Prostate CancerNCT06167629
Monocentric Observational Study on the Diagnostic and Prognostic Role of 18F-PSMA PET (PET/CT and PET/MR) in Prostate Cancer
An observational study of Prostate Cancer, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The general objective of this retrospective and prospective study is to evaluate the diagnostic and prognostic role of a quantitative analysis of PET images with 18F-PSMA in all stages of the disease in patients with prostate cancer. 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?
- PET 18F-PSMA
- How many people
- 2,500 participants
- Where
- 1 siteItaly
- Study dates
- 13 Oct 2022to 13 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: The study will enroll adult patients with a histopathological diagnosis of prostate cancer undergoing PET examination with 18 F-PSMA where requested by the specialist due to clinical need at the U.O. of nuclear medicine of the San Raffaele Hospital.
Who may be able to join
- adult male patients;
- patients with histopathological diagnosis of prostate cancer undergoing staging or restaging;
- patients with clinical indication for PET examination with 18 F-PSMA;
Who cannot join
- medical conditions that do not allow the acquisition of PET images;
- allergic reactions to iodinated contrast medium or creatinine levels >2mg/dL.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The general objective of this retrospective and prospective study is to evaluate the diagnostic and prognostic role of a quantitative analysis of PET images with 18F-PSMA in all stages of the disease in patients with prostate cancer. To this end, both imaging parameters commonly used in clinical practice and the contribution of radiomic features will be investigated. The latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies. This methodology is very promising, but also recent and therefore little studied and standardized. Our objective is also to investigate how to optimize it from a purely methodological point of view.
Read the detailed description
In this study, all PET images with 18F-PSMA will be considered, but also the CT or MR images associated with them to allow better anatomical localization.
This study will allow us to investigate the diagnostic and prognostic role of l8F-PSMA PET, also evaluating its predictive value in terms of disease course, development of metastases and mortality. The retrospective part of this protocol is necessary for the acquisition of a sufficiently large amount of data to guarantee adequate statistical power for the study.
- Conditions
- Prostate Cancer
- Being tested
- PET 18F-PSMA
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET 18F-PSMADiagnostic test
Subjects will be subjected to a PET examination according to international guidelines and where requested by the specialist. In particular, patients will be administered the radiopharmaceutical 18 F PSMA. Approximately two hours after administration, the patient is positioned on the PET/CT equipment table and image acquisition begins.
What is being measured
The primary outcome is the main question the study is designed to answer.
PET with 18F-PSMA for diagnostic accuracy for staging of prostate cancer.
the role of a quantitative-semi-quantitative analysis for the characterization of prostatic pathology in different phases of the disease.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start13 Oct 2022
- Primary completion13 Jul 2027 (estimated)
- Study completion13 Jul 2027 (estimated)
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 IRCCS San RaffaeleThe 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167629
- Sponsor's protocol ID
- OMNIA_PSMA
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Observational Study on the Diagnostic and Prognostic Role of 18F-PSMA PET (PET/CT and PET/MR) in Prostate Cancer
- ClinicalTrials.gov ID
- NCT06167629
- Acronym / sponsor ID
- OMNIA_PSMA
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 13 Jul 2027 (estimated)
- Study completion
- 13 Jul 2027 (estimated)
- First posted
- 12 Dec 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 general objective of this retrospective and prospective study is to evaluate the diagnostic and prognostic role of a quantitative analysis of PET images with 18F-PSMA in all stages of the disease in patients with prostate cancer. To this end, both imaging parameters commonly used in clinical practice and the contribution of radiomic features will be investigated. The latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies. This methodology is very promising, but also recent and therefore little studied and standardized. Our objective is also to investigate how to optimize it from a purely methodological point of view.
Detailed description
In this study, all PET images with 18F-PSMA will be considered, but also the CT or MR images associated with them to allow better anatomical localization.
This study will allow us to investigate the diagnostic and prognostic role of l8F-PSMA PET, also evaluating its predictive value in terms of disease course, development of metastases and mortality. The retrospective part of this protocol is necessary for the acquisition of a sufficiently large amount of data to guarantee adequate statistical power for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- The study will enroll adult patients with a histopathological diagnosis of prostate cancer undergoing PET examination with 18 F-PSMA where requested by the specialist due to clinical need at the U.O. of nuclear medicine of the San Raffaele Hospital.
Key inclusion criteria (3 listed)
- adult male patients;
- patients with histopathological diagnosis of prostate cancer undergoing staging or restaging;
- patients with clinical indication for PET examination with 18 F-PSMA;
Key exclusion criteria (2 listed)
- medical conditions that do not allow the acquisition of PET images;
- allergic reactions to iodinated contrast medium or creatinine levels >2mg/dL.
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 |
|---|---|---|
| PET 18F-PSMASubjects will be subjected to a PET examination according to international guidelines and where requested by the specialist. In particular, patients will be administered the radiopharmaceutical 18 F PSMA. Approximately two hours after administration, the patient is positioned on the PET/CT equipment table and image acquisition begins. | Diagnostic test | – |
Primary outcome
PET with 18F-PSMA for diagnostic accuracy for staging of prostate cancer.
Time frame: 5 years
the role of a quantitative-semi-quantitative analysis for the characterization of prostatic pathology in different phases of the disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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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.
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 IRCCS San Raffaele 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 3 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: looking for participants now, as of the sponsor's last update on 12 Dec 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arturo Chiti (0226432716, chiti.arturo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET with 18F-PSMA for diagnostic accuracy for staging of prostate cancer. (time frame: 5 years). 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 12 Dec 2023.