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

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ClinicalTrials.gov Identifier: NCT02488070
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : March 14, 2017
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition 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
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Hide Arm/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.

Computed Tomography: Undergo PET/CT

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

Laboratory Biomarker Analysis: Correlative studies

Magnetic Resonance Imaging: Undergo PET/MRI

Positron Emission Tomography: Undergo PET/CT

Positron Emission Tomography: Undergo PET/MRI

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Hide Arm/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.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  10.0%
>=65 years
9
  90.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
0
   0.0%
Male
10
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
Hide Description 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.
Time Frame an estimated average of 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background.
Arm/Group Title Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Hide Arm/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.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: SUVmax
12.4  (7.1)
2.Primary Outcome
Title Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
Hide Description 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.
Time Frame an estimated average of 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background.
Arm/Group Title Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Hide Arm/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.

Computed Tomography: Part of PET/CT scan

Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope

Magnetic Resonance Imaging: Part of PET/MRI scan

Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: SUVmean
7.1  (4.0)
3.Primary Outcome
Title Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)
Hide Description 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.
Time Frame an estimated average of 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background.
Arm/Group Title Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Hide Arm/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.

Computed Tomography: Part of PET/CT scan

Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope

Magnetic Resonance Imaging: Part of PET/MRI scan

Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: F/N ratio
10.4  (9.3)
4.Primary Outcome
Title Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)
Hide Description 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.
Time Frame an estimated average of 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background.
Arm/Group Title Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Hide Arm/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.

Computed Tomography: Part of PET/CT scan

Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope

Magnetic Resonance Imaging: Part of PET/MRI scan

Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: F/N ratio
9.2  (7.3)
5.Secondary Outcome
Title Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan
Hide Description Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed.
Time Frame an estimated average of 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population analyzed included all participants receiving Ga-68 PSMA PET/CT or PET/MRI scan.
Arm/Group Title Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Hide Arm/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.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Hide Arm/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.
All-Cause Mortality
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
Affected / at Risk (%)
Total   0/10 (0.00%) 
lack of correlation with pathology results for all patients; limited patient enrollment (pilot study)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Andrei Iagaru, MD
Organization: Stanford University
Phone: 650-725-4711
Responsible Party: Andrei Iagaru, Stanford University
ClinicalTrials.gov Identifier: NCT02488070     History of Changes
Other Study ID Numbers: IRB-32985
NCI-2015-01067 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PROS0068 ( Other Identifier: OnCore )
P30CA124435 ( U.S. NIH Grant/Contract )
First Submitted: June 26, 2015
First Posted: July 2, 2015
Results First Submitted: January 23, 2017
Results First Posted: March 14, 2017
Last Update Posted: March 20, 2018