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Biological Pathways and Next-Generation Imaging Features Predicting 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.
Age
45 - 80 years
Sex
MALE
Healthy Volunteers
No
IRCCS Ospedale San Raffaele
Milan, Italy, Italy
Start Date
May 7, 2025
Primary Completion Date
May 7, 2028
Completion Date
March 1, 2030
Last Updated
May 16, 2025
74
ESTIMATED participants
mpMRI-targeted confirmatory biopsy
PROCEDURE
Lead Sponsor
Università Vita-Salute San Raffaele
Data Source & Attribution
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