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

Thousands of men take a PSA test to investigate whether they have prostate cancer every year. For the vast majority, the test is normal and further investigations are not necessary. In others, the test is sufficiently elevated that men are referred for further investigations. Most men with an elevated PSA are offered an MRI examination of the prostate gland, and for some, a tissue sample of the prostate is also recommended if the suspicion of cancer is high enough. Although this comprehensive investigation reveals most clinically significant , or dangerous cases of cancer, many indolent, or "harmless" cancer cases are also detected, which would not have caused the man any harm during his lifetime (approximately 20% of all prostate cancer diagnoses diagnosed in current clinical practive). Cancer treatment is not recommended for such cases, but for many men, the diagnosis and subsequent follow-up can cause him and his family anxity and concern. In addition, prostate biopsies are unpleasant for the patient and the investigation process is resource-intensive for both the man and the health care service. Risk stratification uses machine learning methods to better identify the men who require further investigations with MRI and tissue samples. In this project, the investigators investigate whether the best risk stratification tools are non-inferior in detecting clinically significant prostate cancer compared to current practice, and whether they lead to fewer tissue samples, MRI scans, less health anxiety, and better cost-effectiveness.

NCT Number	NCT07422597
Lead Sponsor	Norwegian University of Science and Technology Collaborators: Norwegian Cancer Society
Conditions	Prostate Cancer
Enrollment	1,016 participants
Start Date	2026-03-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-16