRI, Biopsy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional
Arm Type
Other
Arm Description
The traditional/control arm consists of systematic biopsies of the prostate if PSA>4ng/ml.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental arm consists of MRI tests and targeted biopsies if PI-RADS scores ≥3 or systematic biopsies if PSA>10ng/ml.
Intervention Type
Diagnostic Test
Intervention Name(s)
Target biopsies
Intervention Description
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
Intervention Name(s)
systemic biopsies
Intervention Description
transrectal ultrasound (TRUS) guided prostate systemic biopsies
Primary Outcome Measure Information:
Title
detection of clinically significant prostate cancer (Gleason Score ≥7)
Description
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
Time Frame
At 2 months after the last included biopsy procedure
Secondary Outcome Measure Information:
Title
detection of clinically insignificant prostate cancer (Gleason Score 3+3)
Description
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
Time Frame
At 2 months after the last included biopsy procedure

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men aged 60-75 with a life expectancy of more than 10 years; Residing continuously in the community for more than 3 years and not previously diagnosed with prostate cancer; Willing to participate in this project. Exclusion Criteria: Previously diagnosed with prostate cancer; Previously diagnosed with any malignant tumor within the past 5 years; Used medication within the past 3 months that can affect PSA values, mainly finasteride, dutasteride, and ketoconazole; Recently had acute prostatitis, acute urinary retention, or underwent transurethral procedures (such as urethral dilation, urinary catheterization, cystoscopy, etc.) within the past week; Have other serious illnesses or cannot perform activities of daily living independently.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yudong Cao, Dr.
Phone
+8615110101301
Email
ydcao@bjmu.edu.cn
Facility Information:
Facility Name
Peking University Cancer Hospital &institute
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100036
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yudong Cao, Dr.
Phone
+8615110101301
Email
ydcao@bjmu.edu.cn

12. IPD Sharing Statement

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the Beijing Randomized Study Of Prostate Cancer Screening

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