NCT06866041Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- First submitted
- 4 Mar 2025
- Start date
- 7 May 2025
- Primary completion date
- 7 May 2028
- Lead sponsor
- Università Vita-Salute San Raffaele
- Diseases
- Prostate cancer
- NCT number
- NCT06866041
What you commit to
- Study type: Interventional
- Planned participants: 74
- From 7 May 2025 to the primary completion date, 7 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of neoadjuvant or curative-intent therapies
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 45 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.