68Ga-PSMA PET/CT in Prostate Cancer

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase

Completed

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: 68Ga-HBED-CC-PSMA PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT03001869

16-293

Details and patient eligibility

About

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.

Full 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.

Enrollment

540 patients

Sex

Male

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)