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Recurrent Prostate CarcinomaPhase 1/2NCT02488070

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

A Phase 1/2 study testing Computed Tomography, Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx) and Magnetic Resonance Imaging in people with Recurrent Prostate Carcinoma, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Recurrent Prostate Carcinoma
What is being tested?
Computed Tomography, Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx) and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jun 2015to Aug 2016
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University, School of Medicine

    Palo Alto, California, 94304

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Computed Tomography, Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx), Magnetic Resonance Imaging, Positron Emission Tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Part of PET/CT scan

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

    Also called (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

    Intravenously-administered (IV) radioisotope

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan

    Part of PET/MRI scan

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan

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

Study groups in NCT02488070
Study groupRoleWhat they receive
Diagnostic (68Ga-PSMA PET/CT or PET/MRI)ExperimentalPatients 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.
Receives: Procedure: Computed Tomography; Drug: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx); Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: an estimated average of 1 hour

  2. 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.

    Measured: an estimated average of 1 hour

  3. 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.

    Measured: an estimated average of 1 hour

  4. 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.

    Measured: an estimated average of 1 hour

Secondary outcomes (1)

  1. 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.

    Measured: an estimated average of 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionAug 2015
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02488070
Sponsor's protocol ID
IRB-32985
Other IDs
NCI-2015-01067, PROS0068, P30CA124435
Status last verified
Feb 2018
First submitted
26 Jun 2015
Last updated
20 Mar 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 23179945

  • 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.

    PubMed 26659347

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Computed Tomography, Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx) and Magnetic Resonance Imaging in people with Recurrent Prostate Carcinoma, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution (time frame: an estimated average of 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02488070, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.

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