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Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803475
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Hope, University of California, San Francisco

Brief Summary:
The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ga-68 labeled PSMA-11 Device: Positron emission tomography-computed tomography (PET/CT) Device: Positron emission tomography-magnetic resonance imaging (PET/MRI) Phase 3

Detailed Description:

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues

Primary Objective:

Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 475 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients
Actual Study Start Date : October 11, 2018
Actual Primary Completion Date : August 25, 2020
Actual Study Completion Date : August 25, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

Arm Intervention/treatment
Experimental: Ga-68 labeled PSMA-11 PET PSMA
The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 mCi +/- 10% of 68Ga-PSMA-11.
Drug: Ga-68 labeled PSMA-11
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Other Names:
  • Ga-68 labeled DKFZ-PSMA-11
  • Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED- CC
  • Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC
  • Ga-68 labeled HBED-CC PSMA

Device: Positron emission tomography-computed tomography (PET/CT)
Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session
Other Name: PET-CT

Device: Positron emission tomography-magnetic resonance imaging (PET/MRI)
A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session
Other Name: PET-MRI




Primary Outcome Measures :
  1. Detection rate stratified by prostate-specific antigen (PSA) level [ Time Frame: 1 day ]
    Based on local reads for the detection of metastatic disease, the rate of localization abnormal focus of radiotracer will be stratified based upon the PSA prior to imaging



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male, age >= 18.
  2. Histopathologically proven prostate adenocarcinoma.
  3. Concern for metastatic disease in one of the following settings:

    1. Initial staging with intermediate to high risk prostate cancer.
    2. Biochemical recurrence after initial therapy.
  4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803475


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
Thomas Hope
Investigators
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Principal Investigator: Thomas Hope, MD University of California, San Francisco
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Responsible Party: Thomas Hope, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03803475    
Other Study ID Numbers: 185513
NCI-2019-01394 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Edetic Acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents