Prostate CancerBROPCSNCT05961514
the Beijing Randomized Study Of Prostate Cancer Screening
A study testing Target biopsies and systemic biopsies in people with Prostate Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Target biopsies and systemic biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital &institute
Beijing, Beijing Municipality, 100036
Yudong Cao, Dr., +8615110101301, ydcao@bjmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Target biopsies, systemic biopsies
- Keywords
- Prostate Cancer, MRI, Biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target biopsiesDiagnostic test
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.
systemic biopsiesDiagnostic test
transrectal ultrasound (TRUS) guided prostate systemic biopsies
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Other | The traditional/control arm consists of systematic biopsies of the prostate if PSA>4ng/ml. Receives: Diagnostic Test: 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. Receives: Diagnostic Test: Target biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of clinically significant prostate cancer （Gleason Score ≥7）
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
Measured: At 2 months after the last included biopsy procedure
Secondary outcomes (1)
detection of clinically insignificant prostate cancer （Gleason Score 3+3）
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
Measured: At 2 months after the last included biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start31 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961514
- Sponsor's protocol ID
- 2022-1G-1021
- Acronym
- BROPCS
- Status last verified
- Mar 2023
- First submitted
- 17 Jul 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Controlled Trial of Prostate Cancer Screening in Beijing, China
- ClinicalTrials.gov ID
- NCT05961514
- Acronym / sponsor ID
- BROPCS / 2022-1G-1021
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, MRI, Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional | Other | Diagnostic Test: systemic biopsiesThe traditional/control arm consists of systematic biopsies of the prostate if PSA>4ng/ml. |
| Experimental | Experimental | Diagnostic Test: Target biopsiesThe experimental arm consists of MRI tests and targeted biopsies if PI-RADS scores ≥3 or systematic biopsies if PSA>10ng/ml. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Target biopsiesMRI/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. | Diagnostic test | Experimental |
| systemic biopsiestransrectal ultrasound (TRUS) guided prostate systemic biopsies | Diagnostic test | Traditional |
Primary outcome
detection of clinically significant prostate cancer （Gleason Score ≥7）
Time frame: At 2 months after the last included biopsy procedure
Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
1 secondary outcome
detection of clinically insignificant prostate cancer （Gleason Score 3+3）
Time frame: At 2 months after the last included biopsy procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Target biopsies and systemic biopsies in people with Prostate Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yudong Cao, Dr. (+8615110101301, ydcao@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of clinically significant prostate cancer （Gleason Score ≥7） (time frame: At 2 months after the last included biopsy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.