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68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216134
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:
This phase I trial studies the side effects of 68GA-PSMA-11 PET imaging in patients with prostate cancer that has come back (recurrent). Gallium (68Ga) is a radiotracer that binds to a molecule, PSMA, that is found in abundance on most prostate cancer cells. PSMA is short for 'prostate specific membrane antigen'. Diagnostic procedures, such as 68GA-PSMA-11 PET imaging, may help measure a patient's response to earlier treatment, and may help plan the best treatment for prostate cancer.

Condition or disease Intervention/treatment Phase
Biochemically Recurrent Prostate Carcinoma Drug: Gallium Ga 68-labeled PSMA-11 Procedure: Positron Emission Tomography Phase 1

Detailed Description:

PRIMARY OBJECTIVE:

I. To provide clinical access to and assess the safety of the investigational agent Gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA-11) positron emission tomography (PET) at City of Hope National Medical Center for patients co-enrolled on Institutional Review Board (IRB) 18517 treatment trial.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over less than 1 minute, and then undergo PET over 60 minutes.

After completion of study, patients are followed up at 1-3 days, and then at 3 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I Study of 68GA-PSMA-11 PET Imaging for Biochemically Recurrent Prostate Cancer
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Gallium

Arm Intervention/treatment
Experimental: Diagnostic (68GA-PSMA-11 PET)
Patients receive gallium Ga 68-labeled PSMA-11 IV over less than 1 minute, and then undergo PET over 60 minutes.
Drug: Gallium Ga 68-labeled PSMA-11
Given IV
Other Names:
  • (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • (68Ga)Glu-urea-Lys(Ahx)-HBED-CC
  • 68Ga-DKFZ-PSMA-11
  • 68Ga-HBED-CC-PSMA
  • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • 68Ga-PSMA
  • 68Ga-PSMA-11
  • 68Ga-PSMA-HBED-CC
  • [68Ga] Prostate-specific Membrane Antigen 11
  • [68Ga]GaPSMA-11
  • Ga PSMA
  • Ga-68 labeled DKFZ-PSMA-11
  • Ga-68 labeled PSMA-11
  • Gallium Ga 68 PSMA-11
  • Gallium-68 PSMA
  • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • GaPSMA
  • PSMA-HBED-CC GA-68

Procedure: Positron Emission Tomography
Undergo 68GA-PSMA-11 PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 3 months ]
    Will be assessed by Common Terminology Criteria for Adverse Events version 5.0.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biochemical recurrent prostate cancer
  • Karnofsky performance status of >= 50
  • The effects of 68Ga-PSMA-11 on the developing fetus are unknown. For this reason, subjects must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation when having sex with a pregnant female or with a female partner of childbearing potential
  • Co-enrollment on IRB 18517
  • Documented informed consent of the patient. All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients should not have any uncontrolled illness including ongoing or active infection
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA-11
  • Use of another concomitant investigational therapy (with the exception of the investigational treatment given in IRB 18517) for prostate cancer within 7 days of scheduled 68Ga-PSMA-11 PET scan
  • Unable to tolerate PET scan (i.e. if the patient is claustrophobic or unable to lie still for 30-60 minutes)
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

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): NCT04216134


Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Ammar Chaudhry    626-218-6442    achaudhry@coh.org   
Principal Investigator: Ammar Chaudhry         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ammar Chaudhry City of Hope Medical Center
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT04216134    
Other Study ID Numbers: 19517
NCI-2019-08625 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19517 ( Other Identifier: City of Hope Comprehensive Cancer Center )
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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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
Genital Diseases, Male
Prostatic Diseases
Edetic Acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Calcium Chelating Agents