NCT04684628

68Ga-PSMA PET/CT in Prostate Cancer

Investigation of the Sensitivity and Specificity of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, multi-arm, open-label, phase III trial in up to 500 patients with biopsy-proven prostate cancer. Participants will receive regular standard of clinical care. The only study-specific procedures will the administration of 68Ga-PSMA-11 followed by a PET/CT (positron emission tomography/computed tomography) scan. Participants will be followed for two hours after the infusion for identification of any immediate adverse events (AE), and will be contacted by telephone after 7 to 14 days to enquire about any delayed AEs. PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. The standard of truth will be a consensus of the readers based on all available clinical, imaging, and histopathological information available for up to 6 months after the PET/CT scan.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	68Ga-PSMA PET/CT	Administration of 68Ga-PSMA-11 followed by a PET/CT scan at 45 min after injection.

Timeline

• Start date: 2020-12-09
• Primary completion: 2025-01-01
• Completion: 2025-12-01
• First posted: 2020-12-24
• Last updated: 2024-05-02

Locations

1 site across 1 country: Canada