A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia
NCT ID: NCT04376008
Last Updated: 2022-10-24
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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COMPLETED
NA
1050 participants
INTERVENTIONAL
2018-05-01
2022-06-01
Brief Summary
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Detailed Description
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Image fusion of Multi-parameter MRI (mpMRI) and TRUS guided prostate targeted biopsy had equivalent results with standard 12-core biopsy. Combination of targeted and standard biopsy was recommended in recent Guidelines. Image fusion targeted biopsy needs satisfactory anesthetic effect, and no prospective studies investigated feasibility in this approach under local anesthesia.
The scientific urological community is focusing on detection rate and concordance with final pathology of the radical prostatectomy specimen, which remain the cornerstones to assess the accuracy of a prostate biopsy technique. In this study, the investigators will additionally assess the functional results of erectile function and urinary function.
Together, the investigators will perform free-hand image fusion targeted biopsies plus standard biopsies under local anesthesia in patients recruited in this study. Then, Feasibility, such as peri-procedural pain, changes in patients quality of life; complications, such as infection rate and bleeding rate; functional results, such as erectile function and urinary function; and concordance with final pathology will be evaluated.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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PI-RADS 1-2
Standard prostate biopsy
Standard prostate biopsy
Transperineal TRUS guided standard prostate biopsy (SB).
PI-RADS 3-5
Targeted and standard prostate biopsy
Targeted and standard prostate biopsy
Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).
Interventions
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Standard prostate biopsy
Transperineal TRUS guided standard prostate biopsy (SB).
Targeted and standard prostate biopsy
Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).
Eligibility Criteria
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Inclusion Criteria
* Serum PSA ≤ 20 ng/ml within the previous 3 months;
* Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;
* No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
* Able to provide written informed consent.
Exclusion Criteria
* Prior treatment for prostate cancer;
* Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
* Contraindication to prostate biopsy.
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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Other Identifiers
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IUNU-PC-104
Identifier Type: -
Identifier Source: org_study_id
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