Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy
NCT ID: NCT04685928
Last Updated: 2025-05-06
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
403 participants
INTERVENTIONAL
2021-05-27
2024-09-24
Brief Summary
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Detailed Description
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In the TP-arm, no MRI will be performed, and all subjects will receive 24-core transperineal prostate biopsy under local anaesthesia. Patient will be followed up in clinic about 30 days after biopsy to review pathology result and complication.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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MRI arm
MRI prostate with contrast, followed by MRI-guided biopsy under local anaesthesia only if MRI show suspicious lesion. Men with non-suspicious MRI will not receive a biopsy.
MRI and MRI-guided prostate biopsy
Multiparametric MRI prostates in the MRI arm will be performed using 1.5 or 3.0 Tesla scanner with a pelvic phased array coil and contrast injection. T2-weighted, diffusion weighted and dynamic contrast enhanced scans will be included and the reporting of MRI finding will be done according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations. MRI-guided targeted biopsy will be performed by Urologists experienced in MRI-guided biopsy for men with PI-RADS score 3-5.
TP-arm Systematic biopsy
24-core Systematic transperineal prostate biopsy under local anaesthesia
TP-arm Systematic biopsy
Transperineal 24-core biopsy using a free-hand technique under local anaesthesia will be performed under transrectal ultrasound guidance for men in this arm
Interventions
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MRI and MRI-guided prostate biopsy
Multiparametric MRI prostates in the MRI arm will be performed using 1.5 or 3.0 Tesla scanner with a pelvic phased array coil and contrast injection. T2-weighted, diffusion weighted and dynamic contrast enhanced scans will be included and the reporting of MRI finding will be done according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations. MRI-guided targeted biopsy will be performed by Urologists experienced in MRI-guided biopsy for men with PI-RADS score 3-5.
TP-arm Systematic biopsy
Transperineal 24-core biopsy using a free-hand technique under local anaesthesia will be performed under transrectal ultrasound guidance for men in this arm
Eligibility Criteria
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Inclusion Criteria
2. Clinical suspicion of prostate cancer and indicated for prostate biopsy
3. Serum Prostate-specific antigen (PSA) 4-20 ng/mL
4. Digital rectal examination ≤ cT2 (organ confined cancer)
5. Able to provide written informed consent
Exclusion Criteria
2. Past or current history of prostate cancer
3. MRI prostate performed within past 5 years
4. Contraindicated to undergo MRI scan (e.g. pacemaker in-situ, claustrophobia, estimated glomerular filtration rate \< 50ml/min in serum renal function test within 3 months)
5. Contraindicated to transperineal prostate biopsy: active urinary tract infection, fail insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (keep aspirin before and after biopsy is permitted)
18 Years
MALE
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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CHIU Ka Fung Peter
Associate Professor
Principal Investigators
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Peter Ka-Fung CHIU, FRCS, PhD
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital, The Chinese University of Hong Kong
Locations
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Kwong Wah Hospital
Hong Kong, , Hong Kong
North District Hospital
Hong Kong, , Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital
Hong Kong, , Hong Kong
Princess Margaret Hospital
Hong Kong, , Hong Kong
Queen Elizabeth Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital, The University of Hong Kong
Hong Kong, , Hong Kong
United Christian Hospital
Hong Kong, , Hong Kong
Countries
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References
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Related Links
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accessed February 20
Other Identifiers
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CRE 2020.569
Identifier Type: -
Identifier Source: org_study_id
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