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This is a single centre non-inferiority randomized controlled trial in comparison of the bpMRI between the traditional pathway in prostate cancer screening
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bpMRI | Experimental | Man receive the bpMRI for Prostate cancer(PCa) screening |
|
| PSA | Active Comparator | Man receive the PSA blood test for Prostate cancer screening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 1 month after the biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 1 month after the biopsy |
| The proportion of men who do not undergo biopsy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biming He | Contact | +8615502139410 | 190589109@qq.com | |
| Haifeng Wang | Contact | +8613681750891 | 446720864@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Haifeng Wang | Shanghai East Hospital of Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital, Tongji University School of Medicine | Shanghai | Shanghai Municipality | 200120 | China |
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
Data will become available after publication with no end date
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
|
The proportion of men who do not need for further biopsy in this trial |
| Within 1 month after the biopsy |
| The proportion of men with adverse events after the intervention | Any of the adverse events during the trial | Within 1 week after the biopsy |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |