Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: TP-arm Systematic biopsyDiagnostic Test: MRI and MRI-guided prostate biopsy
- Registration Number
- NCT04685928
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
This is a randomized controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-targeted approach (MRI-arm) versus 24-core transperineal (TP) systematic biopsy (TP-arm). Clinically significant prostate cancer (csPCa) is defined as ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer. Patients with elevated PSA 4-20 ng/mL with or without abnormal digital rectal examination (DRE) will be randomized in a 1:1 manner to MRI-arm or TP-arm. In the MRI-arm, multiparametric MRI prostate will be performed for each subject. MRI prostate is considered abnormal if PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1) score is 3, 4 or 5. For subjects in MRI-arm with abnormal MRI, MRI-targeted biopsy will be performed, followed by 12-core systematic transperineal biopsy (sparing MRI-target). For subjects in MRI-arm with normal MRI, no biopsy is performed. For subjects in TP-arm, 24-core systematic transperineal biopsy will be performed without MRI guidance. The study flowchart is provided in Figure 1. The detection rates of csPCa will be compared between MRI-targeted biopsy plus 12-core systematic biopsy (in MRI-arm) versus TP-arm. The study hypothesis is MRI-guided prostate biopsy with 12-core systematic biopsy is superior to 24-core transperineal systematic biopsy in detection of csPCa.
- Detailed Description
The current study is a randomized controlled trial using a superiority design with the subjects randomized in 1:1 manner to either MRI-arm or TP-arm. In the MRI-arm, multiparametric MRI is performed for all subjects. If MRI is abnormal (PI-RADS score 3-5), 3-4 core targeted followed by 12-core systematic transperineal biopsies under local anaesthesia will be performed. If MRI is normal, no biopsy is performed. A 12-core systematic biopsy is also included in MRI-targeted biopsy as it has been shown in the Trio study that adding systematic biopsy increased the detection of csPCa.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 403
- Men ≥18 years of age
- Clinical suspicion of prostate cancer and indicated for prostate biopsy
- Serum Prostate-specific antigen (PSA) 4-20 ng/mL
- Digital rectal examination ≤ cT2 (organ confined cancer)
- Able to provide written informed consent
- Prior prostate biopsy
- Past or current history of prostate cancer
- MRI prostate performed within past 5 years
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TP-arm Systematic biopsy TP-arm Systematic biopsy 24-core Systematic transperineal prostate biopsy under local anaesthesia MRI arm MRI and MRI-guided prostate biopsy 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.
- Primary Outcome Measures
Name Time Method Proportion of men with clinically significant Prostate cancer(csPCa), diagnosis of ISUP Grade group 2 or above prostate cancer in at least 1 biopsy core in MRI-arm Vs TP-arm When histology results available, at an expected average of 30 days post-biopsy ISUP Grade 2 or above prostate cancer diagnosed on biopsy
- Secondary Outcome Measures
Name Time Method Proportion of men in MRI arm with normal MRI who could avoid a biopsy When MRI results available, at an expected average of 30 days post-MRI The number of patients in MRI arm with normal MRI
Proportion of men with post-biopsy adverse events within 30 days after biopsy 30 days post biopsy The severity of Adverse event is grade by Clavien-Dindo classification
Proportion of men with csPCa in MRI-arm (Targeted biopsy only) Vs TP-arm (24-core Systematic biopsy) When histology results available, at an expected average of 30 days post-biopsy ISUP Grade 2 or above prostate cancer diagnosed on biopsy
Proportion of men with diagnosis of clinically insignificant prostate cancer (ISUP Grade group 1) When histology results available, at an expected average of 30 days post-biopsy ISUP Grade 1-5, the higher grade the higher risk.
Health-related Quality of life scores At recruitment, and at 30 days after intervention EQ-5D-5L
Cost per diagnosis of cancer 30 days post-biopsy Cost to diagnosis one cancer
Cancer core length of the most involved biopsy core When histology results available, at an expected average of 30 days post-biopsy maximum cancer core length in mm
Trial Locations
- Locations (8)
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