## Protocol Section
### Identification Module
**NCT ID:** NCT06424275

**Acronym:** PRAISE-U

**Brief Title:** Prostate Cancer Awareness and Initiative for Screening in the European Union

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

#### Organization Study ID Info
**ID:** 101101217
#### Organization
**Class:** OTHER
**Full Name:** European Association of Urology Research Foundation
### Status Module
#### Completion Date
**Date:** 2026-04-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Erasmus Medical Center

**Class:** UNKNOWN

**Name:** European Randomised Study of Screening for Prostate Cancer

**Class:** OTHER

**Name:** Region MidtJylland Denmark

**Class:** OTHER_GOV

**Name:** Institute of Health Information and Statistics of the Czech Republic

**Class:** OTHER

**Name:** UMC Utrecht

**Class:** UNKNOWN

**Name:** EUROPEAN CANCER ORGANISATION

**Class:** UNKNOWN

**Name:** Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

**Class:** UNKNOWN

**Name:** Narodowy Instytut Zdrowia Publicznego

**Class:** UNKNOWN

**Name:** Conselleria de Sanidade de Galicia

**Class:** OTHER

**Name:** Althaia Xarxa Assistencial Universitària de Manresa

**Class:** OTHER_GOV

**Name:** Vastra Gotaland Region

**Class:** OTHER

**Name:** Region Skane

**Class:** NIH

**Name:** National Cancer Institute (NCI)

**Class:** OTHER

**Name:** University Ghent

**Class:** OTHER

**Name:** Health Service Executive, Ireland

**Class:** UNKNOWN

**Name:** Estonian Urological Association

**Class:** OTHER

**Name:** University College Dublin

**Class:** UNKNOWN

**Name:** WONCA Europe

**Class:** OTHER

**Name:** Movember Foundation

**Class:** OTHER

**Name:** International Agency for Research on Cancer

**Class:** OTHER

**Name:** European Society of Urogenital Radiology

**Class:** UNKNOWN

**Name:** Europa UOMO

**Class:** UNKNOWN

**Name:** Czech Urological Society

#### Lead Sponsor

**Class:** OTHER

**Name:** European Association of Urology Research Foundation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 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.

### Conditions Module

**Conditions:**

- Prostate Cancer

**Keywords:**

- prostate cancer

- early detection of prostate cancer

- cancer screening

- risk-based algorithm

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The pilot is run by the Althaia Foundation, driven by the director of primary care.

**Intervention Names:**

- Diagnostic Test: Risk-based screening algorithm

**Label:** Manresa, Spain

#### Arm Group 2

**Description:** The pilot is run by the Galician Healthcare Service (SERGAS), publicly funded healthcare system of Galicia, Spain.

**Intervention Names:**

- Diagnostic Test: Risk-based screening algorithm

**Label:** Region Galicia, Spain

#### Arm Group 3

**Description:** The pilot is run by the Health Service Executive, with University College Dublin as the academic institutional partner, in full support of the National Cancer Control programme (NCCP) and the National Screening Service (NSS) in Ireland

**Intervention Names:**

- Diagnostic Test: Risk-based screening algorithm

**Label:** Ireland

#### Arm Group 4

**Description:** The pilot is run by the Lower Silesian Oncology, Pulmonology and Haematology Center. Subdivision of Urology with support from the National Institute of Public Health.

**Intervention Names:**

- Diagnostic Test: Risk-based screening algorithm

**Label:** Poland

#### Arm Group 5

**Description:** The pilot is run by the National Cancer Institute, where residents of the capital Vilnius region are served.

**Intervention Names:**

- Diagnostic Test: Risk-based screening algorithm

**Label:** Lithuania

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ireland

- Lithuania

- Manresa, Spain

- Poland

- Region Galicia, Spain

**Description:** Risk-based screening algorithm

**Name:** Risk-based screening algorithm

**Other Names:**

- PSA

- Risk calculator

- MRI

- Biopsy

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of clinically significant prostate cancer in each pilot site (with clinically significant prostate cancer defined as ISUP grade group ≥2).

**Time Frame:** 1 year

**Description:** The proportion of eligible individuals from the target population personally invited for screening within a given time frame.

