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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Both PSMA-guided and systematic biopsies are performed
Aarhus University Hospital
Aarhus N, Aarhus, Denmark
RECRUITINGGoedstrup Hospital
Herning, Herning, Denmark
RECRUITINGDetection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies
CsPCa is defined as "International Society of Urological Pathology" (ISUP) grade ≥ 2. The ISUP grade scale ranges from 1 to 5, where grade 1 is low-risk / indolent / non-significant prostate cancer and grade 5 is the most aggressive prostate cancer form with worse outcome.
Time frame: From enrollment to pathology report is ready, assessed up to 2 years
High negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2)
A high negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2) means that biopsies can safely be avoided in patients with PRIMARY 1-2 lesions only.
Time frame: From enrollment to pathology report, assessed up to 2 years
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