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

NCT03423303 | Enrolling By Invitation DMC

• 1 other identifier: 2910/2017
• Study Type: interventional
• Target: 17,400
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Prostate cancer; Screening; Randomised trial; Kallikrein; Magnetic resonance imaging; Prostate-specific antigen

Outcome Measures

Primary Outcomes (1)

• Prostate cancer (PrCa) mortality

  An intention to screen analysis will be performed, with all men in the groups defined by random allocation, regardless of compliance. Follow-up starts at randomisation, and ends at death. Cox regression will be used with prostate cancer death as the outcome.

  At 10 years of follow-up.

Secondary Outcomes (3)

• Prostate cancer (PrCa) mortality - secondary analysis

  At 10 years of follow-up.

• Cumulative incidence of advanced (T3-T4 or M1) prostate cancer

  At approximately 5 years of follow-up.

• Cumulative incidence of low-risk cancer (Gleason<7)

  At approximately 5 years of follow-up.

Other Outcomes (7)

• Analysis of screening test performance - 4Kscore

  At 2, 4, and 6 years.

• Analysis of screening test performance - MRI

  At 2, 4, and 6 years.

• Assessment of health-related quality of life in men with prostate cancer

  At 4 years.

Study Arms (2)

Screening arm

EXPERIMENTAL

Invitation to prostate cancer screening and questionnaires.

Diagnostic Test: Prostate cancer screening

Control arm

NO INTERVENTION

Registry-based follow-up and a questionnaire.

Interventions

Prostate cancer screening DIAGNOSTIC_TEST

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.

Screening arm

Eligibility Criteria

• Age: 50 Years - 63 Years
• Gender Eligibility Details: Trial participants will be identified by the Finnish Population Register Centre.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• year-old men (age in 2018) residing in Tampere or Helsinki

You may not qualify if:

• Prevalent prostate cancer

Sponsors & Collaborators

• Tampere University: lead
• Helsinki University Central Hospital: collaborator
• Tampere University Hospital: collaborator
• Finnish Cancer Registry, Finland: collaborator
• University of Turku: collaborator
• Lund University: collaborator
• Fimlab Laboratories, Finland: collaborator
• Laboratory HUSLAB, Finland: collaborator
• University of Helsinki: collaborator
• Hospital District of Helsinki and Uusimaa: collaborator
• Clinical Research Institute HUCH Ltd: collaborator

Study Sites (2)

Helsinki University and Helsinki University Hospital

Helsinki, Finland

Location

University of Tampere

Tampere, Finland

Location

Related Publications (2)

• Auvinen A, Tammela TLJ, Mirtti T, Lilja H, Tolonen T, Kenttamies A, Rinta-Kiikka I, Lehtimaki T, Natunen K, Nevalainen J, Raitanen J, Ronkainen J, van der Kwast T, Riikonen J, Petas A, Matikainen M, Taari K, Kilpelainen T, Rannikko AS; ProScreen Trial Investigators. Prostate Cancer Screening With PSA, Kallikrein Panel, and MRI: The ProScreen Randomized Trial. JAMA. 2024 May 7;331(17):1452-1459. doi: 10.1001/jama.2024.3841.

  PMID: 38581254 RESULT

• Nevalainen J, Raitanen J, Natunen K, Kilpelainen T, Rannikko A, Tammela T, Auvinen A. Early detection of clinically significant prostate cancer: protocol summary and statistical analysis plan for the ProScreen randomised trial. BMJ Open. 2024 Jan 9;14(1):e075595. doi: 10.1136/bmjopen-2023-075595.

  PMID: 38195170 DERIVED

Related Links

• Website of the study.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Anssi Auvinen, MD, PhD

  Tampere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Of the 112,347 men aged 50-63 years resident in Helsinki and Tampere regions, a fourth will be randomised to screening and the rest to control arm (after exclusion of prevalent cases).

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 6, 2018
• Study Start: April 23, 2018
• Primary Completion (Estimated): December 31, 2037
• Study Completion (Estimated): December 31, 2037
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data wil be released after publication of the results (approximately 2032-).
• Access Criteria: CC license, FSD database registered users

Locations

FI (2)