68Ga-PSMA PET/CT for detection of recurrent prostate cancer: Comparison with 18F-fluoride PET/CT, MRI and DW-MRI

Department of Nuclear Medicine, Aalborg University Hospital0 sitesDecember 12, 2014

Overview

No summary available.

Registry

who.int

Start Date

December 12, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Department of Nuclear Medicine, Aalborg University Hospital

•A subject is eligible for the study if all of the following apply:
•Oral and written informed consent.
•18 years and older.
•The patient has undergone a curatively intended treatment for prostate cancer, which is considered to be radical at the end of the intervention/procedure.
•Confirmed PCa recurrence (defined as PSA \= 0\.2 ng/ml or more after radical prostatectomy or a rise of 2\.0 ng/ml above the post\-treatment PSA\-nadir following radiation therapy).
•Subject is able to lie still for the duration of the imaging procedure.
•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 10

•History of another malignancy within the previous 5 years other than curatively treated non\-melanoma skin cancer and prostate cancer.
•History of allergic reactions attributed to compounds of 68Ga\-PSMA radiotracer.
•Subjects unable to undergo the PET/CT imaging procedure due to claustrophobia despite oral anxiolytics (institutional procedure).
•Subjects weighing greater than 180 kilograms (weight limit for scanner table), or unable to fit within the imaging gantry.
•Subjects with any medical condition or other circumstances (e.g. claustrophobia, unable to lie still, unable to comply with study procedures etc.) that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
•If the patient refuses MRI or is not eligible (e.g. claustrophobia or other reasons as outlined in the ESUR guideline for MRI), the patient will be offered a diagnostic CT in combination with 68Ga\-PSMA PET. If the patient refuses a diagnostic CT scan or allergic or ineligible for such procedure only a 68Ga\-PSMA PET/low dose CT will be performed. Such patients will be assessed for secondary endpoints only.