Fluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer
NCT ID: NCT01967862
Last Updated: 2020-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2013-12-31
2018-09-17
Brief Summary
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Detailed Description
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I. To determine the proportion of patients with biochemically-recurrent prostate cancer (PC) in whom imaging with whole body (WB)/axial MRI and F-18 NaF (fluorine F 18 sodium fluoride) PET/CT results in detection of metastatic disease not visualized on CT scan and bone scan.
SECONDARY OBJECTIVES:
I. To estimate the percent of eligible patients with negative, indeterminate and positive CT scan/bone scan and targeted X-rays if done.
II. To determine the proportion of patients with biochemically-recurrent PC in whom recurrence in the prostate bed can be visualized using MRI in the absence of detection using CT scan.
III. To correlate the presence of metastatic disease detected using WB/axial MRI and/or F-18 NaF PET/CT with the predicted 6-year probability of progression-free survival based on the Memorial Sloan Kettering Cancer Center salvage radiation therapy (RT) PC nomogram, and with prostate-specific antigen (PSA) level at baseline.
IV. To compare the role of axial MRI of the spine to WB/axial MRI with respect to their ability to identify sites of disease. Similarly, to evaluate the relative contribution of F-18 NaF PET and WB/axial MRI.
OUTLINE:
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
After completion of study, patients are followed up at 4-6 months and periodically until week 52.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT)
Patients first undergo CT scan and bone scan. Patients with negative results from the CT and bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using 3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.
computed tomography
Undergo CT
bone scan
Undergo bone scan
3-Tesla magnetic resonance imaging
Undergo axial MRI
diffusion-weighted magnetic resonance imaging
Undergo WB MRI
fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT
computed tomography
Undergo fluorine F 18 sodium fluoride PET/CT
positron emission tomography
Undergo fluorine F 18 sodium fluoride PET/CT
laboratory biomarker analysis
Correlative studies
Interventions
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computed tomography
Undergo CT
bone scan
Undergo bone scan
3-Tesla magnetic resonance imaging
Undergo axial MRI
diffusion-weighted magnetic resonance imaging
Undergo WB MRI
fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT
computed tomography
Undergo fluorine F 18 sodium fluoride PET/CT
positron emission tomography
Undergo fluorine F 18 sodium fluoride PET/CT
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Two PSA values \>= 0.2 ng/mL at least 4 weeks after prostatectomy
* Patients who have started radiographic evaluation and underwent CT scan and/or bone scan prior to registration to the study will be able to participate under a late registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF PET/CT) can be completed within 8 weeks after CT scan and bone scan
Exclusion Criteria
* PSA recurrence not verified by elevated PSA as discussed in the eligibility section
* Patients who initiated androgen deprivation therapy or other systemic therapy (chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional supplements used for treatment of PSA recurrence will be allowed
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Cy Stein, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
City of Hope South Pasadena
South Pasadena, California, 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-2013-01924
Identifier Type: REGISTRY
Identifier Source: secondary_id
13365
Identifier Type: OTHER
Identifier Source: secondary_id
13365
Identifier Type: -
Identifier Source: org_study_id
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