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A Randomized Trial of Early Detection of Clinically Significant Prostate Cancer (ProScreen)
Sponsor: Tampere University
Summary
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.
Official title: Randomized Population-Based Pragmatic Prostate Cancer Screening Trial Based on PSA, Kallikrein Panel, and MRI
Key Details
Gender
MALE
Age Range
50 Years - 63 Years
Study Type
INTERVENTIONAL
Enrollment
17400
Start Date
2018-04-23
Completion Date
2037-12-31
Last Updated
2025-04-17
Healthy Volunteers
Yes
Conditions
Interventions
Prostate cancer screening
Depending on each diagnostic test result the participants in the screening arm will undergo PSA-testing, 4Kscore determination, MRI, and MRI/US fusion biopsy only.
Locations (2)
Helsinki University and Helsinki University Hospital
Helsinki, Finland
University of Tampere
Tampere, Finland