Status:
UNKNOWN
Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed
Lead Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Conditions:
Prostate Cancer
Prostatic Neoplasm
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study. Its aim is to evaluate the diagnostic accuracy of \[68Ga\]Ga-PSMA-11 PET/CT in dete...
Detailed Description
This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study. The primary objective of this study is to evaluate the diagnostic accuracy of \[68G...
Eligibility Criteria
Inclusion
- I. Patients with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph)
- II. Patients with conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) performed as baseline in primary PCa staging according to 2019 Prostate Cancer EAU Guidelines
- III. Age \>18 years/old
- IV. Ability to provide written informed consent
Exclusion
- I. Contra-indication for PET/CT scan: Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
- II. Impaired renal function
- III. Impaired liver function: AST or ALT \> 2.5 x ULN
- IV. Patients unable to understand the purpose of the study
- V. Medical history of allergic reactions or hypersensitivity to \[68Ga\] Ga-PSMA-11 as well as to any excipient or component of the experimental medicinal product
- VI. Having partecipated in clinical trial in which the experimental intervention was administered within 30 days (or 5 half-life) from administration the endovenous solution of \[68Ga\]Ga-PSMA-11
Key Trial Info
Start Date :
September 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04462926
Start Date
September 20 2020
End Date
September 20 2024
Last Update
September 17 2020
Active Locations (1)
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1
Azienda Ospedaliero-Universitaria di Modena
Modena, Italy, 41124