Prostate CancerPRAISE-UNCT06424275
Prostate Cancer Awareness and Initiative for Screening in the European Union
An observational study of Prostate Cancer, run by European Association of Urology Research Foundation at 5 sites in 4 countries.
Trial summary
PRAISE-U was initiated on the 1st of April 2023 and is set to last for three years. This collaborative effort involves 25 institutions across 12 countries, all driven by a shared objective: to rationalize prostate cancer screening in Europe and enhance patient outcomes. Read more about this study
- Who is it for?
- Ages 50 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Risk-based screening algorithm
- How many people
- 20,000 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Jun 2024to 1 Apr 2026
- Phase
- Observational
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 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy men aged 50-69 years old.
Who may be able to join
- Age 50-69 years old.
Who cannot join
- Previous diagnosis of prostate cancer.
- Unable to provide written informed consent.
- Had prostate biopsy or MRI within the past six months.
Trial locations and contacts
5 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 4 countries
Spain2 sites
Althaia Foundation
Manresa
Public Health Directorate, SERGAS
Santiago de Compostela, Galicia
Poland1 site
Lower Silesian Oncology, Pulmonology and Hematology Center
Wroclaw, Lower Silesian Voivodeship
About this study
PRAISE-U was initiated on the 1st of April 2023 and is set to last for three years. This collaborative effort involves 25 institutions across 12 countries, all driven by a shared objective: to rationalize prostate cancer screening in Europe and enhance patient outcomes. PRAISE-U advocates for EU member states to offer exceptional clinical standards, incorporating cutting-edge personalized approaches to enable timely detection of prostate cancer in individuals who can benefit from early treatment. To assess the functionality, feasibility, and long-term viability of a risk-based algorithm, the consortium will collaborate with pilot sites in Spain, Poland, Ireland, and Lithuania.
Read the detailed description
The project has several key deliverables that are instrumental in its success. In the early phase of the project, the consortium will prepare a living state-of-play document - a comprehensive review of diverse screening strategies for prostate cancer in the EU, as well their harm/benefit and cost effectiveness. At a later stage, clinical performance indicators of screening effectiveness will be established, and a protocol for implementation of population-based quality assured prostate cancer screening program will be developed. While the protocol will follow a standardized approach, it will also allow for flexibility to accommodate the unique characteristics of each country's healthcare system. The pilot studies will run for 12 months, and all collected data will be used to estimate pre-defined key performance indicators that will be included in the final report. This deliverable will be used to perform a thorough evaluation of how well the screening program worked during the pilot phase and how site characteristics and diagnostic algorithms are associated with performance. The reach, acceptability, and adoption of the screening programme, its cost-effectiveness, as well as attitudes of participants and physicians, will be the research outcomes of interest.
The project aims to have short-term and long-term effects on prostate cancer screening in EU member states. In the short-term (1-3 years), the focus is on advancing population-based risk-adapted prostate cancer screening and increasing awareness among key stakeholders. This will be achieved by providing evidence-based information on the benefits and drawbacks of risk-adapted screening, leading to improved knowledge and future endorsement by healthcare professionals. In the medium-term (4-9 years), the goal is to reduce costs by eliminating ineffective opportunistic screening and implementing an organized risk-based screening algorithm. Ultimately, in the long-term (10+ years), the project aims to decrease the burden of prostate cancer and improve quality of life by reducing mortality rates and the number of advanced/metastatic cases through effective screening practices. PRAISE-U is an important step in assessing how screening for prostate cancer may reduce the burden of the disease for every man in the European Union.
- Conditions
- Prostate Cancer
- Being tested
- Risk-based screening algorithm
- Keywords
- prostate cancer, early detection of prostate cancer, cancer screening, risk-based algorithm
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-based screening algorithmDiagnostic test
Also called PSA, Risk calculator, MRI, Biopsy
Risk-based screening algorithm
| Study group | Role | What they receive |
|---|---|---|
| Manresa, Spain | The pilot is run by the Althaia Foundation, driven by the director of primary care. Receives: Diagnostic Test: Risk-based screening algorithm | |
| Region Galicia, Spain | The pilot is run by the Galician Healthcare Service (SERGAS), publicly funded healthcare system of Galicia, Spain. Receives: Diagnostic Test: Risk-based screening algorithm | |
| Ireland | The pilot is run by the Health Service Executive, with University College Dublin as the academic institutional partner, in full support of the National Cancer Control programme (NCCP) and the National Screening Service (NSS) in Ireland Receives: Diagnostic Test: Risk-based screening algorithm | |
| Poland | The pilot is run by the Lower Silesian Oncology, Pulmonology and Haematology Center. Subdivision of Urology with support from the National Institute of Public Health. Receives: Diagnostic Test: Risk-based screening algorithm | |
| Lithuania | The pilot is run by the National Cancer Institute, where residents of the capital Vilnius region are served. Receives: Diagnostic Test: Risk-based screening algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically significant prostate cancer in each pilot site (with clinically significant prostate cancer defined as ISUP grade group ≥2).
Measured: 1 year
Invitation coverage
The proportion of eligible individuals from the target population personally invited for screening within a given time frame.
