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ACTIVE NOT RECRUITING
NCT07265414

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

Sponsor: Istituto Clinico Humanitas

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

MALE

Age Range

35 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

320

Start Date

2021-01-01

Completion Date

2026-01

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Screening Platform

Screening

Locations (1)

IRCCS Humanitas Research Hospital

Milan, Italy