**Measure:** Invitation coverage

**Time Frame:** 1 year

**Description:** The proportion of eligible individuals from the target population who had the recommended screening test within a given time frame

**Measure:** Examination coverage

**Time Frame:** 1 year

**Description:** The proportion of invited individuals who have undergone a screening test within a given time- frame following an active invitation.

**Measure:** Participation rate

**Time Frame:** 1 year

**Description:** The proportion of eligible individuals re-screened after a negative screening within a specified interval.

**Measure:** Retention rate

**Time Frame:** 1 year

**Description:** The results of the screening test.

**Measure:** Test result

**Time Frame:** 1 year

**Description:** 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)

**Measure:** PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)

**Time Frame:** 1 year

**Description:** 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).

**Measure:** PPV of screening test to detect any prostate cancer (6.1) and clinically significant prostate cancers (6.2)

**Time Frame:** 1 year

**Description:** The proportion of screened individuals who received a positive screening result in which no cancer was detected after workup and diagnostic procedures.

**Measure:** False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)

**Time Frame:** 1 year

**Description:** The proportion of screened individuals who received a positive screening result in which no clinically significant cancer was detected after workup and diagnostic procedures.

**Measure:** False positive rate to detect any PCa (7.1) and clinically significant PCa (7.2)

**Time Frame:** 1 year

**Description:** The proportion of individuals from the screened population undergoing risk assessment (as per protocol of the programme).

**Measure:** Compliance with risk assessment

**Time Frame:** 1 year

**Description:** 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.

**Measure:** Compliance with further assessment

**Time Frame:** 1 year

**Description:** The proportion of individuals with a screen positive test who underwent further assessment with histopathologically proven cancer detected \[expressed per 1,000 individuals screened\].

**Measure:** Detection rate of PCa

**Time Frame:** 1 year

**Description:** The proportion of individuals with cancer diagnosed within the screening program referred for treatment who initiated treatment (including active surveillance, when applicable).

**Measure:** Compliance with treatment

**Time Frame:** 1 year

**Description:** The proportion of individuals reporting at least one complication incurred during the screening procedure.

**Measure:** Complications in screening procedure

**Time Frame:** 1 year

**Description:** The proportion of individuals screened outside the population-based screening programme.

**Measure:** Opportunistic testing

**Time Frame:** 1 year

**Description:** The mortality from prostate cancer (primary cause of death only) per 100,000 target population in a defined 12-month period

**Measure:** Cause-specific mortality

**Time Frame:** 1 year

**Description:** The number of new cases of PCa arising in a specified population (expressed per 100,000) within a time frame of 12-months.\]

**Measure:** Crude Incidence rate

**Time Frame:** 1 year

**Description:** 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.

**Measure:** Interval cancer rate

**Time Frame:** 1 year

**Description:** Time from PSA test sample collection to histopathological confirmation of a malignant diagnosis (further disaggregated by different procedures) to treatment initiation

**Measure:** Delay time

**Time Frame:** 1 year

**Description:** Radiologist's assessment of MRI

**Measure:** Radiologist's assessment of MRI

**Time Frame:** 1 year

**Description:** Proportion of eligible men who underwent biopsy

**Measure:** Compliance with biopsy

**Time Frame:** 1 year

**Description:** The proportion of patients recommended AS due to low/low-intermediate risk PCa who accepted and initiated AS.

**Measure:** Active surveillance

**Time Frame:** 1 year

**Description:** Proportion of prostate cancers detected after positive screening test reported as ISUP grade (group) 1, 2, 3 and 4-5.

**Measure:** Tumour grade distribution

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 69 Years

**Minimum Age:** 50 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Healthy men aged 50-69 years old.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** v.vasilyeva@uroweb.org

**Name:** Vera Vasilyeva

**Phone:** 31622973853

**Role:** CONTACT

**Contact 2:**

**Email:** s.collen@uroweb.org

**Name:** Sarah Collen

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005834

- Term: Genital Neoplasms, Male

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: HIGH

- As Found: Prostate Cancer

- ID: M8946

- Name: Genital Neoplasms, Male

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011471

- Term: Prostatic Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
