Clinical Trial

GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies

Study acronym: GUIDE PSMA PET
Recruiting
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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.
Trial Details
NCT Number NCT07258056
Lead Sponsor Mads Ryo Jochumsen
Conditions Prostate Cancer
Enrollment 100 participants
Start Date 2025-11-03
Primary Completion 2028-12 (estimated)
Study Completion 2038-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-02