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

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cancer [C04]; Men with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification; MedDRA version: 21.1Level: LLTClassification code 10036927Term: Prostate neoplasiaSystem Organ Class: 100000004864

• Registration Number: EUCTR2019-004685-18-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified