Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging (REMRI)

February 22, 2026 updated by: Juha Knaapila, University of Eastern Finland

A Prospective Study of the Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Kuopio, Finland
        • Recruiting
        • Kuopio University Hospital
        • Contact:
        • Sub-Investigator:
          • Markus Venäläinen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.
  • Any treatment given for prostate cancer diagnosed in initial biopsy
  • Hip prosthesis or any other object in the pelvic area that affects high-quality MRI
  • Claustrophobia or other absolute or relative contraindication for high-quality MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Follow up arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of MRI lesions
Time Frame: 3-12 months
The evolution of biparametric prostate MRI findings during follow-up, assessed by lesional ADC value (s/mm2) using repeated biparametric prostate MRI-scan.
3-12 months
Evolution of MRI lesions
Time Frame: 3-12 months
The evolution of biparametric prostate MRI lesions appearance in transrectal ultrasound (visible/non-visible) during follow up using repeated transrectal ultrasound.
3-12 months
Evolution of clinical factors
Time Frame: 3-12 months
Assessment the effect of age (years) to the biopsy result in follow up prostate biopsy.
3-12 months
Evolution of clinical factors
Time Frame: 3-12 months
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
3-12 months
Evolution of clinical factors
Time Frame: 3-12 months
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.
3-12 months
Evolution of clinical factors
Time Frame: 3-12 months
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.
3-12 months
Evolution of MRI lesions
Time Frame: 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.
3-12 months
Evolution of MRI lesions
Time Frame: 3-12 months
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.
3-12 months
Biopsy result during follow up
Time Frame: 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.
3-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Eastern Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2037

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 218/13.00/2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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