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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
| Banner University Medical Center | OTHER |
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Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine F-18 fluciclovine-PET/CT scan | No Intervention | This arm will consist of prostate cancer patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence. These patients would be asked to participate in the study only if there is a need for a standard of care bone biopsy. | |
| Research F-18 fluciclovine-PET/CT scan | Active Comparator | This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. For example, a patient with known lymph node recurrence of prostate cancer and suspicious finding on a bone scan would be asked to participate in the study and get a F-18 fluciclovine-PET/CT scan prior to the standard of care bone biopsy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18 fluciclovine-PET/CT scan | Diagnostic Test | PET/CT imaging with F-18 fluciclovine |
|
| Measure | Description | Time Frame |
|---|---|---|
| True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy | True positive and false positive rates of positive findings in the skeleton on F-18 fluciclovine-PET/CT scan compared to gold standard pathology from bone biopsy | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Diagnosed with prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Phillip H Kuo, MD, PhD | University of Arizona | Principal Investigator |
| Hani Babiker, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States |
We do not plan to make individual participant data available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Research F-18 Fluciclovine-PET/CT Scan | This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. F-18 fluciclovine-PET/CT scan: PET/CT imaging with F-18 fluciclovine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Research F-18 Fluciclovine-PET/CT Scan | This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. For example, a patient with known lymph node recurrence of prostate cancer and suspicious finding on a bone scan would be asked to participate in the study and get a F-18 fluciclovine-PET/CT scan prior to the standard of care bone biopsy. F-18 fluciclovine-PET/CT scan: PET/CT imaging with F-18 fluciclovine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy | True positive and false positive rates of positive findings in the skeleton on F-18 fluciclovine-PET/CT scan compared to gold standard pathology from bone biopsy | Subjects who underwent bone biopsy | Posted | Number | participants | 1 year |
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Adverse events were collected for 1 week after the PET/CT scan was completed.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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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 | Research F-18 Fluciclovine-PET/CT Scan | This arm will consist of prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy. This will include patients with metastatic castrate resistant prostate cancer. F-18 fluciclovine-PET/CT scan: PET/CT imaging with F-18 fluciclovine |
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Due to total lack of recruitment to cohort 1 consisting of Prostate Cancer patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence, cohort 1 was dropped from the study. All consented subjects were in cohort 2.
Data collected for subjects who underwent bone biopsy; 2 subjects were found to have non-bone sites more clinically appropriate to biopsy which resulted in less bone biopsy data to analyze.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Kuo, MD PhD | University of Arizona | 5206268318 | pkuo@arizona.edu |
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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 | Jun 4, 2020 | Jun 15, 2022 | Prot_SAP_000.pdf |
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| Participants |
|
| 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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| Percentage of participants who underwent bone biopsy | Count of Participants | Participants |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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