NCT05415228

Expanded Access to Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrent Prostate Cancer

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Morand Piert, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: —

Summary

This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11). The primary goal of this expanded access program is to make 68Ga PSMA-11 PET/CT imaging available to patients.

Detailed description

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) has recently been approved by the FDA for clinical use in a formulation utilized at the University of California in Los Angeles UCLA) and San Francisco (UCSF). The production process for 68Ga-PSMA-11 at the University of Michigan (UM) is different and not FDA approved. This expanded access program was established to allow a continued use of 68Ga-PSMA-11 produced at the University of Michigan for clinical management for prostate cancer at the University of Michigan.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	68Ga-PSMA-11	68Ga-PSMA-11 is a radiopharmaceutical for the detection of prostate cancer using PET/CT imaging

Timeline

• First posted: 2022-06-13
• Last updated: 2023-05-18