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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45-80
SponsorUniversità Vita-Salute San Raffaele

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Unable to tolerate a PSMA-PET scan

Unwillingness to be managed with AS

Receipt of neoadjuvant or curative-intent therapies

Pacemaker

Trial design

Treatments tested in this trial

  • mpMRI-targeted confirmatory biopsy

Treatment groups

74 Participants
are divided into 1 treatment group