Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

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

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

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.

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

Risk-based screening algorithm

Vera Vasilyeva

Sarah Collen

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.

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.

Prostate Cancer Awareness and Initiative for Screening in the European Union

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

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

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

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

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)

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).

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

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

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

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.

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

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

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

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

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

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

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.

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

Proportion of eligible men who underwent biopsy

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

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

Erasmus Medical Center

European Randomised Study of Screening for Prostate Cancer

Region MidtJylland Denmark

Institute of Health Information and Statistics of the Czech Republic

UMC Utrecht

EUROPEAN CANCER ORGANISATION

Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

Narodowy Instytut Zdrowia Publicznego

Conselleria de Sanidade de Galicia

Althaia Xarxa Assistencial Universitària de Manresa

Vastra Gotaland Region

Region Skane

National Cancer Institute (NCI)

University Ghent

Health Service Executive, Ireland

Estonian Urological Association

University College Dublin

WONCA Europe

Movember Foundation

International Agency for Research on Cancer

European Society of Urogenital Radiology

Europa UOMO

Czech Urological Society

European Association of Urology Research Foundation

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

diagnostic

Matthew Brenner, M.D

This study has been designed to utilize already obtained biopsy specimens for investigation of the utility of a new, non-invasive optical diagnostic technique. The study will allow a careful correlation between the Optical coherence tomography findings and conventional histology.

Optical coherence tomography is a non-invasive diagnostic technique that can provide information about tissue abnormalities, change in structure of an organ. This technique uses a near-infrared diode to emit light that can produce images of the specimen under investigation without causing damage or alterations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prostate Cancer Awareness and Initiative for Screening in the European Union	NCT06424275	Prostate Cancer	Risk-based scre...	50 Years - 69 Years	European Association of Urology Research Foundation
Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer	NCT00581503	Lung Cancer Pleural Cancer Prostate Cancer	diagnostic	18 Years -	University of California, Irvine
Prostate Cancer Awareness and Initiative for Screening in the European Union	NCT06424275	Prostate Cancer	Risk-based scre...	50 Years - 69 Years	European Association of Urology Research Foundation
Early Detection and Staging of Endobronchial Lung and Pleural Cancer, Airway Injury, and Prostate Cancer	NCT00581503	Lung Cancer Pleural Cancer Prostate Cancer	diagnostic	18 Years -	University of California, Irvine

Spots Global Cancer Trial Database for early detection of prostate cancer