Using MRI and shared decision-making to improve prostate cancer diagnosis
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Turku University Hospital Government |
| Locations | 4 sites (Jyväskylä and 3 other locations) |
| Trial ID | NCT04287088 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with a previous diagnosis of prostate cancer or contraindications for MRI will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Jyväskylä and 3 other locations
- 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
- Study coordinator: Peter Boström, MD
- Email: peter.bostrom@tyks.fi
- Phone: 023130000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.