Prostate Cancer Awareness and Initiative for Screening in the European Union (PRAISE-U)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Dublin, Ireland
- University College Dublin
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Vilnius, Lithuania
- National Cancer Institute
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Lower Silesia
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Wrocław, Lower Silesia, Poland
- Lower Silesian Oncology, Pulmonology and Hematology Center
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Manresa, Spain
- Althaia Foundation
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Galicia
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Santiago De Compostela, Galicia, Spain
- Public Health Directorate, SERGAS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Manresa, Spain
The pilot is run by the Althaia Foundation, driven by the director of primary care.
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Risk-based screening algorithm
Other Names:
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Region Galicia, Spain
The pilot is run by the Galician Healthcare Service (SERGAS), publicly funded healthcare system of Galicia, Spain.
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Risk-based screening algorithm
Other Names:
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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
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Risk-based screening algorithm
Other Names:
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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.
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Risk-based screening algorithm
Other Names:
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Lithuania
The pilot is run by the National Cancer Institute, where residents of the capital Vilnius region are served.
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Risk-based screening algorithm
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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1 year
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Invitation coverage
Time Frame: 1 year
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The proportion of eligible individuals from the target population personally invited for screening within a given time frame.
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1 year
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Examination coverage
Time Frame: 1 year
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The proportion of eligible individuals from the target population who had the recommended screening test within a given time frame
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1 year
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Participation rate
Time Frame: 1 year
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The proportion of invited individuals who have undergone a screening test within a given time- frame following an active invitation.
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1 year
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Retention rate
Time Frame: 1 year
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The proportion of eligible individuals re-screened after a negative screening within a specified interval.
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1 year
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Test result
Time Frame: 1 year
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The results of the screening test.
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1 year
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PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
Time Frame: 1 year
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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)
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1 year
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PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
Time Frame: 1 year
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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). |
1 year
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False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
Time Frame: 1 year
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The proportion of screened individuals who received a positive screening result in which no cancer was detected after workup and diagnostic procedures.
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1 year
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False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
Time Frame: 1 year
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The proportion of screened individuals who received a positive screening result in which no clinically significant cancer was detected after workup and diagnostic procedures.
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1 year
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Compliance with risk assessment
Time Frame: 1 year
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The proportion of individuals from the screened population undergoing risk assessment (as per protocol of the programme).
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1 year
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Compliance with further assessment
Time Frame: 1 year
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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.
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1 year
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Detection rate of PCa
Time Frame: 1 year
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The proportion of individuals with a screen positive test who underwent further assessment with histopathologically proven cancer detected [expressed per 1,000 individuals screened].
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1 year
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Compliance with treatment
Time Frame: 1 year
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The proportion of individuals with cancer diagnosed within the screening program referred for treatment who initiated treatment (including active surveillance, when applicable).
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1 year
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Complications in screening procedure
Time Frame: 1 year
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The proportion of individuals reporting at least one complication incurred during the screening procedure.
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1 year
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Opportunistic testing
Time Frame: 1 year
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The proportion of individuals screened outside the population-based screening programme.
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1 year
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Cause-specific mortality
Time Frame: 1 year
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The mortality from prostate cancer (primary cause of death only) per 100,000 target population in a defined 12-month period
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1 year
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Crude Incidence rate
Time Frame: 1 year
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The number of new cases of PCa arising in a specified population (expressed per 100,000) within a time frame of 12-months.]
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1 year
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Interval cancer rate
Time Frame: 1 year
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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.
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1 year
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Delay time
Time Frame: 1 year
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Time from PSA test sample collection to histopathological confirmation of a malignant diagnosis (further disaggregated by different procedures) to treatment initiation
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1 year
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Radiologist's assessment of MRI
Time Frame: 1 year
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Radiologist's assessment of MRI
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1 year
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Compliance with biopsy
Time Frame: 1 year
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Proportion of eligible men who underwent biopsy
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1 year
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Active surveillance
Time Frame: 1 year
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The proportion of patients recommended AS due to low/low-intermediate risk PCa who accepted and initiated AS.
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1 year
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Tumour grade distribution
Time Frame: 1 year
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Proportion of prostate cancers detected after positive screening test reported as ISUP grade (group) 1, 2, 3 and 4-5.
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1 year
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Hendrik Van Poppel, Prof, European Association of Urology and KULeuven
- Principal Investigator: Monique J Roobol, Prof, Erasmus MC Cancer Institute Dep of Urology and European Association of Urology
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101101217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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