GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies
GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies (GUIDE PSMA PET/MRI)
Mads Ryo Jochumsen
100 participants
Nov 3, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical study is to test the performance of PSMA PET/MRI-guided biopsies against systematic biopsies in men with negative MRI scan (PI-RADS 1-2) of the prostate with continuous suspicion of clinically significant prostate cancer (csPCa) due to PSAd \> 0.20. The main questions it aims to answer are: Can biopsies safely be avoided at PRIMARY score 1-2 without missing csPCa? Does targeted PSMA PET/MRI-guided biopsies have a higher detection rate of csPCa compared to systematic biopsies? Participants will undergo both transperineal MRI/ultrasound fusion target biopsies from PRIMARY score 3-5 lesions on PSMA PET and systematic biopsies irrespective of the PRIMARY-lesion.
Eligibility
Inclusion Criteria5
- PSAdensity \> 0.20
- Negative MRI (PI-RADS 1-2) or negative biopsy from MRI-target
- MRI within 6 months
- Read and understand danish
- Expected remaining lifetime \> 10 years
Exclusion Criteria2
- Known prostate cancer
- MRI contraindications
Interventions
Both PSMA-guided and systematic biopsies are performed
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07258056