Positron Emission Radiomics With PSMA Radioligands on Newly Diagnosed Prostate Cancer Patients (PER2PSMA)

September 16, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Other: Immunohistochemistry (IHC) analysis

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Roma, Italy, 00168
    - GSTeP FPG Policlinico Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Patients with newly diagnosed biopsy confirmed intermediate/high risk PCa will be consecutively enrolled.

All patients will undergo a multiparametric MRI (mpMRI) examination at Radiology Department and a PET/CT with PSMA radioligands for staging in the PET/CT Center, both in the Fondazione Policlinico Universitario A. Gemelli IRCCS (Rome, Italy). After PET scan all patients will be eligible for radical prostatectomy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of aggressiveness of prostate cancer. Time Frame: 9 months	Prostate cancer evaluation of aggressivness via semiquantitative and volumetric PSAM PET features	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiogenomic panel of prostate cancer. Time Frame: 9 months	CTCs correlation with Prostate cancer aggressivness expressed by Gleason Score	9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Principal Investigator: Salvatore Annunziata, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2023

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria