A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of Clinically Significant Prostate Cancer: the PROFUSION Trial
Overview
- Phase
- Not Applicable
- Intervention
- MRI-USG fusion approach
- Conditions
- Prostate Cancer
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 1250
- Locations
- 1
- Primary Endpoint
- Proportion of men with clinically significant Prostate cancer(csPCa)
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.
Detailed Description
This study is an international multicentre RCT to compare the csPCa detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion. This is a phase III randomised controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-USG fusion approach (MRUS arm) versus Cognitive-guided approach (COG arm). The study hypothesis is that MRUS arm is superior to COG arm in detecting csPCa. The result of this RCT would impact how MRI-guided prostate biopsies should be done in the future. If the MRI-USG fusion approach is superior to cognitive-guidance in csPCa detection, it should be the standard of practice in the future, and dedicated MRI-USG fusion equipment should be available in centres performing prostate biopsies.
Investigators
CHIU Ka Fung Peter
Associate Professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Men ≥18 years of age
- •Clinical suspicion of prostate cancer and indicated for prostate biopsy
- •Serum Prostate-specific antigen (PSA) \< 20 ng/mL
- •Digital rectal examination ≤ cT2 (organ-confined cancer)
- •Able to provide written informed consent
- •MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5
Exclusion Criteria
- •Prior prostate biopsy in the 2 years before screening visit
- •Prior diagnosis of prostate cancer
- •Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
- •Patient refusal for biopsy
Arms & Interventions
MRUS arm
Targeted biopsies will be performed by software-assisted MRI-ultrasound fusion registration . Software-based fusion targeted biopsy of 4 cores per target followed by 12-core systematic biopsy will be performed. The fusion or overlay of 3D MRI and USG images create a detailed 3D prostate image with both targeted and systematic biopsy core locations recorded.
Intervention: MRI-USG fusion approach
COG arm
The biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and the lesion within it to guide biopsy. Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on transrectal ultrasound (TRUS) corresponding to the MRI suspicious regions. Cognitive-guided biopsy is performed by taking 4 cores from each target followed by 12-core systematic biopsies.
Intervention: Cognitive-guided approach
Outcomes
Primary Outcomes
Proportion of men with clinically significant Prostate cancer(csPCa)
Time Frame: When histology results available, at an expected average of 30 days post-biopsy
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
Secondary Outcomes
- Proportion of men with post-biopsy adverse events within 30 days after biopsy(30 days post biopsy)
- Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm(When histology results available, at an expected average of 30 days post-biopsy)
- Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m(When histology results available, at an expected average of 30 days post-biopsy)
- Proportion of men with a diagnosis of clinically insignificant PCa,(When histology results available, at an expected average of 30 days post-biopsy)
- The proportion of men with a diagnosis of csPCa only in targeted biopsy(When histology results available, at an expected average of 30 days post-biopsy)
- Proportion of men with a diagnosis of csPCa only in systemic biopsy(When histology results available, at an expected average of 30 days post-biopsy)
- Procedure time(During biopsy procedure)
- Pain score on a scale of 0-10 taken after biopsy(Immediately After biopsy procedure)