Prostate Cancer (Diagnosis)REMRINCT07369570
Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging
A study testing MRI in people with Prostate Cancer (Diagnosis), run by University of Eastern Finland at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer (Diagnosis)
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 23 Feb 2026to 31 Dec 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Kuopio University Hospital
Kuopio
Juha Knaapila, MD, PhD, +358447178679, juha.knaapila@pshyvinvointialue.fi
Markus Venäläinen, MD
About this study
Official title: A Prospective Study of the 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?
- Conditions
- Prostate Cancer (Diagnosis)
- Being tested
- MRI
- Keywords
- prostate cancer, magnetic resonance imaging, mri, evolution, progression, pi-rads, significant, likert, pirads, biparametric, bpmri
- Medical subject headings
- Prostatic Neoplasms, Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Follow up arm | Experimental | Follow-up MRI and biopsy Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-12 months
Evolution of clinical factors
Assessment the effect of age (years) to the biopsy result in follow up prostate biopsy.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start23 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juha Knaapila, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369570
- Sponsor's protocol ID
- 218/13.00/2025
- Acronym
- REMRI
- Status last verified
- Feb 2026
- First submitted
- 29 Dec 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Evolution of Lesions in Repeated Biparametric Prostate Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT07369570
- Acronym / sponsor ID
- REMRI / 218/13.00/2025
- Conditions
- Prostate Cancer (Diagnosis)
- Keywords
- prostate cancer, magnetic resonance imaging, mri, evolution, progression, pi-rads, significant, likert
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow up arm | Experimental | Diagnostic Test: MRIFollow-up MRI and biopsy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIBiparametric 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. | Diagnostic test | Follow up arm |
Primary outcome
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.
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.
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.
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.
Evolution of clinical factors
Time frame: 3-12 months
Assessment the effect of age (years) to the biopsy result in follow up prostate biopsy.
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
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Prostate Cancer (Diagnosis), run by University of Eastern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juha Knaapila, MD, PhD (+358447178679, juha.knaapila@pshyvinvointialue.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of MRI lesions (time frame: 3-12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.