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

Phase 1

Completed

• Conditions: Recurrent Prostate Carcinoma
• Interventions: Procedure: Computed Tomography; Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx); Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

• Registration Number: NCT02488070
• Lead Sponsor: Stanford University

Brief 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-07-02
• Primary Completion: 2015-08
• Study Completion: 2016-08
• Results First Submitted: 2017-01-23
• Results First Submitted QC: 2017-01-23
• Results First Posted: 2017-03-14
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-20
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)	Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)	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.
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)	Computed Tomography	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.
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)	Magnetic Resonance Imaging	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.
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)	Positron Emission Tomography	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.

Primary Outcome Measures

Name	Time	Method
Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution	an estimated average of 1 hour	The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI.
Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution	an estimated average of 1 hour	The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI.
Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)	an estimated average of 1 hour	Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax (a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.
Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)	an estimated average of 1 hour	Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean (a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.

Secondary Outcome Measures

Name	Time	Method
Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan	an estimated average of 2 hours	Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed.

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Palo Alto, California, United States