DRG Mutations in Prostate Cancer: a Guiding Light for Enhanced Screening and Personalised Therapy

At the present moment, there is no international consensus on the optimal screening to perform in men with a specific genetic/molecular risk for PCa. The number of studies exploring screening strategies tailored to men with a family history for PCa is limited \[15-17\]: most of them support the use of targeted screening but methodological differences make it impossible to draw conclusions from these data \[18-25\]. On the basis of these considerations, we believe extremely important to investigate a new approach to sort out men who will most benefit from early diagnosis. The optimization of such an approach could generate several benefits to the health service, by both reducing overdiagnosis and overtreatment in low-risk patients and decreasing the risk of underdiagnosis and undertreatment in genetically selected high-risk patients. Indeed, men with DRG mutations have higher grade and higher stage at time of diagnosis, limiting the possibility of care \[2\]. In the present study, we will test the hypothesis that a dedicated screening in patients with a DRG mutation, by the combination of PHI and mp-MRI, could be more effective in the PCa early detection than the current approach (DRE and PSA). We hypothesise that this targeted screening could improve the rate of early detection in PCa-positive men and increase the consequent number of curable diseases.

NCT Number	NCT07265414
Lead Sponsor	Istituto Clinico Humanitas Collaborators: Fondazione Humanitas per la Ricerca
Conditions	Prostate Cancer, Bladder Cancer
Enrollment	320 participants
Start Date	2021-01-01
Primary Completion	2026-01 (estimated)
Study Completion	2026-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-04