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NCT Number: NCT07369570

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?

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Key information

Conditions

Prostate Cancer (Diagnosis) Disease Disease Attributes Disease Progression Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, Finland

Location status: Recruiting

Location contact

Juha Knaapila, MD, PhD

CONTACT

[email protected]

+358447178679

Markus Venäläinen, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. Evolution of clinical factors

    Time frame: 3-12 months

    Assessment the effect of age (years) to the biopsy result in follow up prostate biopsy.

  6. 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

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juha Knaapila, MD, PhD

CONTACT

[email protected]

+358447178679

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Registry information

Official study title

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

Acronym: REMRI

Important dates

Study start
2026
Primary completion
2027
Study completion
2037
First posted
Jan 27, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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