RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - willing to sign a consent form: The patient must sign the appropriate Ethics Committee (EC) approved willing to sign a consent form documents in the presence of the designated staff Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DIAGNOSTIC_TEST

A 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

Locations (4)

Central Finland Central Hospital

Jyväskylä, Finland

Satakunta Central Hospital

Pori, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland