Back to results68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer
Primary Purpose
Biochemically Recurrent Prostate Carcinoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gallium Ga 68-labeled PSMA-11
Positron Emission Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Biochemically Recurrent Prostate Carcinoma
Eligibility 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
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (68GA-PSMA-11 PET)
Arm Description
Patients receive gallium Ga 68-labeled PSMA-11 IV over less than 1 minute, and then undergo PET over 60 minutes.
Outcomes
Primary Outcome Measures
Incidence of adverse events
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0.
Secondary Outcome Measures
Full Information
NCT ID
NCT04216134
First Posted
December 30, 2019
Last Updated
June 14, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04216134
Brief Title
68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer
Official Title
A Phase I Study of 68GA-PSMA-11 PET Imaging for Biochemically Recurrent Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
December 9, 2022 (Actual)
Study Completion Date
December 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biochemically Recurrent Prostate Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (68GA-PSMA-11 PET)
Arm Type
Experimental
Arm Description
Patients receive gallium Ga 68-labeled PSMA-11 IV over less than 1 minute, and then undergo PET over 60 minutes.
Intervention Type
Drug
Intervention Name(s)
Gallium Ga 68-labeled PSMA-11
Other Intervention Name(s)
(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
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo 68GA-PSMA-11 PET
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0.
Time Frame
Up to 3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Parayno
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer
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