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bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis

RecruitingNAAges 18 Years - anyMaleTurku University Hospital
NCT04287088 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The shortcoming of the pre-biopsy prostate MRI approach is the recommendation to biopsy all men post-MRI even if there is no lesion seen in MRI, ie. risk of PCa is very low. Therefore, the primary objective of this trial is to compare if there is a difference between significant cancer detection rate in men undergoing prostate biopsies after MRI scan compared to men undergoing post-MRI prostate biopsies only after a shared decision-making based on prostate cancer risk estimation. The trial will enrol 600 patients. The primary outcome measure is the the proportion of men with CSPCa (Gleason 4+3 prostate cancer or higher) between the control and intervention arms at baseline. Eligible men are randomised 1:1 in two groups. In control arm in all men prostate biopsies are performed after MRI whereas in intervention arm prostate biopsies are performed only after a shared decision-making betwe

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📋 Eligibility rules (as published)
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
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What it tests

  • A shared decision making
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Where

4 sites
Central Finland Central Hospital
Jyväskylä, Finland
Satakunta Central Hospital
Pori, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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