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Clinical trial Recruiting at 4 sites Interventional Ages 18 and up Men only

Using MRI and shared decision-making to improve prostate cancer diagnosis

Official title: Prebiopsy Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer - A Multi-centre Trial on Clinical Utility of IMPROD bpMRI in a Shared Decision Making Setting

Run by Turku University Hospital · NCT04287088 · Data updated 2026-11-12

This study is testing if using MRI scans and shared decision-making with doctors can help men with suspected prostate cancer get diagnosed more accurately compared to just having biopsies based on risk discussions.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment600 (estimated)
SponsorTurku University Hospital
Government
Locations4 sites (Jyväskylä and 3 other locations)
StatusRecruiting
StartedFebruary 17, 2020
Main results expectedDecember 31, 2021
Study endsDecember 31, 2041
Registry record updatedNovember 23, 2021
Trial IDNCT04287088 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men aged 18 years or older with a clinical suspicion of prostate cancer based on elevated PSA levels or abnormal digital rectal examinations.

Probably not a fit

Patients with a previous diagnosis of prostate cancer or contraindications for MRI will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a shared decision-making approach in prostate cancer diagnosis by comparing the detection rates of clinically significant prostate cancer (CSPCa) in men undergoing biopsies after MRI scans versus those undergoing biopsies only after a risk-based discussion with their urologist. The study will enroll 600 patients who have a clinical suspicion of prostate cancer based on elevated PSA levels or abnormal digital rectal examinations. Participants will be randomized into two groups: one receiving standard biopsies post-MRI and the other receiving biopsies only after shared decision-making. The primary outcome will assess the proportion of men diagnosed with CSPCa between the two groups.

Why it matters

Potential benefit: If successful, this approach could reduce unnecessary biopsies and improve the detection of clinically significant prostate cancer.

How similar studies have gone: Previous studies have shown that using MRI as a triage test can reduce unnecessary biopsies and improve cancer detection rates, indicating that this approach has potential based on existing evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age: 18 years or older
* Language spoken: Finnish
* Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 20 ng/ml and/or abnormal digital rectal examination according to the referral physician
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* previous diagnosis of prostate cancer
* any contraindications for MRI
* any other conditions that might compromise patient's safety, based on the clinical judgment of the responsible urologist
* bilateral hip prosthesis

Where it's running

  • Central Finland Central Hospital
    Jyväskylä, Finland     Recruiting
  • Satakunta Central Hospital
    Pori, Finland     Recruiting
  • Tampere University Hospital
    Tampere, Finland     Recruiting
  • Turku University Hospital
    Turku, Finland     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.