Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424275
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-16
Brief Title:
Prostate Cancer Awareness and Initiative for Screening in the European Union
Sponsor:
European Association of Urology Research Foundation
Organization:
European Association of Urology Research Foundation
Study Overview
Official Title:
Prostate Cancer Awareness and Initiative for Screening in the European Union
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRAISE-U
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 harmbenefit 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 countrys 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 advancedmetastatic 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
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 advancedmetastatic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None