An interventional study of Target biopsies and systemic biopsies in Prostate Cancer, sponsored by Peking University Cancer Hospital & Institute. Status unknown at 1 site in China. Open to male participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Peking University Cancer Hospital & Institute · Not applicable, Interventional, and Screening
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 30,000 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Peking University Cancer Hospital & Institute is the lead sponsor of 261 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The traditional/control arm consists of systematic biopsies of the prostate if PSA\>4ng/ml.
Diagnostic Test: systemic biopsies
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.
transrectal ultrasound (TRUS) guided prostate systemic biopsies
detection of clinically significant prostate cancer （Gleason Score ≥7）
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
detection of clinically insignificant prostate cancer （Gleason Score 3+3）
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
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Peking University Cancer Hospital & Institute