RecruitingNot ApplicableNCT06866041

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

Sponsor

Università Vita-Salute San Raffaele

Enrollment

74 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

Low-Risk Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 45 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study follows men with low-risk prostate cancer on active surveillance (watchful waiting without immediate treatment) to find better biological markers and imaging tools that can predict when the cancer might progress. **You may be eligible if...** - You have been diagnosed with low-risk prostate cancer confirmed by biopsy (PSA ≤10, stage T2a or lower, Gleason grade group 1) - You have no evidence of cancer spread - You have not received hormone therapy or other prostate cancer treatments - You are willing to undergo regular monitoring and follow-up visits **You may NOT be eligible if...** - Your prostate cancer is intermediate or high risk - You have already started treatment (surgery, radiation, or hormone therapy) - You have other active cancers - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.