The goal of this clinical trial is to prospectively investigate the evolution of lesions in biparametric magnetic resonance imaging (bpMRI) of the prostate in men with no clinically significant prostate cancer (csPCa) in their initial biopsy. The main questions it aims to answer are:
Does lesion progression in bpMRI predict a diagnosis of csPCa in per-protocol follow-up biopsies?
What are the radiological and clinical risk factors for csPCa in per-protocol follow-up biopsies?
Suspicion of a local prostate cancer
Patient have 1-2 PI-RADS 3-5 lesion/lesions in biparametric prostate MRI, with no ISUP 2-5 prostate cancer in an initial systematic or lesion-targeted (at least two biopsy cores per lesion) biopsy
Prostate biopsies can be taken via transrectal approach in an outpatient clinic
An estimated life expentancy exceeding 10 years
The patient had undergone prostate biopsies prior to the biopsies that led to recruitment for the current study.
The physician's suspicion of a locally advanced or a high risk prostate cancer. Absolute exclusion criteria are PSA >20 ng/ml or T4 staged prostate finding MRI or clinical examination
Seriuos infectious or non-infectious complication after initial biopsy
Deep immunosuppression due to organ transplant, hematologic disease, or related causes.
Single group
MRI
Diagnostic testBiparametric follow-up prostate MRI and biopsies (systematic and targeted) for all study patients within one year, or earlier if the PSA value measured every three months increases by more than 50% from the baseline level in study inclusion, or if the physician has any other suspicion of high-risk prostate cancer.
Evolution of MRI lesions
The evolution of biparametric prostate MRI findings during follow-up, assessed by the PRECISE score (1-5) using repeated biparametric prostate MRI-scan. Higher PRECISE score is associated with a higher risk of significant prostate cancer in prostate biopsy.
Evolution of MRI lesions
The evolution of biparametric prostate MRI findings (lesions) during follow-up, assessed by PI-RADS version 2.1 score (1-5), using repeated biparametric prostate MRI-scan. Higher PI-RADS score is associated with a higher risk of significant prostate cancer in prostate biopsy.
Evolution of MRI lesions
The evolution of biparametric prostate MRI findings during follow-up, assessed by lesional ADC value (s/mm2) using repeated biparametric prostate MRI-scan.
Evolution of MRI lesions
The evolution of biparametric prostate MRI lesions appearance in transrectal ultrasound (visible/non-visible) during follow up using repeated transrectal ultrasound.
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