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

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.

NCT Number	NCT04287088
Lead Sponsor	Turku University Hospital Collaborators: Tampere University Hospital, Satakunta Central Hospital, Central Finland Hospital District, Memorial Sloan Kettering Cancer Center, Mount Sinai Hospital, New York
Conditions	Prostate Cancer
Enrollment	600 participants
Start Date	2020-02-17
Primary Completion	2021-12-31 (estimated)
Study Completion	2041-12-31 (estimated)
Updated on ClinicalTrials.gov	2021-11-23