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Recruiting
NCT07386496
The Role of 18F-PSMA PET in Prostate Cancer Diagnosis in Equivocal MRI
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 250
Sponsor: Chinese University of Hong Kong
Location: Prince of Wales Hospital Hong Kong
Summary
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.
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 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 \
Source: ClinicalTrials.gov (NCT07386496). StuddyBuddy aggregates publicly available trial information.
