This study is a multi-center RCT to compare the clinically significant prostate cancer (csPCa) detection and/or change in clinical management in MRI guided (MRI arm) biopsy and MRI+18F-PSMA guided (Combined arm) biopsies in men with equivocal MRI prostate scans. If additional clinical value is shown by adding 18F-PSMA PET to equivocal MRI, then this should be the new standard of care.
Conditions: Prostate Cancer
Eligibility Criteria
Inclusion Criteria
- Men ≥18 years of age
- Serum Prostate-specific antigen (PSA) 4-15 ng/mL, repeated at least once
- Prostate mpMRI done within 6 months
- MRI prostate with PI-RADS (11) scores of:
- PI-RADS score 2 with red flag (PSA density \>0.2 OR Prostate health index, PHI\>35),
- PI-RADS 3, OR
- PI-RADS 4 with lower csPCa risks (PSAd \<0.1 OR PHI\<35)
- Normal Digital rectal examination
- Patient agrees for targeted and systematic prostate biopsy
Exclusion Criteria
- Prostate biopsy within past 5 years
- Past or current history of prostate cancer
- Contraindicated to undergo PSMA PET-CT scan
- Contraindicated to prostate biopsy: active urinary tract infection, fail insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (keep aspirin before and after biopsy is permitted)
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.