NCT06866041

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

Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low-Risk Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	mpMRI-targeted confirmatory biopsy	mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines

Timeline

• Start date: 2025-05-07
• Primary completion: 2028-05-07
• Completion: 2030-03-01
• First posted: 2025-03-10
• Last updated: 2025-05-16

Locations

1 site across 1 country: Italy