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

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.

Conditions

• Prostate Cancer

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

• Helsinki University Central Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Finnish Cancer Registry, Finland

  collaborator UNKNOWN

• University of Turku

  collaborator OTHER

• Lund University

  collaborator OTHER

• Fimlab Laboratories, Finland

  collaborator UNKNOWN

• Laboratory HUSLAB, Finland

  collaborator UNKNOWN

• University of Helsinki

  collaborator OTHER

• Hospital District of Helsinki and Uusimaa

  collaborator OTHER

• Clinical Research Institute HUCH Ltd

  collaborator OTHER

• Tampere University

  lead OTHER

Principal Investigators

• Anssi Auvinen, MD, PhD · Tampere University

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

63 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-04-23

Primary Completion

2037-12-31

Completion

2037-12-31

Countries

• Finland

Study Locations