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 - PSMA-PROSTAPET

AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA0 个研究点目标入组 100 人开始时间: 2020年10月21日最近更新: 2022年3月14日

适应症

试验速览

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•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Patients who meet one of the following criteria:
•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

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