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Trial Title:
the Beijing Randomized Study Of Prostate Cancer Screening
NCT ID:
NCT05961514
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
MRI
Biopsy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Target biopsies
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.
Arm group label:
Experimental
Intervention type:
Diagnostic Test
Intervention name:
systemic biopsies
Description:
transrectal ultrasound (TRUS) guided prostate systemic biopsies
Arm group label:
Traditional
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.
Criteria for 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.
Gender:
Male
Minimum age:
60 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Peking University Cancer Hospital &institute
Address:
City:
Beijing
Zip:
100036
Country:
China
Status:
Recruiting
Contact:
Last name:
Yudong Cao, Dr.
Phone:
+8615110101301
Email:
ydcao@bjmu.edu.cn
Start date:
October 31, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05961514
