Fluciclovine PET scans for prostate cancer that returned after unclear PSMA PET results
Tests fluciclovine PET scans in adults whose prostate cancer may have returned.
Plain-language title generated from the registry record
Registry title: Impact of Fluciclovine (18F) PET (Positron Emission Tomography) on the Management of Prostate Cancer Following Negative or Equivocal PSMA (Prostate-Specific Membrane Antigen) PET Imaging at the Time of Biochemical Recurrence
Key facts
- Where
- Atlanta, Austin, Boston, Portland, San Diego, and St Louis, United StatesSee the 6 sites
- Phase
- Phase 4
Where in United States
- Emory UniversityAtlanta, United StatesTaking people
- Urology AustinAustin, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Oregon Health Science UniversityPortland, United StatesTaking people
- University of California San Diego HealthSan Diego, United StatesNot yet recruiting
- Washington UniversitySt Louis, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Blue Earth Diagnostics
- Trial code
- NCT07569926
- Record updated
- 5 November 2026
- Original description
The impact of fluciclovine (18F) PET on the management of participants with prostate cancer following negative or equivocal PSMA PET Imaging at the time of biochemical recurrenceRead full original descriptionShow less
The Impact of Fluciclovine (18F) PET on the Management of Participants With Prostate Cancer Following Negative or Equivocal PSMA PET Imaging at the Time of Biochemical Recurrence
The impact of fluciclovine (18F) PET on the management of participants with prostate cancer following negative or equivocal PSMA PET Imaging at the time of biochemical recurrence
Inclusion: Participants must be males aged ≥18 years at Screening; Participants with suspected BCR of prostate cancer (see Inclusion Criterion #3 below) following prior curative intent treatment and a negative or equivocal PSMA PET scan with any FDA-approved PSMA PET tracer (must be within 45 days prior to Visit 2 [fluciclovine (18F) PET/CT scan]), regardless of findings on conventional imaging; Participants suspicious for a biochemically recurrent prostate cancer with a detectable or rising PSA after definitive therapy on the basis of: Post-radical prostatectomy (with or without adjuvant or salvage radiation therapy): PSA that is ≥0.2 ng/mL (completed >6 weeks after surgery) or Post-radiation therapy (with or without ADT): Increase in PSA level that is ≥2.0 ng/mL above the nadir PSA level and rising PSA is confirmed on consecutive PSA determinations; Men who are sexually active with women of childbearing potential (WOCBP), must agree to use a highly effective method(s) of contraception for 24 hours post-fluciclovine (18F) injection; Participants must provide written informed consent before any study-specific procedures or interventions are performed; Ability of the participants to comply with planned study procedures.
Exclusion: Participants with any medical condition (including intercurrent illness and uncontrolled serious infection) or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to comply with the study requirements; Participants who are planned to have an x-ray contrast agent or any other PET radiotracer within five physical half-lives of the first PET radionuclide prior to the study fluciclovine (18F) PET/CT scan; Participants participating in an interventional clinical trial within 30 days and having received an IP five physical half-lives prior to the study fluciclovine (18F) PET/CT scan; Participants who have received salvage therapy for the current episode of BCR; Participants with known metastatic castrate resistant prostate cancer; Participants with known hypersensitivity to the active substance or to any of the excipients of fluciclovine (18F); Participants who initiate cancer treatment (systemic or radiation therapy) or who have started any supplements or herbal medications intended to treat cancer between the PSMA PET and fluciclovine (18F) PET/CT scans.