Tests whether adding a PSMA PET scan helps find prostate cancer after unclear MRI
Compares MRI-guided biopsy with MRI plus PSMA PET-guided biopsy in men with unclear MRI.
Plain-language title generated from the registry record
Registry title: The Role of 18F-PSMA PET in Prostate Cancer Diagnosis in Equivocal MRI
Key facts
- Where
- Hong Kong, Hong KongSee the site
Where in Hong Kong
- Prince of Wales HospitalHong Kong, Hong KongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese University of Hong Kong
- Trial code
- NCT07386496
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
The Role of 18F-PSMA PET in Prostate Cancer Diagnosis in Equivocal MRI: a Multi-center Randomised Controlled Trial
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.
Inclusion: Men ≥18 years of age; Serum Prostate-specific antigen (PSA) 4-15 ng/mL, repeated at least once; Prostate mpMRI done within 18 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: Past or current history of prostate cancer; 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); Prostate biopsy within past 5 years; Contraindicated to undergo PSMA PET-CT scan.