Clinical trial NCT06424275: Prostate Cancer Awareness and Initiative for Screening in the European Union
Official title: Prostate Cancer Awareness and Initiative for Screening in the European Union
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Keywords: prostate cancer
early detection of prostate cancer
cancer screening
risk-based algorithm
Lead sponsor: European Association of Urology Research Foundation
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: European Randomised Study of Screening for Prostate Cancer
name: Region MidtJylland Denmark
name: Institute of Health Information and Statistics of the Czech Republic
name: UMC Utrecht
name: EUROPEAN CANCER ORGANISATION
name: Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
name: Narodowy Instytut Zdrowia Publicznego
name: Conselleria de Sanidade de Galicia
name: Althaia Xarxa Assistencial Universitària de Manresa
name: Vastra Gotaland Region
name: Region Skane
name: National Cancer Institute (NCI)
name: University Ghent
name: Health Service Executive, Ireland
name: Estonian Urological Association
name: University College Dublin
name: WONCA Europe
name: Movember Foundation
name: International Agency for Research on Cancer
name: European Society of Urogenital Radiology
name: Europa UOMO
name: Czech Urological Society
First posted: 2024-05-22
Enrollment: 20000
Sex: MALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy men aged 50-69 years old.

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age 50-69 years old.

Exclusion Criteria:

* Previous diagnosis of prostate cancer.
* Unable to provide written informed consent.
* Had prostate biopsy or MRI within the past six months.

Primary outcomes:
measure: Incidence of clinically significant prostate cancer in each pilot site (with clinically significant prostate cancer defined as ISUP grade group ≥2).
timeFrame: 1 year
measure: Invitation coverage
timeFrame: 1 year
measure: Examination coverage
timeFrame: 1 year
measure: Participation rate
timeFrame: 1 year
measure: Retention rate
timeFrame: 1 year
measure: Test result
timeFrame: 1 year
measure: PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
timeFrame: 1 year
measure: PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
timeFrame: 1 year
measure: False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
timeFrame: 1 year
measure: False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
timeFrame: 1 year
measure: Compliance with risk assessment
timeFrame: 1 year
measure: Compliance with further assessment
timeFrame: 1 year
measure: Detection rate of PCa
timeFrame: 1 year
measure: Compliance with treatment
timeFrame: 1 year
measure: Complications in screening procedure
timeFrame: 1 year
measure: Opportunistic testing
timeFrame: 1 year
measure: Cause-specific mortality
timeFrame: 1 year
measure: Crude Incidence rate
timeFrame: 1 year
measure: Interval cancer rate
timeFrame: 1 year
measure: Delay time
timeFrame: 1 year
measure: Radiologist's assessment of MRI
timeFrame: 1 year
measure: Compliance with biopsy
timeFrame: 1 year
measure: Active surveillance
timeFrame: 1 year
measure: Tumour grade distribution
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
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Study officials:
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