Integrated Diagnostics in Prostate Cancer
The reseach group from the DROAP 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. 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).
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 two prostate cancer specific microRNAs. Overall, 261 men were enrolled and underwent MRDB for PCa detection. A total of 178 patients represented the entire cohort: 55 (30.9%) were negative for PCa, 39 (21.9%) had grade group (GG) 1 PCa, and 84 (47.2%) had GG >1 PCa. The proposed integrated pathway, including clinical data, MRI biomarkers, and microRNAs, provided the best net benefit with a biopsy avoidance rate of about 20% at a low disease probability. The main limitation is the monocentric design in a referral center. The integrated pathway represents a validated model that sees MRI biomarkers and microRNAs as a prebiopsy triage of patients at a risk for clinically significant PCa. The proposed pathway showed the highest net benefit in terms of unnecessary biopsy avoidance.
Currently, the research group is publlishing the results of a new screening pathways for prostate cancer with the ongoing RCT - PROSA. In particular, the aim of the study was 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.
An other research line is the role of the PRECISE score in patients enrolled in active surveillance protocol and of the PI-QUAL score.
The group is also focused on the role of MRI and PI-RR score in the setting of prostate cancer recurrence, and its integration with PET/CT imaging, stratifying and personalizing the diagnostic pathway according to patient's risk of local recurrence and nodal/distant metastasis.
Of note, also the research group has worked 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), and the PI-CAI international grand challenge on the role of AI for prostate cancer diagnosis.
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.
