Clinical trial · Interventional
A Randomized Trial of Early Detection of Clinically Significant Prostate Cancer (ProScreen)
Randomized Population-Based Pragmatic Prostate Cancer Screening Trial Based on PSA, Kallikrein Panel, and MRI
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate cancer screening | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Screening arm
- description
- Invitation to prostate cancer screening and questionnaires.
- interventionNames
- Diagnostic Test: Prostate cancer screening
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Registry-based follow-up and a questionnaire.
Primary outcomes (1)
- measure
- Prostate cancer (PrCa) mortality
- timeFrame
- At 10 years of follow-up.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 63 Years
Show eligibility criteria text
Inclusion Criteria: * 50-63-year-old men (age in 2018) residing in Tampere or Helsinki Exclusion Criteria: * Prevalent prostate cancer
References
Publications (2)
- RESULTAuvinen 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
- DERIVEDNevalainen 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