the Beijing Randomized Study Of Prostate Cancer Screening

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Target biopsies
* Diagnostic Test: systemic biopsies


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Traditional<br>The traditional/control arm consists of systematic biopsies of the prostate if PSA>4ng/ml. | Diagnostic Test: systemic biopsies<br>* transrectal ultrasound (TRUS) guided prostate systemic biopsies<br>|
| Experimental: Experimental<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Prostate Cancer, Biopsy