This is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
This trial is a prospective, multi-centre, randomized controlled, and non-inferiority study in which all men suspicious to have clinically significant prostate cancer. This study aims to determine whether the cognitive fusion targeted biopsy is non-inferior to software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
626
A cognitive fusion targeted biopsy
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGThe detection rate of clinically significant prostate cancer for targeted biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for targeted biopsy samples
Time frame: 5-6 weeks after signing the consent
The detection rate of any prostate cancer for targeted biopsy
The proportion of men with a Gleason score ≥3+3 in pathological assessment for targeted biopsy samples
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer for combined biopsy
The proportion of men with a Gleason score ≥3+4 in pathological assessment for combined biopsy samples
Time frame: 5-6 weeks after signing the consent
The detection rate of any prostate cancer for combined biopsy
The proportion of men with a Gleason score ≥3+3 in pathological assessment for combined biopsy samples
Time frame: 5-6 weeks after signing the consent
Prostate volume
To measure the prostate volume by ultrasound and MRI
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter <0.5cm
Proportion of separate suspicious lesion with maximum diameter \<0.5cm, detected ISUP grade group\>=2 cancers by targeted biopsy only.
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter range from 0.5 ~ 1.0 cm
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Proportion of separate suspicious lesion with maximum diameter range from 0.5 \~ 1.0 cm, detected ISUP grade group\>=2 cancers by targeted biopsy only.
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with maximum diameter >1.0 cm
Proportion of separate suspicious lesion with maximum diameter \>1.0 cm, detected ISUP grade group\>=2 cancers by targeted biopsy only.
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 3
Proportion of separate suspicious lesion with PI-RADS 3, detected ISUP grade group\>=2 cancers by targeted biopsy only.
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 4
Proportion of separate suspicious lesion with PI-RADS 4, detected ISUP grade group\>=2 cancers by targeted biopsy only.
Time frame: 5-6 weeks after signing the consent
The detection rate of clinically significant prostate cancer in suspicious lesion with PI-RADS 5
Proportion of separate suspicious lesion with PI-RADS 5, detected ISUP grade group\>=2 cancers by targeted biopsy only.
Time frame: 5-6 weeks after signing the consent