Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Diagnosis). Basic parameters: from 40 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study of the Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging
Overview
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?
Interventions
- Diagnostic test MRI
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 outcome measures
- Evolution of MRI lesions [Time frame: 3-12 months]
- Evolution of MRI lesions [Time frame: 3-12 months]
- Evolution of MRI lesions [Time frame: 3-12 months]
- Evolution of MRI lesions [Time frame: 3-12 months]
- Evolution of clinical factors [Time frame: 3-12 months]
- Evolution of clinical factors [Time frame: 3-12 months]
- Evolution of clinical factors [Time frame: 3-12 months]
- Evolution of clinical factors [Time frame: 3-12 months]
- Biopsy result during follow up [Time frame: 3-12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Finland · 1 center
- Kuopio University Hospital — Kuopio
Identifiers
NCT: NCT07369570 · 218/13.00/2025