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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02488070
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 14
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Prostate Carcinoma	Procedure: Computed Tomography; Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx); Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 68Ga-PSMA PET/CT or PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

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

Procedure: Computed Tomography; Part of PET/CT scan; Other Names: CAT CAT Scan Computerized Axial Tomography Computerized Tomography CT CT SCAN tomography ; Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx); Intravenously-administered (IV) radioisotope; Other Names: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC 68Ga-HBED-CC-PSMA ProstaMedix ; Procedure: Magnetic Resonance Imaging; Part of PET/MRI scan; Other Names: Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging ; Procedure: Positron Emission Tomography; Part of PET/CT and/or PET/MRI scans; Other Names: Medical Imaging, Positron Emission Tomography PET PET SCAN Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University, School of Medicine	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Stanford University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Andrei Iagaru, Stanford Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• Afshar-Oromieh A, Malcher A, Eder M, Eisenhut M, Linhart HG, Hadaschik BA, Holland-Letz T, Giesel FL, Kratochwil C, Haufe S, Haberkorn U, Zechmann CM. PET imaging with a [68Ga]gallium-labelled PSMA ligand for the diagnosis of prostate cancer: biodistribution in humans and first evaluation of tumour lesions. Eur J Nucl Med Mol Imaging. 2013 Apr;40(4):486-95. doi: 10.1007/s00259-012-2298-2. Epub 2012 Nov 24. Erratum in: Eur J Nucl Med Mol Imaging. 2013 May;40(5):797-8.

• Responsible Party: Andrei Iagaru, Associate Professor of Radiology, Stanford University
• ClinicalTrials.gov Identifier: NCT02488070
• Other Study ID Numbers: IRB-32985; NCI-2015-01067; PROS0068; P30CA124435
• First Posted: Jul 2, 2015
• Last Update Posted: Mar 20, 2018
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Edetic Acid; Gallium 68 PSMA-11

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
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 Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 10%
>=65 years	9 90%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	10 100%
Region of Enrollment (Count of Participants)
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
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

Outcome Measure Data

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)
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.
Measure Participants	10
Mean (Standard Deviation) [SUVmax]	12.4 (7.1)

2. Primary Outcome

Title	Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
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

Outcome Measure Data

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)
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
Measure Participants	10
Mean (Standard Deviation) [SUVmean]	7.1 (4.0)

3. Primary Outcome

Title	Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)
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

Outcome Measure Data

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)
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
Measure Participants	10
Mean (Standard Deviation) [F/N ratio]	10.4 (9.3)

4. Primary Outcome

Title	Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)
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

Outcome Measure Data

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)
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
Measure Participants	10
Mean (Standard Deviation) [F/N ratio]	9.2 (7.3)

5. Secondary Outcome

Title	Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan
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

Outcome Measure Data

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)
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.
Measure Participants	10
Number [participants]	10 100%

Adverse Events

Arm/Group Title	Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
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 (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Diagnostic (68Ga-PSMA PET/CT or PET/MRI)
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

lack of correlation with pathology results for all patients; limited patient enrollment (pilot study)

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.