Diagnostic Performance of PET/CT-PSMA in Patients With Non-prostatic PSMA-expressing Neoplasms

• Conditions: PSMA Positive Tumors or Tumor Tissues; Cancer

• Registration Number: NCT06835244
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

Study to collect data from PET/CT-PSMA performed in patients with neoplasms expressing PSMA, other than prostate cancer.

Objectives The primary objective is to evaluate the diagnostic performance of PET/CT-PSMA in the staging and management of patients with non-prostatic neoplasms expressing PSMA.

The secondary objective is to analyze the prognostic value of PET-PSMA in such neoplasms and the possible use in the selection of patients eligible for target therapies against neovascularization (i.e. monoclonal anti-VEGF antibodies) and radiopharmaceutical treatments (i.e. 177Lu-PSMA).

Detailed Description

Purpose of the register: This single-centre observational register is intended to collect data from PET/CT-PSMA performed in patients with neoplasms expressing PSMA, other than prostate cancer.

Design of the register: observational, pharmacological, non-profit, prospective, monocentric.

Duration of the record: The expected duration for the collection of PET/CT-PSMA examinations is 10 years.

Objectives The primary objective of the following registry is to evaluate the diagnostic performance of PET/CT-PSMA in the staging and management of patients with non-prostatic neoplasms expressing PSMA.

The secondary objective is to analyze the prognostic value of PET-PSMA in such neoplasms and the possible use in the selection of patients eligible for target therapies against neovascularization (i.e. monoclonal anti-VEGF antibodies) and radiopharmaceutical treatments (i.e. 177Lu-PSMA).

Study Timeline

• Study Start: 2021-09-17
• Status Verified: 2025-01
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2031-06
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients diagnosed with a neoplasm other than prostate carcinoma who are referred to our unit as part of the standard care pathway to undergo a PSMA PET/CT scan for staging, restaging, and pre- and post-treatment evaluation
• Signed informed consent for the collection and processing of data
• Minimum age 18 years old."

Exclusion Criteria

• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSMA PET/CT performance	From the enrollment up to 10 years	the evaluation of diagnostic performance of PSMA PET/CT and the positivity rate (%) globally and stratified by specific pathology in staging, re-staging and management of patients with non-prostatic neoplasms expressing PSMA.

Secondary Outcome Measures

Name	Time	Method
Prognostic and predictive value	From the enrollment up to 10 years	Prognostic and predictive values (%) of PSMA PET/CT in such cancers and the possible use in the selection of patients eligible for target therapies against neovascularization and radioligand treatment according to specific score of PSMA expressing cells (%).

Trial Locations

Locations (1)

Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy