🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 45 Years - 80 YearsMaleUniversità Vita-Salute San Raffaele
NCT06866041 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
Inclusion Criteria: * Histologically proven low-risk PCa (PSA ≤10 ng/ml; clinical stage ≤T2a, and biopsy ISUP GG 1) * Non-metastatic status at study inclusion (patient enrollment). * No prior or concomitant androgen deprivation therapy * Ability to understand a written informed consent and willingness to sign it. Exclusion Criteria: * Unable to tolerate a PSMA-PET scan * Unwillingness to be managed with AS * Receipt of neoadjuvant or curative-intent therapies * Pacemaker * Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy
💊

What it tests

  • mpMRI-targeted confirmatory biopsy
📍

Where

1 site
IRCCS Ospedale San Raffaele
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy