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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

20,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jun 2024

Geographic Reach

4 countries

5 active sites

Status

enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

May 16, 2024

Completed

6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed

10 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1.8 years

First QC Date

May 16, 2024

Last Update Submit

August 12, 2025

Conditions

Prostate Cancer

Keywords

prostate cancerearly detection of prostate cancercancer screeningrisk-based algorithm

Outcome Measures

Primary Outcomes (24)

Incidence of clinically significant prostate cancer in each pilot site (with clinically significant prostate cancer defined as ISUP grade group ≥2).
1 year
Invitation coverage
The proportion of eligible individuals from the target population personally invited for screening within a given time frame.
1 year
Examination coverage
The proportion of eligible individuals from the target population who had the recommended screening test within a given time frame
1 year
Participation rate
The proportion of invited individuals who have undergone a screening test within a given time- frame following an active invitation.
1 year
Retention rate
The proportion of eligible individuals re-screened after a negative screening within a specified interval.
1 year
Test result
The results of the screening test.
1 year
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
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
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
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
Compliance with risk assessment
The proportion of individuals from the screened population undergoing risk assessment (as per protocol of the programme).
1 year
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
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
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
Complications in screening procedure
The proportion of individuals reporting at least one complication incurred during the screening procedure.
1 year
Opportunistic testing
The proportion of individuals screened outside the population-based screening programme.
1 year
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
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
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
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
Radiologist's assessment of MRI
Radiologist's assessment of MRI
1 year
Compliance with biopsy
Proportion of eligible men who underwent biopsy
1 year
Active surveillance
The proportion of patients recommended AS due to low/low-intermediate risk PCa who accepted and initiated AS.
1 year
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