Measured: 1 year
Examination coverage
The proportion of eligible individuals from the target population who had the recommended screening test within a given time frame
Measured: 1 year
Participation rate
The proportion of invited individuals who have undergone a screening test within a given time- frame following an active invitation.
Measured: 1 year
Retention rate
The proportion of eligible individuals re-screened after a negative screening within a specified interval.
Measured: 1 year
Test result
The results of the screening test.
Measured: 1 year
PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
The proportion of individuals who have histopathology confirmed PCa to all those who had positive test results (with PSA result of >3 ng/ml) (including healthy subjects who were incorrectly diagnosed to have prostate cancer)
Measured: 1 year
PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
The proportion of individuals who have histopathologically confirmed clinically significant PCa to all those who had positive test results (with PSA result of >3 ng/ml)
(including healthy subjects who were incorrectly diagnosed as clinically significant PCa).
Measured: 1 year
False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
The proportion of screened individuals who received a positive screening result in which no cancer was detected after workup and diagnostic procedures.
Measured: 1 year
False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
The proportion of screened individuals who received a positive screening result in which no clinically significant cancer was detected after workup and diagnostic procedures.
Measured: 1 year
Compliance with risk assessment
The proportion of individuals from the screened population undergoing risk assessment (as per protocol of the programme).
Measured: 1 year
Compliance with further assessment
The proportion of individuals referred for diagnostic work up based on elevated PSA and risk assessment (as per protocol of the programme) attending all workup and diagnostic procedures assigned.
Measured: 1 year
Detection rate of PCa
The proportion of individuals with a screen positive test who underwent further assessment with histopathologically proven cancer detected [expressed per 1,000 individuals screened].
Measured: 1 year
Compliance with treatment
The proportion of individuals with cancer diagnosed within the screening program referred for treatment who initiated treatment (including active surveillance, when applicable).
Measured: 1 year
Complications in screening procedure
The proportion of individuals reporting at least one complication incurred during the screening procedure.
Measured: 1 year
Opportunistic testing
The proportion of individuals screened outside the population-based screening programme.
Measured: 1 year
Cause-specific mortality
The mortality from prostate cancer (primary cause of death only) per 100,000 target population in a defined 12-month period
Measured: 1 year
Crude Incidence rate
The number of new cases of PCa arising in a specified population (expressed per 100,000) within a time frame of 12-months.]
Measured: 1 year
Interval cancer rate
The proportion of individuals with a negative screening test or a positive screening test but negative further assessment results who were diagnosed with prostate cancer prior to the next screening round.
Measured: 1 year
Delay time
Time from PSA test sample collection to histopathological confirmation of a malignant diagnosis (further disaggregated by different procedures) to treatment initiation
Measured: 1 year
Radiologist's assessment of MRI
Radiologist's assessment of MRI
Measured: 1 year
Compliance with biopsy
Proportion of eligible men who underwent biopsy
Measured: 1 year
Active surveillance
The proportion of patients recommended AS due to low/low-intermediate risk PCa who accepted and initiated AS.
Measured: 1 year
Tumour grade distribution
Proportion of prostate cancers detected after positive screening test reported as ISUP grade (group) 1, 2, 3 and 4-5.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jun 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Association of Urology Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, European Randomised Study of Screening for Prostate Cancer, Region MidtJylland Denmark, Institute of Health Information and Statistics of the Czech Republic, UMC Utrecht, EUROPEAN CANCER ORGANISATION, Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii, Narodowy Instytut Zdrowia Publicznego, Conselleria de Sanidade de Galicia, Althaia Xarxa Assistencial Universitària de Manresa, Vastra Gotaland Region, Region Skane, National Cancer Institute (NCI), University Ghent, Health Service Executive, Ireland, Estonian Urological Association, University College Dublin, WONCA Europe, Movember Foundation, International Agency for Research on Cancer, European Society of Urogenital Radiology, Europa UOMO, Czech Urological Society
- Responsible party
- Sponsor
- Investigators
- Hendrik Van Poppel, Prof, Study director, European Association of Urology and KULeuvenMonique J Roobol, Prof, Principal investigator, Erasmus MC Cancer Institute Dep of Urology and European Association of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424275
- Sponsor's protocol ID
- 101101217
- Acronym
- PRAISE-U
- Status last verified
- Aug 2025
- First submitted
- 16 May 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Patient Data data sharing is not foreseen in the informed consent form, however, de-identified patient data will be shared for research purposes.
Publications
Palaniraja S, Mosquera I, Carvalho AL, Singh D, Vilaseca J, Patasius A, Tupikowski K, Amorin AG, Tarrazo Antelo AM, Quinteiro MC, Galvin D, van den Bergh R, Roobol MJ, FrancellaVenderbos LD, Collen S, van Poppel H, Basu P, Chandran A; PRAISE-U consortiuml; PRAISE-U consortium. Mapping the readiness landscape for prostate cancer screening in Europe: analysis of health system capacity across the PRAISE-U pilots. EClinicalMedicine. 2026 Aug 6;99:104093. doi: 10.1016/j.eclinm.2026.104093. eCollection 2026 Sep.
PubMed 42802883