Comparing Prostate Biopsy Approaches After MRI in Men With Suspected Prostate Cancer Using Shared Decision Making

What this Trial Is About

This research focuses on men suspected of having prostate cancer and aims to compare two approaches for deciding when to perform prostate biopsies after MRI scans. The study evaluates whether biopsies guided by shared decision-making based on prostate cancer risk estimation differ in detecting significant cancer compared to biopsies performed routinely after MRI. Researchers seek to improve diagnosis while reducing unnecessary biopsies and have enrolled 600 patients from multiple hospital districts for this randomized trial. Participants undergo biparametric MRI bpMRI scans interpreted by an experienced urologist using specific scoring systems. Men are randomly assigned to two groups in the control group, all men receive biopsies after MRI in the intervention group, biopsies are done only after a shared decision process considering individual risk. Biopsies involve systematic and targeted samples depending on MRI findings. Men without biopsies or with negative results enter a five-year follow-up with regular PSA tests. During the study, participants undergo MRI scans, prostate biopsies when indicated, and follow-up PSA testing every six months for five years. Researchers assess the proportion of men with clinically significant prostate cancer Gleason 43 or higher at baseline, biopsy complications, anxiety levels through questionnaires, and biopsy rates. Long-term follow-up continues for 15 years using health records and registries to monitor outcomes beyond the initial study period.

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