Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance (PSMA-AS)

Università Vita-Salute San Raffaele

Status: Enrolling

Conditions: Low-Risk Prostate Cancer

Treatments: Procedure: mpMRI-targeted confirmatory biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06866041

PSMA-AS

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

single arm

Experimental group

Description:

All patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance will undergo: * PSMA-PET/MRI → Evaluation of intraprostatic PSMA expression (SUVmax, PRIMARY-likert score). * Whole Exome Sequencing (WES) → Genomic analysis of diagnostic biopsies. Multiplex Immunohistochemistry (IHC) → Study of biomarkers on diagnostic biopsies. Confirmation biopsy one year after diagnosis, according to international guidelines.

Treatment:

Procedure: mpMRI-targeted confirmatory biopsy