Condition: Low-Risk Prostate Cancer · Sponsor: Università Vita-Salute San Raffaele
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.
This description comes directly from the study's public registry record.
Giorgio Gandaglia · +39 0226438068 · gandaglia.giorgio@hsr.it
Lucia Dambrosio · dambrosio.lucia@hsr.it
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| IRCCS Ospedale San Raffaele | Milan, Italy, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06866041