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Enrolling by Invitation

NCT Number: NCT03423303

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–63 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University and Helsinki University Hospital, Helsinki, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Prevalent prostate cancer

Treatment and study plan

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.

Primary outcomes

  1. Prostate cancer (PrCa) mortality

    Time frame: At 10 years of follow-up.

    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.

Secondary outcomes

  1. Prostate cancer (PrCa) mortality - secondary analysis

    Time frame: At 10 years of follow-up.

    A secondary analysis of prostate cancer mortality will be performed using instrumental variable/ Cuzick method with correction for contamination and selection bias due to non-compliance.

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

    Time frame: At approximately 5 years of follow-up.

    Intermediate outcomes include cumulative incidence of advanced (T3-T4 or M1) prostate cancer (number of cases relative to population size, not using incidence density to avoid the lead-time bias due to early detection by screening).

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

    Time frame: At approximately 5 years of follow-up.

    Intermediate outcomes include cumulative incidence of low-risk cancer (Gleason<7) as an indicator of overdiagnosis.

Other outcomes

  1. Analysis of screening test performance - 4Kscore

    Time frame: At 2, 4, and 6 years.

    Diagnostic performance of 4Kscore among men with PSA>3 in terms of predictive values, sensitivity, and specificity for clinically significant PrCa (defined as Gleason 7+ cancers - including those diagnosed within the next four years for test-negative non-biopsied men i.e. false negatives).

  2. Analysis of screening test performance - MRI

    Time frame: At 2, 4, and 6 years.

    Diagnostic performance of MRI based on PI-RADS v2 scores among men with PSA>3 and positive 4Kscore in terms of predictive values, sensitivity, and specificity for clinically significant PrCa (defined as Gleason 7+ cancers - including those diagnosed within the next four years for test-negative non-biopsied men i.e. false negatives).

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

    Time frame: At 4 years.

    Health-related quality of life among men diagnosed with prostate cancer will be assessed using the EPIC 26 instrument enrolling screen-detected and interval cases, as well as those diagnosed among non-participants and in the control arm.

  4. Assessment of short-term prostate cancer (PrCa)-specific anxiety

    Time frame: At 4 years.

    Anxiety among men diagnosed with prostate cancer will be assessed using the Memorial Anxiety Scale for Prostate Cancer (MAX-PC), enrolling screen-detected and interval cases, as well as those diagnosed among non-participants and in the control arm.

  5. Adverse effects of prostate biopsy immediately after the biopsy

    Time frame: During the first year.

    Adverse effects of biopsy are evaluated using a questionnaire on complications including assessment of bleeding, lower urinary tract symptoms (LUTS), erectile dysfunction (ED), pain, and antibiotic treatment immediately after the biopsy.

  6. Adverse effects of prostate biopsy 30 days after the biopsy

    Time frame: During the first year.

    Adverse effects of biopsy are evaluated with a questionnaire on complications, including assessment of bleeding, lower urinary tract symptoms (LUTS), erectile dysfunction (ED), pain, and antibiotic treatment 30 days after the biopsy.

  7. Cost analysis (incremental cost effectiveness ratio)

    Time frame: At 5 (cost analysis) and 10-15 (final analysis) years of follow-up.

    Economic evaluation will commence with cost analysis, and the final analysis of incremental cost effectiveness ratio (with a decision analysis) will be conducted once data on both long-term cost and real outcome data on both utilities (quality-adjusted life-years) and mortality are available.

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ProScreen

Important dates

Study start
2018
Primary completion
2037
Study completion
2037
First posted
Feb 6, 2018
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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