Ricerc@Sapienza

Prostate cancer (PCa) screening is still a controversial topic in the scientific community, this is mostly related to the low specificity of PSA value that has been the cause of overdiagnosis of clinically insignificant PCa, with lack of survival improvement. Imaging plays a valuable role in the non-invasive diagnosis of PCa. MRI has been recognized as "state of the art" management tool and the most cost-effective exam for PCa detection in patient at risk. In the screening setting, instead, the role of MRI is still under investigation. At the same time, Health technology Assessment (HTA) is a well-known approach that has as focus to appraise technologies for the provision of health care to assess not just their safety and efficacy but also whether the outcomes they achieve justify their costs.
With this background, the primary aim of the project is to evaluate the cost-effectiveness of non-contrast MRI in adjunct to an artificial intelligence (AI) tool, as secondary screening test for early PCa detection, in males aged between 49-69 years. The project will be conducted in adjunct to the ongoing randomized controlled trial PROSA (ClinicalTrials Ident: NCT04803188), on a cohort of 710 patients, employees of the AOU Policlinico Umberto I and Sapienza University, enrolled by the Occupational Medicine Division.
The HTA will cover an evaluation of the epidemiology of PCa, of the efficacy and safety of non-contrast MRI and AI using the PRISMA statement methodology, and of the economic analysis including cost-effectiveness, cost-utility, cost-benefit and budget impact assessments. Also, the organizational aspects related to the mode of delivery of MRI, patient preferences from the perspective of patient-reported outcome (defined as any outcome concerning the state of health reported directly by the patient), and of the ethical aspects of introducing non-contrast MRI and AI to maximize the benefits and minimize the harms of research, will be analyzed.