Prostate CancerProScreenNCT03423303
A Randomized Trial of Early Detection of Clinically Significant Prostate Cancer (ProScreen)
A study testing Prostate cancer screening in people with Prostate Cancer, run by Tampere University at 2 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 63 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate cancer screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,400 participants
- Where
- 2 sitesFinland
- Study dates
- 23 Apr 2018to 31 Dec 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 63 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 50-63-year-old men (age in 2018) residing in Tampere or Helsinki
Who cannot join
- Prevalent prostate cancer
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites
Helsinki University and Helsinki University Hospital
Helsinki
University of Tampere
Tampere
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Prostate cancer screening
- Keywords
- Prostate cancer, Screening, Randomised trial, Kallikrein, Magnetic resonance imaging, Prostate-specific antigen
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate cancer screeningDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Screening arm | Experimental | Invitation to prostate cancer screening and questionnaires. Receives: Diagnostic Test: Prostate cancer screening |
| Control arm | No intervention | Registry-based follow-up and a questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 10 years of follow-up.
Secondary outcomes (3)
Prostate cancer (PrCa) mortality - secondary analysis
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.
Measured: At 10 years of follow-up.
Cumulative incidence of advanced (T3-T4 or M1) prostate cancer
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).
Measured: At approximately 5 years of follow-up.
Cumulative incidence of low-risk cancer (Gleason<7)
Intermediate outcomes include cumulative incidence of low-risk cancer (Gleason<7) as an indicator of overdiagnosis.
Measured: At approximately 5 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start23 Apr 2018
- Primary completion31 Dec 2037 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 17,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Tampere University Hospital, Finnish Cancer Registry, Finland, University of Turku, Lund University, Fimlab Laboratories, Finland, Laboratory HUSLAB, Finland, University of Helsinki, Hospital District of Helsinki and Uusimaa, Clinical Research Institute HUCH Ltd
- Responsible party
- Principal investigator, Anssi Auvinen, Tampere University
- Investigators
- Anssi Auvinen, MD, PhD, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423303
- Sponsor's protocol ID
- 2910/2017
- Acronym
- ProScreen
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2018
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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. doi: 10.1001/jama.2024.3841.
PubMed 38581254Nevalainen 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.
PubMed 38195170
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Population-Based Pragmatic Prostate Cancer Screening Trial Based on PSA, Kallikrein Panel, and MRI
- ClinicalTrials.gov ID
- NCT03423303
- Acronym / sponsor ID
- ProScreen / 2910/2017
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Screening, Randomised trial, Kallikrein, Magnetic resonance imaging, Prostate-specific antigen
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 17,400 participants (estimated)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Tampere University Hospital, Finnish Cancer Registry, Finland, University of Turku, Lund University, Fimlab Laboratories, Finland, Laboratory HUSLAB, Finland, University of Helsinki, Hospital District of Helsinki and Uusimaa, Clinical Research Institute HUCH Ltd
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 31 Dec 2037 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Screening arm | Experimental | Diagnostic Test: Prostate cancer screeningInvitation to prostate cancer screening and questionnaires. |
| Control arm | No intervention | –Registry-based follow-up and a questionnaire. |
Who may qualify
- Ages
- 50 to 63 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 50-63-year-old men (age in 2018) residing in Tampere or Helsinki
Key exclusion criteria (1 listed)
- Prevalent prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate cancer screeningDepending on each diagnostic test result the participants in the screening arm will undergo PSA-testing, 4Kscore determination, MRI, and MRI/US fusion biopsy only. | Diagnostic test | Screening arm |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Results publication: PubMed 38581254Auvinen 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.
- Derived from this study: PubMed 38195170Nevalainen 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.
- Website of the study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anssi Auvinen, MD, PhD principal investigator
Tampere University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate cancer screening in people with Prostate Cancer, run by Tampere University at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate cancer (PrCa) mortality (time frame: At 10 years of follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423303, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.