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

April 11, 2025 updated by: Anssi Auvinen, Tampere University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University and Helsinki University Hospital
      • Tampere, Finland
        • University of Tampere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 63 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Prevalent prostate cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Screening arm
Invitation to prostate cancer screening and questionnaires.
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.
No Intervention: Control arm
Registry-based follow-up and a questionnaire.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At 10 years of follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
At approximately 5 years of follow-up.
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.
At approximately 5 years of follow-up.
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.
At 10 years of follow-up.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
At 2, 4, and 6 years.
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).
At 2, 4, and 6 years.
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.
At 4 years.
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.
At 4 years.
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.
During the first year.
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.
During the first year.
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.
At 5 (cost analysis) and 10-15 (final analysis) years of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tampere University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lund University
Helsinki University Central Hospital
University of Turku
University of Helsinki
Tampere University Hospital
Hospital District of Helsinki and Uusimaa
Finnish Cancer Registry, Finland
Fimlab Laboratories, Finland
Laboratory HUSLAB, Finland
Clinical Research Institute HUCH Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anssi Auvinen, MD, PhD, Tampere University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2037

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2910/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be managed and made openly available with Finnish Social Science Data Archive (FSD) and publisher websites. The type of data includes numerical data, mainly counts, and continuous variables classified as categorical. The data will be uploaded in tabular form (as a data matrix). The data will be deidentified and supplied only as frequencies. The released data will be available under CC license for research purposes (accessible for registered users of FSD database). Citation of the original research is needed whenever used by third parties.

IPD Sharing Time Frame

The data wil be released after publication of the results (approximately 2032-).

IPD Sharing Access Criteria

CC license, FSD database registered users

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Study Data/Documents

  1. Statistical Analysis Plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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