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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,250
MRI-USG fusion approach prostate biopsy
Cognitive-guided approach prostate biopsy
Prince of Wales Hospital
Hong Kong, Hong Kong
RECRUITINGProportion of men with clinically significant Prostate cancer(csPCa)
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm
MRI lesions with maximal size ≤10mm versus \>10mm
Time frame: 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
prostate size of ≤50ml vs \>50ml
Time frame: 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
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
Time frame: 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
ISUP Grade 2 or above prostate cancer diagnosed on biopsy
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Proportion of men with a diagnosis of clinically insignificant PCa,
ISUP grade group 1 Prostate cancer diagnosed on biopsy
Time frame: When histology results available, at an expected average of 30 days post-biopsy
Procedure time
Total time of procedure
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Time frame: During biopsy procedure
Pain score on a scale of 0-10 taken after biopsy
The higher the score, the more pain
Time frame: Immediately After biopsy procedure
Proportion of men with post-biopsy adverse events within 30 days after biopsy
The severity of Adverse event is grade by Clavien-Dindo classification
Time frame: 30 days post biopsy