A Randomized Trial of Early Detection of Clinically Significant Prostate Cancer (ProScreen)

A population-based randomised trial of prostate cancer screening will be carried out. A total of approximately 117,200 men aged 50-63 in Helsinki and Tampere are randomised to intervention (screening) or control arm. A reduction in harms of screening in the form of overdiagnosis is sought, while retaining as much as possible of the mortality benefit (reduction in prostate cancer mortality). Novel methods that have been shown to increase specificity for clinically relevant prostate cancer but never tested in a randomised setting will be employed in screening and diagnostics. The main end-point is prostate cancer mortality at 10 and 15 years of follow-up.

NCT Number	NCT03423303
Lead Sponsor	Tampere University Collaborators: Helsinki University Central Hospital, Tampere University Hospital, Finnish Cancer Registry, Finland, University of Turku, Lund University, Fimlab Laboratories, Finland, Laboratory HUSLAB, Finland, University of Helsinki, Hospital District of Helsinki and Uusimaa, Clinical Research Institute HUCH Ltd
Conditions	Prostate Cancer
Enrollment	17,400 participants
Start Date	2018-04-23
Primary Completion	2037-12-31 (estimated)
Study Completion	2037-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-17