Monocentric Observational Study on the Diagnostic and Prognostic Role of 18F-PSMA PET (PET/CT and PET/MR) in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Monocentric Observational Study on the Diagnostic and Prognostic Role of 18F-PSMA PET (PET/CT and PET/MR) in Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167629
• Other study ID #: OMNIA_PSMA
• Status: Recruiting
• Start date: October 13, 2022
• Est. completion date: July 13, 2027

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: Arturo Chiti
• Phone: 0226432716
• Email: chiti.arturo[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: July 13, 2027
• Est. primary completion date: July 13, 2027
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• medical conditions that do not allow the acquisition of PET images;
• allergic reactions to iodinated contrast medium or creatinine levels >2mg/dL.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• PET 18F-PSMA
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.

Locations

Country	Name	City	State
Italy	IRC	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years