Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunohistochemistry (IHC) analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluation of aggressiveness of prostate cancer.
- timeFrame
- 9 months
- description
- Prostate cancer evaluation of aggressivness via semiquantitative and volumetric PSAM PET features
Secondary outcomes (1)
- measure
- Radiogenomic panel of prostate cancer.
- timeFrame
- 9 months
- description
- CTCs correlation with Prostate cancer aggressivness expressed by Gleason Score
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available