An interventional study of MRI in Prostate Cancer (Diagnosis), sponsored by University of Eastern Finland. Recruiting at 1 site in Finland. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by University of Eastern Finland · Not applicable, Interventional, and Diagnostic
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?
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Eastern Finland is the lead sponsor of 54 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Follow-up MRI and biopsy
Diagnostic Test: MRI
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.
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.
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.
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
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University of Eastern Finland