Fluciclovine-PET/CT for Bone Metastases From Prostate Adenocarcinoma
Not Applicable
Completed
- Conditions
- Prostate Adenocarcinoma
- Interventions
- Diagnostic Test: F-18 fluciclovine-PET/CT scan
- Registration Number
- NCT03496844
- Lead Sponsor
- University of Arizona
- Brief Summary
Determine diagnostic accuracy of Axumin-PET positive bone lesion by confirmatory bone biopsy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
Inclusion Criteria
- Male
- Be ≥ 18 years of age
- Diagnosed with prostate cancer
- Be willing and able to provide informed consent
- Be informed of the investigational nature of this study
Exclusion Criteria
- Having a history of severe claustrophobia
- Weight exceeding 400lbs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Research F-18 fluciclovine-PET/CT scan 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Arizona
🇺🇸Tucson, Arizona, United States