Integrated Diagnostics in Prostate Cancer supported by Computational Algorithms (AI and network analysis)

The reseach group from the DROAP (Dir. Prof. Carlo Catalano) provides highly relevant scientific and technological skills in the fields of biomedical imaging, to
optimize and encourage high quality, large-scale medical research and to promote the application of innovative technologies for the management of diseases that require an integrated and multidisciplinary approach. Also, the research group aims at ensuring the necessary skills and training to support technological developments to meet the different research and clinical needs. The DROAP cooperating with other healthcare professionals from other departments, promotes the training and dissemination of the technological knowledge. In particular, the DROAP has a strong expertice and experience in prostate cancer diagnostics, especially for its early detection using new MRI pathway (MRI and MRI directed biopsy). This experience has resulted in a publication of the results of the PRECISION RCT on the New England Journal of Medicine in 2018, which has provided evidence for guidelines reccomendation update.

More recently, among others, the group of research has aimed at comprehensively integrating tissue and circulating microRNA profiling, MRI biomarkers and clinical data to implement prostate cancer early detection, by exploiting the large amount of data available in the digital format, analysed using artificial intelligence and network medicine algorithm. The research led to the discovery of three prostate cancer specific microRNAs: miR-548a-3p, miR-138-5p and miR-520d-3p. These molecular profiles in addition to imaging biomarkers might produce a diagnostic paradigm shift that sees molecular data as adjunct to MRI biomarkers during the prebiopsy triage of patients at risk for prostate cancer. The clinical implications of this approach would be a dramatic reduction in the number of unnecessary biopsies, and more accurate patient stratification. This integrative approach will ultimately reduce prostate associated overdiagnosis, overtreatment and overall related costs. Once further validated this approach might be remodelled for other projects for the sustainability of the proposed method.

Currently, the research group is working on the validation of new screening pathways for prostate cancer with the ongoing RCT - PROSA. In particular, to test the hypothesis that non-contrast MRI can represent a cost-effective (according to an HTA approach) secondary prevention test for prostate in healthy man (age range 49-69 years old, or 40-69 years old + positive family history), regardless of PSA test, we are undertaking Prostate Cancer secOndary screening in Sapienza (PROSA) interventional randomized controlled trial (Institutional Ethics Committee approval 09/09/2020, Rif. 5996) - details on the study protocol can be found at https://clinicaltrials.gov/ct2/show/NCT04803188.

Of note, also the research group is working on an international clinical study on the role of non-contrast MRI compared to contrast-MRI for prostate cancer early detection: the PRIME study, in which more than 20 countries worlwide are cooperating to reach the same goal (study protocol: NCT04571840.

To reach our objectives we follow a highly multi- and interdisciplinary approach with a team of researchers and clinicians with internationally recognised expertise in radiology, urology, oncology, molecular medicine, pathology oncology, computer science and AI. Also, the group has access to cutting-edge infrastructure including but not limited to (advanced imaging units, advanced molecular and genetic laboratories with innovative devices, and digital laboratories) that are essential for projects progression.

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