bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis (multiIMPROD2)
Prostate Cancer
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring bpMRI, shared decision making, IMPROD, risk calculation
Eligibility 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
Sites / Locations
- Central Finland Central HospitalRecruiting
- Satakunta Central HospitalRecruiting
- Tampere University HospitalRecruiting
- Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control
Intervention
After IMPROD bpMRI all men undergo prostate biopsies. In men with Likert scores of 1-2, TRUS guided systematic biopsies are performed. In men with Likert 3-5 score, in addition to systematic biopsies, two targeted biopsies are taken from each lesion (up to two lesions).
After IMPROD bpMRI prostate biopsies are performed according to shared decision-making by the treating urologist and the patient. If biopsies are to be performed, in men with IMPROD bpMRI likert scores of 1-2, 12-core systematic TRUS guided biopsies are performed and in men with Likert 3-5 score lesions systematic biopsies are performed and two targeted biopsies are taken from each lesion (up to two lesions). If biopsies are not performed, men are referred for a PSA follow-up.