RecruitingNot ApplicableNCT07369570

Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging

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

Sponsor

University of Eastern Finland

Enrollment

100 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer (Diagnosis)

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?

Eligibility

Sex: MALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is following men who have suspicious lesions on their prostate MRI (rated PI-RADS 3–5) but whose initial biopsy came back negative for significant cancer. It tracks whether these lesions grow or change over time using repeated MRI scans, to help doctors understand when a repeat biopsy is truly needed. **You may be eligible if...** - You have a suspicion of localized prostate cancer - Your most recent prostate MRI showed 1 or 2 suspicious lesions rated PI-RADS 3–5 - Your initial biopsy (at least 2 cores per lesion) did not find significant cancer (ISUP grade 2–5) - You are cooperative, speak Finnish, and understand the study - Your life expectancy exceeds 10 years **You may NOT be eligible if...** - You had prior prostate biopsies before the one that led to this study - Your doctor strongly suspects locally advanced or high-risk prostate cancer - You already have a confirmed diagnosis of significant prostate cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.