A Phase 4 interventional study of Fluciclovine PET/CT in Prostate Cancer, sponsored by OHSU Knight Cancer Institute. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by OHSU Knight Cancer Institute · Phase 4, Interventional, and Diagnostic
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 50 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo Fluciclovine PET/CT within 30 days of a negative or equivocal PSMA PET scan. After the Fluciclovine PET/CT, the patient will follow up with their treating physician as per standard-of-care. The research team will collect clinical and imaging data at 6 months post Fluciclovine-PET/CT.
Drug: Fluciclovine PET/CT
8 mCi (± 20%) of Fluciclovine administered as a bolus intravenous injection
Also known as: 18F-FACBC, Axumin®
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
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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OHSU Knight Cancer Institute