An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer
NCT ID: NCT04134208
Last Updated: 2025-01-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2019-09-19
2022-06-28
Brief Summary
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Detailed Description
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I. Evaluate metabolic response by fluciclovine F18 (18F-fluciclovine) PET qualitatively and semi-quantitatively with standardized uptake values (SUV) following androgen deprivation therapy (ADT) plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and prostate-specific antigen (PSA) response.
SECONDARY OBJECTIVES:
I. To correlate pelvic 18F-fluciclovine PET imaging findings with pathologic findings at radical prostatectomy and pelvic lymph node dissection to determine 18F-fluciclovine PET imaging sensitivity and specificity for pelvic lymph node cancer involvement.
II. To evaluate 18F-fluciclovine PET imaging response and its correlation with progression free survival (defined by Prostate Cancer Working Group 2 \[PCWG2\] criteria).
III. To determine if sites of progressive disease develop at the initial/prior site (diagnostic site) of metastases or in newly developed sites at the time of metastatic progression.
IV. To evaluate metabolic response by 18F-fluciclovine PET semi-quantitatively with target to blood pool ratio (TBR) following ADT plus abiraterone at 22-28 weeks (+/- 4 weeks), and correlate the findings with size changes as defined by conventional imaging and PSA response.
OUTLINE:
Within 4 weeks before starting standard systemic therapy (SST), patients receive fluciclovine F18 intravenously (IV) then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.
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)
Within 4 weeks before starting SST, patients receive fluciclovine F18 IV then undergo a PET-CT scan over 30 minutes. Within 22-28 weeks after starting SST, patients receive fluciclovine F18 IV and undergo a second PET-CT scan over 30 minutes.
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
* Documented evidence of M1 disease by American Joint Committee on Cancer (AJCC) staging by bone scan, CT and magnetic resonance imaging (MRI)
* Castration naive disease, no prior systemic therapy for prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Ability to understand and willingness to sign informed consent
Exclusion Criteria
* Small cell carcinoma of the prostate
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Gregory C Ravizzini
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, 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
Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-06047
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-0030
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0030
Identifier Type: -
Identifier Source: org_study_id
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