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

Stanford University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Recurrent Prostate Carcinoma

Treatments: Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx); Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02488070

NCI-2015-01067 (Registry Identifier)

PROS0068 (Other Identifier)

P30CA124435 (U.S. NIH Grant/Contract)

IRB-32985

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provides written informed consent
• Known diagnosis of prostate cancer
• Patient has suspected recurrence based on biochemical data (prostate specific antigen [PSA] > 2 ng/mL)
• Able to remain still for duration of each imaging procedure (about one hour)

Exclusion criteria

• Unable to provide informed consent
• Inability to lie still for the entire imaging time
• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
• Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Diagnostic (68Ga-PSMA PET/CT or PET/MRI)

Experimental group

Description:

Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.

Treatment:

Procedure: Positron Emission Tomography

Procedure: Magnetic Resonance Imaging

Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)

Procedure: Computed Tomography