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

Not Applicable

Recruiting

• Conditions: Low-Risk Prostate Cancer

• Registration Number: NCT06866041
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-10
• Status Verified: 2025-05
• Study Start: 2025-05-07
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2028-05-07
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 74

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy