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
Università Vita-Salute San Raffaele
74 participants
May 7, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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
Interventions
mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06866041