The investigators propose to conduct a phase III multi-center randomised controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-guided biopsy approach (MRI arm) versus MRI+PSMA approach (COMBINED arm). Clinically significant prostate cancer (csPCa) is defined as prostate cancer classified as ISUP (International Society of Urogenital Pathology) Grade group 2 or higher. Patients with clinical suspicion of prostate cancer on MRI with PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1) score 2 with red flag (PSA density \>0.2 OR Prostate health index, PHI\>35), PI-RADS 3, or PI-RADS 4 (and PSAd \<0.1 OR PHI\<35) will be randomised in a 1:1 manner to MRI arm or COMBINED arm. The detection rates of csPCa will be compared between arms. The study hypothesis is that COMBINED arm is superior to MRI arm in detecting csPCa and changing clinical management.
