Comparison of Upfront MRI Versus Risk Calculator for Detecting Prostate Cancer in Men Aged 50 to 75 with Suspected Prostate Cancer

What this Trial Is About

Researchers are evaluating whether using risk stratification tools based on machine learning can detect clinically significant prostate cancer as well as the current standard practice of performing MRI scans for men suspected of having prostate cancer. The study focuses on men aged 50 to 75 who have elevated prostate-specific antigen PSA levels or suspicious digital rectal exam results. The goal is to find out if these tools can reduce unnecessary MRIs and biopsies, lower health anxiety, and improve cost-effectiveness while maintaining cancer detection rates. In this study, all participants undergo risk assessment using the European Randomised Study of Screening for Prostate Cancer ERSPC risk calculators to decide if further testing with MRI and biopsy is needed. This approach is compared to the usual care where most men with elevated PSA receive an MRI and, if necessary, a prostate biopsy. The study evaluates whether risk stratification can safely reduce the number of MRIs and biopsies without missing significant cancers. The study is interventional with a single group design. Participants will be followed during the initial diagnostic work-up lasting up to six weeks to measure detection of clinically significant prostate cancer. Additional outcomes include detection of insignificant cancer, number of biopsies and MRIs performed, quality of life impacts related to biopsy decisions, and cost-effectiveness assessed one year after inclusion. Researchers will monitor participants health-related quality of life and assess the efficiency of diagnostic procedures over time.

Prostate Risk Or Radiology Assessment Non-inferiority Design, Upfront MRI or Risk Calculator in Men With Suspected Prostate Cancer