68Ga-PSMA PET/CT in Prostate Cancer

• Status: Enrolling by invitation
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborator: Isologic Innovative Radiopharmaceuticals
• Treatments: Edetic Acid; Gallium 68 PSMA-11

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)