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

NCT05819606 | Completed

• 1 other identifier: 5641
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of aggressiveness of prostate cancer.

  Prostate cancer evaluation of aggressivness via semiquantitative and volumetric PSAM PET features

  9 months

Secondary Outcomes (1)

• Radiogenomic panel of prostate cancer.

  9 months

Interventions

Immunohistochemistry (IHC) analysis OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

GSTeP FPG Policlinico Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Salvatore Annunziata

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: April 15, 2023
• Primary Completion: April 15, 2024
• Study Completion: December 31, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

IT (1)