Overview

This trial is active, not recruiting.

Condition recurrent prostate carcinoma
Treatments computed tomography, gallium ga 68-labeled psma ligand glu-urea-lys(ahx), laboratory biomarker analysis, magnetic resonance imaging, positron emission tomography
Sponsor Stanford University
Collaborator National Cancer Institute (NCI)
Start date June 2015
End date June 2016
Trial size 10 participants
Trial identifier NCT02488070, 350, 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 tumors in patients with prostate cancer that has come back after a period of improvement (recurrent). 68Ga-PSMA is a radioactive drug that may attach to specific prostate cancer cells and light up. Scanners, such as PET/CT or PET/MRI, can then be used to take pictures of the body to see where the cancer is. Using 68Ga-PSMA for PET/CT or PET/MRI may allow doctors to identify smaller tumors than standard methods.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification bio-availability study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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
Undergo PET/CT
gallium ga 68-labeled psma ligand glu-urea-lys(ahx) (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
Given IV
laboratory biomarker analysis
Correlative studies
magnetic resonance imaging Magnetic Resonance Imaging Scan
Undergo PET/MRI
positron emission tomography Medical Imaging, Positron Emission Tomography
Undergo PET/CT
positron emission tomography Medical Imaging, Positron Emission Tomography
Undergo PET/MRI

Primary Outcomes

Measure
Biodistribution of gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)
time frame: After completion of imaging scan (week 1)
Number of patients who complete the examination
time frame: Up to 24 months

Eligibility Criteria

Male participants at least 19 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: I. To evaluate the feasibility and biodistribution of 68Ga-PSMA. OUTLINE: Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45-60 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 June 2016.
Information provided to ClinicalTrials.gov by Stanford University.
Location data was received from the National Cancer Institute and was last updated in August 2016.