Actively Recruiting

Phase Not Applicable
Age: 40Years +
MALE
NCT07369570

Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging

Led by University of Eastern Finland · Updated on 2026-02-24

100

Participants Needed

1

Research Sites

618 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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?

CONDITIONS

Official Title

Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging

Who Can Participate

Age: 40Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspicion of local prostate cancer
  • Presence of 1-2 PI-RADS 3-5 lesions in biparametric prostate MRI
  • No ISUP 2-5 prostate cancer found in initial systematic or lesion-targeted biopsy (at least two biopsy cores per lesion)
  • Ability to have prostate biopsies via transrectal approach in an outpatient clinic
  • Estimated life expectancy over 10 years
  • Patient is cooperative, fluent in Finnish, and understands the study significance
  • Signed informed consent approved by the ethics committee
Not Eligible

You will not qualify if you...

  • Previous prostate biopsies before the biopsy leading to current study recruitment
  • Physician suspicion of locally advanced or high-risk prostate cancer (PSA >20 ng/ml or T4 stage prostate finding on MRI or clinical exam)
  • Serious infectious or non-infectious complications after initial biopsy
  • Deep immunosuppression due to organ transplant, hematologic disease, or related causes
  • Any treatment received for prostate cancer diagnosed in initial biopsy
  • Hip prosthesis or other pelvic objects affecting high-quality MRI
  • Claustrophobia or other contraindications for high-quality MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kuopio University Hospital

Kuopio, Finland

Actively Recruiting

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Research Team

J

Juha Knaapila, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging | DecenTrialz