Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance

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.

NCT Number	NCT06866041
Lead Sponsor	Università Vita-Salute San Raffaele
Conditions	Low-Risk Prostate Cancer
Enrollment	74 participants
Start Date	2025-05-07
Primary Completion	2028-05-07 (estimated)
Study Completion	2030-03 (estimated)
Updated on ClinicalTrials.gov	2025-05-16