Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial

Not Applicable

Not yet recruiting

Interventions: Procedure: MRI-USG fusion approach
Procedure: Cognitive-guided approach

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
MRUS arm	MRI-USG fusion approach	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.
COG arm	Cognitive-guided approach	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.

Primary Outcome Measures

Name	Time	Method
Proportion of men with clinically significant Prostate cancer(csPCa)	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 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	MRI lesions with maximal size ≤10mm versus \>10mm
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	prostate size of ≤50ml vs \>50ml
Proportion of men with a diagnosis of clinically insignificant PCa,	When histology results available, at an expected average of 30 days post-biopsy	ISUP grade group 1 Prostate cancer diagnosed on biopsy
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
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	ISUP Grade 2 or above prostate cancer diagnosed on 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	ISUP Grade 2 or above prostate cancer diagnosed on biopsy
Procedure time	During biopsy procedure	Total time of procedure
Pain score on a scale of 0-10 taken after biopsy	Immediately After biopsy procedure	The higher the score, the more pain