NCT05819606Completed
Positron Emission Radiomics With PSMA Radioligands on Newly Diagnosed Prostate Cancer Patients
PERsonalized Positron Emission Radiomics With Prostate Cancer Specific Membrane Antigen Radioligands on Newly Diagnosed Prostate Cancer Patients.
Source: ClinicalTrials.gov · Last updated 22 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 70 (actual)
- First submitted
- 6 Apr 2023
- Start date
- 15 Apr 2023
- Primary completion date
- 15 Apr 2024
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Prostate cancer
- NCT number
- NCT05819606
What you commit to
- Study type: Observational
- Participants enrolled: 70
- From 15 Apr 2023 to the primary completion date, 15 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to mpMRI (such. Metal implants and/or pacemaker)
Other
- Poor compliance to undergo PET/CT (i.e.claustrophobia)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSTeP FPG Policlinico Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.