RecruitingNot ApplicableNCT04287088

bpMRI and Risk Based Shared Clinical Decision Making in 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

Sponsor

Turku University Hospital

Enrollment

600 participants

Start Date

Feb 17, 2020

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

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 between urologist and the patient and the discussion is based on risk estimation.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Finnish study tests whether using an MRI scan of the prostate (called bpMRI) combined with a personalized risk assessment can help men and their doctors make better, more informed decisions about whether to do a prostate biopsy. The goal is to reduce unnecessary procedures while catching cancers that need treatment. **You may be eligible if...** - You are 18 or older - You speak Finnish - Your doctor suspects prostate cancer based on a PSA level between 2.5 and 20 ng/ml and/or an abnormal rectal exam - You understand the study's purpose and can sign a consent form **You may NOT be eligible if...** - You have already been diagnosed with prostate cancer - You are unable to understand the study information - There are medical reasons preventing you from having an MRI or biopsy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTA shared decision making

Based on prostate cancer risk calculation (age, usage of 5-ARI medication, baseline PSA, IMPROD bpMRI Likert, prostate volume) a shared decision making whether to perform prostate biopsies or not