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

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): 70

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Salvatore Annunziata, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

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: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytological Techniques; Histocytochemistry; Histological Techniques; Immunologic Techniques; Immunohistochemistry
• Other Study ID Numbers: 5641

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No