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NCT Number: NCT05819606

Positron Emission Radiomics With PSMA 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

GSTeP FPG Policlinico Gemelli IRCCS

Roma, 00168, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Primary outcomes

  1. Evaluation of aggressiveness of prostate cancer.

    Time frame: 9 months

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

Secondary outcomes

  1. Radiogenomic panel of prostate cancer.

    Time frame: 9 months

    CTCs correlation with Prostate cancer aggressivness expressed by Gleason Score

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

PERsonalized Positron Emission Radiomics With Prostate Cancer Specific Membrane Antigen Radioligands on Newly Diagnosed Prostate Cancer Patients.

Acronym: PER2PSMA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2023
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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