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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02083 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (fluciclovine F18, PET/CT) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Standardized Uptake Value (SUVmean) by Lesion Type | Mean SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic). | Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy |
| Maximum Standardized Uptake Value (SUVmax) by Lesion Type | Maximum SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic). | Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Yap, PhD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| 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 | May 5, 2022 |
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| Fluciclovine F18 | Drug | Given IV |
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| Positron Emission Tomography | Procedure | Undergo PET/CT scan |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | ||||||||||||||||||||||
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| Primary | Mean Standardized Uptake Value (SUVmean) by Lesion Type | Mean SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic). | The [18F]Fluciclovine-PET/CT scans were evaluated for 17 enrolled participants. The 19 lesions seen on PET that had a definitive CT correlate were categorized by lesion type. The number of units analyzed for each row reflect the number of lesions in each category. Some participants had multiple lesions of different types. | Posted | Mean | Standard Deviation | SUV by body weight (kg) | Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy | Lesions | Lesions |
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| Primary | Maximum Standardized Uptake Value (SUVmax) by Lesion Type | Maximum SUV values are reported according to the type of bone lesion (osteoblastic dense, osteoblastic ground glass, osteoblastic mixed, and osteolytic). | The [18F]Fluciclovine-PET/CT scans were evaluated for 17 enrolled participants. The 19 lesions seen on PET that had a definitive CT correlate were categorized by lesion type. The number of units analyzed for each row reflect the number of lesions in each category. Some participants had multiple lesions of different types. | Posted | Mean | Standard Deviation | SUV by body weight (kg) | Participants were assessed using [18F]Fluciclovine-PET/CT at baseline, prior to initiating radium-223 therapy | lesions | lesions |
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Adverse events were assessed for 24 hours following administration of [18F] Fluciclovine dose.
The collection of any adverse events will begin when a patient receives their first dose of [18F] Fluciclovine and will end 24 hours after receiving that dose. As there is the potential for each patient to receive up to three scanning visits, each constituting a radioactive tracer to be injected into the mpatient, the adverse events will be monitored for 24 hours after each injection and subsequent scan.
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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 (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 | 0 | 17 | 0 | 17 | 0 | 17 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sam Mitchell | Huntsman Cancer Institute, Center for Quantitative Cancer Imaging | 8012136110 | sam.mitchell@hci.utah.edu |
| Feb 4, 2023 |
| Prot_SAP_000.pdf |
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| 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 |
|---|---|
| C117460 | fluciclovine F-18 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Osteoblastic Ground Glass |
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| Osteoblastic Mixed |
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| Osteolytic |
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| lesions |
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