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Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance
Sponsor: Università Vita-Salute San Raffaele
Summary
This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo: * PSMA PET with calculation of SUVmax and PRIMARY-Likert score * Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies * Immunohistochemistry on diagnostic prostate biopsies * Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.
Official title: Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance
Key Details
Gender
MALE
Age Range
45 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2025-05-07
Completion Date
2030-03
Last Updated
2025-05-16
Healthy Volunteers
No
Conditions
Interventions
mpMRI-targeted confirmatory biopsy
mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines
Locations (1)
IRCCS Ospedale San Raffaele
Milan, Italy, Italy