Gallium Ga 68-DOTATATE PET/CT in Diagnosing Patients With Metastatic Castration Resistant Prostate Cancer
NCT ID: NCT03448458
Last Updated: 2025-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2018-02-22
2023-02-06
Brief Summary
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Detailed Description
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Establish the feasibility of using gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET as a predictive imaging biomarker for neuroendocrine transdifferentiation in prostate cancer.
SECONDARY OBJECTIVE:
Correlate progression of disease with degree of uptake on 68Ga-DOTATATE PET examination.
OUTLINE:
Patients receive gallium Ga 68-DOTATATE intravenously (IV). Within 55-70 minutes, patients undergo PET/CT.
After completion of study, patients are followed up for at least 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Gallium Ga 68-DOTATATE PET/CT
Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).
CT (Computed Tomography)
Undergo PET/CT
Gallium Ga 68-DOTATATE
Given IV
Positron Emission Tomography
Undergo PET/CT
Interventions
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CT (Computed Tomography)
Undergo PET/CT
Gallium Ga 68-DOTATATE
Given IV
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to lie still for PET scanning
* Patients must be able to provide written informed consent
Exclusion Criteria
* Patients without metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
* Inability to lie still for PET scanning
* Patients unable to provide written informed consent
18 Years
MALE
No
Sponsors
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Emory University
OTHER
Responsible Party
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Mehmet Bilen
Principal Investigator
Principal Investigators
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Mehmet Asim Bilen, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2017-02055
Identifier Type: REGISTRY
Identifier Source: secondary_id
Winship4165-17
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00099167
Identifier Type: -
Identifier Source: org_study_id
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