Tests imaging and markers to predict prostate cancer progression during surveillance
Studies men with low-risk prostate cancer on surveillance, using PSMA scans and biopsy markers.
Plain-language title generated from the registry record
Registry title: Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance
Key facts
- Where
- Milan, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with low-risk prostate cancer (ISUP Grade Group 1) who plan active surveillance. It studies imaging and tumour markers that may show who is at higher risk of the cancer getting worse.
- Age
- 45 to 80 years
- Sex
- Men only
- Disease stage
- Low-risk prostate cancer proven by biopsy: PSA ≤10 ng/ml, clinical stage ≤T2a, biopsy ISUP Grade Group 1. No spread to other parts of the body.
- Earlier treatment
- No earlier or current androgen deprivation therapy. No earlier treatment meant to remove all of the disease, and no treatment given before surgery.
Main reasons for not taking part
- Cannot tolerate a PSMA-PET scan
- Does not want to be managed with active surveillance
- Has a pacemaker
- Biopsy tissue from the first biopsy cannot be obtained
- Cannot understand or sign the written consent
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 80 years old?
Source: NCT06866041, who can take part
Where in Italy
- IRCCS Ospedale San RaffaeleMilan, ItalyContact: Giorgio GandagliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Università Vita-Salute San Raffaele
- Trial code
- NCT06866041
- Record updated
- 16 May 2025
- Original description
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:Read full original descriptionShow less
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.
Inclusion: 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: Receipt of neoadjuvant or curative-intent therapies; Unable to tolerate a PSMA-PET scan; Unwillingness to be managed with AS; Pacemaker; Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy.