An observational study in Prostate Cancer, sponsored by European Association of Urology Research Foundation. Enrolling by invitation at 5 sites in 4 countries. Open to male participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by European Association of Urology Research Foundation · Observational
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →European Association of Urology Research Foundation is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy men aged 50-69 years old.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The pilot is run by the Althaia Foundation, driven by the director of primary care.
Diagnostic Test: Risk-based screening algorithm
The pilot is run by the Galician Healthcare Service (SERGAS), publicly funded healthcare system of Galicia, Spain.
Diagnostic Test: Risk-based screening algorithm
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
Diagnostic Test: Risk-based screening algorithm
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.
Diagnostic Test: Risk-based screening algorithm
The pilot is run by the National Cancer Institute, where residents of the capital Vilnius region are served.
Diagnostic Test: Risk-based screening algorithm
Risk-based screening algorithm
Also known as: PSA, Risk calculator, MRI, Biopsy
Incidence of clinically significant prostate cancer in each pilot site (with clinically significant prostate cancer defined as ISUP grade group ≥2).
Time frame: 1 year
Invitation coverage
The proportion of eligible individuals from the target population personally invited for screening within a given time frame.
Time frame: 1 year
Examination coverage
The proportion of eligible individuals from the target population who had the recommended screening test within a given time frame
Time frame: 1 year
Participation rate
The proportion of invited individuals who have undergone a screening test within a given time- frame following an active invitation.
Time frame: 1 year
Retention rate
The proportion of eligible individuals re-screened after a negative screening within a specified interval.
Time frame: 1 year
Test result
The results of the screening test.
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Compliance with risk assessment
The proportion of individuals from the screened population undergoing risk assessment (as per protocol of the programme).
Time frame: 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.
Time frame: 1 year
Detection rate of PCa
The proportion of individuals with a screen positive test who underwent further assessment with histopathologically proven cancer detected \[expressed per 1,000 individuals screened\].
Time frame: 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).
Time frame: 1 year
Complications in screening procedure
The proportion of individuals reporting at least one complication incurred during the screening procedure.
Time frame: 1 year
Opportunistic testing
The proportion of individuals screened outside the population-based screening programme.
Time frame: 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
Time frame: 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.\]
Time frame: 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.
Time frame: 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
Time frame: 1 year
Radiologist's assessment of MRI
Radiologist's assessment of MRI
Time frame: 1 year
Compliance with biopsy
Proportion of eligible men who underwent biopsy
Time frame: 1 year
Active surveillance
The proportion of patients recommended AS due to low/low-intermediate risk PCa who accepted and initiated AS.
Time frame: 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.
Time frame: 1 year
Plan to share: 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.
Started Jun 2024 (actual). Primary completion is estimated for Apr 2026, 22 months after the start.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 22 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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European Association of Urology Research Foundation