68Ga-PSMA PET/CT in Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: 68Ga-HBED-CC-PSMA PET/CT
- Registration Number
- NCT03001869
- Lead Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 540
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-PSMA PET/CT 68Ga-HBED-CC-PSMA PET/CT 68Ga-HBED-CC-PSMA PET/CT
- Primary Outcome Measures
Name Time Method 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 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 lesion basis as compared to standard of truth 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada