The purpose of this prospective cohort study is to investigate the role of Fluciclovine Positron Emission Tomography (PET) in patients with biochemical recurrence of prostate cancer (BCR) and a negative Prostate Specific Membrane Antigen (PSMA) PET, specifically, whether Fluciclovine PET can help detect local recurrence and whether the results of Fluciclovine PET can change management.
PRIMARY OBJECTIVE: I. To evaluate the detection rate of local recurrence of prostate cancer on Fluciclovine PET in patients with BCR and a negative or equivocal PSMA PET obtained within 30 days prior to the Fluciclovine PET. SECONDARY OBJECTIVES: I. To evaluate the correct localization rate of Fluciclovine PET in patients with positive scans. II. To distinguish the detection rate by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), and stratify by PSA level at the time of the scan and tumor grade III. To evaluate the change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET. OUTLINE: Patients will be imaged with Fluciclovine PET within 30 days of the negative or equivocal PSMA scan. A short questionnaire inquiring about the intended management will be sent to the referring physician at two timepoints: 1) the first is at the time of screening, prior to the Fluciclovine PET; and 2) the second is after the availability of the results of Fluciclovine PET. Change in intended management will be recorded. Participants will be followed for 6 months and will be managed by their treating physician as per standard-of-care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
8 mCi (± 20%) of Fluciclovine administered as a bolus intravenous injection
Oregon Health & Science University
Portland, Oregon, United States
Number of participants with BCR and a positive Fluciclovine PET performed within 30 days after a negative or equivocal PSMA PET
Time frame: During PET scan procedure
Correct localization rate (CLR) of Fluciclovine PET in patients with positive scans.
The CLR of Fluciclovine PET will be determined by the following formula: true positive/(true positive + false positive). This will be evaluated by patient, and only for patients in whom the standard-of-reference is available for analysis. Standard of reference, the combination of: 1. Pathology, if site of recurrence is biopsied 2. Drop in PSA levels if the site of recurrence undergoes radiation therapy 3. Imaging follow up confirming the suspicious finding as true positive.
Time frame: During PET scan procedure
Number of participants with positive Fluciclovine PET summarized by site of recurrence (local recurrence in the prostate bed, lymph node involvement, or distant metastatic disease), stratified by PSA level
Time frame: During PET scan procedure
Change in management based on the results of Fluciclovine PET, relative to intended management based on the result of negative PSMA PET alone, prior to obtaining the Fluciclovine PET.
Questionnaire filled by the referring physician stating the intended management at 2 timepoints, before and after the Fluciclovine PET/CT.
Time frame: Enrollment up to 1 month after scan
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