PSMA PET/CT for Prostate Cancer (NGP2)
Prostate Cancer
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate cancer, biochemical recurrence, 18F-PET imaging
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with prostate cancer, either in the setting of diagnosis of biochemical recurrence after previous treatment, or at primary diagnosis and staging.
Exclusion Criteria:
- Age: <18 years
- Physically or mentally unfit to perform the sequential procedures
- Refusal of patient to be informed about accidental findings on scans
- Patients with heart failure if ejection fraction < 45% (phase 2 trial)
- History of anaphylactic shock after administration of Visipaque CT contrast (phase 2 trial)
Sites / Locations
- Ghent University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
2.0 ± 0.2 MBq/kg [18F]PSMA-11 dosing group
4.0 ± 0.4 MBq/kg [18F]PSMA-11 dosing group
To define the optimal [18F]PSMA-11 scan protocol, the quality of the PET images from patients that received 2.0 ± 0.2 MBq/kg will be compared to the images from patients that received 4.0 ± 0.4 MBq/kg. Patients in this study arm will receive 2.0 ± 0.2 MBq/kg for acquiring the [18F]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm. As for the use of radiopharmaceuticals, the ALARA ('as low as reasonably achievable') principle must be applied, this study arm is considered to be the reference.
Concerning the dose of [18F]PSMA-11, the patients in this study arm will receive 4.0 ± 0.4 MBq/kg for the [18F]PSMA-11 scan. All other study parameters and procedures are identical to those in the other study arm