Optimization of the Core Number and Location for Targeted Prostate Biopsy
NCT ID: NCT04983706
Last Updated: 2021-07-30
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
100 participants
INTERVENTIONAL
2021-07-05
2022-05-31
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
DIAGNOSTIC
NONE
Study Groups
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MRI/Ultrasound Fusion Saturation Biopsy
MRI/Ultrasound Fusion Saturation Biopsy
MRI/Ultrasound fusion saturation biopsy: the core number and location are designed according to the lession condition.
Interventions
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MRI/Ultrasound Fusion Saturation Biopsy
MRI/Ultrasound fusion saturation biopsy: the core number and location are designed according to the lession condition.
Eligibility Criteria
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Inclusion Criteria
2. Serum PSA ≤ 20 ng/ml within the previous 3 months;
3. No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
4. mpMRI PI-RADS V2.1 score ≥4, diameter of ≤2.5 cm；
5. Able to provide written informed consent.
Exclusion Criteria
2. Prior treatment for prostate cancer;
3. Contraindication to MRI (e.g. claustrophobia, pacemaker);
4. Contraindication to prostate biopsy;
5. Men in whom artifact would reduce the quality of the MRI.
18 Years
80 Years
MALE
No
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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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Hongqian Guo, MD
Role: primary
Qun Lu, MD
Role: backup
Other Identifiers
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IUNU-PC-110
Identifier Type: -
Identifier Source: org_study_id