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

Recurrent Prostate Carcinoma Clinical Trial

Official title:

68Ga-PSMA PET/CT or PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488070
• Other study ID #: IRB-32985
• Secondary ID: NCI-2015-01067PR
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 26, 2015
• Last updated: February 20, 2018
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Recurrent Prostate Carcinoma

Intervention

Procedure:
• Computed Tomography
Part of PET/CT scan

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

Procedure:
• Magnetic Resonance Imaging
Part of PET/MRI scan
• Positron Emission Tomography
Part of PET/CT and/or PET/MRI scans

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Minamimoto R, Hancock S, Schneider B, Chin FT, Jamali M, Loening A, Vasanawala S, Gambhir SS, Iagaru A. Pilot Comparison of 68Ga-RM2 PET and 68Ga-PSMA-11 PET in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2016 Apr;57(4):557-62. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution	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.	an estimated average of 1 hour
Primary	Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution	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.	an estimated average of 1 hour
Primary	Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)	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.	an estimated average of 1 hour
Primary	Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)	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.	an estimated average of 1 hour
Secondary	Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan	Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed.	an estimated average of 2 hours