Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Diagnosis) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Follow up arm
- description
- Follow-up MRI and biopsy
- interventionNames
- Diagnostic Test: MRI
Primary outcomes (9)
- measure
- Evolution of MRI lesions
- timeFrame
- 3-12 months
- description
- 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.
- measure
- Evolution of MRI lesions
- timeFrame
- 3-12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available