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

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06167629
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

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 Timeline

• Study Start: 2022-10-13
• Study First Submitted: 2023-11-24
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Primary Completion: 2027-07-13
• Study Completion: 2027-07-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 2500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PET with 18F-PSMA for diagnostic accuracy for staging of prostate cancer.	5 years	the role of a quantitative-semi-quantitative analysis for the characterization of prostatic pathology in different phases of the disease.

Trial Locations

Locations (1)

IRC; 🇮🇹 Milano, Italy