NCT02488070

68Ga-PSMA PET/CT or PET/MRI in Evaluating Patients With Recurrent Prostate Cancer

68Ga-PSMA PET/CT or PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys\[Ahx\]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.

Detailed description

PRIMARY OBJECTIVES: Evaluate the feasibility and biodistribution of 68Ga-PSMA. OUTLINE: Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45 to 60 minutes later. After completion of study, patients are followed up at 24 hours and 1 week.

Conditions

• Recurrent Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Part of PET/CT scan
DRUG	Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)	Intravenously-administered (IV) radioisotope
PROCEDURE	Magnetic Resonance Imaging	Part of PET/MRI scan
PROCEDURE	Positron Emission Tomography	Part of PET/CT and/or PET/MRI scans

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-08-01
• Completion: 2016-08-01
• First posted: 2015-07-02
• Last updated: 2018-03-20
• Results posted: 2017-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study