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NCT Number: NCT06167629

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

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.

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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

IRC

Milan, Italy

Location status: Recruiting

Location contact

Arturo Chiti

CONTACT

[email protected]

About this study

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.

Who can participate

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

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.

Treatment and study plan

PET 18F-PSMA

Diagnostic 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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra Maielli

CONTACT

[email protected]

0226432716

Arturo Chiti

CONTACT

[email protected]

0226432716

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2023
Registry last updated
Dec 12, 2023

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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