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

Recruiting now · Not applicable

Conditions studied: Low-Risk Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06866041

Run by

Università Vita-Salute San Raffaele

People needed

74

Starts

2025-05-07

Expected to finish

2030-03-01

Last updated by the study team

2025-05-16

Who can join

Age: 45 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• IRCCS Ospedale San Raffaele — Milan, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.