Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging

NCT07369570 | Recruiting

• 1 other identifier: 218/13.00/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Prostate Cancer (Diagnosis)

Keywords

prostate cancer; magnetic resonance imaging; mri; evolution; progression; pi-rads; significant; likert; pirads; biparametric; bpmri

Outcome Measures

Primary Outcomes (9)

• Evolution of MRI lesions

  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

  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

• Evolution of MRI lesions

  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

  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

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

  3-12 months

• Evolution of clinical factors

  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

  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

  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

• Biopsy result during follow up

  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

Study Arms (1)

Follow up arm

EXPERIMENTAL

Follow-up MRI and biopsy

Diagnostic Test: MRI

Interventions

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.

Follow up arm

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Eastern Finland: lead

Study Sites (1)

Kuopio University Hospital

Kuopio, Finland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease; Disease Progression

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Juha Knaapila, MD, PhD

CONTACT

+358447178679; juha.knaapila@pshyvinvointialue.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 27, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2037
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

FI (1)