Prostate CancerNCT05025527
Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study
A study testing biparametric MRI (bpMRI) and Prostate cancer antigen (PSA) in people with Prostate Cancer, run by Shanghai East Hospital at 1 site in China.
Trial summary
This is a single centre non-inferiority randomized controlled trial in comparison of the bpMRI between the traditional pathway in prostate cancer screening Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- biparametric MRI (bpMRI) and Prostate cancer antigen (PSA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 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 50 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 80 years old
- life-expectancy at least 10 years
- fully understand the clinical trial protocol and sign the informed consent;
Who cannot join
- Already diagnosis with prostate cancer;
- cannot tolerate prostate biopsy or has contraindication to biopsy;
- cannot tolerate prostate biopsy or has contraindication to MRI examination;
- undergo biopsy within 1 year
- patients judged by the investigator to be unsuitable to participate in the clinical trial;
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200120
About this study
This is a single centre non-inferiority randomized controlled trial in comparison of the bpMRI between the traditional pathway in prostate cancer screening
- Conditions
- Prostate Cancer
- Being tested
- biparametric MRI (bpMRI), Prostate cancer antigen (PSA)
- Keywords
- Prostate Cancer, screen, bpMRI, PSA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biparametric MRI (bpMRI)Diagnostic test
Men go for the bpMRI for PCa (prostate cancer) screening, those who had a suspicious result will go for the next confirmation test
Prostate cancer antigen (PSA)Diagnostic test
Men go for the PSA test for PCa screening, those who had a suspicious result will go for the next confirmation test
| Study group | Role | What they receive |
|---|---|---|
| bpMRI | Experimental | Man receive the bpMRI for Prostate cancer(PCa) screening Receives: Diagnostic Test: biparametric MRI (bpMRI) |
| PSA | Active comparator | Man receive the PSA blood test for Prostate cancer screening Receives: Diagnostic Test: Prostate cancer antigen (PSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of men with clinically significant cancer
The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 2 or more
Measured: Within 1 month after the biopsy
Secondary outcomes (3)
The proportion of men with clinically insignificant cancer
The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 1
Measured: Within 1 month after the biopsy
The proportion of men who do not undergo biopsy
The proportion of men who do not need for further biopsy in this trial
Measured: Within 1 month after the biopsy
The proportion of men with adverse events after the intervention
Any of the adverse events during the trial
Measured: Within 1 week after the biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haifeng Wang, Principal investigator, Shanghai East Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025527
- Sponsor's protocol ID
- 2021076
- Status last verified
- Oct 2022
- First submitted
- 23 Aug 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05025527
- Acronym / sponsor ID
- 2021076
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, screen, bpMRI, PSA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 27 Aug 2021 (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.
This is a single centre non-inferiority randomized controlled trial in comparison of the bpMRI between the traditional pathway in prostate cancer screening
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bpMRI | Experimental | Diagnostic Test: biparametric MRI (bpMRI)Man receive the bpMRI for Prostate cancer(PCa) screening |
| PSA | Active comparator | Diagnostic Test: Prostate cancer antigen (PSA)Man receive the PSA blood test for Prostate cancer screening |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 80 years old
- life-expectancy at least 10 years
- fully understand the clinical trial protocol and sign the informed consent;
Key exclusion criteria (5 listed)
- Already diagnosis with prostate cancer;
- cannot tolerate prostate biopsy or has contraindication to biopsy;
- cannot tolerate prostate biopsy or has contraindication to MRI examination;
- undergo biopsy within 1 year
- patients judged by the investigator to be unsuitable to participate in the clinical trial;
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 |
|---|---|---|
| biparametric MRI (bpMRI)Men go for the bpMRI for PCa (prostate cancer) screening, those who had a suspicious result will go for the next confirmation test | Diagnostic test | bpMRI |
| Prostate cancer antigen (PSA)Men go for the PSA test for PCa screening, those who had a suspicious result will go for the next confirmation test | Diagnostic test | PSA |
Primary outcome
The proportion of men with clinically significant cancer
Time frame: Within 1 month after the biopsy
The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 2 or more
3 secondary outcomes
The proportion of men with clinically insignificant cancer
Time frame: Within 1 month after the biopsy
The proportion of men who do not undergo biopsy
Time frame: Within 1 month after the biopsy
The proportion of men with adverse events after the intervention
Time frame: Within 1 week after the biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: Yes. Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee
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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.
Haifeng Wang principal investigator
Shanghai East Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biparametric MRI (bpMRI) and Prostate cancer antigen (PSA) in people with Prostate Cancer, run by Shanghai East Hospital 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 28 Oct 2022. 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 Biming He (+8615502139410, 190589109@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of men with clinically significant cancer (time frame: Within 1 month after the biopsy). 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 28 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.