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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01924 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 13365 | Other Identifier | City of Hope Medical Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) and whole body and axial magnetic resonance imaging (MRI) work in finding metastases in patients with recurrent prostate cancer. New imaging techniques, such as fluorine F 18 sodium fluoride PET/CT and whole body and axial MRI, may be more effective than standard CT and bone scan in finding metastatic prostate cancer.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (CT, bone scan, WB/axial MRI, F18 NaF PET/CT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computed tomography | Procedure | Undergo CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan. | Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cy Stein, MD, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| City of Hope South Pasadena |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2017 |
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| bone scan | Procedure | Undergo bone scan |
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| 3-Tesla magnetic resonance imaging | Procedure | Undergo axial MRI |
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| diffusion-weighted magnetic resonance imaging | Procedure | Undergo WB MRI |
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| fluorine F 18 sodium fluoride | Radiation | Undergo fluorine F 18 sodium fluoride PET/CT |
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| computed tomography | Procedure | Undergo fluorine F 18 sodium fluoride PET/CT |
|
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| positron emission tomography | Procedure | Undergo fluorine F 18 sodium fluoride PET/CT |
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| laboratory biomarker analysis | Other | Correlative studies |
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| South Pasadena |
| California |
| 91030 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Eligible Patients With Positive CT Scan/Bone Scan, MRI and PET Scan. | Count of eligible patients with positive CT chest, abdomen, pelvis scan, positive WB/axial MRI, positive F-18 NaF PET/CT and positive Bone scan for detection of metastatic disease. | Posted | Count of Participants | Participants | Up to 12 months |
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Adverse Event occurred over a period of 1 year and 10 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 54 | 0 | 54 | 4 | 54 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pancreatic lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Hot flashes | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 626-218-5265 | pfrankel@coh.org |
| Aug 26, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C062942 | 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| African American |
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| Asian |
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| Title | Measurements |
|---|---|
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| Positive PET |
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