Prostate Cancer Awareness and Initiative for Screening in the European Union

Prostate Cancer Clinical Trial

— PRAISE-U  

Official title:

Prostate Cancer Awareness and Initiative for Screening in the European Union

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424275
• Other study ID #: 101101217
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: May 2024
• Source: European Association of Urology Research Foundation
• Contact: Vera Vasilyeva
• Phone: 31622973853
• Email: v.vasilyeva[@]uroweb.org
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Risk-based screening algorithm
Risk-based screening algorithm

Locations

Country	Name	City	State
n/a

Sponsors (24)

Lead Sponsor

Collaborator

European Association of Urology Research Foundation

Althaia Xarxa Assistencial Universitària de Manresa, Conselleria de Sanidade de Galicia, Czech Urological Society, Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii, Erasmus Medical Center, Estonian Urological Association, Europa UOMO, EUROPEAN CANCER ORGANISATION, European Randomised Study of Screening for Prostate Cancer, European Society of Urogenital Radiology, Health Service Executive, Ireland, Institute of Health Information and Statistics of the Czech Republic, International Agency for Research on Cancer, Movember Foundation, Narodowy Instytut Zdrowia Publicznego, National Cancer Institute (NCI), Region MidtJylland Denmark, Region Skane, UMC Utrecht, University College Dublin, University Ghent, Vastra Gotaland Region, WONCA Europe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of clinically significant prostate cancer in each pilot site (with clinically significant prostate cancer defined as ISUP grade group =2).		1 year
Primary	Invitation coverage	The proportion of eligible individuals from the target population personally invited for screening within a given time frame.	1 year
Primary	Examination coverage	The proportion of eligible individuals from the target population who had the recommended screening test within a given time frame	1 year
Primary	Participation rate	The proportion of invited individuals who have undergone a screening test within a given time- frame following an active invitation.	1 year
Primary	Retention rate	The proportion of eligible individuals re-screened after a negative screening within a specified interval.	1 year
Primary	Test result	The results of the screening test.	1 year
Primary	PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)	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)	1 year
Primary	PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)	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
Primary	False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)	The proportion of screened individuals who received a positive screening result in which no cancer was detected after workup and diagnostic procedures.	1 year
Primary	False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)	The proportion of screened individuals who received a positive screening result in which no clinically significant cancer was detected after workup and diagnostic procedures.	1 year
Primary	Compliance with risk assessment	The proportion of individuals from the screened population undergoing risk assessment (as per protocol of the programme).	1 year
Primary	Compliance with further assessment	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.	1 year
Primary	Detection rate of PCa	The proportion of individuals with a screen positive test who underwent further assessment with histopathologically proven cancer detected [expressed per 1,000 individuals screened].	1 year
Primary	Compliance with treatment	The proportion of individuals with cancer diagnosed within the screening program referred for treatment who initiated treatment (including active surveillance, when applicable).	1 year
Primary	Complications in screening procedure	The proportion of individuals reporting at least one complication incurred during the screening procedure.	1 year
Primary	Opportunistic testing	The proportion of individuals screened outside the population-based screening programme.	1 year
Primary	Cause-specific mortality	The mortality from prostate cancer (primary cause of death only) per 100,000 target population in a defined 12-month period	1 year
Primary	Crude Incidence rate	The number of new cases of PCa arising in a specified population (expressed per 100,000) within a time frame of 12-months.]	1 year
Primary	Interval cancer rate	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.	1 year
Primary	Delay time	Time from PSA test sample collection to histopathological confirmation of a malignant diagnosis (further disaggregated by different procedures) to treatment initiation	1 year
Primary	Radiologist's assessment of MRI	Radiologist's assessment of MRI	1 year
Primary	Compliance with biopsy	Proportion of eligible men who underwent biopsy	1 year
Primary	Active surveillance	The proportion of patients recommended AS due to low/low-intermediate risk PCa who accepted and initiated AS.	1 year
Primary	Tumour grade distribution	Proportion of prostate cancers detected after positive screening test reported as ISUP grade (group) 1, 2, 3 and 4-5.	1 year