Prostate Cancer Awareness and Initiative for Screening in the European Union
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 20,000
- Locations
- 5
- Primary Endpoint
- Compliance with risk assessment
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 69 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Compliance with risk assessment
Time Frame: 1 year
The proportion of individuals from the screened population undergoing risk assessment (as per protocol of the programme).
Tumour grade distribution
Time Frame: 1 year
Proportion of prostate cancers detected after positive screening test reported as ISUP grade (group) 1, 2, 3 and 4-5.
Crude Incidence rate
Time Frame: 1 year
The number of new cases of PCa arising in a specified population (expressed per 100,000) within a time frame of 12-months.\]
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
Opportunistic testing
Time Frame: 1 year
The proportion of individuals screened outside the population-based screening programme.
Participation rate
Time Frame: 1 year
The proportion of invited individuals who have undergone a screening test within a given time- frame following an active invitation.
PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)
Time Frame: 1 year
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).
False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)
Time Frame: 1 year
The proportion of screened individuals who received a positive screening result in which no clinically significant cancer was detected after workup and diagnostic procedures.
Detection rate of PCa
Time Frame: 1 year
The proportion of individuals with a screen positive test who underwent further assessment with histopathologically proven cancer detected \[expressed per 1,000 individuals screened\].
Complications in screening procedure
Time Frame: 1 year
The proportion of individuals reporting at least one complication incurred during the screening procedure.
Cause-specific mortality
Time Frame: 1 year
The mortality from prostate cancer (primary cause of death only) per 100,000 target population in a defined 12-month period
Examination coverage
Time Frame: 1 year
The proportion of eligible individuals from the target population who had the recommended screening test within a given time frame
Retention rate
Time Frame: 1 year
The proportion of eligible individuals re-screened after a negative screening within a specified interval.
Invitation coverage
Time Frame: 1 year
The proportion of eligible individuals from the target population personally invited for screening within a given time frame.
Test result
Time Frame: 1 year
The results of the screening test.
Compliance with further assessment
Time Frame: 1 year
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.
Compliance with treatment
Time Frame: 1 year
The proportion of individuals with cancer diagnosed within the screening program referred for treatment who initiated treatment (including active surveillance, when applicable).
Interval cancer rate
Time Frame: 1 year
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.
Compliance with biopsy
Time Frame: 1 year
Proportion of eligible men who underwent biopsy
Active surveillance
Time Frame: 1 year
The proportion of patients recommended AS due to low/low-intermediate risk PCa who accepted and initiated AS.
Delay time
Time Frame: 1 year
Time from PSA test sample collection to histopathological confirmation of a malignant diagnosis (further disaggregated by different procedures) to treatment initiation
Radiologist's assessment of MRI
Time Frame: 1 year
Radiologist's assessment of MRI
Secondary Outcomes
No secondary outcomes reported