Prostate Cancer Awareness and Initiative for Screening in the European Union

Condition(s) studied

Investigational drug(s) / intervention(s)

Risk-based screening algorithm: Risk-based screening algorithm

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (5)

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