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Enrolling by invitation NCT03423303

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

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prostate cancer screening.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 50 years — 63 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Randomized Population-Based Pragmatic Prostate Cancer Screening Trial Based on PSA, Kallikrein Panel, and MRI

Overview

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.

Detailed description

Frequent adverse effects have so far tipped the balance of benefits and harms against prostate cancer screening, and therefore the investigators will focus on employing the best possible means for reducing them. The project introduces a novel concept for PC screening that minimises overdiagnosis and overtreatment, while retaining the mortality benefit to shift the balance of screening benefits and harms to a favourable net effect. The strategy for implementation as a randomised screening trial utilises three levels of risk assessment (PSA, kallikrein panel and MRI) before the diagnostic procedure (prostate biopsy), each aimed at eliminating detection of indolent disease. The study hypothesis is that by virtue of the novel three-tiered screening algorithm, the beneficial screening effect (prostate cancer mortality reduction) can be retained, while the overdiagnosis can be largely eliminated. The impact of an integrative approach has never been evaluated - each of the methods has only been assessed in isolation. The breakthrough potential of the proposal lies in combining the three novel approaches and taking them to the forefront of applied research through a randomised trial. The key impact of the study is in defining whether the overall balance of benefits and harms of prostate cancer screening can be reversed by applying the best possible methods to detect only clinically important disease. If the study hypothesis is affirmed, it opens the way to introduction of prostate cancer screening. If the balance of harms and benefits is still unfavourable, the problem of overdiagnosis in prostate cancer may be intractable.

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.

Primary outcome measures

  • Prostate cancer (PrCa) mortality [Time frame: At 10 years of follow-up.]
Secondary outcome measures (3)
  • Prostate cancer (PrCa) mortality - secondary analysis [Time frame: At 10 years of follow-up.]
  • Cumulative incidence of advanced (T3-T4 or M1) prostate cancer [Time frame: At approximately 5 years of follow-up.]
  • Cumulative incidence of low-risk cancer (Gleason<7) [Time frame: At approximately 5 years of follow-up.]

Eligibility criteria

Inclusion criteria

  • 50-63-year-old men (age in 2018) residing in Tampere or Helsinki

Exclusion criteria

  • Prevalent prostate cancer

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

Finland · 2 centers
  • Helsinki University and Helsinki University Hospital — Helsinki
  • University of Tampere — Tampere

Publications

  • 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. do PMID 38581254
  • 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

Identifiers

NCT: NCT03423303 · 2910/2017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