Orkanger

Prostate cancer is the most common non-skin cancer in men and is often suspected after an elevated prostate-specific antigen (PSA) blood test. This trial evaluates whether using multivariable risk stratification tools, specifically risk calculators from the European Randomised Study of Screening for Prostate Cancer, can detect clinically significant prostate cancer as well as the current standard practice of performing an MRI on all men with suspected prostate cancer. The study aims to determine if these risk calculators can safely reduce the number of MRIs and biopsies needed, while also assessing their cost-effectiveness and impact on men's health-related quality of life. All men in the study undergo risk assessment using the ERSPC risk calculators to decide if they need an MRI or biopsy. The trial compares this risk stratification approach to the current practice of performing MRI in all men with elevated PSA levels. The study includes men aged 50 to 75 years who have suspected localized prostate cancer, a suspicious digital rectal exam, and PSA levels between 3 and 20 ng/ml. Men with higher PSA levels, advanced cancer signs, prior prostate cancer diagnosis, or contraindications to MRI or biopsy are excluded. Participants are monitored during the initial diagnostic work-up of up to 6 weeks to detect clinically significant prostate cancer. Researchers measure how well the risk calculators identify significant cancer compared to MRI-based diagnosis, as well as the number of biopsies and MRIs performed, health anxiety, quality of life, and cost-effectiveness. The study collects clinical data, prostate examinations, PSA levels, and follows participants through diagnostic decisions and outcomes during the trial period.