Prostate Cancer Awareness and Initiative for Screening in the European Union — PRAISE-U  

Prostate Cancer Clinical Trial

Official title: Prostate Cancer Awareness and Initiative for Screening in the European Union

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT06424275
• Study type: Observational
• Source: European Association of Urology Research Foundation
• Contact: Vera Vasilyeva
• Phone: 31622973853
• Email: v.vasilyeva@uroweb.org
• Status: Not yet recruiting
• Start date: June 1, 2024
• Completion date: April 1, 2026