Actively Recruiting
GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies
Led by Mads Ryo Jochumsen · Updated on 2025-12-02
100
Participants Needed
2
Research Sites
682 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- PSA density greater than 0.20
- Negative MRI scan of the prostate with PI-RADS score of 1 or 2 or negative biopsy from MRI-target
- MRI performed within the last 6 months
- Ability to read and understand Danish
- Expected remaining lifetime of more than 10 years
You will not qualify if you...
- Known diagnosis of prostate cancer
- Contraindications to MRI
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Aarhus University Hospital
Aarhus N, Aarhus, Denmark, 8200
Actively Recruiting
2
Goedstrup Hospital
Herning, Herning, Denmark, 7400
Actively Recruiting
Research Team
M
Mads R Jochumsen, MD, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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