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.
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.
Unable to tolerate a PSMA-PET scan
Unwillingness to be managed with AS
Receipt of neoadjuvant or curative-intent therapies
Pacemaker
Single group
mpMRI-targeted confirmatory biopsy
Procedure/SurgerympMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines
Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance"
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).
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