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?
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Biparametric 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.
Kuopio University Hospital
Kuopio, Finland
RECRUITINGEvolution 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.
Time frame: 3-12 months
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.
Time frame: 3-12 months
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.
Time frame: 3-12 months
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.
Time frame: 3-12 months
Evolution of clinical factors
Assessment the effect of age (years) to the biopsy result in follow up prostate biopsy.
Time frame: 3-12 months
Evolution of clinical factors
Assessment the effect of PSA (ng/ml) level in baseline and during a follow up to the follow up prostate biopsy result using repeated laboratory tests and repeated prostate biopsy
Time frame: 3-12 months
Evolution of clinical factors
Assessment the effect of prostate size (g) to the biopsy result in follow up prostate biopsy. These factors will be measured by repeated biparametric prostate MRI scan and repeated prostate biopsy.
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Time frame: 3-12 months
Evolution of clinical factors
Assessment the effect of PSA density (prostate size \[g\]/PSA value \[ng/ml\]) in baseline and follow up to the biopsy result in follow up prostate biopsy. These factors will be measured by repeated biparametric prostate MRI scan, repeated laboratory tests and repeated prostate biopsy.
Time frame: 3-12 months
Biopsy result during follow up
Amount of prostate cancer and prostate cancer upgrade/downgrade in repeated systematic and lesion targeted prostate biopsy during the follow up. Prostate biopsy result will be graded using ISUP Gleason Grade Group (benign, 1-5). Higher ISUP Gleason Grade Groups score is associated with a worse oncological outcomes.
Time frame: 3-12 months