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

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT05819606
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-06
• Study Start: 2023-04-15
• Study First Posted: 2023-04-19
• Primary Completion: 2024-04-15
• Study Completion: 2024-12-31
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• Able to sign informed consent
• Biopsy-confirmed intermediate/high risk prostate cancer
• Good compliance to undergo mpMRI scan and PET/CT scan
• Eligible for radical prostatectomy

Exclusion Criteria

• Contraindication to mpMRI (such. Metal implants and/or pacemaker)
• Poor compliance to undergo PET/CT (i.e.claustrophobia)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of aggressiveness of prostate cancer.	9 months	Prostate cancer evaluation of aggressivness via semiquantitative and volumetric PSAM PET features

Secondary Outcome Measures

Name	Time	Method
Radiogenomic panel of prostate cancer.	9 months	CTCs correlation with Prostate cancer aggressivness expressed by Gleason Score

Trial Locations

Locations (1)

GSTeP FPG Policlinico Gemelli IRCCS; 🇮🇹 Roma, Italy