Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study
NCT ID: NCT05025527
Last Updated: 2022-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2022-12-01
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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bpMRI
Man receive the bpMRI for Prostate cancer(PCa) screening
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
PSA
Man receive the PSA blood test for Prostate cancer screening
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
2. life-expectancy at least 10 years
3. fully understand the clinical trial protocol and sign the informed consent;
Exclusion Criteria
2. cannot tolerate prostate biopsy or has contraindication to biopsy;
3. cannot tolerate prostate biopsy or has contraindication to MRI examination;
4. undergo biopsy within 1 year
5. patients judged by the investigator to be unsuitable to participate in the clinical trial;
50 Years
80 Years
MALE
Yes
Sponsors
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Shanghai East Hospital
OTHER
Responsible Party
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Principal Investigators
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Haifeng Wang
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital,Tongji University School of Medicine
Locations
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Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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2021076
Identifier Type: -
Identifier Source: org_study_id
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