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

NCT02488070 | Completed Phase 1 Results DMC FDA Drug

• 4 other identifiers: IRB-32985NCI-2015-01067PROS0068P30CA124435
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Prostate Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

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

  an estimated average of 2 hours

Study Arms (1)

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

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.

Procedure: Computed Tomography; Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx); Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Interventions

Computed Tomography PROCEDURE

Part of PET/CT scan

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

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

Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx) DRUG

Intravenously-administered (IV) radioisotope

Also known as: (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

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

Magnetic Resonance Imaging PROCEDURE

Part of PET/MRI scan

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

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

Positron Emission Tomography PROCEDURE

Part of PET/CT and/or PET/MRI scans

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

Related 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.

  PMID: 23179945 BACKGROUND

• Minamimoto R, Hancock S, Schneider B, Chin FT, Jamali M, Loening A, Vasanawala S, Gambhir SS, Iagaru A. Pilot Comparison of (6)(8)Ga-RM2 PET and (6)(8)Ga-PSMA-11 PET in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2016 Apr;57(4):557-62. doi: 10.2967/jnumed.115.168393. Epub 2015 Dec 10.

  PMID: 26659347 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

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

Results Point of Contact

• Title: Andrei Iagaru, MD
• Organization: Stanford University

aiagaru@stanford.edu

650-725-4711

Study Officials

• Andrei Iagaru

  Stanford Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: March 20, 2018
• Results First Posted: March 14, 2017

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)