68Ga-PSMA PET/CT in Prostate Cancer

Status Suspended

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04684628
Study type	Interventional
Source	University of Saskatchewan
Contact
Status	Suspended
Phase	Phase 3
Start date	December 9, 2020
Completion date	December 2025

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See also
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