Prostate CancerPER2PSMANCT05819606
Positron Emission Radiomics With PSMA Radioligands on Newly Diagnosed Prostate Cancer Patients
An observational study of Prostate Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Immunohistochemistry (IHC) analysis
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Contraindication to mpMRI (such. Metal implants and/or pacemaker)
- Poor compliance to undergo PET/CT (i.e.claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PERsonalized Positron Emission Radiomics With Prostate Cancer Specific Membrane Antigen 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,
Read more
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- Immunohistochemistry (IHC) analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry (IHC) analysisOther
Setting of the percentage amount of PSMA expression on the primary tumor cell surface on post-surgical samples by the Immunohistochemistry method (IHC)
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of aggressiveness of prostate cancer.
Prostate cancer evaluation of aggressivness via semiquantitative and volumetric PSAM PET features
Measured: 9 months
Secondary outcomes (1)
Radiogenomic panel of prostate cancer.
CTCs correlation with Prostate cancer aggressivness expressed by Gleason Score
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start15 Apr 2023
- Primary completion15 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salvatore Annunziata, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819606
- Sponsor's protocol ID
- 5641
- Acronym
- PER2PSMA
- Status last verified
- Sep 2025
- First submitted
- 6 Apr 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERsonalized Positron Emission Radiomics With Prostate Cancer Specific Membrane Antigen Radioligands on Newly Diagnosed Prostate Cancer Patients.
- ClinicalTrials.gov ID
- NCT05819606
- Acronym / sponsor ID
- PER2PSMA / 5641
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Contraindication to mpMRI (such. Metal implants and/or pacemaker)
- Poor compliance to undergo PET/CT (i.e.claustrophobia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunohistochemistry (IHC) analysisSetting of the percentage amount of PSMA expression on the primary tumor cell surface on post-surgical samples by the Immunohistochemistry method (IHC) | Other | – |
Primary outcome
Evaluation of aggressiveness of prostate cancer.
Time frame: 9 months
Prostate cancer evaluation of aggressivness via semiquantitative and volumetric PSAM PET features
1 secondary outcome
Radiogenomic panel of prostate cancer.
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Annunziata principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of aggressiveness of prostate cancer. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.