Actively Recruiting
Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance
Led by Università Vita-Salute San Raffaele · Updated on 2025-05-16
74
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven low-risk prostate cancer with PSA ≤10 ng/ml, clinical stage ≤T2a, and biopsy ISUP Grade Group 1
- Non-metastatic status at study enrollment
- No prior or current androgen deprivation therapy
- Ability to understand and sign written informed consent
You will not qualify if you...
- Unable to tolerate a PSMA-PET scan
- Unwillingness to be managed with active surveillance
- Prior receipt of neoadjuvant or curative-intent therapies
- Presence of a pacemaker
- Inability to obtain formalin-fixed paraffin-embedded prostate biopsy samples from the initial biopsy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, Italy, Italy, 20132
Actively Recruiting
Research Team
G
Giorgio Gandaglia
CONTACT
L
Lucia Dambrosio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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