Gallium-68 PSMA-11 PET in Participants With Prostate Cancer
NCT ID: NCT05034562
Last Updated: 2024-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2022-09-26
2022-09-26
Brief Summary
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Detailed Description
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I. To assess the positive predictive value (PPV) of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA11) positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MRI) on a patient level using histopathology or confirmatory imaging as a standard of truth (SoT).
SECONDARY OBJECTIVES:
I. To assess the PPV per-patient for 68Ga-PSMA-11 PET/CT and PET/MRI detection of tumor location confirmed by histopathology/biopsy alone.
II. Demonstrate the safety of 68Ga-PSMA-11 PET/CT or PET/MRI imaging in participants with prostate cancer.
III. Demonstrate the efficacy of 68Ga-PSMA-11 PET/CT or PET/MRI imaging to monitor response to treatment in participants with prostate cancer.
OUTLINE:
Patients receive gallium 68Ga-PSMA-11 intravenously (IV). 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.
After completion of study, patients are followed up at 30 and 90 days, then between 3-36 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (gallium Ga 68-labeled PSMA-11, PET/CT, PET/MRI)
Patients receive gallium Ga 68-labeled PSMA-11 IV. 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.
Computed Tomography
Undergo PET/CT
Gallium Ga 68-labeled PSMA-11
Given IV
Magnetic Resonance Imaging
Undergo PET/MRI
Positron Emission Tomography
Undergo PET/CT or PET/MRI
Interventions
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Computed Tomography
Undergo PET/CT
Gallium Ga 68-labeled PSMA-11
Given IV
Magnetic Resonance Imaging
Undergo PET/MRI
Positron Emission Tomography
Undergo PET/CT or PET/MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
* Karnofsky performance status (KPS) \>= 50 (Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] 0, 1, or 2)
* Ability to understand and willingness to provide informed consent
* Participants with known metastatic prostate cancer planned to undergo active systemic treatment
Exclusion Criteria
18 Years
MALE
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Gregory C Ravizzini, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2020-03699
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-1203
Identifier Type: OTHER
Identifier Source: secondary_id
2019-1203
Identifier Type: -
Identifier Source: org_study_id
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