NCT05819606

Positron Emission Radiomics With PSMA Radioligands on Newly Diagnosed Prostate Cancer Patients

PERsonalized Positron Emission Radiomics With Prostate Cancer Specific Membrane Antigen Radioligands on Newly Diagnosed Prostate Cancer Patients.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this large prospective study consists of exploring the correlation among Volumetric and Radiomic parameters extracted from staging PSMA PET/CT Imaging versus conventional baseline clinical biochemical data, conventional imaging and the aggressiveness of the tumor based on the post-surgical-Gleason Score (GS) in patients with intermediate/high risk prostate cancer (PCa). Secondarily, Volumetric and Radiomic features extracted from the same PET images will be compared with the amount of the Circulating Tumor Cells (CTCs), with the expression of specific receptors on CTCs surface, Possible mutations encoding androgen receptors (AR) on CTCs surface, and with PSMA density on primary tumor cells provided by the Immunohistochemistry method (IHC) applied on post-surgical histological samples. According to PET images, Volumes of interest (VOI) encompassing the whole prostate with foci of PSMA uptake suspected for PCa will be drawn to extract semiquantitative and radiomic PET features. The association between PSMA PET radiomics and CTCs molecular and genomic panel at staging could potentially lead to a more personalized and more effective therapeutic chances.

Detailed description

The following clinical conventional parameters will be collected : * age (years), * results of DRE, digital rectal examination (positivie or negative) * Prostate-Specific Antigen. PSA levels (ng/ml) * conventional PET parameters and ,(tSUVmax, tSUVmean, tMTV, tTLA), * first-order radiomic features (tSkewness, tKurtosis) * results from mpMRI (PIRADS categories from 1 to 5 according to v2.1) * biopsy-based Gleason Score, GS (referrred to WHO/ISUP score) * the amount of circulating tumor cells by the bloodstream peripheral samples CTCs (cells number/ml of blood volume) * the overexpression of specific receptors on the CTCs surface, such as the epidermal grow factor receptor (EGFR), PSMA receptor. * percentage of expression of specific receptors and their potential mutations on CTCs surface, in terms of percentage of expression of PSMA and GRPR based on histological post-surgical specimen on tumor cell surface.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Immunohistochemistry (IHC) analysis	Setting of the percentage amount of PSMA expression on the primary tumor cell surface on post-surgical samples by the Immunohistochemistry method (IHC)

Timeline

• Start date: 2023-04-15
• Primary completion: 2024-04-15
• Completion: 2024-12-31
• First posted: 2023-04-19
• Last updated: 2025-09-22

Locations

1 site across 1 country: Italy