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

Inclusion Criteria6

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 Criteria6

The patient had undergone prostate biopsies prior to the biopsies that led to recruitment for the current study.
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

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.