Overview

This trial has been completed.

Condition recurrent prostate carcinoma
Treatments computed tomography, gallium ga 68-labeled psma ligand glu-urea-lys(ahx), magnetic resonance imaging, positron emission tomography
Phase phase 1/phase 2
Sponsor Stanford University
Collaborator National Cancer Institute (NCI)
Start date June 2015
End date August 2015
Trial size 10 participants
Trial identifier NCT02488070, IRB-32985, NCI-2015-01067, P30CA124435, PROS0068

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose diagnostic
Masking no masking
Arm
(Experimental)
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.
computed tomography CAT
Part of PET/CT scan
gallium ga 68-labeled psma ligand glu-urea-lys(ahx) (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Intravenously-administered (IV) radioisotope
magnetic resonance imaging Magnetic Resonance Imaging Scan
Part of PET/MRI scan
positron emission tomography Medical Imaging, Positron Emission Tomography
Part of PET/CT and/or PET/MRI scans

Primary Outcomes

Measure
SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
time frame: an estimated average of 1 hour
SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
time frame: an estimated average of 1 hour
Focal Uptake (SUVmax)/ Background (F/N) Ratio of Ga68 PSMA
time frame: an estimated average of 1 hour
Focal Uptake (SUVmean)/ Background (F/N) Ratio of Ga68 PSMA
time frame: an estimated average of 1 hour

Secondary Outcomes

Measure
Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan
time frame: an estimated average of 2 hours

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title 68Ga-PSMA PET/CT or PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
Principal investigator Andrei Iagaru
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Stanford University.