Prostate Cancer
Conditions
Brief summary
The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and as a diagnostic and decision making tool in the management prostate cancer patients.The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.
Detailed description
Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine diagnostic imaging procedure based on the measurement of positron emission from radiolabeled tracer molecules in vivo. A radiotracer in use today is 68Ga-HBED-CC-PSMA (DKFZ-11) - hereinafter abbreviated 68Ga-PSMA - which is a radiolabeled urea-based ligand for prostate specific membrane antigen (PSMA) PET/CT. Imaging with 68Ga-PSMA PET is used to characterize and localize prostate cancer in humans in vivo. There is extensive data in the literature showing the value of 68Ga-PSMA PET/CT imaging in accurately staging and restaging prostate cancer. The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and to establish our ability to reproduce results from the literature using 68Ga-PSMA PET/CT as a diagnostic and decision making tool in the management prostate cancer patients. During the study eligible prostate cancer patients will undergo one 68Ga-PSMA PET/CT. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.
Interventions
DRUG68Ga-HBED-CC-PSMA PET/CT
68Ga-HBED-CC-PSMA PET/CT Scan
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
Global Inclusion Criteria: * Resident of Canada * Male sex * Age 18 years or older * Previously diagnosed with prostate cancer, under referring physician's care * ECOG performance status 0 - 3, inclusive * Able to understand and provide written informed consent * Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation Global
Exclusion criteria
* Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter) * Patients with unmanageable claustrophobia Clinical Indication Criteria Subgroups: * BCR: Biochemical recurrence as defined by serum PSA \> 0.1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management * HRS: Staging of high risk patients as defined by any one of the following: * Gleason score \> 7 * Serum PSA \> 10 ng/ml * T stage of T3 or greater on TNM staging * Equivocal conventional staging such as CT, MRI or bone scan * Clinical suspicion of advance stage disease (e.g. bone pain)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of Ga68-PSMA PET/CT imaging as measured by the incidence of adverse events (AE) | 7 days |
| Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth | 12 months |
| Efficacy of Ga68-PSMA PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth | 12 months |
Countries
Canada
Outcome results
None listed