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

NCT05819606 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2025-09-22

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Salvatore Annunziata · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-15
Primary Completion
2024-04-15
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05819606 on ClinicalTrials.gov