Prostate Cancer (Diagnosis)
Conditions
Keywords
prostate cancer, magnetic resonance imaging, mri, evolution, progression, pi-rads, significant, likert, pirads, biparametric, bpmri
Brief summary
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?
Interventions
DIAGNOSTIC_TESTMRI
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.
Sponsors
University of Eastern Finland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 is cooperative, fluent in Finnish and understands the significance of the study * The patient signs an informed consent form approved by the ethics committee.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of MRI lesions | 3-12 months | 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 clinical factors | 3-12 months | Assessment the effect of age (years) to the biopsy result in follow up prostate biopsy. |
| Biopsy result during follow up | 3-12 months | 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. |
Countries
Finland
Contacts
CONTACTJuha Knaapila, MD, PhD
Outcome results
None listed