GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies
About this study
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.
- Condition
- Prostate Cancer
- Tested
- PSMA-guided and systematic biopsies
- Sponsor
- Mads Ryo Jochumsen
Who can join
- Age
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Eligible sex: Male
- Study condition: Prostate Cancer
- 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 2
- Known prostate cancer
- MRI contraindications
Where
2 sites, 2 recruiting
Aarhus University Hospital
Aarhus N, Aarhus, Denmark
Goedstrup Hospital
Herning, Herning, Denmark
Contact
-
Mads R Jochumsen, MD, Ph.D.
+45 + 78456270 madsjoch@rm.dk
Potential match only. Final eligibility is determined by the study team.