Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone
NCT ID: NCT03707184
Last Updated: 2024-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2018-10-02
2022-02-03
Brief Summary
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Detailed Description
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I. Abnormal fluciclovine F18 (\[18F\] fluciclovine) uptake on visual assessment will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).
II. Maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on (18F) fluciclovine-positron emission tomography (PET)/computed tomography (CT) imaging will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).
SECONDARY OBJECTIVES:
I. Determine if a 25% or greater reduction in average (ave) SUVmax or ave SUVmean on (18F) fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive of increased time to biochemical failure.
II. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and (18F) fluciclovine- PET/CT at baseline.
III. Determine the correlation between the number of lesions, their visual uptake, and semi-quantitative uptake on 99mTc-MDP bone scintigraphy and (18F) fluciclovine- PET/CT after 3 and 6 cycles of treatment.
OUTLINE: This is a companion imaging study to Institutional Review Board (IRB) #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).
Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.
After completion of diagnostic testing, patients are followed for 2 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (fluciclovine F18, PET/CT)
Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, 3 months and at approximately 6 months of radium-223 therapy.
Computed Tomography
Undergo PET/CT scan
Fluciclovine F18
Given IV
Positron Emission Tomography
Undergo PET/CT scan
Interventions
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Computed Tomography
Undergo PET/CT scan
Fluciclovine F18
Given IV
Positron Emission Tomography
Undergo PET/CT scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must document their willingness to be followed for up to 24 months after recruitment by signing informed consent documenting their agreement to allow access to the data obtained on IRB #102312 and information and data entered into a research database.
* All patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines.
Exclusion Criteria
* Patients who require monitored anesthesia for PET scanning.
* Patients who are too claustrophobic to undergo PET scanning.
MALE
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Yap, PhD
Role: PRINCIPAL_INVESTIGATOR
Huntsman Cancer Institute/ University of Utah
Locations
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2018-02083
Identifier Type: REGISTRY
Identifier Source: secondary_id
HCI113970
Identifier Type: -
Identifier Source: org_study_id