Prostate Adenocarcinoma
Conditions
Brief summary
Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.
Interventions
DIAGNOSTIC_TESTF-18 fluciclovine-PET/CT scan
PET/CT imaging with F-18 fluciclovine
Sponsors
Blue Earth Diagnostics
Banner University Medical Center
University of Arizona
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male 2. Be ≥ 18 years of age 3. Diagnosed with prostate cancer 4. Be willing and able to provide informed consent 5. Be informed of the investigational nature of this study
Exclusion criteria
1. Having a history of severe claustrophobia 2. Weight exceeding 400lbs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy | 1 year | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Research F-18 Fluciclovine-PET/CT Scan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Percentage of participants who underwent bone biopsy no bone biospy | 2 Participants |
| Percentage of participants who underwent bone biopsy with bone biopsy | 13 Participants |
| Race/Ethnicity, Customized White/Hispanic | 2 Participants |
| Race/Ethnicity, Customized White/Non-Hispanic | 13 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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
Time frame: 1 year
Population: Subjects who underwent bone biopsy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Research F-18 Fluciclovine-PET/CT Scan | True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy | Total participants with bone biopsy | 13 participants |
| Research F-18 Fluciclovine-PET/CT Scan | True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy | Number of Participants with Positive Bone Biopsy on Pathology | 7 participants |
| Research F-18 Fluciclovine-PET/CT Scan | True Positive and False Positive Rates of F-18 Fluciclovine-PET/CT Findings Compared to Bone Biopsy | Number of Participants with Negative Bone Biopsy on Pathology | 6 participants |