NCT03623425

Comparison of PET With 68GA-PSMA-11 and 18F-Fluorocholine for Recurrence in Men With Prostate Cancer

Comparison of PET Imaging With 68GA-PSMA-11 and 18F-Fluorocholine for the Identification of Site of Recurrence in Men With Prostate Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

As choline transport and phosphorylation are upregulated in most cancers, including prostate cancer, positron emission tomography (PET) with choline tracers has found widespread use to detect recurrent disease. However, choline metabolism is not increased in a significant number of cases, probably explaining why this imaging method has been reported to be weakly sensitive and specific fro the detection of prostate cancer lesions, especially at low prostate-specific antigen (PSA) levels. By contrast, prostate-specific membrane antigen (PSMA) is overexpressed in most prostate cancer, suggesting that 68Ga-labelled PSMA ligands could be superior to choline tracers. A meta-analysis published in 2016 (Perera M. and al.), which included 18 studies, of which five reported histolopathologic correlation data for 68Ga-PSMA PET-positive lesions, indicated favourable sensitivity and specificity profiles of 68Ga-labelled PSMA ligands compared to choline-based PET imaging techniques.

Detailed description

HBED-PSMA Sterile Cold Kit is a kit for preparation of radiolabelled 68Ga-PSMA-11. After radiolabelling with a 68Ga chloride solution complying with the requirements of monograph 2464 of the European Pharmacopoeia (Ph Eur), the solution may be used in men with biochemical relapse of prostate cancer after treatment. A large number of studies have been published on 68Ga-PSMA-ligands but none has yet been conducted with a product manufactured in accordance with ANMI technology. The aim of the study is to demonstrate the superiority of 68Ga-PSMA-11, prepared from a room temperature radiolabel kit containing PSMA-11 (PSMA-11 Sterile Cold Kit) and gallium 68 obtained from a 68Ge / 68Ga generator on 18F-Fluorocholine (18F-FCH) in identifying prostate cancer recurrence after radical treatment sites. So, patients will be evaluated with the current workup at CHRU of Nancy and will then be submitted to 68GA-PSMA-11 and 18F-FCH imaging. Patients will be randomized to the imaging procedure after workup in a 1/1 ratio between 68GA-PSMA-11 and comparator. So all patients will be submitted to 68GA-PSMA-11 and 18F-FCH; 50% of patients will receive the 68GA-PSMA-11 first; 50% of patients will receive the comparator first. There will be a time interval of minimum 7 days and maximum 14 days between both imaging procedures. In order to mimic, as far as possible, the routine clinical practices, a sequential unblinding will be used for image readers. Readers will evaluate 68GA-PSMA-11 and 18F-FCH images with progressive access to more clinical information on each read. It will be done in three steps: fully blinded image evaluation, then image evaluation with results of the patient's clinical history and finally image evaluation with results of the patient's workup and clinical history.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	68Ga-PSMA-11 PET	a 68GA-PSMA-11 PET exam before the a 18F-FCH PET exam
DRUG	18F-FCH PET	a 18F-FCH PET exam before the 68Ga-PSMA-11 PET exam

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2018-08-09
• Last updated: 2018-08-09

Locations

1 site across 1 country: France