Combined Prostate-specific Antigen, Multi-parametric MRI and Targeted Prostate Biopsy for Prostate Cancer Screening
NCT ID: NCT04322045
Last Updated: 2020-03-26
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
10000 participants
INTERVENTIONAL
2020-04-30
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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participants
All tested serum PSA. Some conducted mpMRI with/without prostate biopsy under instruction.
multi-parametric MRI
Multi-parametric MRI will be suggested for those PSA ≥4 ng/mL, PI-RADS v2 score will be used to evaluate images.
Interventions
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multi-parametric MRI
Multi-parametric MRI will be suggested for those PSA ≥4 ng/mL, PI-RADS v2 score will be used to evaluate images.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (Eastern Cooperative Oncology Group)ECOG grade: 0-1
* Normal organic function indexes:
* (absolute neutrophil count)ANC ≧1.5×109/L
* (platelet count)PLT ≧100×109/L
* Hb ≧90 g/L
* (total bilirubin)TBIL ≦1.5×ULN
* (aspartate aminotransferase)ALT≦2.5×ULN
* (alanine aminotransferase)AST ≦2.5×ULN
* (blood urea nitrogen)BUN (orUREA) and Cr ≦1.5×ULN
Exclusion Criteria
* Having took Proscar in the past 3 months
* Suffered from any other malignant tumor in the past 5 years
* History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system
* Having took Proscar in the past 3 months
* Suffered from any other malignant tumor in the past 5 years
* History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system
50 Years
MALE
Yes
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Hongqian Guo
Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Locations
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Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IUNU-PC-102
Identifier Type: -
Identifier Source: org_study_id
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