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

Condition(s) studied

Investigational drug(s) / intervention(s)

mpMRI-targeted confirmatory biopsy: mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines

Study 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

Primary outcome measure(s)

• Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance" — Baseline diagnostic biopsy and 12 months after diagnosis (when the confirmatory biopsy will be performed)
  To determine the discriminative ability of the multivariable model, quantified using the concordance index (c-index), to predict prostate cancer upgrading in low-risk PCa patients managed with active surveillance (AS).

Trial sites (1)

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