NCT07386496Recruiting
The Role of 18F-PSMA PET in Prostate Cancer Diagnosis in Equivocal MRI
The Role of 18F-PSMA PET in Prostate Cancer Diagnosis in Equivocal MRI: a Multi-center Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 20 Jan 2026
- Start date
- 7 Oct 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Prostate cancer
- NCT number
- NCT07386496
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 7 Oct 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Prostate biopsy within past 5 years
- Contraindicated to undergo PSMA PET-CT scan
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.